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
1 other identifier
interventional
34
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 4, 2025
CompletedFirst Submitted
Initial submission to the registry
February 5, 2026
CompletedFirst Posted
Study publicly available on registry
February 13, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2026
February 13, 2026
February 1, 2026
1.5 years
February 5, 2026
February 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Soft Tissue Volumetric Changes
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 Outcomes (4)
Creeping Attachment
Baseline, 1 month, 3 months, and 6 months
Soft Tissue Thickness Gain
Baseline and 6 months postoperatively
Gingival Recession Depth
Baseline, 1 month, 3 months, and 6 months
Width of Keratinized Tissue
Baseline, 1 month, 3 months, and 6 months
Study Arms (2)
Modified Free Gingival Graft (ModFGG)
EXPERIMENTALParticipants 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.
Conventional Free Gingival Graft (FGG)
ACTIVE COMPARATORParticipants 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kahramanmaraş Sütçü İmam University
Kahramanmaraş, Kahramanmaraş, 46000, Turkey (Türkiye)
Related Publications (2)
Carcuac O, Derks J. Modified Free Gingival Graft Technique for Root Coverage at Mandibular Incisors: A Case Series. Int J Periodontics Restorative Dent. 2021 Mar-Apr;41(2):e37-e44. doi: 10.11607/prd.5398.
PMID: 33819324BACKGROUNDCarcuac O, Trullenque-Eriksson A, Derks J. Modified free gingival graft technique for treatment of gingival recession defects at mandibular incisors: A randomized clinical trial. J Periodontol. 2023 Jun;94(6):722-730. doi: 10.1002/JPER.22-0581. Epub 2023 Jan 30.
PMID: 36627509BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
February 5, 2026
First Posted
February 13, 2026
Study Start
January 4, 2025
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
July 31, 2026
Last Updated
February 13, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share
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.