Clinical trial NCT06615687: Inverted T-shape Free Gingival Graft for Treatment of RT2 / RT3 Gingival Recession Defects
Official title: Inverted T-shape Free Gingival Graft Versus Free Gingival Graft for Treatment of RT2/RT3 Gingival Recession Defects : a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gingival Recession
Keywords: Inverted T-shape Free Gingival Graft
Gingival Recession
Free Gingival Graft
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-09-26
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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?


Eligibility criteria: 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) \&amp;amp;lt; 2 mm.
* Ages 18-40 years old.
* Patients with healthy systemic condition (Brightman. 1994).
* Gingival and plaque index \&amp;amp;lt;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. -

Primary outcomes:
measure: Recession depth.
timeFrame: baseline, 1 month , 3 months and 6 months
Secondary outcomes:
measure: Width of keratinized gingiva .
timeFrame: baseline, 1 month , 3 months and 6 months
measure: Recession width
timeFrame: baseline, 1 month , 3 months and 6 months
measure: Gingival thickness
timeFrame: baseline, 1 month , 3 months and 6 months
measure: Root coverage esthetic score
timeFrame: baseline, 1 month , 3 months and 6 months
measure: The Distance between the contact point and the top of the papilla (DCP).
timeFrame: baseline, 1 month , 3 months and 6 months
measure: Probing Depth
timeFrame: baseline, 1 month , 3 months and 6 months
measure: Gingival Index
timeFrame: baseline, 1 month , 3 months and 6 months
measure: Plaque Index
timeFrame: baseline, 1 month , 3 months and 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Cairo university
Study officials:
affiliation: Cairo University
name: Dina Galal Hafeez, Bachelor
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Manar El-Zanaty, lecturer
role: STUDY_CHAIR
affiliation: Cairo University
name: Noha Ghallab, Professor
role: STUDY_DIRECTOR
References: