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Comparison of Two Different Surgical Approaches To Increase Peri-Implant Mucosa Thickness

Primary Purpose

Tooth Loss, Peri-implant Mucosa Defect

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Acellular Dermal Matrix

Autologous subepithelial connective tissue graft

About this trial

This is an interventional treatment trial for Tooth Loss

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria:

Age: 18 to 80 years.
Subjects must be able and willing to follow instructions related to the study procedures.
Subjects must have read, understood and signed an informed consent form.
At least one single-tooth edentulous site, with adjacent natural teeth, planned for tooth replacement therapy with an implant-supported restoration.

Exclusion criteria:

Reported allergy or hypersensitivity to any of the products to be used in the study.
Severe hematologic disorders, such as hemophilia or leukemia.
Active severe infectious diseases that may compromise normal healing.
Liver or kidney dysfunction/failure.
Currently under cancer treatment or within 18 months from completion of radio- or chemotherapy.
Subjects with uncontrolled diabetes, defined as Hba1c > 6.5% (According to the American Diabetes Association 2014 Guidelines)
Pregnant women or nursing mothers.
Smokers: Subjects who have smoked within 6 months of study onset.
Concomitant medications for systemic conditions that may affect the outcomes of the study.
Any other non-specified reason that from the point of view of the investigators will make a candidate not a suitable subject for the study (e.g. limited mouth opening).

Sites / Locations

University of Iowa College of Dentistry - Craniofacial Clinical Research Center and Department of Periodontics

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Experimental

Arm Description

Autologous subepithelial connective tissue graft

Acellular Dermal Matrix

Outcomes

Primary Outcome Measures

Change in Buccal Peri-implant Mucosa Thickness Between Baseline and 16 Weeks After Surgery

Buccal mucosa thickness measurements were obtained by a calibrated, masked examiner using a custom-made stent and an endo file for precision and reproducibility between different time points

Secondary Outcome Measures

Changes in Peri-implant Keratinized Mucosa Width (Apico-coronal) at 16 Weeks After Surgery

Patient-perceived Discomfort, Measured by VAS

Patient-reported outcome measures of perceived discomfort using a visual analog scale (VAS) from 0 (no pain) to 100 (maximum pain) were recorded

Wound Healing, Measured Using a Standardized Visual Wound Healing Index

Wound healing status was evaluated by the same calibrated clinician using a standardized visual wound healing index at different time points A simple wound healing scoring system including 3 categories was used: 1- uneventful wound healing, 2- slight gingival edema, erythema or discomfort, 3- poor wound healing

Full Information

NCT ID

NCT02450383

First Posted

January 26, 2015

Last Updated

September 16, 2017

Sponsor

University of Iowa

Collaborators

BioHorizons, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02450383

Brief Title

Comparison of Two Different Surgical Approaches To Increase Peri-Implant Mucosa Thickness

Official Title

Comparison of Two Different Surgical Approaches to Increase Peri-Implant Mucosa Thickness: A Randomized Controlled Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Completed

Study Start Date

January 2015 (Actual)

Primary Completion Date

September 2016 (Actual)

Study Completion Date

September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Iowa

Collaborators

BioHorizons, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this non-inferiority trial is to determine the clinical efficacy of acellular dermal matrix (ADM) in the augmentation of the gum around dental implants as compared to an autologous gum graft (sCTG) obtained from the palate (roof of the mouth) in human adults. AlloDerm is regulated by the US Food and Drug Administration (FDA) as human tissue for transplantation. AlloDerm is processed and marketed in accordance with the FDA's requirements for banked human tissue (21 CFR, Part 1270 and Part 1271) and Standards for Tissue Banking of the American Association of Tissue Banks (AATB). Twenty adult subjects will be recruited who are in need of dental implant placement with simultaneous gum grafting to increase the thickness of the facial mucosa. Half of the subjects will be randomized to the ADM group and half will be randomized to the sCTG group. The surgical intervention will be performed according to the protocol and subjects will return for follow-up 2, 4, 8, and 16 weeks post-surgery for follow-up measurements of healing, gum thickness, subject perception of pain, and esthetic photographs.

