Immediate or Delayed Provisionalization in Posterior Healed Sites

• Sponsor: Columbia University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02387970
• Collaborator: (none)
• Enrollment: 52
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 66.1
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

In this study, the investigators will examine the performance of a new dental implant that has been approved by the Food and Drug Administration for use to replace of missing teeth. The investigators will study two groups of patients: one group will receive a temporary crown to replace the missing tooth at the same day as implant surgery; the second group will receive a similar crown 3 months later. Both groups will receive a permanent crown on the implant 4 months after surgery, and will be followed up for a period of 12 months. The investigators want to examine whether the healing of the bone and gums surrounding the implant that receives a crown immediately is similar to the healing of the implant when the crown is delivered later. If this is indeed the case, then the investigators will be able to recommend faster treatment for all patients.

Condition or Disease	Intervention/Treatment	Phase
Partial Edentulism	Procedure: Immediate provisionalization; Procedure: Delayed provisionalization; Device: NobelParallel CC implant; Device: Dental crown	N/A

Detailed Description

Dental implants are a widely used treatment option for the replacement of lost teeth due to trauma or oral diseases. The original protocol for placement of dental implants in edentulous spaces in the maxilla or the mandible was introduced more than thirty years ago and called for a two-stage approach, i.e., surgical placement of submerged dental implants and subsequent uncovering with abutment connection, prosthesis fabrication and functional loading approximately 6 months after. Today, the time between surgery and loading in a two-stage protocol has been commonly abbreviated to 3-4 months, while immediate implant provisionalization has emerged as a reliable and predictable option in cases of adequate osseous support, having similar survival and success rates to the two-step procedure. Comparison of histological healing has demonstrated no significant differences in bone to implant contact between implants surgically placed according to a two-stage protocol and those immediately provisionalized. However, substantial variability was noted among the clinical protocols used in the studies carried out so far, and additional well-designed randomized controlled trials (RCTs) are needed to fully appreciate the clinical outcomes of immediate and early loading protocols.

The design of dental implants is a subject of continuous improvement, and implant manufacturers regularly introduce new products the use of which may result in accelerated soft and hard tissue healing, increased initial implant stability, and enhanced aesthetic outcomes. The purpose of this randomized, controlled trial is to compare treatment outcomes when using a newly-introduced dental implant (NobelParallel™ CC) in a one-stage or a two-stage protocol. This new implant has the same titanium oxide surface coating (TiUnite®) and the same design principles of the parallel-walled NobelSpeedy Groovy™ implants, and an internal conical connection. The implant is marketed under the premarket notifications K050406 and K073142 (510(k), Food and Drug Administration).

Study Design

• Study Type: Interventional
• Actual Enrollment: 52 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Non-inferiority Study of Immediate or Delayed Provisionalization at Posterior Healed Sites Using NobelParallelCC Implants
• Actual Study Start Date: Mar 1, 2015
• Actual Primary Completion Date: Feb 13, 2019
• Anticipated Study Completion Date: Sep 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Immediate provisionalization Individuals will receive temporary dental crowns supported by NobelParallel CC implant at the same day as implant surgery	Procedure: Immediate provisionalization; Stage one protocol: Individuals will receive temporary crowns at the same day as implant surgery, and a final restoration at four months after surgery.; Device: NobelParallel CC implant; Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments.; Other Names: NobelParallel Conical Connection implant ; Device: Dental crown; A tooth-shaped "cap" that is placed over a tooth or implant for teeth restoration and improvement in appearance.; Other Names: Dental prosthetics
Active Comparator: Delayed provisionalization Individuals will receive temporary dental crowns supported by NobelParallel CC implant 3 months after implant surgery	Procedure: Delayed provisionalization; Stage two protocol: Individuals will receive temporary crowns 3 months after implant surgery, and a final restoration at four months after surgery.; Device: NobelParallel CC implant; Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments.; Other Names: NobelParallel Conical Connection implant ; Device: Dental crown; A tooth-shaped "cap" that is placed over a tooth or implant for teeth restoration and improvement in appearance.; Other Names: Dental prosthetics

Outcome Measures

Primary Outcome Measures

1. Radiographic Bone Level Mesial to the Implant [Baseline and 6 months]

   Radiographic measurements of alveolar bone level mesial to the implant (at surgical placement and 6 months) will be carried out using the MIPACS software. The implant platform will be the reference point.

2. Radiographic Bone Level Mesial to the Implant [Baseline and 12 months]

   Radiographic measurements of alveolar bone level mesial to the implant (at surgical placement and 12 months) will be carried out using the MIPACS software. The implant platform will be the reference point.

3. Radiographic Bone Level Distal to the Implant [Baseline and 6 months]

   Radiographic measurements of alveolar bone level distal to the implant (at surgical placement and 6 months) will be carried out using the MIPACS software. The implant platform will be the reference point.

4. Radiographic Bone Level Distal to the Implant [Baseline and 12 months]

   Radiographic measurements of alveolar bone level distal to the implant (at surgical placement and 12 months) will be carried out using the MIPACS software. The implant platform will be the reference point.

Secondary Outcome Measures

1. Mean Change in Peri-implant Mucosal Margin Level [Baseline and 6 months]

   Measurements of peri-implant mucosal margin levels will be measured at baseline and 6 months post-procedure.

2. Mean Change in Peri-implant Mucosal Margin Level [Baseline and 12 months]

   Measurements of peri-implant mucosal margin levels will be measured at baseline and 12 months post-procedure.

3. Mean Change in Peri-implant Mucosal Margin Level [6 months and 12 months]

   Measurements of peri-implant mucosal margin levels will be measured at 6 months and 12 months post-procedure.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 50 subjects will be recruited among those referred to the Columbia University College of Dental Medicine for tooth replacement using a dental implant in a posterior maxillary or mandibular region (premolar/molar area)

• Age 18 or older

• Healed extraction sockets (extraction carried out at least 3 months prior to recruitment)

• Implant site free of infection

• Systemically healthy patients or with controlled common systemic conditions

• Adjacent teeth present both mesially and distally to the implant site

Exclusion Criteria:

• Pregnancy or intent to be pregnant over the next 12 months

• Current smoking exceeding 10 cigarettes/day

• Parafunctional habits/ excessive occlusal forces

• Current orthodontic therapy

• Uncontrolled hypertension (blood pressure over 160/100) or poorly-controlled diabetes (HbA1c>8%)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Columbia University College of Dental Medicine	New York	New York	United States	10032

Sponsors and Collaborators

• Columbia University

Investigators

• Principal Investigator: Panos N Papapanou, DDS, PhD, Columbia University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 18, 2015

More Information

Publications

• Brånemark PI, Adell R, Albrektsson T, Lekholm U, Lundkvist S, Rockler B. Osseointegrated titanium fixtures in the treatment of edentulousness. Biomaterials. 1983 Jan;4(1):25-8.
• Esposito M, Grusovin MG, Chew YS, Coulthard P, Worthington HV. One-stage versus two-stage implant placement. A Cochrane systematic review of randomised controlled clinical trials. Eur J Oral Implantol. 2009 Summer;2(2):91-9. Review.
• Piattelli A, Ruggeri A, Franchi M, Romasco N, Trisi P. An histologic and histomorphometric study of bone reactions to unloaded and loaded non-submerged single implants in monkeys: a pilot study. J Oral Implantol. 1993;19(4):314-20.

• Responsible Party: Panos Papapanou, Professor of Dental Medicine, Columbia University
• ClinicalTrials.gov Identifier: NCT02387970
• Other Study ID Numbers: AAAO5901
• First Posted: Mar 13, 2015
• Last Update Posted: Feb 18, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Panos Papapanou, Professor of Dental Medicine, Columbia University: Dental implants; Partial edentulism; Immediate/delayed provisionalization

Study Results

Participant Flow

Arm/Group Title	Immediate Provisionalization	Delayed Provisionalization
Arm/Group Description	Individuals will receive temporary dental crowns supported by NobelParallel CC implant at the same day as implant surgery Immediate provisionalization: Stage one protocol: Individuals will receive temporary crowns at the same day as implant surgery, and a final restoration at four months after surgery. NobelParallel CC implant: Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments. Dental crown: A tooth-shaped "cap" that is placed over a tooth or implant for teeth restoration and improvement in appearance.	Individuals will receive temporary dental crowns supported by NobelParallel CC implant 3 months after implant surgery Delayed provisionalization: Stage two protocol: Individuals will receive temporary crowns 3 months after implant surgery, and a final restoration at four months after surgery. NobelParallel CC implant: Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments. Dental crown: A tooth-shaped "cap" that is placed over a tooth or implant for teeth restoration and improvement in appearance.
Period Title: Overall Study
STARTED	27	25
COMPLETED	26	23
NOT COMPLETED	1	2

