Free Mucogingival Graft for Isolated Root Coverage

Gingival Recession Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05851248
• Other study ID #: 4157/2022
• Status: Recruiting
• Phase: N/A
• Start date: January 2, 2023
• Est. completion date: December 22, 2024

Study information

• Verified date: May 2023
• Source: Universidad de Murcia
• Contact: Antonio J Ortiz-Ruiz, MD
• Phone: +34 868888581
• Email: ajortiz[@]um.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 22, 2024
• Est. primary completion date: December 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gingival Recession
• Root Coverage

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Centro Odontologico Del Sureste Slp	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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