An interventional study of Tunneling with laser de-epithelized gingival graft and Tunnelingwith subepithelial connective tissue graf in Gingival Recession, sponsored by Cairo University. Completed at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2023-08-03.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
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.
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.
402 studies on the registry are indexed under Gingival Recession; 98 are open to participants now.
This study's enrollment of 22 is below the median of 30 across 368 interventional studies indexed under Gingival Recession.
Browse Gingival Recession studies →Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Exclusion Criteria:
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
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
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 .
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
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, \[Gingival thickness gain (mm) = volume (mm3) / area (mm2)\].
Time frame: 6 month
root coverage gain
it will be calculated digitally by comparing base line digital impression to a 6 month postsurgical digital impression. A digital ruler will be used to measure the distance from gingival margin to the cemento-enamel junction on a point mid-buccally pre-surgically then post-surgically. The digital measurements will be taken to nearest 0.01mm. Mean of root coverage and its percentage will be calculated. Mean root coverage will be measured in millimeters and percentage in percent.
Time frame: 6 month
Keratinized tissue width gain
Will be measured by a periodontal probe from the gingival margin to the mucogingival junction, at the mid buccal area.
Time frame: 6 month
Probing depth
Will be measured by a periodontal probe from the base of sulcus/pocket to the gingival margin mid- buccally.
Time frame: 6 month
Clinical attachment level gain
Will be measured by a periodontal probe from the base of sulcus/pocket to the cement enamel junction mid- buccally.
Time frame: 6 month
Post-operative pain score
Patients will be questioned in arabic after two weeks post-operative to assess pain, number of analgesic pills taken and number of days pills were taken. That will be assessed by visual analog scale (VAS) graduated from one to ten, where one indicates minimal pain and ten refers to severe pain.
Time frame: 2 weeks
Patient satisfaction
Patients will be questioned in arabic about the palatal wound after two weeks of the surgery. The questionnaire will include four graduated visual analog scales to describe pain intensity, hemorrhage intensity, fear of jeopardizing the palatal wound, their chewing ability, their willingness to perform the surgery another time if needed and their satisfaction about the esthetic outcome after the surgery. Graduation will be from one to ten, where one indicates minimal and ten refers to severe.
Time frame: 2 weeks
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Cairo University