Baseline Characteristics

Arm/Group Title	Immediate Provisionalization	Delayed Provisionalization	Total
Arm/Group Description	Individuals will receive temporary dental crowns supported by NobelParallel CC implant at the same day as implant surgery Immediate provisionalization: Stage one protocol: Individuals will receive temporary crowns at the same day as implant surgery, and a final restoration at four months after surgery. NobelParallel CC implant: Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments. Dental crown: A tooth-shaped "cap" that is placed over a tooth or implant for teeth restoration and improvement in appearance.	Individuals will receive temporary dental crowns supported by NobelParallel CC implant 3 months after implant surgery Delayed provisionalization: Stage two protocol: Individuals will receive temporary crowns 3 months after implant surgery, and a final restoration at four months after surgery. NobelParallel CC implant: Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments. Dental crown: A tooth-shaped "cap" that is placed over a tooth or implant for teeth restoration and improvement in appearance.	Total of all reporting groups
Overall Participants	26	23	49
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	45.1	48.8	46.8
Sex: Female, Male (Count of Participants)
Female	18 69.2%	16 69.6%	34 69.4%
Male	8 30.8%	7 30.4%	15 30.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	11 42.3%	9 39.1%	20 40.8%
Not Hispanic or Latino	8 30.8%	8 34.8%	16 32.7%
Unknown or Not Reported	7 26.9%	6 26.1%	13 26.5%
Tooth Type (Count of Participants)
Premolar	12 46.2%	9 39.1%	21 42.9%
Molar	14 53.8%	14 60.9%	28 57.1%
Arch (Count of Participants)
Maxilla	14 53.8%	13 56.5%	27 55.1%
Mandible	12 46.2%	10 43.5%	22 44.9%

Outcome Measures

1. Primary Outcome

Title	Radiographic Bone Level Mesial to the Implant
Description	Radiographic measurements of alveolar bone level mesial to the implant (at surgical placement and 6 months) will be carried out using the MIPACS software. The implant platform will be the reference point.
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

Only includes individuals with analyzable data.

Arm/Group Title	Immediate Provisionalization	Delayed Provisionalization
Arm/Group Description	Individuals will receive temporary dental crowns supported by NobelParallel CC implant at the same day as implant surgery Immediate provisionalization: Stage one protocol: Individuals will receive temporary crowns at the same day as implant surgery, and a final restoration at four months after surgery. NobelParallel CC implant: Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments. Dental crown: A tooth-shaped "cap" that is placed over a tooth or implant for teeth restoration and improvement in appearance.	Individuals will receive temporary dental crowns supported by NobelParallel CC implant 3 months after implant surgery Delayed provisionalization: Stage two protocol: Individuals will receive temporary crowns 3 months after implant surgery, and a final restoration at four months after surgery. NobelParallel CC implant: Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments. Dental crown: A tooth-shaped "cap" that is placed over a tooth or implant for teeth restoration and improvement in appearance.
Measure Participants	24	21
Mean (Standard Deviation) [Millimeters]	1.26 (1.10)	1.85 (1.16)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Delayed Provisionalization
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.088
	Comments
	Method	t-test, 2 sided
	Comments

2. Primary Outcome

Title	Radiographic Bone Level Mesial to the Implant
Description	Radiographic measurements of alveolar bone level mesial to the implant (at surgical placement and 12 months) will be carried out using the MIPACS software. The implant platform will be the reference point.
Time Frame	Baseline and 12 months

Outcome Measure Data

Analysis Population Description

Only includes individuals who completed the 1-year follow up.

Arm/Group Title	Immediate Provisionalization	Delayed Provisionalization
Arm/Group Description	Individuals will receive temporary dental crowns supported by NobelParallel CC implant at the same day as implant surgery Immediate provisionalization: Stage one protocol: Individuals will receive temporary crowns at the same day as implant surgery, and a final restoration at four months after surgery. NobelParallel CC implant: Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments. Dental crown: A tooth-shaped "cap" that is placed over a tooth or implant for teeth restoration and improvement in appearance.	Individuals will receive temporary dental crowns supported by NobelParallel CC implant 3 months after implant surgery Delayed provisionalization: Stage two protocol: Individuals will receive temporary crowns 3 months after implant surgery, and a final restoration at four months after surgery. NobelParallel CC implant: Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments. Dental crown: A tooth-shaped "cap" that is placed over a tooth or implant for teeth restoration and improvement in appearance.
Measure Participants	25	21
Mean (Standard Deviation) [Millimeters]	1.14 (1.20)	1.57 (1.17)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Delayed Provisionalization
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.235
	Comments
	Method	t-test, 2 sided
	Comments

3. Primary Outcome

Title	Radiographic Bone Level Distal to the Implant
Description	Radiographic measurements of alveolar bone level distal to the implant (at surgical placement and 6 months) will be carried out using the MIPACS software. The implant platform will be the reference point.
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

Only includes individuals with analyzable data.

Arm/Group Title	Immediate Provisionalization	Delayed Provisionalization
Arm/Group Description	Individuals will receive temporary dental crowns supported by NobelParallel CC implant at the same day as implant surgery Immediate provisionalization: Stage one protocol: Individuals will receive temporary crowns at the same day as implant surgery, and a final restoration at four months after surgery. NobelParallel CC implant: Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments. Dental crown: A tooth-shaped "cap" that is placed over a tooth or implant for teeth restoration and improvement in appearance.	Individuals will receive temporary dental crowns supported by NobelParallel CC implant 3 months after implant surgery Delayed provisionalization: Stage two protocol: Individuals will receive temporary crowns 3 months after implant surgery, and a final restoration at four months after surgery. NobelParallel CC implant: Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments. Dental crown: A tooth-shaped "cap" that is placed over a tooth or implant for teeth restoration and improvement in appearance.
Measure Participants	22	20
Mean (Standard Deviation) [Millimeters]	1.36 (1.27)	1.82 (0.76)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Delayed Provisionalization
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.165
	Comments
	Method	t-test, 2 sided
	Comments

4. Primary Outcome

Title	Radiographic Bone Level Distal to the Implant
Description	Radiographic measurements of alveolar bone level distal to the implant (at surgical placement and 12 months) will be carried out using the MIPACS software. The implant platform will be the reference point.
Time Frame	Baseline and 12 months

Outcome Measure Data

Analysis Population Description

Only includes individuals who completed the 1-year follow up.

Arm/Group Title	Immediate Provisionalization	Delayed Provisionalization
Arm/Group Description	Individuals will receive temporary dental crowns supported by NobelParallel CC implant at the same day as implant surgery Immediate provisionalization: Stage one protocol: Individuals will receive temporary crowns at the same day as implant surgery, and a final restoration at four months after surgery. NobelParallel CC implant: Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments. Dental crown: A tooth-shaped "cap" that is placed over a tooth or implant for teeth restoration and improvement in appearance.	Individuals will receive temporary dental crowns supported by NobelParallel CC implant 3 months after implant surgery Delayed provisionalization: Stage two protocol: Individuals will receive temporary crowns 3 months after implant surgery, and a final restoration at four months after surgery. NobelParallel CC implant: Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments. Dental crown: A tooth-shaped "cap" that is placed over a tooth or implant for teeth restoration and improvement in appearance.
Measure Participants	23	21
Mean (Standard Deviation) [Millimeters]	1.22 (1.40)	1.60 (0.88)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Delayed Provisionalization
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.297
	Comments
	Method	t-test, 2 sided
	Comments

5. Secondary Outcome

Title	Mean Change in Peri-implant Mucosal Margin Level
Description	Measurements of peri-implant mucosal margin levels will be measured at baseline and 6 months post-procedure.
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Immediate Provisionalization	Delayed Provisionalization
Arm/Group Description	Individuals will receive temporary dental crowns supported by NobelParallel CC implant at the same day as implant surgery Immediate provisionalization: Stage one protocol: Individuals will receive temporary crowns at the same day as implant surgery, and a final restoration at four months after surgery. NobelParallel CC implant: Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments. Dental crown: A tooth-shaped "cap" that is placed over a tooth or implant for teeth restoration and improvement in appearance.	Individuals will receive temporary dental crowns supported by NobelParallel CC implant 3 months after implant surgery Delayed provisionalization: Stage two protocol: Individuals will receive temporary crowns 3 months after implant surgery, and a final restoration at four months after surgery. NobelParallel CC implant: Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments. Dental crown: A tooth-shaped "cap" that is placed over a tooth or implant for teeth restoration and improvement in appearance.
Measure Participants	22	17
Mean (Standard Deviation) [millimeters of tissue]	0.28 (0.96)	-0.10 (0.65)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Delayed Provisionalization
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.121
	Comments
	Method	t-test, 2 sided
	Comments

