Growth Factor Enhanced Matrix With Subepithelial Connective Tissue Graft or Collagen Membrane in Treatment of Gingival Recession

March 21, 2023 updated by: malak mohamed shoukheba, Tanta University

Growth Factor Enhanced Matrix Combined Either With Free Connective Tissue Graft or With Collagen Membrane in the Treatment of Miller Class II Gingival Recession

The study aimed to compare, the effectiveness of Growth Factor Enhanced Matrix (GEM 21s) ® combined either with free connective tissue graft or collagen membrane in the treatment of Miller class II gingival recession.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Materials and Methods: Twenty sites in 10 patients, with class II Miller gingival recession were allocated randomly to be treated by (GEM 21s) ® with free connective tissue graft (groupI) or GEM 21s with collagen membrane (groupII). Plaque index, bleeding on probing, recession width, recession depth, height of keratinized tissue and digital measurements were recorded at baseline, 1, 3 and 6-months'. Probing pocket depth, clinical attachment level, gingival thickness and Radiographic parameters were recorded at baseline and 6 months'. Root coverage percentage were recorded 6 months postoperative and wound healing index were recorded at 1,3 and 6-months' post-operative .

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 4

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

  • Egypt
      • Tanta, Egypt, 020
        • Malak Mohamed Shoukheba
      • Tanta, Egypt, 20
        • Malak Yousef Mohamed Shoukheba

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

25 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • lack of any related medical issues that contraindicate periodontal surgery,
  • optimum adherence as confirmed by a positive attitude towards oral hygiene, and successfully showing up for treatment appointments.
  • No history of any medications in the previous six months that may interfere with periodontal surgery Gingival thickness for the selected sites should be > 1mm (as measured 2mm apical to gingival margin),
  • Clinical attachment level ≥ 4mm measured from cemento-enamel junction till the deepest probing depth.

Exclusion Criteria:

  • the presence of class V caries or restoration in the site to be treated,
  • previous mucogingival surgery at the selected site.
  • Teeth that are tilted, rotated, or have any occlusal abnormalities.
  • Smokers and pregnant patients were excluded from the participation.

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: (groupI)
10 recession sites treated by (GEM 21s) ® with free connective tissue graft
Procedure: GROUPI
10 sites treated with Free connective tissue graft (FCTG) + growth factors enhanced matrix 21 s GEM 21S + coronally advanced flap (CAF)
Other Names:
  • free connective tissue graft
  • growth factors enhanced matrix 21s (GEM21s)
  • coronally advanced flap
Active Comparator: (groupII)
10 recession sites GEM 21s with collagen membrane
Procedure: GROUP II
10 sites treated withCollagen membrane + GEM 21S + coronally advanced flap (CAF)
Other Names:
  • coronally advanced flap
  • collagen membrane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recession width
Time Frame: up to 6 months
the distance between the mesial and distal papillae along the CEJ measured at baseline , 1, 3, and 6 months
up to 6 months
recession depth
Time Frame: up to 6 months
The distance between the CEJ and the gingival margin at the midbuccal aspect of the involved tooth measured at baseline , 1, 3, and 6 months
up to 6 months
Height of keratinized tissue
Time Frame: up to 6 months
distance from the most apical point of the free gingival margin to the mucogingival junction mid-facially measured at baseline , 1, 3, and 6 months
up to 6 months
Gingival thickness (Gingival biotype)
Time Frame: up to 6 months
measured at mid-buccal area 2 mm apical to the free gingival margin measured at baseline, and 6 months postoperatively
up to 6 months
radiographic measurements of facial bone level, thickness and density
Time Frame: up to 6 months
from cone beam CT radiography measured at baseline, and 6 months postoperative
up to 6 months
Percentage of root coverage
Time Frame: up to 6 months
according to the following formula: (RD at baseline - RD at 6 months) / RD at baseline)x100 was calculated after 6 months
up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
probing pocket depth
Time Frame: up to 6 months
measured from gingival margin to the bottom of the pocket measured at baseline, 3, and 6 months
up to 6 months
clinical attachment level
Time Frame: up to 6 months
measured from CEJ to the bottom of the pocket measured at baseline, 3, and 6 months
up to 6 months
Digital measurements
Time Frame: up to 6 months
all recession areas were photographed The photos were taken by a digital camera at a fixed resolution (mega pixel) taken at baseline, 1,3,and 6 months postoperative
up to 6 months
healing index
Time Frame: up to 6 months
recorded at 1, 3 and 6 months postoperatively (Score 1: uneventful healing while score 3: poor wound healing
up to 6 months

Collaborators and Investigators

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

Sponsor

Tanta University

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)

January 1, 2019

Primary Completion (Actual)

August 30, 2022

Study Completion (Actual)

August 30, 2022

Study Registration Dates

First Submitted

February 27, 2023

First Submitted That Met QC Criteria

March 21, 2023

First Posted (Actual)

March 24, 2023

Study Record Updates

Last Update Posted (Actual)

March 24, 2023

Last Update Submitted That Met QC Criteria

March 21, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

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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