3D Digital Assessment of Soft Tissue Changes After Modified FGG
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKahramanmaras Sutcu Imam University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Pregnancy or lactation
Untreated periodontal disease
Presence of parafunctional habits
Poor oral hygiene, defined as a full-mouth plaque score >20%
Trial design
Design model
Parallel
Treatments tested in this trial
Modified Free Gingival Graft (ModFGG)
Procedure/SurgeryA 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)
Procedure/SurgeryA 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.
Treatment groups
34 Participants
are divided into 2 treatment groupsGroup A: Modified Free Gingival Graft (ModFGG)Experimental treatment 1 intervention
Group B: Conventional Free Gingival Graft (FGG)Active comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline, 1 month, 3 months, and 6 monthsSecondary outcomes
1
Creeping Attachment
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.
Time frame
Baseline, 1 month, 3 months, and 6 months2
Soft Tissue Thickness Gain
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.
Time frame
Baseline and 6 months postoperatively3
Gingival Recession Depth
Gingival recession depth will be measured as the distance from the cemento-enamel junction to the gingival margin using calibrated digital photographs.
Time frame
Baseline, 1 month, 3 months, and 6 months4
Width of Keratinized Tissue
The width of keratinized tissue will be measured from the gingival margin to the mucogingival junction following iodine staining.
Time frame
Baseline, 1 month, 3 months, and 6 monthsSponsors and contacts
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Source ClinicalTrials.gov