Time Effect on the Predictability of Different Grafting for Gingival Recession RT 1

November 23, 2023 updated by: mahetab mohamed abdel el wahab, Ain Shams University

Time Effect on the Predictability of Different Grafting Materials in Treatment of Gingival Recession RT 1in the Esthetic Zone

The primary objective of this study was to evaluate time effect on the clinical predictability of collagen matrix Xenograft (CMX) with melatonin gel versus connective tissue graft (CTG) and determine whether it is proposed to be an alternative in multiple adjacent gingival recession (MAGR) in recession type one (RT1)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

this study was conducted to evaluate time effect on the clinical predictability of collagen matrix Xenograft (CMX) with melatonin gel versus connective tissue graft (CTG) and determine whether it is proposed to be an alternative in multiple adjacent gingival recession

Study Type

Interventional

Enrollment (Actual)

22

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

  • Egypt
    • Al Qahirah
      • Cairo, Al Qahirah, Egypt, 11566
        • Ain shams university

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Presence of RT1 GRs of the maxillary or mandibular arch in the esthetic zone with a GR depth ≥2 mm,
  • patients >18 years old,
  • Full mouth plaque index score <20%
  • Systemically and periodontally healthy patients.

Exclusion Criteria:

  • Smokers
  • Patients with periodontitis stage III and IV were previous surgical treatment of GR,
  • Pregnant or breastfeeding women; P
  • Patients with para-functional habits or any source of occlusal trauma.

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: collagen matrix
melatonin in collagen matrix with Modified Coronally Advanced Tunneling Technique (MCAT)
Combination product: melatonin with collagen matrix
(CMX) with melatonin in the esthetic zone using Modified Coronally Advanced Tunneling Technique (MCAT)
Active Comparator: connective tissue graft (CTG)
connective tissue graft with Modified Coronally Advanced Tunneling Technique (MCAT)
Combination product: connective tissue graft (CTG)
control group connective tissue graft using Modified Coronally Advanced Tunneling Technique (MCAT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
interproximal clinical attachment level
Time Frame: 6-9 months
measured from CEJ to base of pocket depth by using periodontal prob
6-9 months
Probing pocket depth (PPD)
Time Frame: 6-9 months
from gingival margin to pocket depth measured by mm
6-9 months
Recession depth
Time Frame: 6-9 months
measure from CEJ to gingival margin by mm
6-9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Keratinized tissue width
Time Frame: 6-9 months
from free gingival groove to MGJ
6-9 months

Collaborators and Investigators

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

Sponsor

Ain Shams 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)

October 1, 2020

Primary Completion (Actual)

April 1, 2022

Study Completion (Actual)

March 3, 2023

Study Registration Dates

First Submitted

March 12, 2023

First Submitted That Met QC Criteria

July 27, 2023

First Posted (Actual)

August 4, 2023

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 23, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1011

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

Clinical Trials on Gingival Recession Types One(RT1)

Clinical Trials on melatonin with collagen matrix

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malaysia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe