Evaluation of SECTG Vs. Laser-DGG in Management of Gingival Recessions.

NCT ID: NCT04133298

Last Updated: 2023-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2023-06-01

Brief Summary

This study evaluates laser de-epithelialized gingival graft to be as effective as subepithelial connective tissue graft in management of multiple gingival recessions using tunneling technique. half pf participants will be treated from gingival recession using tunneling technique with laser de-epithelized gingival graft, while the other half will be treated using tunneling technique with subepithelial connective tissue graft.

Detailed Description

Tunneling technique is a minimal invasive method for coronal advancement during gingival recession coverage. The technique provide better blood supply which enhances wound healing and results in successful root coverage and attachment gain. Tunneling technique is suggested to be incorporated with a soft tissue tissue for better recipient site outcome.

In a systemic review and meta-analysis conducted in 2019 there was limited evidence available comparing subepithelial connective tissue graft to the de-epithelialized gingival graft. However the de-epithelialized gingival graft showed superior mean root coverage, keratinized tissue gain and clinical attachment gain over the subepithelial connective tissue graft making it the technique of choice when incorporated with coronal advancement flap in treatment of gingival recession. Laser de-epithelization may enrich the advantages of the conventional de-epithelization method where more uniform predictable epithelization can be obtained.

Conditions

Gingival Recession

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Tunneling with laser de-epithelized gingival graft.

After the administration of local anesthesia, the dimension of the needed graft will be marked by a #15c blade and then diode laser de-epithelization will take place. The de-epithelized area will be then harvested using a # 15c blade. The donor site will be covered by cyanoacrylate tissue adhesive dressing .

Group Type: ACTIVE_COMPARATOR

Tunneling with laser de-epithelized gingival graft

Intervention Type: PROCEDURE

After the administration of local anesthesia, the dimension of the needed graft will be marked by a #15c blade and then diode laser de-epithelization will take place. The de-epithelized area will be then harvested using a # 15c blade. The donor site will be covered by cyanoacrylate tissue adhesive dressing .

Tunnelingwith subepithelial connective tissue graft.

After administration of local anesthesia. A single incision will be made to the bone in a horizontal direction 3mm apical to the gingival margin of the maxillary teeth. The length of the incision will be determined by the dimensions of the graft required. A partial-thickness dissection will be then made within the single incision aiming to harvest an average thickness of two mm subepithelial connective tissue. Then, the graft will be carefully elevated from the palate with the use of the blade. Primary closure will be obtained using 4-0 polyglycolic acid.

Group Type: ACTIVE_COMPARATOR

Tunnelingwith subepithelial connective tissue graf

Intervention Type: PROCEDURE

After administration of local anesthesia. A single incision will be made to the bone in a horizontal direction 3mm apical to the gingival margin of the maxillary teeth. The length of the incision will be determined by the dimensions of the graft required. A partial-thickness dissection will be then made within the single incision aiming to harvest an average thickness of two mm subepithelial connective tissue. Then, the graft will be carefully elevated from the palate with the use of the blade. Primary closure will be obtained using 4-0 polyglycolic acid

Interventions

Tunneling with laser de-epithelized gingival graft

After the administration of local anesthesia, the dimension of the needed graft will be marked by a #15c blade and then diode laser de-epithelization will take place. The de-epithelized area will be then harvested using a # 15c blade. The donor site will be covered by cyanoacrylate tissue adhesive dressing .

Intervention Type: PROCEDURE

Tunnelingwith subepithelial connective tissue graf

After administration of local anesthesia. A single incision will be made to the bone in a horizontal direction 3mm apical to the gingival margin of the maxillary teeth. The length of the incision will be determined by the dimensions of the graft required. A partial-thickness dissection will be then made within the single incision aiming to harvest an average thickness of two mm subepithelial connective tissue. Then, the graft will be carefully elevated from the palate with the use of the blade. Primary closure will be obtained using 4-0 polyglycolic acid

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Anterior teeth and premolars with multiple Miller's Class I and II gingival recessions.

2. Identifiable cemento-enamel junction.

3. The teeth with gingival recessions are vital teeth.

4. Plaque Index and Gingival bleeding index less than 20% after phase one therapy.

Exclusion Criteria

1. Patients with systemic diseases and medical conditions that may affect the treatment outcomes.

2. Prosthetic crown, restoration or tooth decay involving the CEJ.

3. Previous periodontal surgery in the area of interest.

4. Smokers.

5. Pregnancy.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Gamal

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed Akawi

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

CairoU

Cairo, , Egypt

Countries

Egypt

Other Identifiers

25354999

Identifier Type: -

Identifier Source: org_study_id