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

NCT04133298 | Completed

• 1 other identifier: 25354999
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingival Recession

Outcome Measures

Primary Outcomes (1)

• Gingival Thickness gain

  it will be calculated based on volumetric difference of a defined area located on attached gingiva above the site to be corrected surgically, that is by taking a base line digital impression and superimpose it to another digital impression 6 month postoperatively. Buccal tooth surface will be used as a reference for the superimposition procedure. The digital measurements will be taken to nearest 0.01mm. Finally, gingival thickness gain will be calculated as the measured volume gain per measured area, \[Gingival thickness gain (mm) = volume (mm3) / area (mm2)\].

  6 month

Secondary Outcomes (6)

• root coverage gain

  6 month

• Keratinized tissue width gain

  6 month

• Probing depth

  6 month

• Clinical attachment level gain

  6 month

• Post-operative pain score

  2 weeks

Study Arms (2)

Tunneling with laser de-epithelized gingival graft.

ACTIVE COMPARATOR

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 .

Procedure: Tunneling with laser de-epithelized gingival graft

Tunnelingwith subepithelial connective tissue graft.

ACTIVE COMPARATOR

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.

Procedure: Tunnelingwith subepithelial connective tissue graf

Interventions

Tunneling with laser de-epithelized gingival graft 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 .

Tunneling with laser de-epithelized gingival graft.

Tunnelingwith subepithelial connective tissue graf 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

Tunnelingwith subepithelial connective tissue graft.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Anterior teeth and premolars with multiple Miller's Class I and II gingival recessions.
• Identifiable cemento-enamel junction.
• The teeth with gingival recessions are vital teeth.
• Plaque Index and Gingival bleeding index less than 20% after phase one therapy.

You may not qualify if:

• Patients with systemic diseases and medical conditions that may affect the treatment outcomes.
• Prosthetic crown, restoration or tooth decay involving the CEJ.
• Previous periodontal surgery in the area of interest.
• Smokers.
• Pregnancy.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

CairoU

Cairo, Egypt

Location

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Officials

• Mohamed Akawi

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: * Blinding of the participants is not applicable. * Blinding of the operator is not applicable. * The outcome assessor and biostatistician will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 17, 2019
• First Posted: October 21, 2019
• Study Start: March 1, 2020
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: August 3, 2023

Record last verified: 2023-08

Locations

EG (1)