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Tunneling Technique in Treatment of Miller's Class III Gingival Recession

Primary Purpose

Gingival Recession

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
group A (Tunnel procedure with subepithelial connective tissue graft (sCTG)
group B (Tunnel procedure with modified free gingival graft (mFGG))
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

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Patients with healthy systemic condition.
  2. Buccal recession defects classified as Miller class III.
  3. Clinical indication and/or patient request for recession coverage.
  4. O'Leary index less than 20%.

Exclusion Criteria:

  1. Pregnant females.
  2. Smokers as smoking is a contraindication for any plastic periodontal surgery.
  3. Unmotivated, uncooperative patients with poor oral hygiene
  4. Patients with habits that may compromise the longevity and affect the result of the study as alcoholism or para-functional habits.

Sites / Locations

  • Cairo university

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

group A

group B

Arm Description

tunnel procedure with subepithelial connective tissue graft (sCTG)

tunnel procedure with modified free gingival graft (mFGG)

Outcomes

Primary Outcome Measures

root coverage aesthetic score (RES)
RES evaluated five variables 6 months: gingival margin (GM), marginal tissue contour (MTC), soft tissue texture (STT), MGJ alignment, and gingival color (GC). Zero, 3, or 6 points were used for the evaluation of the position of the gingival margin, whereas a score of 0 or 1 point was used for each of the other variables. The ideal esthetic score was 10. Zero points were assigned if the final position of the gingival margin was equal or apical to the previous recession depth (failure of root coverage procedure), irrespective of color, the presence of a scar, MTC, or MGJ. Zero points were also assigned when a partial or total loss of interproximal papilla (black triangle) occurred following the treatment

Secondary Outcome Measures

recession depth
Measured from the cemento-enamel junction the most apical extension of the gingival margin.

Full Information

First Posted
June 26, 2018
Last Updated
September 4, 2018
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03657706
Brief Title
Tunneling Technique in Treatment of Miller's Class III Gingival Recession
Official Title
Analysis of the Aesthetic Outcome After Root Coverage Using Tunneling Technique With Subepithelial Connective Tissue Graft Versus Tunneling Technique With Modified Free Gingival Graft in Miller's Class III Recession Defect: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 15, 2018 (Actual)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
October 2020 (Anticipated)

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Several surgical techniques have been proposed to correct recession defect and attain root coverage. Though, the majority were executed on Miller Class I and II recession defects. Moreover, Analysis of literature revealed only a few studies that treated miller class III recession defects. In the current study, a new modification in the free gingival graft is proposed to provide the patient with more esthetic outcome, less pain and postoperative trauma. Likewise, the proposed graft modification will combined both FGG and CTG benefits, overcome the limitations of the FGG and enhances the advantages of CTG.
Detailed Description
In the current study, patients with Miller's class III will be randomly allocated in two groups. In the first group, gingival recession will be treated by tunneling technique with subepithelial connective tissue graft (sCTG). the tunnel preparation will be performed in the recession site then the sCTG will be harvested from the palate and inserted in the prepared tunnel and sutured in a coronally advanced position. Equally , the second group will be treated with modified free gingival graft (mFGG). Initially, after tunnel preparation in the recession site and harvesting of the free gingival graft,the proposed modification is performed by mimicking the recession defect shape and size leaving the rest of the free gingival graft deepithelialized and inserted in the prepared tunnel. then, suturing will be performed in a coronally advanced position.

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
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group A
Arm Type
Active Comparator
Arm Description
tunnel procedure with subepithelial connective tissue graft (sCTG)
Arm Title
group B
Arm Type
Active Comparator
Arm Description
tunnel procedure with modified free gingival graft (mFGG)
Intervention Type
Procedure
Intervention Name(s)
group A (Tunnel procedure with subepithelial connective tissue graft (sCTG)
Other Intervention Name(s)
Tunnel procedure with subepithelial connective tissue graft (sCTG), Autogenous sCTG will be used with tunnel procedure
Intervention Description
Subepithelial connective tissue graft (autogenous graft) will be harvested from the palate by Single incision technique to be used with the prepared tunnel to treating gingival recession
Intervention Type
Procedure
Intervention Name(s)
group B (Tunnel procedure with modified free gingival graft (mFGG))
Other Intervention Name(s)
Tunnel procedure with modified free gingival graft (mFGG), Autogenous mFGG will be used with tunnel procedure
Intervention Description
modified free gingival graft (autogenous graft) will be harvested from the palate and will be used with the prepared tunnel to be used in treating gingival recession
Primary Outcome Measure Information:
Title
root coverage aesthetic score (RES)
Description
RES evaluated five variables 6 months: gingival margin (GM), marginal tissue contour (MTC), soft tissue texture (STT), MGJ alignment, and gingival color (GC). Zero, 3, or 6 points were used for the evaluation of the position of the gingival margin, whereas a score of 0 or 1 point was used for each of the other variables. The ideal esthetic score was 10. Zero points were assigned if the final position of the gingival margin was equal or apical to the previous recession depth (failure of root coverage procedure), irrespective of color, the presence of a scar, MTC, or MGJ. Zero points were also assigned when a partial or total loss of interproximal papilla (black triangle) occurred following the treatment
Time Frame
6 months
Secondary Outcome Measure Information:
Title
recession depth
Description
Measured from the cemento-enamel junction the most apical extension of the gingival margin.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with healthy systemic condition. Buccal recession defects classified as Miller class III. Clinical indication and/or patient request for recession coverage. O'Leary index less than 20%. Exclusion Criteria: Pregnant females. Smokers as smoking is a contraindication for any plastic periodontal surgery. Unmotivated, uncooperative patients with poor oral hygiene Patients with habits that may compromise the longevity and affect the result of the study as alcoholism or para-functional habits.
Facility Information:
Facility Name
Cairo university
City
Giza
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
all the study records may be shared except that include participant name or personal information identifiers

Learn more about this trial

Tunneling Technique in Treatment of Miller's Class III Gingival Recession

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