Healing Dynamics of Free Gingival Grafts; a Colorimetric and Volumetric Assessment

Not Applicable

Completed

• Conditions: Free Gingival Graft
• Interventions: Procedure: Free gingival graft technique

• Registration Number: NCT05729919
• Lead Sponsor: Universitat Internacional de Catalunya

Brief Summary

Gingival recession on vestibular surfaces of teeth is a frequent occurrence in patients with high standards of oral hygiene, affecting all types of teeth. During the last three decades, several surgical techniques have been proposed to treat single and multiple gingival recessions: pedicled flaps (laterally displaced (CDL) or coronally advanced (ACC) flaps), free gingival grafts (IGL), bilaminar techniques or procedures regenerative.

Detailed Description

One month before surgery, an interview and periodontal therapy (pre-surgical prophylaxis, oral hygiene instructions and brushing technique teaching) will be carried out.

A digital scan of the arch with the teeth to be treated will be made before the surgery, during the surgery (recipient bed and with sutures), at 6 weeks, 3 months, 6 months and 1 year.

On the day of surgery, the recipient bed will be prepared and a free gingival graft will be taken from the palate to cover the exposed root surface or gain keratinized gingiva.

In terms of aesthetics, morbidity and satisfaction will be evaluated through questions.

At 6 weeks, 3 months, 6 months and 1year, the color of the gum will be evaluated using a spectrophotometer.

Study Timeline

• Study Start: 2021-02-16
• Primary Completion: 2021-03-12
• Study First Submitted: 2023-01-13
• Study First Submitted QC: 2023-02-06
• Study First Posted: 2023-02-15
• Study Completion: 2023-04-24
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-09
• Last Update Posted: 2023-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Male or female patients between 18 and 90 years old
• Patients exhibiting deficient KT and indicated for FGG procedure (28)
• Good systemic health with absence of active periodontal disease
• Plaque and bleeding index <20%

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Exclusion Criteria

• Uncontrolled systemic disease
• Heavy smokers (> 10 cigarettes per day)
• Restorations that cannot be removed for proper treatment
• Pregnant or lactant women

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Free gingival graft	Free gingival graft technique	Free gingival technique will be done

Primary Outcome Measures

Name	Time	Method
Volumetric changes of keratinized tissue (KT) around teeth after free gingival graft (FGG).	6 weeks, 3 months, 6 months, 1 year	A digital scan of the arch will be performed with an optical 3D measurement system (3Shape Trios) creating STL files. The corresponding reference and follow-up examinations of each clinical case will be virtually overlaid and combined into a common coordinate system (Geomagic, 3D Systems) using the Control X tool. By using of the buccal surfaces of the affected teeth as reference points for the superposition of the different time points
Colorimetric changes of keratinized tissue (KT) around teeth after free gingival	6 weeks, 3 months, 6 months, 1 year	A spectrophotometer (Easy Shade, VITA) will be used for the evaluation of the gingiva color. Before each measurement, the camera will be calibrated. To objectively measure gingiva discoloration, spectrophotometric measurements of the buccal gingiva will be performed on the study and on the adjacent untreated control tooth. The spectrophotometer camera will be positioned perpendicular to the mid-buccal gum and two images will be captured at each site.The center of the area of interest will be located 1.5 mm apical to the mid-buccal gingival margin and 3 mm.; The spectral analysis will generate the CIE-Lab (Commission Internationale d'Eclairage) color coordinates L: luminosity, a: chroma along the red-green axis and b: chroma along the yellow-blue axis. The total color difference DE between the gingiva will be calculated according to the formula DE = \[(Limpl Lcontr) 2 + (aimpl acontr) 2 + (bimpl bcontr) 2\] 1/2 (CIE 2004)

Secondary Outcome Measures

Name	Time	Method
Influence of the volume of an FGG on the contraction of the keratinized gingiva	6 weeks, 3 months, 6 months, 1 year	Influence of the volume of an FGG on the contraction of the keratinized gingiva being evaluated with intraoral scans (IS) A digital scan of the arch will be performed with an optical 3D measurement system (3Shape Trios) creating STL files. The corresponding reference and follow-up examinations of each clinical case will be virtually overlaid and combined into a common coordinate system (Geomagic, 3D Systems) using the Control X tool. By using of the buccal surfaces of the affected teeth as reference points for the superposition of the different time points
Influence of the volume of an FGG on the color changes	6 weeks, 3 months, 6 months, 1 year	A spectrophotometer (Easy Shade, VITA) will be used for the evaluation of the gingiva color. Before each measurement, the camera will be calibrated. To objectively measure gingiva discoloration, spectrophotometric measurements of the buccal gingiva will be performed on the study and on the adjacent untreated control tooth. The spectrophotometer camera will be positioned perpendicular to the mid-buccal gum and two images will be captured at each site.The center of the area of interest will be located 1.5 mm apical to the mid-buccal gingival margin and 3 mm.; The spectral analysis will generate the CIE-Lab (Commission Internationale d'Eclairage) color coordinates L: luminosity, a: chroma along the red-green axis and b: chroma along the yellow-blue axis. The total color difference DE between the gingiva will be calculated according to the formula DE = \[(Limpl Lcontr) 2 + (aimpl acontr) 2 + (bimpl bcontr) 2\] 1/2 (CIE 2004)

Trial Locations

Locations (1)

International University of Catalunya; 🇪🇸 Barcelona, Spain