Free Mucogingival Graft for Isolated Root Coverage

NCT05851248 | Recruiting

• 1 other identifier: 4157/2022
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to to describe and evaluate an approach, free mucogingival graft (FMG), in periodontal plastic surgery for root coverage (RC) in lower incisor gingival recessions (GR) with mucogingival conditions and deformities (MCD) that might negatively influence the outcomes of conventional RC procedures.

Conditions

Gingival Recession; Root Coverage; Periodontal Plastic Surgery; Free Mucogingival Grafts

Outcome Measures

Primary Outcomes (1)

• buccal Recession (bREC)

  Buccal recession measurement, will be assessed with a periodontal probe, measured in mmm on the buccal aspect, from the CEJ to the gingival margin zenith.

  12 months

Secondary Outcomes (6)

• buccal Clinical Attachment Level (bCAL)

  12 months

• interproximal Clinical Attachment Level (iCAL)

  12 months

• Interproximal papilla tip location (PT)

  12 months

• keratinized tissue width (KT)

  12 months

• vestibule depth (VD)

  12 months

Other Outcomes (2)

• Root Coverage (RC percentage)

  12 months

• Complete root coverage (CRC)

  12 months

Study Arms (2)

Buccal muco-gingival tissue graft

EXPERIMENTAL

Procedure: Buccal muco-gingival tissue graft

Palatal connective tissue graft

ACTIVE COMPARATOR

Procedure: Palatal connective tissue graft

Interventions

Buccal muco-gingival tissue graft PROCEDURE

Recipient Site Preparation. In the GR, a sulcular incision limited to the vestibular face will be made, which will continue until reaching the tip of the buccal papillae on each side of the GR. Two vertical incisions from the base of the two papillae to the bottom of the vestibule and one horizontal incision will connect the ends of both vertical incisions to remove the pedicle tissue. The exposed root surface will be cleaned and smoothed with mini-curettes. Donor site preparation. The incisions will be made in the same way as in the recipient area, including both papillae. The vertical incision will measure the distance from the cementoenamel junction (CEJ) to the bony dehiscence in the GR tooth, plus at least 2 mm. The tissue between the incisions will be elevated fjull or partial thickness close to the bone in the keratinized portion and superficially in the mucosal portion. A soft tissue substitute will be adapted and sutured to protect the donor site.

Buccal muco-gingival tissue graft

Palatal connective tissue graft PROCEDURE

Recipient Site Preparation. In the GR, a sulcular incision limited to the vestibular face will be made, which will continue until reaching the tip of the buccal papillae on each side of the GR. Two vertical incisions from the base of the two papillae to the bottom of the vestibule and one horizontal incision will connect the ends of both vertical incisions to remove the pedicle tissue. The exposed root surface will be cleaned and smoothed with mini-curettes. Donor site preparation A connective tissue graft will be taken from the palatal area, at the level of the premolars, which will include the two papillae. The size of the graft will be the same as that of the recipient area. A soft tissue substitute will be adapted and sutured to protect the donor site, especially if there is exposed bone.

Palatal connective tissue graft

Eligibility Criteria

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

You may qualify if:

• Healthy patients with deep GR associated with lower incisor MCD.
• Full mouth plaque and bleeding scores were \<20%.

You may not qualify if:

• Patient characteristics:
• Smoking ≥10 cigarettes a day.
• Medications or systemic contraindications for oral surgery.
• Pregnancy.
• Defects:
• Thin scalloped biotype (AND/OR)
• Underlying bone dehiscence (AND /OR)
• Generalized GR affecting most sextants.

Sponsors & Collaborators

• Universidad de Murcia: lead

Study Sites (1)

Centro Odontologico Del Sureste Slp

Murcia, Murcia, 30007, Spain

RECRUITING

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Central Study Contacts

Antonio J Ortiz-Ruiz, MD

CONTACT

+34 868888581; ajortiz@um.es

José A Moreno-Rodríguez, DDS

CONTACT

+34 620538483; joseantonio171087@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Researcher

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: May 9, 2023
• Study Start: January 2, 2023
• Primary Completion (Estimated): December 22, 2026
• Study Completion (Estimated): April 22, 2027
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

ES (1)