Success Rate of Immediately Loaded Implants With Platform Switched Design Placed in Anterior Part of Mandible and Restored With Fixed Prostheses

• Sponsor: Dentsply International (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00780273
• Collaborator: (none)
• Enrollment: 19
• Location: 1
• Arms: 2
• Duration (Months): 43
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

Change in crestal bone level implants at 5% significance level.

Condition or Disease	Intervention/Treatment	Phase
Edentulism	Device: Ankylos Implants; Device: Biomet 3i Prevail Implants	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 19 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Official Title: Success Rate of Immediately Loaded Implants With Platform Switched Design Placed in the Anterior Part of the Mandible and Restored With Fixed Prostheses: a Randomized, Split-mouth, Masked, Prospective, Open, Comparison, Monocenter Trial
• Study Start Date: Sep 1, 2008
• Actual Primary Completion Date: Apr 1, 2012
• Actual Study Completion Date: Apr 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ankylos dental implants. 3 Ankylos dental implants placed in platform switch configuration on one side of the mandible in support of a fixed restoration. A total number of 19 subjects participated in this randomized, split mouth, masked, prospective, open, comparison, monocenter study. Participants were subjects with an edentulous mandible who recieved 3 implants on each side which were splinted for the delivery of a fixed prosthesis.	Device: Ankylos Implants; ANKYLOS Implant System vs Certain PREVAIL Implant
Active Comparator: 3i Prevail dental implants. Three 3i Prevail dental implants placed on the opposite side of the mandible from the Ankylos implants in support of fixed dental restoration. After a baseline phase of 1 month the mandible sides of subjects were randomly assigned to one of the 2 parallel treatment groups: one side received ANKYLOS plus implants. The contralateral sde recieved Certain PREVAIL Implants. Abutments were installed and loaded immediately by a fixed temporary bridge. After 3 months the final prosthesis was incorporated.	Device: Biomet 3i Prevail Implants

Outcome Measures

Primary Outcome Measures

1. Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level [6 months after surgery]

   Incidence of greater than 2 mm crestal bone (mesial or distal) loss. Reported in the percentage of analyzed implants.

2. Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level [12 months after surgery]

   Incidence of greater than 2 mm crestal bone (mesial or distal) loss. Reported in the percentage of analyzed implants.

3. Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level [24 months after surgery]

   Incidence of greater than 2 mm crestal bone (mesial or distal) loss. Reported in the percentage of analyzed implants.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• age 18 to 80

• male or female (female non-pregnant)

• sufficient oral hygiene

• no inflammation/disorder in the area of implant site

• edentulous mandible and sufficient prosthetic and conservative

• sufficient width and height of bone to place implants with diameters of 4.8mm and length of 11 mm

• provide written informed consent

Exclusion Criteria:

• demonstrate a need for pre-surgical bone or soft tissue augmentation in planned implant areas

• exhibit angulation requirements of restoration exceeding 15 degrees

• systemic metabolic disorder that would compromise post-operative tissue regeneration or osseointegration

• taking medication that would compromise post-operative healing and/or osseointegration

• bone disorders such as osteoporosis, hyperparathyroidism, Paget's disease, diabetes mellitus

• oncology treatment

• oral infection

• acute gingivitis and/or periodontitis

• local bone defects in the area of planned implantation

• disorders of oral mucosa (e.g., leukoplakia, oral lichen, pemphigoid lesions)

• received investigational drug within 30 days

• history of illicit drugs or alcohol abuse

• history of addiction to medication

• allergic to dental materials

• nicotine abuse (> 20 cigarettes/day)

• pregnant or nursing

• clinical significant or unstable medical or physiological conditions that would compromise participation in study

• unable or unwilling to return for follow-up visits for a period of 24 months

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Rochester, Eastman Dept of Dentistry	Rochester	New York	United States	14620

Sponsors and Collaborators

• Dentsply International

Investigators

• Principal Investigator: George Romanos, DDS, University of Rochester

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dentsply International
• ClinicalTrials.gov Identifier: NCT00780273
• Other Study ID Numbers: DF 245
• First Posted: Oct 27, 2008
• Last Update Posted: Aug 19, 2014
• Last Verified: Aug 1, 2014

• Keywords provided by Dentsply International: subjects with edentulous mandible
• Additional relevant MeSH terms: Cimetidine

Study Results

Participant Flow

Arm/Group Title	Dental Implants.
Arm/Group Description	3 Ankylos dental implants placed in platform switch configuration on one side of the mandible in support of a fixed restoration. Ankylos Implants: ANKYLOS Implant System vs Certain PREVAIL Implant in split mouth study. A total of 19 subjects participated in this randomized, split-mouth, masked, prospective, open, comparison, monocenter study. Participants were subjects with an edentulous mandible who received 3 implants on each side which were splinted for the delivery of a fixed prosthesis. After a baseline phase of 1 month the mandible sides of subjects were randomly assigned to one of 2 parallel treatment groups: one side received ANKYLOS® plus Implants. The contralateral side received Certain® PREVAILTM Implants. Abutments were installed and loaded immediately by a fixed temporary bridge. After 3 months the final prosthesis was incorporated.
Period Title: Overall Study
STARTED	19
COMPLETED	17
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Dental Implants.
Arm/Group Description	3 Ankylos dental implants placed in platform switch configuration on one side of the mandible in support of a fixed restoration. Ankylos Implants: ANKYLOS Implant System vs Certain PREVAIL Implant in split mouth study. A total of 19 subjects participated in this randomized, split-mouth, masked, prospective, open, comparison, monocenter study. Participants were subjects with an edentulous mandible who received 3 implants on each side which were splinted for the delivery of a fixed prosthesis. After a baseline phase of 1 month the mandible sides of subjects were randomly assigned to one of 2 parallel treatment groups: one side received ANKYLOS® plus Implants. The contralateral side received Certain® PREVAILTM Implants. Abutments were installed and loaded immediately by a fixed temporary bridge. After 3 months the final prosthesis was incorporated.
Overall Participants	19
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	18 94.7%
>=65 years	1 5.3%
Sex: Female, Male (Count of Participants)
Female	3 15.8%
Male	16 84.2%
Region of Enrollment (participants) [Number]
United States	19 100%

Outcome Measures

1. Primary Outcome

Title	Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level
Description	Incidence of greater than 2 mm crestal bone (mesial or distal) loss. Reported in the percentage of analyzed implants.
Time Frame	6 months after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ankylos Dental Implants.	3i Prevail Dental Implants.
Arm/Group Description	3 Ankylos dental implants placed in platform switch configuration on one side of the mandible in support of a fixed restoration. Ankylos Implants: ANKYLOS Implant System vs Certain PREVAIL Implant	Three 3i Prevail dental implants placed on the opposite side of the mandible from the Ankylos implants in support of fixed dental restoration. Biomet 3i Prevail Implants
Measure Participants	19	19
Measure Implants	52	53
Number [Percentage of implants]	13	55

2. Primary Outcome

Title	Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level
Description	Incidence of greater than 2 mm crestal bone (mesial or distal) loss. Reported in the percentage of analyzed implants.
Time Frame	12 months after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ankylos Dental Implants.	3i Prevail Dental Implants.
Arm/Group Description	3 Ankylos dental implants placed in platform switch configuration on one side of the mandible in support of a fixed restoration. Ankylos Implants: ANKYLOS Implant System vs Certain PREVAIL Implant	Three 3i Prevail dental implants placed on the opposite side of the mandible from the Ankylos implants in support of fixed dental restoration. Biomet 3i Prevail Implants
Measure Participants	19	19
Measure Implants	49	50
Number [Percentage of implants]	20	56

3. Primary Outcome

Title	Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level
Description	Incidence of greater than 2 mm crestal bone (mesial or distal) loss. Reported in the percentage of analyzed implants.
Time Frame	24 months after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ankylos Dental Implants.	3i Prevail Dental Implants.
Arm/Group Description	3 Ankylos dental implants placed in platform switch configuration on one side of the mandible in support of a fixed restoration. Ankylos Implants: ANKYLOS Implant System vs Certain PREVAIL Implant	Three 3i Prevail dental implants placed on the opposite side of the mandible from the Ankylos implants in support of fixed dental restoration. Biomet 3i Prevail Implants
Measure Participants	19	19
Measure Implants	44	47
Number [Percentage of implants]	11	70

Adverse Events

Arm/Group Title	Dental Implants.
Arm/Group Description	3 Ankylos dental implants placed in platform switch configuration on one side of the mandible in support of a fixed restoration. Ankylos Implants: ANKYLOS Implant System vs Certain PREVAIL Implant in split mouth study.
All Cause Mortality
	Dental Implants.
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Dental Implants.
	Affected / at Risk (%)	# Events
Total	0/19 (0%)
Other (Not Including Serious) Adverse Events
	Dental Implants.
	Affected / at Risk (%)	# Events
Total	0/19 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT 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.