6. Secondary Outcome

Title	Mean Change in Peri-implant Mucosal Margin Level
Description	Measurements of peri-implant mucosal margin levels will be measured at baseline and 12 months post-procedure.
Time Frame	Baseline and 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Immediate Provisionalization	Delayed Provisionalization
Arm/Group Description	Individuals will receive temporary dental crowns supported by NobelParallel CC implant at the same day as implant surgery Immediate provisionalization: Stage one protocol: Individuals will receive temporary crowns at the same day as implant surgery, and a final restoration at four months after surgery. NobelParallel CC implant: Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments. Dental crown: A tooth-shaped "cap" that is placed over a tooth or implant for teeth restoration and improvement in appearance.	Individuals will receive temporary dental crowns supported by NobelParallel CC implant 3 months after implant surgery Delayed provisionalization: Stage two protocol: Individuals will receive temporary crowns 3 months after implant surgery, and a final restoration at four months after surgery. NobelParallel CC implant: Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments. Dental crown: A tooth-shaped "cap" that is placed over a tooth or implant for teeth restoration and improvement in appearance.
Measure Participants	21	16
Mean (Standard Deviation) [millimeters]	0.27 (0.80)	-0.20 (0.92)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Delayed Provisionalization
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.248
	Comments
	Method	t-test, 2 sided
	Comments

7. Secondary Outcome

Title	Mean Change in Peri-implant Mucosal Margin Level
Description	Measurements of peri-implant mucosal margin levels will be measured at 6 months and 12 months post-procedure.
Time Frame	6 months and 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Immediate Provisionalization	Delayed Provisionalization
Arm/Group Description	Individuals will receive temporary dental crowns supported by NobelParallel CC implant at the same day as implant surgery Immediate provisionalization: Stage one protocol: Individuals will receive temporary crowns at the same day as implant surgery, and a final restoration at four months after surgery. NobelParallel CC implant: Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments. Dental crown: A tooth-shaped "cap" that is placed over a tooth or implant for teeth restoration and improvement in appearance.	Individuals will receive temporary dental crowns supported by NobelParallel CC implant 3 months after implant surgery Delayed provisionalization: Stage two protocol: Individuals will receive temporary crowns 3 months after implant surgery, and a final restoration at four months after surgery. NobelParallel CC implant: Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments. Dental crown: A tooth-shaped "cap" that is placed over a tooth or implant for teeth restoration and improvement in appearance.
Measure Participants	23	20
Mean (Standard Deviation) [millimeters]	0.10 (0.76)	-0.08 (0.67)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Delayed Provisionalization
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.854
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Time Frame	Up to 36 months from procedure
Arm/Group Title	Immediate Provisionalization		Delayed Provisionalization
Arm/Group Description	Individuals will receive temporary dental crowns supported by NobelParallel CC implant at the same day as implant surgery Immediate provisionalization: Stage one protocol: Individuals will receive temporary crowns at the same day as implant surgery, and a final restoration at four months after surgery. NobelParallel CC implant: Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments. Dental crown: A tooth-shaped "cap" that is placed over a tooth or implant for teeth restoration and improvement in appearance.		Individuals will receive temporary dental crowns supported by NobelParallel CC implant 3 months after implant surgery Delayed provisionalization: Stage two protocol: Individuals will receive temporary crowns 3 months after implant surgery, and a final restoration at four months after surgery. NobelParallel CC implant: Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments. Dental crown: A tooth-shaped "cap" that is placed over a tooth or implant for teeth restoration and improvement in appearance.
All Cause Mortality
	Immediate Provisionalization		Delayed Provisionalization
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/26 (15.4%)		3/23 (13%)
Serious Adverse Events
	Immediate Provisionalization		Delayed Provisionalization
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		0/23 (0%)
Other (Not Including Serious) Adverse Events
	Immediate Provisionalization		Delayed Provisionalization
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/26 (15.4%)		3/23 (13%)
General disorders
Implant mobile/removed	0/26 (0%)	0	1/23 (4.3%)	1
Cement - retained due to angle correction	1/26 (3.8%)	1	0/23 (0%)	0
Product Issues
Prosthetic Screw Loosening - Multiple	1/26 (3.8%)	1	2/23 (8.7%)	2
Crown fracture	1/26 (3.8%)	1	0/23 (0%)	0
Prosthetic Screw Loosening - Single	1/26 (3.8%)	1	0/23 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.