Laterally Closed Tunnel VS Tunneling Technique in Recession Type 2

November 30, 2023 updated by: Yahya Hassan El Banna Amer, Cairo University

Clinical Efficacy of Laterally Closed Tunnel With Subepithelial Connective Tissue Graft Versus Tunneling Technique With Subepithelial Connective Tissue Graft in Isolated Recession Type 2; Randomized Clinical Trial

This study aims to assess the effect of tunneling technique with subepithelial connective tissue graft versus tunneling technique with laterally closed tunnel in treatment of recession type 2 defect.Few randomized clinical trial has been involved with recession type 2 defects treated with tunneling technique and coronal advanced flap.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Tunneling with subepithelial connective tissue graft:

At the recipient site (recession defect):

After scaling and root planning. A sulcular incision is made through the gingival margin and extends post the mucogingival line leaving the interdental papilla intact.

At donor site (palate):

A connective tissue graft is harvested from the palate after administration of local anesthesia using a partial thickness flap which will be raised with single incision.

Then the graft is placed and secured in the recipient site using suture. The flap is displaced to be in a coronal position using a suture.

Tunneling technique with the laterally closed tunnel):

After local anesthesia, root planing of the exposed root surface will be performed. An intrasulcular incisions will be made creating a tunnel extending to the mucogingival line and mesial and distal recession defects while keeping the interdental papilla intact as well as not perforating the flap.

  • Donor SCTG Subsequently, a palatal SCTG will be harvested by means of the single incision technique with immediate closure of the donor site.
  • Recipient site; Using either single or mattress sutures, the SCTG will be pulled and fixed mesially and distally at the inner aspect of the pouch. The graft will be adapted to the CEJ by means of a sling suture. Finally, the margins of the pouch will be pulled together over the graft and sutured with interrupted sutures to accomplish tension-free complete or partial coverage of the graft as well as the denuded root surface.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Almanyal , Cairo
      • Cairo, Almanyal , Cairo, Egypt, 12613
        • Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients 18 years or older.
  • Patients with healthy systemic condition
  • Buccal recession defects with recession type 2 defects.
  • Clinical indication and/or patient request for recession coverage.
  • O'Leary index less than 20%

Exclusion Criteria:

  • Pregnant females.
  • Smokers as it 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A : Lateral closed Tunnel

Laterally closed tunnel procedure with subepithelial connective tissue graft (sCTG) After local anesthesia, root planing will be performed. Recession defect - a tunneling technique will be prepared using sulcular incision is made through the gingival margin and extends post the mucogingival line leaving the interdental papilla intact.

• Recipient site; Using either single or mattress sutures, the graft will be pulled and fixed mesially and distally at the inner aspect of the pouch. The graft will be adapted to the CEJ by means of a sling suture. Margins of the pouch will be pulled together over the graft and sutured with interrupted sutures to accomplish tension-free complete or partial coverage of the graft as well as the denuded root surface.
Procedure: Group A (Lateral closed tunnel subepithelial CT graft)
Subepithelial connective tissue graft (autogenous graft) will be harvested from the palate by Single incision technique to be used with the adjacent teeth to treating gingival recession with edges of the recession sutured together after placing connective tissue graft
Active Comparator: Group B : Tunneling

Tunnel procedure with subepithelial connective tissue graft (sCTG) - Control:

At the recipient site (recession defect): a tunneling technique will be prepared using sulcular incision is made through the gingival margin and extends post the mucogingival line leaving the interdental papilla intact.

Then the graft is placed and secured in the recipient site. The flap is displaced to be in a coronal position using a sling suture with no suturing to approximate the margins together.
Procedure: Group B (Tunnel procedure with subepithelial CT graft)
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
Other Names:
  • Autogenous sCTG will be used with tunnel procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction Recession Depth
Time Frame: 6 month
recession depth measured from CEJ to the gingival margin in a cross-section at the central buccal site.
6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage complete root coverage
Time Frame: 6 month
(Preoperative vertical recession -- Postoperative vertical recession/preoperative vertical recession) x 100
6 month
Gingival recession depth.
Time Frame: 6 month
Measured as the distance between the gingival margin and the mucogingival junction
6 month
Gingival recession width
Time Frame: 6 month
Measured as the distance between the gingival margin adjacent to the defect
6 month
Root coverage esthetic score (RES)
Time Frame: 6 month
system used to evaluated five variables 6 months gingival margin (GM), marginal tissue contour (MTC), soft tissue texture (STT), MGJ alignment, and gingival color (GC).
6 month
Probing depth
Time Frame: 6 month
Measured from the gingival margin to the bottom of the gingival sulcus
6 month
Clinical attachment level
Time Frame: 6 month
Measured from the CEJ to the bottom of the gingival sulcus.
6 month
Width of keratinized tissue
Time Frame: 6 month
Measured as the distance between the gingival margin and the mucogingival junction
6 month
Gingival thickness
Time Frame: 6 month
The measurement of Gingival tissue thickness is performed 2 mm apical from the gingival margin.
6 month
Post-operative pain
Time Frame: 2 weeks
Visual Analogue Scale (VAS) with numbers from 0 to 10 ('no pain' to 'worst' pain imaginable)
2 weeks
Post-Surgical Patient Satisfaction Questionnaire
Time Frame: 6 month
A 3-item questionnaire is asked and the patients shall use a 7-point answer scale. The answers were given on a 7-point scale ranging from 1 ''not at all'' to 7 ''very likely''
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Director: Hani El-Nahass, PhD, Cairo University
  • Study Chair: Manal Hosny, PhD, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2020

Primary Completion (Actual)

March 16, 2021

Study Completion (Actual)

September 1, 2021

Study Registration Dates

First Submitted

December 15, 2018

First Submitted That Met QC Criteria

December 30, 2018

First Posted (Actual)

January 2, 2019

Study Record Updates

Last Update Posted (Estimated)

December 6, 2023

Last Update Submitted That Met QC Criteria

November 30, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Perio2414

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

I will check with my Study Chair

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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