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

NCT06615687 | Not Yet Recruiting

• 1 other identifier: Dgalal33724
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

Gingival Recession

Keywords

Inverted T-shape Free Gingival Graft; Gingival Recession; Free Gingival Graft

Outcome Measures

Primary Outcomes (1)

• Recession depth.

  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 Outcomes (8)

• Width of keratinized gingiva .

  baseline, 1 month , 3 months and 6 months

• Recession width

  baseline, 1 month , 3 months and 6 months

• Gingival thickness

  baseline, 1 month , 3 months and 6 months

• Root coverage esthetic score

  baseline, 1 month , 3 months and 6 months

• The Distance between the contact point and the top of the papilla (DCP).

  baseline, 1 month , 3 months and 6 months

Study Arms (2)

Inverted T -Shape Free Gingival Graft

EXPERIMENTAL

Procedure: Inverted T shape Free Gingival Graft

Free Gingival Graft

ACTIVE COMPARATOR

Procedure: Free Gingival Graft

Interventions

Inverted T shape Free Gingival Graft PROCEDURE

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

Inverted T -Shape Free Gingival Graft

Free Gingival Graft PROCEDURE

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.

Free Gingival Graft

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo university

Cairo, Egypt

Location

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Officials

• Dina Galal Hafeez, Bachelor

  Cairo University

  PRINCIPAL INVESTIGATOR

• Manar El-Zanaty, lecturer

  Cairo University

  STUDY CHAIR

• Noha Ghallab, Professor

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Dina Galal Hafeez

CONTACT

+201223996994; dina.hafeez@dentistry.cu.edu.eg

Manar El-zanaty

CONTACT

+201001775660; manar.elzanaty@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 14, 2024
• First Posted: September 26, 2024
• Study Start: October 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: August 1, 2025
• Last Updated: September 26, 2024

Record last verified: 2024-09

Locations

EG (1)