Comparison Between Connective Graft and Xenogeneic Matrix, in Patients With Multiple Gingival Recessions

February 27, 2023 updated by: Raphaella Coelho Michel, University of Sao Paulo

Xenogeneic Collagen Matrix and Connective Tissue Graft Comparison for Multiple Gingival Recessions in Esthetic Areas: A Non-inferiority Clinical Trial

Subepithelial connective tissue graft (SCTG) is considered the gold standard for root coverage treatment. However, it is associated with postoperative morbidity, limited amount of donor tissue, and longer surgical time. Thus, the search for a tissue substitute for SCTG is increasing. Currently, one of the possible autogenous soft tissue substitutes found in the market is the Mucograft® xenogeneic matrix (CM). The results with the use of MC are very promising, both for root coverage as well as for the gain of keratinized tissue. The present study consists of a parallel randomized clinical trial to compare SCTG (control group) and CM (test group) in the treatment of Miller's class I and II gingival recessions, multiple in aesthetic areas (upper central incisors, Lateral and canine).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Obtaining an aesthetic smile is one of the main reasons for the patient's demand for dental treatment, especially when it comes to gingival recession. However, there is a lack of evidence in the literature explaining the most appropriate type of treatment for multiple recessions in aesthetic areas. For unitary gingival recessions, the subepithelial connective tissue graft (SCTG) is considered the gold standard because it presents greater predictability for root coverage. However, it is associated with postoperative morbidity, limited amount of donor tissue, and longer surgical time. Thus, the search for a tissue substitute for SCTG is increasing. Currently, one of the possible autogenous soft tissue substitutes found in the market is the Mucograft® xenogeneic matrix (CM). The results with the use of CM are very promising, both for root coverage as well as for the gain of keratinized mucosa. The present study will consist of a double-blind parallel randomized clinical trial to compare SCTG (control group) and CM (test group) in the treatment of Miller's class I and II gingival recessions, multiple in aesthetic areas (central incisors, Lateral, upper canine). All measurements will be evaluated initially and in the periods of 3, 6, and 12 months after the surgical procedure.

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Bauru, SP, Brazil, 17012-901
        • Raphaella C Michel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of multiple gingival recessions ≥ 2 mm, only in aesthetic areas (upper central and lateral incisive, and canine);
  • Miller class I and II gingival recession areas
  • Non-abrasive, erosive, or carious root surfaces
  • Unrotated, non-extruded, and non-movable teeth
  • Systemically healthy patients without contraindication to periodontal surgical procedures

Exclusion Criteria:

  • Smokers
  • Pregnant women and infants
  • Patients with a history of periodontal disease or recurrent abscess formation
  • Patients previously submitted to surgical procedures for root coverage
  • Patients taking anti-convulsant drugs
  • Antihypertensives, contraceptives or immunosuppressors
  • Patients with low oral hygiene (plaque and bleeding index over 20%)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control SCTG
Root coverage surgery with subepithelial connective tissue graft to an extensive treat multiple gingival recessions in aesthetic areas
Procedure: Root coverage surgery
Periodontal plastic surgery aiming the treatment of multiple gingival recessions in aesthetics areas with SCTG and CM
Experimental: Test CM
Root coverage surgery with Mucograft® collagen matrix to treat an extensive multiple gingival recessions in aesthetic areas
Procedure: Root coverage surgery
Periodontal plastic surgery aiming the treatment of multiple gingival recessions in aesthetics areas with SCTG and CM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gingival recession depth (GRD)
Time Frame: one year
Distance in millimeters from ECJ to gingival margin at three points (mesial, center and distal); Distance from cemento-enamel junction to gingival margin = 0 mm
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dentin hypersensitivity
Time Frame: year
Dentin hypersensitivity measured by applying an air jet on teeth and patient fills up a visual analogue scale Ideal if scale = 0
year
Keratinized mucosa width
Time Frame: year
Keratinized mucosa width measured with a periodontal probe in millimeters Ideal if keratinized mucosa width > 5mm
year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Probing Depth (PD)
Time Frame: year
Distance in millimeters from the gingival margin to the bottom of the gingival sulcus at three points (mesial, center and distal)
year
Clinical attachment level loss (CAL)
Time Frame: year
Measured in millimeters from the bottom of the periodontal pocket to the cementoenamel junction at three sites per tooth (mesial, center and distal)
year
Soft tissue thickness (STT)
Time Frame: year
Determined at 2mm apical the gingival margin at the central buccal site with anesthetic needle and endodontic stop and digital pachymeter
year
Complete root coverage
Time Frame: year
Assessed in which the gingival margin was at or above the cementoenamel junction (CEJ)
year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Collaborators

Geistlich Pharma AG

Investigators

  • Principal Investigator: Raphaella C Michel, PhD, University of São Paulo, Bauru School of Dentistry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2017

Primary Completion (Actual)

September 20, 2020

Study Completion (Actual)

December 1, 2021

Study Registration Dates

First Submitted

June 30, 2017

First Submitted That Met QC Criteria

June 30, 2017

First Posted (Actual)

July 5, 2017

Study Record Updates

Last Update Posted (Actual)

March 2, 2023

Last Update Submitted That Met QC Criteria

February 27, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9075852

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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