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

Primary Purpose

Gingival Recession

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Tunneling with laser de-epithelized gingival graft
Tunnelingwith subepithelial connective tissue graf
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • CairoU

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Tunneling with laser de-epithelized gingival graft.

Tunnelingwith subepithelial connective tissue graft.

Arm Description

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.

Outcomes

Primary Outcome Measures

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)].

Secondary Outcome Measures

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.
Keratinized tissue width gain
Will be measured by a periodontal probe from the gingival margin to the mucogingival junction, at the mid buccal area.
Probing depth
Will be measured by a periodontal probe from the base of sulcus/pocket to the gingival margin mid- buccally.
Clinical attachment level gain
Will be measured by a periodontal probe from the base of sulcus/pocket to the cement enamel junction mid- buccally.
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.
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.

Full Information

First Posted
October 17, 2019
Last Updated
August 2, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04133298
Brief Title
Evaluation of SECTG Vs. Laser-DGG in Management of Gingival Recessions.
Official Title
Evaluation of Tunneling Technique With Subepithelial Connective Tissue Graft Vs. Laser De-epithelialized Gingival Graft in Management of Multiple Cairo RT-2 Gingival Recessions.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
June 1, 2023 (Actual)
Study Completion Date
June 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
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.
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tunneling with laser de-epithelized gingival graft.
Arm Type
Active Comparator
Arm Description
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 .
Arm Title
Tunnelingwith subepithelial connective tissue graft.
Arm Type
Active Comparator
Arm Description
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
Intervention Name(s)
Tunneling with laser de-epithelized gingival graft
Intervention Description
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
Intervention Name(s)
Tunnelingwith subepithelial connective tissue graf
Intervention Description
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
Primary Outcome Measure Information:
Title
Gingival Thickness gain
Description
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
Secondary Outcome Measure Information:
Title
root coverage gain
Description
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
Title
Keratinized tissue width gain
Description
Will be measured by a periodontal probe from the gingival margin to the mucogingival junction, at the mid buccal area.
Time Frame
6 month
Title
Probing depth
Description
Will be measured by a periodontal probe from the base of sulcus/pocket to the gingival margin mid- buccally.
Time Frame
6 month
Title
Clinical attachment level gain
Description
Will be measured by a periodontal probe from the base of sulcus/pocket to the cement enamel junction mid- buccally.
Time Frame
6 month
Title
Post-operative pain score
Description
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
Title
Patient satisfaction
Description
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

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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. Smokers. Pregnancy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Akawi
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
CairoU
City
Cairo
Country
Egypt

12. IPD Sharing Statement

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

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