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

NCT05729919 | Completed

• 1 other identifier: PER-ECL-2020-08
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Free Gingival Graft

Keywords

FGG; Volume; Color

Outcome Measures

Primary Outcomes (2)

• Volumetric changes of keratinized tissue (KT) around teeth after free gingival graft (FGG).

  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

  6 weeks, 3 months, 6 months, 1 year

• Colorimetric changes of keratinized tissue (KT) around teeth after free gingival

  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)

  6 weeks, 3 months, 6 months, 1 year

Secondary Outcomes (2)

• Influence of the volume of an FGG on the color changes

  6 weeks, 3 months, 6 months, 1 year

• Influence of the volume of an FGG on the contraction of the keratinized gingiva

  6 weeks, 3 months, 6 months, 1 year

Study Arms (1)

Free gingival graft

EXPERIMENTAL

Free gingival technique will be done

Procedure: Free gingival graft technique

Interventions

Free gingival graft technique PROCEDURE

A horizontal partial thickness incision will be trace at the MGJ to dissect the alveolar mucosa from the keratinized tissue. The alveolar mucosa will be dissected from the underlying periosteum to create an envelope of 4-5 mm apical to the bone dehiscence associated with the gingival recessions. The keratinized tissue coronal to the first incision and neighboring the recession will be de-epithelialized to expose the connective tissue and create a trapezoidal recipient bed having a large apical base at the MGJ and a narrower coronal base just coronal to the CEJ of the experimental units. The grafts will be taken from the palate.The grafts will be positionned with the coronal edge of the CEJ. Interrupted sutures (6-0 polypropylene, prolene) will be positionned to stabilize the graft. Sling crossed sutures anchored to the periosteum apical to the graft and placed to ensure a tight adaptation of the graft to the root surface

Free gingival graft

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

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

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead

Study Sites (1)

International University of Catalunya

Barcelona, 08172, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator Gonzalo Blasi

Study Record Dates

• First Submitted: January 13, 2023
• First Posted: February 15, 2023
• Study Start: February 16, 2021
• Primary Completion: March 12, 2021
• Study Completion: April 24, 2023
• Last Updated: May 10, 2023

Record last verified: 2023-05

Locations

ES (1)