Periimplant Mucosa Dynamics Around Divergent and Concave Atlantis Abutment Transition Profiles

• Sponsor: Christopher Barwacz (Other)
• Overall Status: Completed
• CT.gov ID: NCT01871220
• Collaborator: (none)
• Enrollment: 61
• Location: 1
• Arms: 2
• Actual Duration (Months): 57.1
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the effect of two different implant abutment designs on gum tissue volume changes over time after implant placement.

Condition or Disease	Intervention/Treatment	Phase
Dental Implant, Single-Tooth; Esthetics, Dental	Device: Concave Transition Profile; Device: Divergent Transition Profile	N/A

Detailed Description

This is a randomized, prospective, controlled clinical trial comparing the facial gingival profiles around Atlantis™ abutments that have either a linear "divergent" or "concave" transitional profile on the facial and proximal aspect of the abutments.

Sixty study subjects requiring replacement of a single-rooted tooth with an implant-supported restoration will be recruited.

The Osseospeed™ Plus implant will be placed for all 60 subjects, with the use of Uni healing abutments to minimize lateral tissue displacement during healing. After implant placement, but before final impressions are obtained (8 weeks post-placement), subjects will be randomized to either a "divergent" or a "concave" transmucosal abutment design. For fabrication of the experimental abutment, Atlantis™ engineers will initially design a control "divergent" prototype that will be modified with a concavity on the facial and proximal transition zones to obtain an abutment that will otherwise retain all the features of the control abutment. Engineers will measure the linear topographical changes (ΔL=Lc-Ld) of the transition zone, as well as the volumetric change (x) on the mid-facial aspect of the abutment induced by the formation of a submucosal concavity. The primary outcome of the study will be the apico-coronal change of the peri-implant mucosal zenith from prosthesis delivery to one year.

Study Design

• Study Type: Interventional
• Actual Enrollment: 61 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Peri-implant Mucosa Dynamics Around Divergent and Concave Atlantis™ Abutment Transition Profiles.
• Actual Study Start Date: Dec 30, 2013
• Actual Primary Completion Date: Oct 3, 2018
• Actual Study Completion Date: Oct 3, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Divergent Abutment Divergent Transition Profile	Device: Divergent Transition Profile; An Atlantis abutment is delivered with a linear transition profile
Experimental: Concave Abutment Concave Transition Profile	Device: Concave Transition Profile; An Atlantis abutment is delivered with a concave transition profile.

Outcome Measures

Primary Outcome Measures

1. Peri-Implant Mucosal Zenith Distance (in Millimeters) at the Concave/Divergent Abutment Sites [Delivery, and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration Delivery]

   Determine if there is a difference in soft tissue peri-implant zenith changes (in millimeters) for the concave/divergent abutment sites, specifically between at delivery and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration Delivery. This measurement is taken using a standardized stereotactic digital photography system that allows for increased measurement accuracy and precision, specifically with the Canfield Dental Camera, Canfield Imaging Systems.

Secondary Outcome Measures

1. Submarginal Buccal-lingual Thickness (Millimeters) in the Peri-implant Transition Zone Relative to a Fixed Reference Point After Prosthesis Delivery [Baseline and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration Delivery]

   Determine if there is a difference in submarginal buccal-lingual soft tissue thickness in the peri-implant transition zone relative to a fixed reference point, specifically at baseline and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration Delivery. This measurement is taken using a standardized stereotactic digital photography system that allows for increased measurement accuracy and precision, specifically with the Canfield Dental Camera, Canfield Imaging Systems.

