Gingival Recession (RT1) Treatment With Different Gingival Augmentation Surgeries

February 8, 2025 updated by: Misr International University

Gingival Recession (RT1) Treatment With Different Gingival Augmentation Surgeries Compared With Untreated Contralateral Sites: A Randomized Controlled Clinical Study

Thin gingival phenotype is one of the major causative factors of gingival recession type 1 which can result in hypersensitivity, discomfort, and compromised esthetics. This study assess the efficacy of increasing the gingival thickness from thin gingival phenotype to thick gingival phenotype in the treatment of patients suffering from gingival recession (RT1) and maintenance of results using either connective tissue graft or de-epithelized free gingival graft after non-surgical periodontal debridement compared to non-surgical periodontal debridement alone.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This parallel arm randomized controlled clinical trial study will include systematically free patients with thin gingival phenotype. They will be randomly allocated to three equal groups. Group A (test group, n=10) will receive non-surgical periodontal treatment and connective tissue graft using tunneling technique, Group B (test group, n=10) will receive non-surgical periodontal treatment and partially de-epithelized free gingival graft, while group C (control group, n=10) will receive non-surgical periodontal treatment only. After 3, 6 and 12 months gingival biotype will be clinically assessed (1ry outcome). This parameter will be recorded at baseline, 3, 6 and 12 months. The 2ry outcomes will include recording of recession depth, plaque index, bleeding on probing, keratinized tissue width . Postoperative pain and swelling will be recorded daily by the patient for the 1st two weeks post-surgically. Postoperative instructions and medication will be given to the patient. All readings will be carried out by a calibrated outcome assessor who will be masked. Follow-up will be performed to assess the outcomes and to ensure performing proper oral hygiene. Data collected will be tabulated and statistically analyzed.

Study Type

Interventional

Enrollment (Estimated)

30

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 Contact

Study Contact Backup

Study Locations

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 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Medically free patients (American Society of Anesthesiologists I; ASA I)
  • Patients diagnosed with recession (RT1)
  • Fair oral hygiene
  • Patient accepting to provides an informed consent and the follow-up

Exclusion Criteria:

  • Carious teeth and teeth with periapical infection.
  • Patients diagnosed with periodontitis
  • Smokers
  • Pregnant and lactating females

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Connective tissue graft
Patients will receive non-surgical periodontal treatment and connective tissue graft using tunneling technique
Procedure: Connective tissue graft
non-surgical periodontal treatment and connective tissue graft
Active Comparator: Free gingival Graft
Patients will receive non-surgical periodontal treatment and partially de-epithelized free gingival graft
Procedure: Free gingival graft
will receive non-surgical periodontal treatment and partially de-epithelized free gingival graft
Active Comparator: Non surgical procedure
Patients will receive non-surgical periodontal treatment only
Procedure: Non surgical
non-surgical periodontal treatment only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gingival phenotype change
Time Frame: at baseline 3,6 and 12 months
determination of the change in gingival thickness in mm using periodontal probe
at baseline 3,6 and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Keratinized tissue width
Time Frame: at baseline 3,6 and 12 months
determination of Keratinized tissue width in mm using periodontal probe
at baseline 3,6 and 12 months
Root coverage esthetic score (RES)
Time Frame: at baseline 3,6 and 12 months
It is a scoring system to assess the level of gingival margin (GM),marginal tissue contour (MTC),Soft tissue texture, Mucogingival alignment (MGJ),Gingival color The score is 0,1 and 3 where 0 is the minimum and 3 is the maximum
at baseline 3,6 and 12 months

Collaborators and Investigators

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

Sponsor

Misr International University

Investigators

  • Principal Investigator: Yahia Amer, Lecturer, Lecturer, faculty of oral and dental medicine misr international universit
  • Principal Investigator: Zainab Hafez, Lecturer, Lecturer, faculty of oral and dental medicine misr international university
  • Study Director: Shahinaz Al ashiry, Asso. Prof, Associate professor, faculty of oral and dental medicine misr international 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)

February 5, 2025

Primary Completion (Estimated)

January 20, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

January 6, 2023

First Submitted That Met QC Criteria

January 14, 2023

First Posted (Actual)

January 18, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 8, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PER 5213005

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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