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

NCT ID: NCT05729919

Last Updated: 2023-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-16
• Study Completion Date: 2023-04-24

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.

Conditions

Free Gingival Graft

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Free gingival graft

Free gingival technique will be done

Group Type: EXPERIMENTAL

Free gingival graft technique

Intervention Type: 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

Interventions

Free gingival graft technique

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

Intervention Type: PROCEDURE

Eligibility Criteria

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%

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitat Internacional de Catalunya

OTHER

Sponsor Role: lead

Responsible Party

Gonzalo Blasi

Principal Investigator Gonzalo Blasi

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

International University of Catalunya

Barcelona, , Spain

Countries

Spain

Other Identifiers

PER-ECL-2020-08

Identifier Type: -

Identifier Source: org_study_id