2. Keratinized Mucosa Width (Millimeters) at the Midfacial Aspect of the Implant Site. [Baseline and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration Delivery]

   Determine if there is a difference in Keratinized Mucosa Width (millimeters) in the apico-coronal direction at the midfacial aspect of the implant site, specifically at baseline and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration Delivery. This measurement is taken using a standardized stereotactic digital photography system that allows for increased measurement accuracy and precision, specifically with the Canfield Dental Camera, Canfield Imaging Systems.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 18 years of age or greater

• Subjects requiring replacement of a single-rooted tooth in the maxillary arch from first premolar to first premolar with an implant-supported restoration

• Teeth adjacent (mesial and distal) to study site must consist of two stable, natural teeth without signs of periodontal bone loss (<2.0mm) and/or significant soft tissue loss

• An opposing dentition with teeth, implants, or fixed prosthesis

• Subjects must be willing to follow instructions related to the study procedures

• Subjects must have read, understood, and signed the informed consent document

Exclusion Criteria:

Exclusion Criteria:

• Insufficient interocclusal space for implant placement and/or restoration at study site

• More than 2.0mm vertical bone loss at study site as measured from the mid-buccal crest of the bone on the adjacent teeth

• Untreated rampant caries

• Tobacco use free for ≤ 6 months

• Liver or kidney disfunction/failure

• Active severe infectious diseases that may affect normal healing and/or bone metabolism (e.g. AIDS)

• Uncontrolled diabetes

• Current alcohol or drug abuse

• Need for systemic corticosteroids or any other medication that would influence post-operative healing and/or osseointegration

• History of relevant head/neck cancer and/or radiation of the head/neck

• Subjects who currently use bisphosphonates or have a history of bisphosphonate use

• Subjects with metabolic bone diseases such as osteoporosis or Paget's disease of bone

• Known pregnancy or nursing mothers

• Unable or unwilling to return for follow-up visits for a period of 1 year

• Unlikely to be able to comply with study procedures according to investigators judgement

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Iowa College of Dentistry	Iowa City	Iowa	United States	52242

Sponsors and Collaborators

• Christopher Barwacz

Investigators

• Principal Investigator: Christopher A Barwacz, DDS, University of Iowa

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 1, 2019

More Information

Publications

None provided.

• Responsible Party: Christopher Barwacz, Assistant Professor, University of Iowa
• ClinicalTrials.gov Identifier: NCT01871220
• Other Study ID Numbers: 201302798
• First Posted: Jun 6, 2013
• Last Update Posted: Jun 14, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Christopher Barwacz, Assistant Professor, University of Iowa: Implant Abutments; Oral Mucosa Changes; Implant Esthetics

Study Results

Participant Flow

Arm/Group Title	Divergent Abutment	Concave Abutment
Arm/Group Description	Divergent Transition Profile Divergent Transition Profile: An Atlantis abutment is delivered with a linear transition profile	Concave Transition Profile Concave Transition Profile: An Atlantis abutment is delivered with a concave transition profile.
Period Title: Overall Study
STARTED	29	32
COMPLETED	25	29
NOT COMPLETED	4	3

Baseline Characteristics

Arm/Group Title	Concave	Divergent	Total
Arm/Group Description	Participants were missing a single-rooted tooth on the upper jaw and were randomly-assigned to receive a concave-shaped implant abutment.	Participants were missing a single-rooted tooth on the upper jaw and were randomly assigned to receive a divergent-shaped implant abutment.	Total of all reporting groups
Overall Participants	32	29	61
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	26 81.3%	26 89.7%	52 85.2%
>=65 years	6 18.8%	3 10.3%	9 14.8%
Sex: Female, Male (Count of Participants)
Female	19 59.4%	10 34.5%	29 47.5%
Male	13 40.6%	19 65.5%	32 52.5%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%

Outcome Measures

1. Primary Outcome

Title	Peri-Implant Mucosal Zenith Distance (in Millimeters) at the Concave/Divergent Abutment Sites
Description	Determine if there is a difference in soft tissue peri-implant zenith changes (in millimeters) for the concave/divergent abutment sites, specifically between at delivery and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration Delivery. This measurement is taken using a standardized stereotactic digital photography system that allows for increased measurement accuracy and precision, specifically with the Canfield Dental Camera, Canfield Imaging Systems.
Time Frame	Delivery, and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration Delivery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Divergent Abutment	Concave Abutment
Arm/Group Description	Divergent Transition Profile Divergent Transition Profile: An Atlantis abutment is delivered with a linear transition profile	Concave Transition Profile Concave Transition Profile: An Atlantis abutment is delivered with a concave transition profile.
Measure Participants	25	29
Delivery	9.860 (1.148)	9.770 (1.146)
1 Month After Delivery	9.684 (1.203)	9.618 (1.160)
3 Months after Delivery	9.674 (1.231)	9.610 (1.174)
6 Months after Delivery	9.652 (1.166)	9.599 (1.160)
12 Months after Delivery	9.622 (1.258)	9.596 (1.167)

