3D Digital Assessment of Soft Tissue Changes After Modified FGG

NCT07409558 · tracked via the Priya Life Science Turkey tracker

Sponsor

Kahramanmaras Sutcu Imam University

Phase

Not applicable

Started

2025-01-04

Last updated

2026-02-13

Condition(s) studied

Gingival Recession, LocalizedSoft Tissue Volume ChangesKeratinized Tissue Deficiency

Investigational drug(s) / intervention(s)

Modified Free Gingival Graft (ModFGG)Conventional Free Gingival Graft (FGG)

Modified Free Gingival Graft (ModFGG): A connective tissue pedicle flap is prepared from the apical area of the gingival recession defect and rotated coronally to cover the exposed root surface. Subsequently, a free gingival graft harvested from the palatal donor site is placed over the recipient area to enhance graft vascularization, soft tissue thickness, and volumetric stability.

Conventional Free Gingival Graft (FGG): A free gingival graft harvested from the palatal donor site is placed onto a prepared recipient bed without the use of a connective tissue pedicle flap.

Study summary

The aim of this randomized controlled clinical trial is to evaluate the effects of conventional free gingival graft (FGG) and modified free gingival graft (ModFGG) techniques on soft tissue thickness, volumetric change, and creeping attachment in mandibular incisors using three-dimensional direct digital analysis. The study will include a total of 34 systemically healthy, non-smoking individuals with localized Cairo Class II gingival recession. Participants will be randomly assigned to the FGG (control) and ModFGG (test) groups. Clinical measurements will be performed before surgery and at 1, 3, and 6 months post-surgery. Soft tissue thickness and volumetric changes will be analyzed three-dimensionally by overlaying digital models obtained with an intraoral scanner. Gingival recession depth, keratinized tissue height, and creeping attachment will also be assessed. The aim is to provide clinical evidence regarding the effects of the modified free gingival graft technique on soft tissue stability and volumetric gains.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Age 18 years or older * Systemically healthy individuals * Non-smokers * Presence of localized Cairo Class II gingival recession with a vertical recession depth of ≥3 mm on the buccal surfaces of mandibular incisors * Probing pocket depth of ≤3 mm at the tooth/teeth to be treated * No tooth mobility (mobility grade ≤1) * Absence of cervical composite restorations or non-carious cervical lesions * Presence of a shallow vestibule (\<5 mm) Exclusion Criteria: * Pregnancy or lactation * Untreated periodontal disease * Presence of parafunctional habits * Poor oral hygiene, defined as a full-mouth plaque score \>20% * Malpositioned, rotated, or crowded teeth in the buccal position * Known systemic diseases (e.g., acquired immunodeficiency syndrome, diabetes mellitus) * Any condition or medication that may affect gingival wound healing * ASA physical status classification III or higher

Primary outcome measure(s)

Soft Tissue Volumetric Changes — Baseline, 1 month, 3 months, and 6 months
Volumetric changes of the recipient site will be evaluated using three-dimensional digital models obtained with an intraoral scanner. Volumetric differences will be calculated by superimposing follow-up scans (1, 3, and 6 months) onto the baseline reference model.

Trial sites (1)

Facility	City	Region	Status
Kahramanmaraş Sütçü İmam University	Kahramanmaraş	Kahramanmaraş	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07409558 on ClinicalTrials.gov ↗ ← All trials in Turkey