Xenogenic Collagen Matrix and Subepithelial Connective Tissue Graft in the Treatment of Gingival Recession

January 10, 2021 updated by: Damascus University

Clinical Comparison of Coronally-advanced Flap Plus Xenogeneic Collagen Matrix (Fibro-Gide®) and Subepithelial Connective Tissue Graft in the Treatment of Gingival Recessions

this study is a Clinical evaluation of using Xenogenic collagen matrix (XCM) plus coronally advanced flap (CAF) compared to subepithelial connective tissue graft (SCTG) plus coronally advanced flap to treat Miller class I gingival recession. A split-full-split thickness flap will be elevated in the (XCM+CAF) group while it will be an only partial thickness flap in the (SCTG+CAF) group. The sample size will be 15 patients. Each patient has bilateral Miller Class I gingival recessions; and as a split-mouth study design one side will be treated with (SCTG+CAF), while the other will be treated with (XCM+CAF).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to clinically compare between the subepithelial connective tissue graft (SCTG) plus coronally advanced flap (CAF) which is defined as the golden standard for the treatment of gingival recessions and Xenogenic collagen matrix (XCM) plus coronally advanced flap (CAF) to treat class I Miller gingival recession. CAF elevation will be done as it described by (De Sanctis & Zucchelli 2007) with modifications in the the control group.The flap will be partially elevated in the (SCTG+CAF) group while it will be a split-full-split thickness flap in the (XCM+CAF) group, and finally the flap will stabilized coronally. Fifteen patients who have bilateral buccal Miller Class I gingival recession defects will be enrolled in this study. These defects will be distributed randomly into two groups: the test group (XCM+CAF) and control group (SCTG+CAF). Clinical parameters will be evaluated: Recession depth (REC), change in visible plaque index, recession width (RW), width of keratinized tissue (KT), thickness of gingival tissue (GT), probing depth (PD), clinical attachment level (CAL), healing index (HI), questionnaires will be given to evaluate each of patient perceptions, pain index (PI), and changes in root sensitivity by using visual analog scale (VAS).

Study Type

Interventional

Enrollment (Actual)

15

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

  • Syrian Arab Republic
      • Damascus, Syrian Arab Republic, DM20AM18
        • Department of Periodontics, University of Damascus Dental School

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

18 years to 47 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Good general health.
  • No contraindications for periodontal surgery.
  • Presence of one localized gingival recession in each side of the maxilla and/or mandible, All recessions will be Class I defects (Miller 1985).
  • The cemento-enamel junction (CEJ) is visible in the defective teeth.
  • All patients demonstrating good plaque control.
  • No previous periodontal surgery in the targeted area.

Exclusion Criteria:

  • Smokers.
  • pregnant or nursing patients.
  • history of malignancy, radiotherapy, or chemotherapy.
  • Patients taking medications that affect mucosal healing.
  • Patients with allergy to collagen.
  • Previous participation in a clinical trial.
  • Type-1 diabetes patients.
  • Patient who have diseases that affect connective tissue metabolism.

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: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: (XCM)+(CAF)

Surgical protocol for test treatment with CAF + XCM:

After local anesthetizing the recipient site,CAF elevation will be done using (De Sanctis & Zucchelli 2007) design.Horizontal incisions will be done at the recession site,another two slightly divergent vertical incisions will be done at the end of previous incisions extending to the mucogingival junction.The resulting flap will be split thickness in the surgical papillae area,then will be full thickness exposing 3-4 mm of the bone apically of the dehiscence and after that it will be split thickness in the apical direction,all the muscle insertions will be eliminated,the root surface will be prepared by curettes and chemically treated with 24% EDTA gel.De-epithelialization of the interdental papillae will be done.The XCM will be trimmed and fix onto the root surface 1-2mm coronally of the CEJ using absorbable sutures,and the flap will be coronally advanced to fully cover the XCM and then sutured to the de-epithelialized papillae.
Procedure: (XCM)+(CAF)
The description of this intervention has been already given before.
ACTIVE_COMPARATOR: (SCTG)+(CAF)

The surgical protocol in the control group will be identical with test group protocol with these exceptions:

