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

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

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.

Study Overview

• Status: Completed
• Conditions: Tooth Loss; Peri-implant Mucosa Defect
• Intervention / Treatment: Procedure: Autologous subepithelial connective tissue graft; Drug: Acellular Dermal Matrix

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa College of Dentistry - Craniofacial Clinical Research Center and Department of Periodontics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; Autologous subepithelial connective tissue graft	Procedure: 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; Other Names: sCTG
Experimental: Experimental; Acellular Dermal Matrix	Drug: 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; Other Names: Alloderm®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Patient-reported outcome measures of perceived discomfort using a visual analog scale (VAS) from 0 (no pain) to 100 (maximum pain) were recorded	2 weeks
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	2 weeks

Collaborators and Investigators

• Sponsor: University of Iowa
• Collaborators: BioHorizons, Inc.
• Investigators: Principal Investigator: Gustavo Avila-Ortiz, DDS, MS, PhD, University of Iowa College of Dentistry

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: January 26, 2015
• First Submitted That Met QC Criteria: May 20, 2015
• First Posted (Estimate): May 21, 2015

Study Record Updates

• Last Update Posted (Actual): October 18, 2017
• Last Update Submitted That Met QC Criteria: September 16, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Diseases; Tooth Loss
• Other Study ID Numbers: 201407810

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: We are not planning on sharing IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes