Gingival Recession (RT1) Treatment With Different Gingival Augmentation Surgeries

NCT05688293 — Not applicable, Recruiting, 30 participants, Misr International University

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

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

RegistryNCT05688293
StatusRecruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: double, treatment
Enrollment30 (Estimated)
SponsorMisr International University (Other)
ConditionsGingival Recession
InterventionsConnective tissue graft, Free gingival graft, Non surgical (Procedure)
Datesstart 2025-02-05, primary completion 2027-01-20 (estimated), completion 2027-03-01 (estimated), first posted 2023-01-18, last updated 2026-07-06
Locations1 site in Egypt

Related Papers Related Patents Related Grants Related Experts
All trials for Gingival Recession All trials of Connective tissue graft All trials of Free gingival graft

-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.

Expand all sections  ·  Collapse all

+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.

+Arms and interventions

ArmTypeInterventionsDescription
Connective tissue graftActive comparatorProcedure: Connective tissue graftPatients will receive non-surgical periodontal treatment and connective tissue graft using tunneling technique
Free gingival GraftActive comparatorProcedure: Free gingival graftPatients will receive non-surgical periodontal treatment and partially de-epithelized free gingival graft
Non surgical procedureActive comparatorProcedure: Non surgicalPatients will receive non-surgical periodontal treatment only
  • Connective tissue graft (Procedure): non-surgical periodontal treatment and connective tissue graft
  • Free gingival graft (Procedure): will receive non-surgical periodontal treatment and partially de-epithelized free gingival graft
  • Non surgical (Procedure): non-surgical periodontal treatment only

+Outcome measures

Primary outcomes

  • Gingival phenotype change [at baseline 3,6 and 12 months]: determination of the change in gingival thickness in mm using periodontal probe

Secondary outcomes

  • Keratinized tissue width [at baseline 3,6 and 12 months]: determination of Keratinized tissue width in mm using periodontal probe
  • 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

Sex: All, ages: 18 Years to 55 Years, accepts healthy volunteers

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

+Locations (1)

FacilityCityCountryStatus
Faculty of oral and dental medicine, Misr international universityCairoEgyptRecruiting

+Investigators

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