Free Mucogingival Graft for Isolated Root Coverage

Free Mucogingival Graft for Isolated Root Coverage and Correct Unfavorable Mucogingival Conditions in Lower Incisors: A Randomized Clinical Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Gingival Recession; Root Coverage; Free Mucogingival Grafts; Periodontal Plastic Surgery
• Intervention / Treatment: Procedure: Buccal muco-gingival tissue graft; Procedure: Palatal connective tissue graft

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Antonio J Ortiz-Ruiz, MD; Phone Number: +34 868888581; Email: ajortiz@um.es
• Study Contact Backup: Name: José A Moreno-Rodríguez, DDS; Phone Number: +34 620538483; Email: joseantonio171087@hotmail.com

Study Locations

• Spain
  • Murcia, Spain, 30007
    • Recruiting
    • Centro Odontologico Del Sureste Slp
    • Contact: Antonio J Ortiz-Ruiz, MD; Phone Number: +34 868888581; Email: ajortiz@um.es
    • Contact: Jose A Moreno-Rodriguez; Phone Number: +34 620538483; Email: joseantonio171087@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Buccal muco-gingival tissue graft	Procedure: Buccal muco-gingival tissue graft; 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.
Active Comparator: Palatal connective tissue graft	Procedure: Palatal connective tissue graft; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
buccal Clinical Attachment Level (bCAL)	bCAL will be assessed with a periodontal probe, measured in mm from the CEJ to the bottom of the pocket, on the buccal aspect.	12 months
interproximal Clinical Attachment Level (iCAL)	iCAL will be assessed with a periodontal probe, measured in mm from the CEJ to the bottom of the pocket, on the interproximal aspect.	12 months
Interproximal papilla tip location (PT)	Taking as reference the level of the mid-axis of the tooth, PT will be measured the distance from the CEJ at the zenith of the tooth to the tip of the papilla. A positive value will be recorded when the tip of the papillae is located coronally to the CEJ and a negative value otherwise. This outcome will be assessed with a periodontal probe and measured in mmm.	12 months
keratinized tissue width (KT)	KT will be assessed with a periodontal probe, measured in mm on the buccal aspect, from the gingival margin to the mucogingival line.	12 months
vestibule depth (VD)	VD will be measured, from the mucosal margin to the point of greatest concavity of the mucobuccal fold. The measure will be assessed with a periodontal probe in mm.	12 months
Soft tissue attached to alveolar bone (STAB)	STAB will be measured from the gingival margen to the perpendicular mucosal insertion. The measure will be assessed with a periodontal probe in mm.	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Root Coverage (RC percentage)	RC percentage will be calculated by the following formula: [(basaline recession depth - 12 months recession depth) / basaline recession depth] x100. The measure will be assessed with a periodontal probe in mm.	12 months
Complete root coverage (CRC)	It will assessed if the gingival margen is at or above the CEJ. The measure will be assessed with a periodontal probe in mm.	12 months

Collaborators and Investigators

• Sponsor: Universidad de Murcia

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2023
• Primary Completion (Anticipated): December 22, 2023
• Study Completion (Anticipated): December 22, 2024

Study Registration Dates

• First Submitted: April 25, 2023
• First Submitted That Met QC Criteria: May 6, 2023
• First Posted (Actual): May 9, 2023

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 6, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession
• Other Study ID Numbers: 4157/2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No