Detailed Description

Although little is known about the influence of peri-implant mucosa thickness (PMT) on long-term biologic outcomes, soft tissue thickness is a critical component to esthetic dental implant restorations. While the subepithelial connective tissue graft (sCTG) has been recognized as the gold standard for gingival augmentation, several studies have reported acellular dermal matrix (ADM) may produce similar outcomes. Healthy patients with a thin biotype were selected on the basis of an eligibility criteria and randomized to the control (sCTG) or test (ADM) group. Measurements were completed by a masked examiner at baseline and at implant uncovering. Patient reported outcomes were recorded, as well. A power analysis suggested 20 subjects be recruited. The gain in PMT at 1mm, 3mm and 5mm from the expected CEJ and recipient site wound dehiscence were measured and recorded in both groups at different time points by a calibrated, masked examiner. Patient-related outcome measures (PROMs), such as pain and level of satisfaction with final outcome, were also recorded for all study participants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tooth Loss, Peri-implant Mucosa Defect

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

Active Comparator

Arm Description

Autologous subepithelial connective tissue graft

Arm Title

Experimental

Arm Type

Experimental

Arm Description

Acellular Dermal Matrix

Intervention Type

Drug

Intervention Name(s)

Acellular Dermal Matrix

Other Intervention Name(s)

Alloderm®

Intervention Description

Placement of acellular dermal matrix (Alloderm®) on the buccal/coronal aspect of the alveolar ridge at the time of implant placement, following a two-stage approach

Intervention Type

Procedure

Intervention Name(s)

Autologous subepithelial connective tissue graft

Other Intervention Name(s)

sCTG

Intervention Description

Placement of autologous subepithelial connective tissue graft on the buccal/coronal aspect of the alveolar ridge at the time of implant placement, following a two-stage approach

Primary Outcome Measure Information:

Title

Change in Buccal Peri-implant Mucosa Thickness Between Baseline and 16 Weeks After Surgery

Description

Buccal mucosa thickness measurements were obtained by a calibrated, masked examiner using a custom-made stent and an endo file for precision and reproducibility between different time points

Time Frame

Baseline and 16 weeks after baseline

Secondary Outcome Measure Information:

Title

Changes in Peri-implant Keratinized Mucosa Width (Apico-coronal) at 16 Weeks After Surgery

Time Frame

Baseline to 16 weeks after baseline

Title

Patient-perceived Discomfort, Measured by VAS

Description

Patient-reported outcome measures of perceived discomfort using a visual analog scale (VAS) from 0 (no pain) to 100 (maximum pain) were recorded

Time Frame

2 weeks

Title

Wound Healing, Measured Using a Standardized Visual Wound Healing Index

Description

Time Frame

2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Age: 18 to 80 years. Subjects must be able and willing to follow instructions related to the study procedures. Subjects must have read, understood and signed an informed consent form. At least one single-tooth edentulous site, with adjacent natural teeth, planned for tooth replacement therapy with an implant-supported restoration. Exclusion criteria: Reported allergy or hypersensitivity to any of the products to be used in the study. Severe hematologic disorders, such as hemophilia or leukemia. Active severe infectious diseases that may compromise normal healing. Liver or kidney dysfunction/failure. Currently under cancer treatment or within 18 months from completion of radio- or chemotherapy. Subjects with uncontrolled diabetes, defined as Hba1c > 6.5% (According to the American Diabetes Association 2014 Guidelines) Pregnant women or nursing mothers. Smokers: Subjects who have smoked within 6 months of study onset. Concomitant medications for systemic conditions that may affect the outcomes of the study. Any other non-specified reason that from the point of view of the investigators will make a candidate not a suitable subject for the study (e.g. limited mouth opening).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gustavo Avila-Ortiz, DDS, MS, PhD

Organizational Affiliation

University of Iowa College of Dentistry

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Iowa College of Dentistry - Craniofacial Clinical Research Center and Department of Periodontics

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

We are not planning on sharing IPD

Citations:

PubMed Identifier

29633268

Citation

Hutton CG, Johnson GK, Barwacz CA, Allareddy V, Avila-Ortiz G. Comparison of two different surgical approaches to increase peri-implant mucosal thickness: A randomized controlled clinical trial. J Periodontol. 2018 Jul;89(7):807-814. doi: 10.1002/JPER.17-0597. Epub 2018 Jul 20.

Results Reference

derived

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Comparison of Two Different Surgical Approaches To Increase Peri-Implant Mucosa Thickness

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