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

NCT ID: NCT02450383

Last Updated: 2017-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2016-09-30

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.

Conditions

Tooth Loss; Peri-implant Mucosa Defect

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control

Autologous subepithelial connective tissue graft

Group Type: ACTIVE_COMPARATOR

Autologous subepithelial connective tissue graft

Intervention Type: 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

Experimental

Acellular Dermal Matrix

Group Type: EXPERIMENTAL

Acellular Dermal Matrix

Intervention Type: 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

Interventions

Acellular Dermal Matrix

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: DRUG

Autologous subepithelial connective tissue graft

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

Intervention Type: PROCEDURE

Other Intervention Names

Alloderm®; sCTG

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

BioHorizons, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Iowa

OTHER

Sponsor Role: lead

Responsible Party

Gustavo Avila-Ortiz

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gustavo Avila-Ortiz, DDS, MS, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa College of Dentistry

Locations

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

Iowa City, Iowa, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 29633268 (View on PubMed)

Other Identifiers

201407810

Identifier Type: -

Identifier Source: org_study_id