RecruitingNot ApplicableNCT07409558

3D Digital Assessment of Soft Tissue Changes After Modified FGG

Three-Dimensional Direct Digital Evaluation of Soft Tissue Volumetric Changes After Modified Free Gingival Graft Surgery: A Randomized Controlled Clinical Trial


Sponsor

Kahramanmaras Sutcu Imam University

Enrollment

34 participants

Start Date

Jan 4, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria8

  • 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 Criteria8

  • 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

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Interventions

PROCEDUREModified 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.

PROCEDUREConventional 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.


Locations(1)

Kahramanmaraş Sütçü İmam University

Kahramanmaraş, Kahramanmaraş, Turkey (Türkiye)

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NCT07409558


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