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

NCT ID: NCT03657706

Last Updated: 2018-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-15

Study Completion Date

2020-10-31

Brief Summary

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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

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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.

Conditions

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Gingival Recession

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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group A

tunnel procedure with subepithelial connective tissue graft (sCTG)

Group Type ACTIVE_COMPARATOR

group A (Tunnel procedure with subepithelial connective tissue graft (sCTG)

Intervention Type PROCEDURE

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

group B

tunnel procedure with modified free gingival graft (mFGG)

Group Type ACTIVE_COMPARATOR

group B (Tunnel procedure with modified free gingival graft (mFGG))

Intervention Type PROCEDURE

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

Interventions

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group A (Tunnel procedure with subepithelial connective tissue graft (sCTG)

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

group B (Tunnel procedure with modified free gingival graft (mFGG))

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

Intervention Type PROCEDURE

Other Intervention Names

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Tunnel procedure with subepithelial connective tissue graft (sCTG) Autogenous sCTG will be used with tunnel procedure Tunnel procedure with modified free gingival graft (mFGG) Autogenous mFGG will be used with tunnel procedure

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Nourhan Abdallah Abdelkhalek

Principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cairo university

Giza, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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CEBD-CU-2018-06-34

Identifier Type: -

Identifier Source: org_study_id

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