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Clinical Trials/NCT04133298
NCT04133298CompletedNot Applicable

Evaluation of Tunneling Technique With Subepithelial Connective Tissue Graft Vs. Laser De-epithelialized Gingival Graft in Management of Multiple Cairo RT-2 Gingival Recessions.

Cairo University1 site in 1 country22 target enrollmentStarted: March 1, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
22
Locations
1
Primary Endpoint
Gingival Thickness gain

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Masking Description

  • Blinding of the participants is not applicable.
  • Blinding of the operator is not applicable.
  • The outcome assessor and biostatistician will be blinded.

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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.

Exclusion Criteria

  • •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.

Arms & Interventions

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 .

Intervention: Tunneling with laser de-epithelized gingival graft (Procedure)

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.

Intervention: Tunnelingwith subepithelial connective tissue graf (Procedure)

Outcomes

Primary Outcomes

Gingival Thickness gain

Time Frame: 6 month

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, \[Gingival thickness gain (mm) = volume (mm3) / area (mm2)\].

Secondary Outcomes

  • root coverage gain(6 month)
  • Clinical attachment level gain(6 month)
  • Post-operative pain score(2 weeks)
  • Patient satisfaction(2 weeks)
  • Keratinized tissue width gain(6 month)
  • Probing depth(6 month)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mohamed Gamal

Principal Investigator

Cairo University

Study Sites (1)

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