  1. The entire flap will be elevated as split thickness instead of split-full-split thickness flap.
  2. A SCTG harvested from the palate will be used to cover the exposed denuded root surface in lieu of placement of XCM in the test group. And absorbable sutures will be used to stabilize it 2 mm coronally from the CEJ.
  3. As in the test group the mucosal flap will coronally advanced to completely cover the SCTG then sutured to the de-epithelialized papillae.
Procedure: (SCTG)+(CAF)
The description of this intervention has been already given before.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recession depth (REC): (Change in the amount of root coverage)
Time Frame: 1)At baseline, 2) 2 weeks post-surgery, 3) At 1 month post-surgery and 4) 3 months post-surgery.
from the free gingival margin to the cemento-enamel junction at the mid-buccal aspect. Using University of North Carolina periodontal probe UNC15 (Medesey®-Italy).
1)At baseline, 2) 2 weeks post-surgery, 3) At 1 month post-surgery and 4) 3 months post-surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in visible plaque index:
Time Frame: 1) baseline, 2) at 2 weeks postoperative,3) 1 month and 4) 3 month postoperative
  1. Score 0 - No plaque
  2. Score 1 - Separate flecks of plaque at the cervical margin of the tooth
  3. Score 2 - A thin continuous band of plaque at the cervical margin of the tooth
  4. Score 3 - A band of plaque wider then 1mm covering less than 1/3rd of the crown of the tooth
  5. Score 4 - Plaque covering at least 1/3rd but less than 2/3rd of the crown of the tooth
  6. Score 5 - Plaque covering 2/3rd or more of the crown of the tooth
1) baseline, 2) at 2 weeks postoperative,3) 1 month and 4) 3 month postoperative
Recession width (RW)
Time Frame: 1) at baseline, 2) at 2 weeks postoperative, 3) at 1 month postoperative, 4) and at 3 months postoperative.
at the cemento-enamel junction using periodontal probe of University of North Carolina UNC15 (Medesey®-Italy).
1) at baseline, 2) at 2 weeks postoperative, 3) at 1 month postoperative, 4) and at 3 months postoperative.
Width of keratinized tissue (KT)
Time Frame: 1) baseline, 2) 2 weeks postoperative, 3) 1 month postoperative and 4) 3 months postoperative.
from the free gingival margin to the mucogingival junction using periodontal probe of University of North Carolina UNC15 (Medesey®-Italy).
1) baseline, 2) 2 weeks postoperative, 3) 1 month postoperative and 4) 3 months postoperative.
Thickness of gingival tissue (GT)
Time Frame: 1) at baseline, and 2) 3 months postoperative.
with an injection needle and a silicon marker, at the mid-buccal aspect below the gingival margin.
1) at baseline, and 2) 3 months postoperative.
Probing depth (PD)
Time Frame: 1) at baseline, 2) and 3 months postoperative.
the distance between the gingival margin and the bottom of the pocket measured at the mid-buccal aspect of the tooth using periodontal probe of University of North Carolina UNC15 (Medesey®-Italy).
1) at baseline, 2) and 3 months postoperative.
Clinical attachment level (CAL)
Time Frame: 1) at baseline, 2) at 3 months postoperative.
distance between the CEJ and the bottom of the pocket measured at the mid-buccal aspect of the tooth using periodontal probe of University of North Carolina UNC15 (Medesey®-Italy).
1) at baseline, 2) at 3 months postoperative.
Healing index
Time Frame: 1) at two weeks following surgery and (2) at one month following surgery.

score 1 = uneventful healing with no gingival edema, erythema, suppuration, patient discomfort, or flap dehiscence.

score 2 = uneventful healing with slight gingival edema, erythema, patient discomfort, or flap dehiscence, but no suppuration.

score 3 = poor wound healing with significant gingival edema, erythema, patient discomfort, flap dehiscence, or any suppuration.
1) at two weeks following surgery and (2) at one month following surgery.
Pain index (PI)
Time Frame: 1) at 2 hours, 2) 24 hours, 3) 48 hours,4) 72 hours following surgery and 5) at 1-week after surgery.
Using Visual Analogue scale (VAS) (2001 Crichton), Patients will be asked to select among 100 scores (0 indicating no pain at all , 50 indicating average pain, and 100 indicating very painful).
1) at 2 hours, 2) 24 hours, 3) 48 hours,4) 72 hours following surgery and 5) at 1-week after surgery.
Patient Perceptions
Time Frame: at three months post-surgery.
Using 100 cm Visual Analogue Scale (VAS)Patients will be asked to select among 100 scores (0 indicating very bad, 50 indicating average, and 100 indicating excellent results).
at three months post-surgery.
Change in root sensitivity
Time Frame: 1) at baseline, 2) and at 3 months postoperative.
Using a 100 cm-visual analog scale (VAS), patients' root sensitivity will be recorded with zero indicating no pain or sensitivity, 50 indicating moderate pain or sensitivity and 100 indicating worst pain or sensitivity possible.
1) at baseline, 2) and at 3 months postoperative.

Collaborators and Investigators

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

Sponsor

Damascus University

Investigators

  • Principal Investigator: Noor Alhuda Ewaz Ali, DDS, MSc student in Periodontics, University of Damascus Dental School
  • Study Chair: Suleiman Dayoub, DDS MSc PhD, Professor of Periodontics, University of Damascus Dental School
  • Study Director: Mohammad Alharissy, DDS MSc PhD, Assistant Professor of Periodontics, Academic Staff Member At Wadi International University

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)

August 25, 2019

Primary Completion (ACTUAL)

June 30, 2020

Study Completion (ACTUAL)

August 1, 2020

Study Registration Dates

First Submitted

August 28, 2019

First Submitted That Met QC Criteria

September 5, 2019

First Posted (ACTUAL)

September 9, 2019

Study Record Updates

Last Update Posted (ACTUAL)

January 12, 2021

Last Update Submitted That Met QC Criteria

January 10, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UDDS-Perio-01-2019

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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