2. Secondary Outcome

Title	Submarginal Buccal-lingual Thickness (Millimeters) in the Peri-implant Transition Zone Relative to a Fixed Reference Point After Prosthesis Delivery
Description	Determine if there is a difference in submarginal buccal-lingual soft tissue thickness in the peri-implant transition zone relative to a fixed reference point, specifically at baseline and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration Delivery. This measurement is taken using a standardized stereotactic digital photography system that allows for increased measurement accuracy and precision, specifically with the Canfield Dental Camera, Canfield Imaging Systems.
Time Frame	Baseline and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration Delivery

Outcome Measure Data

Analysis Population Description

The reason why the overall number of participants analyzed differs from the data in the rows is due to some participants being lost to follow-up.

Arm/Group Title	Divergent Abutment	Concave Abutment
Arm/Group Description	Divergent Transition Profile Divergent Transition Profile: An Atlantis abutment is delivered with a linear transition profile	Concave Transition Profile Concave Transition Profile: An Atlantis abutment is delivered with a concave transition profile.
Measure Participants	27	31
Baseline	2.722 (1.1294)	2.814 (1.1291)
1 month after delivery	2.667 (0.6202)	2.597 (0.6248)
3 months after delivery	2.840 (0.7176)	2.468 (0.5764)
6 months after delivery	2.920 (0.6403)	2.517 (0.5796)
12 months after delivery	2.740 (0.7654)	2.500 (0.5000)

3. Secondary Outcome

Title	Keratinized Mucosa Width (Millimeters) at the Midfacial Aspect of the Implant Site.
Description	Determine if there is a difference in Keratinized Mucosa Width (millimeters) in the apico-coronal direction at the midfacial aspect of the implant site, specifically at baseline and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration Delivery. This measurement is taken using a standardized stereotactic digital photography system that allows for increased measurement accuracy and precision, specifically with the Canfield Dental Camera, Canfield Imaging Systems.
Time Frame	Baseline and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration Delivery

Outcome Measure Data

Analysis Population Description

The reason why the number analyzed in one or more rows differs from the overall number analyzed is that some subjects were lost to follow-up.

Arm/Group Title	Divergent Abutment	Concave Abutment
Arm/Group Description	Divergent Transition Profile Divergent Transition Profile: An Atlantis abutment is delivered with a linear transition profile	Concave Transition Profile Concave Transition Profile: An Atlantis abutment is delivered with a concave transition profile.
Measure Participants	27	31
Baseline	2.704 (1.1373)	3.307 (1.8425)
1 month after delivery	3.407 (1.1522)	3.936 (1.7212)
3 months after delivery	3.620 (0.8930)	4.177 (1.6711)
6 months after delivery	3.478 (0.9946)	4.067 (1.6439)
12 months after delivery	3.560 (1.0832)	4.035 (1.8609)

Adverse Events

Time Frame	1 year
Arm/Group Title	Divergent Abutment		Concave Abutment
Arm/Group Description	Divergent Transition Profile Divergent Transition Profile: An Atlantis abutment is delivered with a linear transition profile		Concave Transition Profile Concave Transition Profile: An Atlantis abutment is delivered with a concave transition profile.
All Cause Mortality
	Divergent Abutment		Concave Abutment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/29 (0%)		0/32 (0%)
Serious Adverse Events
	Divergent Abutment		Concave Abutment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/29 (0%)		0/32 (0%)
Other (Not Including Serious) Adverse Events
	Divergent Abutment		Concave Abutment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/29 (0%)		0/32 (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.