Inverted T-shape Free Gingival Graft for Treatment of RT2 / RT3 Gingival Recession Defects

September 25, 2024 updated by: Dina Galal Fouad Mohamed Hafeez, Cairo University

Inverted T-shape Free Gingival Graft Versus Free Gingival Graft for Treatment of RT2/RT3 Gingival Recession Defects : a Randomized Clinical Trial

The aim of this study is to compare the use of T-inverted shape Free Gingival Graft with Free Gingival Graft for improving the clinical attachment, gain partial root coverage, and improve Keratinized tissue width in recession type 2 /recession type 3 gingival recession defects .

Research question : In patients with RT2 / RT3 mandibular defects will the use of inverted T-shape free gingival graft differ from free gingival graft in Recession depth?

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

34

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 Contact Backup

Study Locations

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients with RT2/RT3 gingival recession.
  • Indication for FGG treatment at mandibular incisor area (i.e., difficulty or discomfort during oral hygiene; gingival margin mobility; high muscle attachment and/or frenum pull; shallow vestibule and gingival recession.
  • KT width (KTW) < 2 mm.
  • Ages 18-40 years old.
  • Patients with healthy systemic condition (Brightman. 1994).
  • Gingival and plaque index <10.
  • Good oral hygiene (Wiesner et al. 2010).
  • Accepts 6 months follow-up period (cooperative patients)

Exclusion Criteria:

  • Smokers.
  • Poor oral hygiene.
  • Patient with a physical disability that hinders the upkeep of good oral hygiene measures.
  • Intake of any medications known to affect gingival homeostasis or to interfere with wound healing.
  • Pregnant or lactating women.
  • RT1 gingival recession.
  • Caries or non-carious cervical lesions at recipient sites.
  • Severely malpositioned teeth.
  • Teeth with residual probing depth ≥ 4 mm.
  • Mobility ≥ 1 mm.
  • Pervious periodontal surgery within the last 6 months before the start of the trial.
  • Patients with active periodontal disease. -

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Free Gingival Graft
Procedure: Free Gingival Graft

Preparation of the recipient site :Following an intrasulcular incision, 2 mm-long horizontal incisions at the level of the CEJ will be performed bilaterally. From these, vertical releasing incisions will be placed in a diverging manner, extending well into the alveolar mucosa, a thin partial thickness flap will be subsequently raised then excised. The dimension of the resulting site will be measured to obtain a rectangular foil template .

Harvesting of the Graft :Using the foil template, graft dimensions will be outlined in the palate adjacent to the premolars and first molar. A partial thickness graft consisting of epithelium and a thin layer of underlying connective tissue will be harvested (intended total thickness of graft: 1.5 mm), maintaining a distance of ≥2 mm to the maxillary teeth.
Experimental: Inverted T -Shape Free Gingival Graft
Procedure: Inverted T shape Free Gingival Graft

the preparation of the recipient site commenced by making a horizontal incision at the mucogingival junction (MGJ) as well as two vertical incisions extending to the adjacent teeth and about 3-4 mm beyond the MGJ. A sharp split-thickness flap will be reflected, and the surfaces between these incisions will be de-epithelialized. Also, all the surfaces of the interdental papilla up to the lingual side will be de-epithelized using a 15c blade and microsurgical scissor .(Harvesting of the palatal donor site will be designed 2 mm away from the gingival margin using a template in the form of an inverted T-shape, taking into consideration the position of the greater palatine blood vessels at 5 mm. 2 mm is required for the width of the interproximal extension with 3 mm length to obtain an even thickness of 1-1.5 mm .

Placement of the graft : The Inverted T FGG will be inserted between the teeth to cover interproximal tissue defect and sutured lingually into the lingual marginal gingiva

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recession depth.
Time Frame: baseline, 1 month , 3 months and 6 months
Will be measured as the distance from the CEJ to the most apical extension of the gingival margin.
baseline, 1 month , 3 months and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Width of keratinized gingiva .
Time Frame: baseline, 1 month , 3 months and 6 months
Will be measured from the MGJ to the free gingival margin. The MGJ will be identified using the roll technique.
baseline, 1 month , 3 months and 6 months
Recession width
Time Frame: baseline, 1 month , 3 months and 6 months
Will be measured as the distance from mesial and distal papillae along the CEJ
baseline, 1 month , 3 months and 6 months
Gingival thickness
Time Frame: baseline, 1 month , 3 months and 6 months
An endodontic file and a 3 mm diameter silicon disc stop will be used to measure gingival thickness 2mm apical to the gingival border. The file will be inserted into the soft tissue with mild pressure, perpendicular to the mucosal surface, until a firm surface is felt. The silicon disc stop will be then pressed against the soft tissue, with the coronal border covering the soft tissue boundary.GT will be measured 2 mm apical from the gingival margin
baseline, 1 month , 3 months and 6 months
Root coverage esthetic score
Time Frame: baseline, 1 month , 3 months and 6 months
The RES system evaluated five variables 6 months following surgery: GM, marginal tissue contour (MTC), soft tissue texture (STT), MGJ alignment, and gingival color (GC). The clinical esthetic evaluation performed without magnification. 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.
baseline, 1 month , 3 months and 6 months
The Distance between the contact point and the top of the papilla (DCP).
Time Frame: baseline, 1 month , 3 months and 6 months
Measured as the distance between contact point and the tip of the papilla (DCP) in mms using UNC periodontal probe .
baseline, 1 month , 3 months and 6 months
Probing Depth
Time Frame: baseline, 1 month , 3 months and 6 months
The assessment of probing depth will be measured from the gingival margin to the bottom of the sulcus using a periodontal probe, rounded to the nearest millimeter.
baseline, 1 month , 3 months and 6 months
Gingival Index
Time Frame: baseline, 1 month , 3 months and 6 months

0 Normal gingiva.

  1. Mild inflammation.
  2. Moderate inflammation.
  3. Severe inflammation.
baseline, 1 month , 3 months and 6 months
Plaque Index
Time Frame: baseline, 1 month , 3 months and 6 months

0 No plaque in the gingival area.

  • 1 A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may only be recognized by running a probe across the tooth surface.
  • 2 Moderate accumulation of soft deposits within the gingival pocket, on the gingival margin and/or adjacent tooth surface, which can be seen by the naked eye.
  • 3 Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface.
baseline, 1 month , 3 months and 6 months

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Principal Investigator: Dina Galal Hafeez, Bachelor, Cairo University
  • Study Chair: Manar El-Zanaty, lecturer, Cairo University
  • Study Director: Noha Ghallab, Professor, Cairo University

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 (Estimated)

October 1, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

September 14, 2024

First Submitted That Met QC Criteria

September 25, 2024

First Posted (Actual)

September 26, 2024

Study Record Updates

Last Update Posted (Actual)

September 26, 2024

Last Update Submitted That Met QC Criteria

September 25, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dgalal33724

Drug and device information, study documents

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.

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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