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

Gingival Recession Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03657706
• Other study ID #: CEBD-CU-2018-06-34
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 15, 2018
• Est. completion date: October 2020

Study information

• Verified date: September 2018
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 22
• Est. completion date: October 2020
• Est. primary completion date: June 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gingival Recession

Intervention

Procedure:
• 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
• 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

Locations

Country	Name	City	State
Egypt	Cairo university	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 months
Secondary	recession depth	Measured from the cemento-enamel junction the most apical extension of the gingival margin.	6 months