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

NCT02450383 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 201407810
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Tooth Loss; Peri-implant Mucosa Defect

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline and 16 weeks after baseline

Secondary Outcomes (3)

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

  Baseline to 16 weeks after baseline

• Patient-perceived Discomfort, Measured by VAS

  2 weeks

• Wound Healing, Measured Using a Standardized Visual Wound Healing Index

  2 weeks

Study Arms (2)

Control

ACTIVE COMPARATOR

Autologous subepithelial connective tissue graft

Procedure: Autologous subepithelial connective tissue graft

Experimental

EXPERIMENTAL

Acellular Dermal Matrix

Drug: Acellular Dermal Matrix

Interventions

Acellular Dermal Matrix DRUG

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

Also known as: Alloderm®

Experimental

Autologous subepithelial connective tissue graft PROCEDURE

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

Also known as: sCTG

Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Iowa: lead
• BioHorizons, Inc.: collaborator

Study Sites (1)

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

Iowa City, Iowa, 52242, United States

Location

Related Publications (1)

• 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.

  PMID: 29633268 DERIVED

MeSH Terms

Conditions

Tooth Loss

Interventions

Alloderm

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Results Point of Contact

• Title: Gustavo Avila-Ortiz
• Organization: University of Iowa

gustavo-avila@uiowa.edu

3193357241

Study Officials

• Gustavo Avila-Ortiz, DDS, MS, PhD

  University of Iowa College of Dentistry

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 26, 2015
• First Posted: May 21, 2015
• Study Start: January 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 18, 2017
• Results First Posted: September 18, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)