Gingival Recession (RT1) Treatment With Different Gingival Augmentation Surgeries

Misr International University

Status: Enrolling

Conditions: Gingival Recession

Treatments: Procedure: Free gingival graft; Procedure: Connective tissue graft; Procedure: Non surgical

Study type: Interventional

Funder types: Other

Identifiers

NCT05688293

PER 5213005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 3 patient groups

Connective tissue graft

Active Comparator group

Description:

Patients will receive non-surgical periodontal treatment and connective tissue graft using tunneling technique

Treatment:

Procedure: Connective tissue graft

Free gingival Graft

Active Comparator group

Description:

Patients will receive non-surgical periodontal treatment and partially de-epithelized free gingival graft

Treatment:

Procedure: Free gingival graft

Non surgical procedure

Active Comparator group

Description:

Patients will receive non-surgical periodontal treatment only

Treatment:

Procedure: Non surgical