3D Digital Assessment of Soft Tissue Changes After Modified FGG

February 12, 2026 updated by: Esra Bozkurt, Kahramanmaras Sutcu Imam University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Keratinized tissue deficiency and gingival recession are common mucogingival problems that may compromise periodontal health, esthetics, and patient comfort. Soft tissue grafting procedures are widely used to increase tissue thickness and volume and to achieve keratinized tissue augmentation. Among autogenous grafting techniques, free gingival grafts (FGG) are considered a predictable and reliable approach for enhancing soft tissue stability and long-term marginal tissue outcomes.

Despite their effectiveness, conventional FGG procedures may exhibit postoperative shrinkage and volume reduction due to limited vascularization at the recipient site. To overcome this limitation, a modified free gingival graft (ModFGG) technique has recently been introduced. In this technique, a connective tissue pedicle flap harvested from the apical region of the recession defect is used to cover the exposed root surface prior to placement of the free gingival graft, with the aim of improving graft vascularization and enhancing wound healing. Although previous studies have reported favorable outcomes for ModFGG in terms of root coverage, keratinized tissue gain, and patient satisfaction, available evidence is largely based on two-dimensional clinical measurements.

Conventional methods used to assess soft tissue changes, such as periodontal probing, needles, and ultrasonic devices, are either invasive or limited to linear measurements, thereby restricting the evaluation of volumetric tissue alterations. Recent advances in three-dimensional digital analysis techniques allow for reliable, non-invasive, and reproducible assessment of both linear and volumetric soft tissue changes. However, to date, no clinical study has evaluated soft tissue thickness, volumetric changes, and creeping attachment following conventional FGG and ModFGG procedures in mandibular incisors using direct three-dimensional digital analysis.

This randomized controlled clinical trial aims to compare the effects of conventional free gingival graft and modified free gingival graft techniques on soft tissue thickness, volumetric changes, and creeping attachment in mandibular incisors using a direct three-dimensional digital evaluation method. Systemically healthy, non-smoking adult patients presenting with localized Cairo Class II gingival recession will be enrolled and randomly allocated to either the FGG (control) group or the ModFGG (test) group.

Clinical and digital assessments will be performed at baseline and at 1, 3, and 6 months postoperatively. Soft tissue thickness and volumetric changes will be analyzed by superimposing digital models obtained using an intraoral scanner. Additional clinical parameters, including gingival recession depth, width of keratinized tissue, and probing depth, will also be recorded. The results of this study are expected to provide high-quality evidence regarding the effectiveness of the modified free gingival graft technique in enhancing soft tissue stability and volumetric outcomes in periodontal plastic surgery.

Study Type

Interventional

Enrollment (Estimated)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
    • Kahramanmaraş
      • Kahramanmaraş, Kahramanmaraş, Turkey (Türkiye), 46000
        • Recruiting
        • Kahramanmaraş Sütçü İmam University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Modified Free Gingival Graft (ModFGG)

Participants in this arm will receive a modified free gingival graft (ModFGG) procedure.

A connective tissue pedicle flap will be prepared from the apical area of the recession defect and rotated coronally to cover the exposed root surface. A free gingival graft harvested from the palatal donor site will then be placed over the recipient area to enhance graft vascularization, soft tissue thickness, and volumetric stability.
Procedure: 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.
Active Comparator: Conventional Free Gingival Graft (FGG)

Participants in this arm will receive a conventional free gingival graft (FGG) procedure.

A free gingival graft harvested from the palatal donor site will be placed onto a prepared recipient bed without the use of a connective tissue pedicle flap.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Soft Tissue Volumetric Changes
Time Frame: 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.
Baseline, 1 month, 3 months, and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Creeping Attachment
Time Frame: Baseline, 1 month, 3 months, and 6 months
Creeping attachment will be assessed by linear measurements of coronal migration of the gingival margin relative to the baseline position using calibrated digital images and software analysis.
Baseline, 1 month, 3 months, and 6 months
Soft Tissue Thickness Gain
Time Frame: Baseline and 6 months postoperatively
Soft tissue thickness will be assessed using three-dimensional direct digital analysis by superimposing intraoral scanner-derived STL files. Horizontal soft tissue thickness measurements will be performed at 1 mm, 3 mm, and 5 mm apical to the baseline gingival margin. Soft tissue thickness gain will be calculated as the difference between baseline and 6-month measurements.
Baseline and 6 months postoperatively
Gingival Recession Depth
Time Frame: Baseline, 1 month, 3 months, and 6 months
Gingival recession depth will be measured as the distance from the cemento-enamel junction to the gingival margin using calibrated digital photographs.
Baseline, 1 month, 3 months, and 6 months
Width of Keratinized Tissue
Time Frame: Baseline, 1 month, 3 months, and 6 months
The width of keratinized tissue will be measured from the gingival margin to the mucogingival junction following iodine staining.
Baseline, 1 month, 3 months, and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kahramanmaras Sutcu Imam University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

February 5, 2026

First Submitted That Met QC Criteria

February 12, 2026

First Posted (Actual)

February 13, 2026

Study Record Updates

Last Update Posted (Actual)

February 13, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025/01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The collected data include detailed clinical and digital intraoral scan records that may compromise participant privacy and confidentiality. In addition, informed consent for public data sharing was not obtained from participants.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gingival Recession, Localized

Clinical Trials on Modified Free Gingival Graft (ModFGG)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kazakhstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe