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

NCT ID: NCT06615687

Last Updated: 2024-09-26

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-31

Study Completion Date

2025-08-31

Brief Summary

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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?

Detailed Description

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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

Participants

Study Groups

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Inverted T -Shape Free Gingival Graft

Group Type EXPERIMENTAL

Inverted T shape Free Gingival Graft

Intervention Type 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

Free Gingival Graft

Group Type ACTIVE_COMPARATOR

Free Gingival Graft

Intervention Type 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.

Interventions

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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

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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. -
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 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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Dina Galal Fouad Mohamed Hafeez

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dina Galal Hafeez, Bachelor

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Manar El-Zanaty, lecturer

Role: STUDY_CHAIR

Cairo University

Noha Ghallab, Professor

Role: STUDY_DIRECTOR

Cairo University

Locations

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Faculty of Dentistry, Cairo university

Cairo, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Dina Galal Hafeez

Role: CONTACT

+201223996994

Manar El-zanaty

Role: CONTACT

+201001775660

Facility Contacts

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Dina Galal Hafeez

Role: primary

+201223996994

Other Identifiers

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Dgalal33724

Identifier Type: -

Identifier Source: org_study_id

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