Gingival Recession (RT1) Treatment With Different Gingival Augmentation Surgeries

Sponsor
Misr International University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05688293
Collaborator
(none)
30
1
3
13.8
2.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Connective tissue graft
  • Procedure: Free gingival graft
  • Procedure: Non surgical
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Three parallel groupsThree parallel groups
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
the patient won't know the type of the procedures done to him The outcome assessor won't know which group he the is assessing it's results
Primary Purpose:
Treatment
Official Title:
Gingival Recession (RT1) Treatment With Different Gingival Augmentation Surgeries Compared With Untreated Contralateral Sites: A Randomized Controlled Clinical Study
Actual Study Start Date :
Jan 5, 2023
Anticipated Primary Completion Date :
Jan 20, 2024
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Gingival phenotype change [at baseline 3,6 and 12 months]

    determination of the change in gingival thickness in mm using periodontal probe

Secondary Outcome Measures

  1. Keratinized tissue width [at baseline 3,6 and 12 months]

    determination of Keratinized tissue width in mm using periodontal probe

  2. Root coverage esthetic score (RES) [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of oral and dental medicine, Misr international university Cairo Egypt 12345

Sponsors and Collaborators

  • Misr International University

Investigators

  • 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
  • Principal Investigator: Yahia Amer, Lecturer, Lecturer, faculty of oral and dental medicine misr international universit

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Misr International University
ClinicalTrials.gov Identifier:
NCT05688293
Other Study ID Numbers:
  • PER 5213005
First Posted:
Jan 18, 2023
Last Update Posted:
Jan 18, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 18, 2023