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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06615687
Enrollment
34
Registered
2024-09-26
Start date
2024-10-31
Completion date
2025-08-31
Last updated
2024-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingival Recession

Keywords

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

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?

Interventions

PROCEDUREInverted 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

PROCEDUREFree 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.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

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. -

Design outcomes

Primary

MeasureTime frameDescription
Recession depth.baseline, 1 month , 3 months and 6 monthsWill be measured as the distance from the CEJ to the most apical extension of the gingival margin.

Secondary

MeasureTime frameDescription
Recession widthbaseline, 1 month , 3 months and 6 monthsWill be measured as the distance from mesial and distal papillae along the CEJ
Gingival thicknessbaseline, 1 month , 3 months and 6 monthsAn 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
Root coverage esthetic scorebaseline, 1 month , 3 months and 6 monthsThe 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.
Width of keratinized gingiva .baseline, 1 month , 3 months and 6 monthsWill be measured from the MGJ to the free gingival margin. The MGJ will be identified using the roll technique.
Probing Depthbaseline, 1 month , 3 months and 6 monthsThe 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.
Gingival Indexbaseline, 1 month , 3 months and 6 months0 Normal gingiva. 1. Mild inflammation. 2. Moderate inflammation. 3. Severe inflammation.
Plaque Indexbaseline, 1 month , 3 months and 6 months0 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.
The Distance between the contact point and the top of the papilla (DCP).baseline, 1 month , 3 months and 6 monthsMeasured as the distance between contact point and the tip of the papilla (DCP) in mms using UNC periodontal probe .

Countries

Egypt

Contacts

Primary ContactDina Galal Hafeez
dina.hafeez@dentistry.cu.edu.eg+201223996994
Backup ContactManar El-zanaty
manar.elzanaty@dentistry.cu.edu.eg+201001775660

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026