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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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05851248
Enrollment
24
Registered
2023-05-09
Start date
2023-01-02
Completion date
2027-04-22
Last updated
2026-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

PROCEDUREBuccal 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.

PROCEDUREPalatal 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.

Sponsors

Universidad de Murcia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
buccal Recession (bREC)12 monthsBuccal recession measurement, will be assessed with a periodontal probe, measured in mmm on the buccal aspect, from the CEJ to the gingival margin zenith.

Secondary

MeasureTime frameDescription
buccal Clinical Attachment Level (bCAL)12 monthsbCAL will be assessed with a periodontal probe, measured in mm from the CEJ to the bottom of the pocket, on the buccal aspect.
interproximal Clinical Attachment Level (iCAL)12 monthsiCAL will be assessed with a periodontal probe, measured in mm from the CEJ to the bottom of the pocket, on the interproximal aspect.
Interproximal papilla tip location (PT)12 monthsTaking 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.
keratinized tissue width (KT)12 monthsKT will be assessed with a periodontal probe, measured in mm on the buccal aspect, from the gingival margin to the mucogingival line.
vestibule depth (VD)12 monthsVD 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.
Soft tissue attached to alveolar bone (STAB)12 monthsSTAB will be measured from the gingival margen to the perpendicular mucosal insertion. The measure will be assessed with a periodontal probe in mm.

Countries

Spain

Contacts

CONTACTAntonio J Ortiz-Ruiz, MD
ajortiz@um.es+34 868888581
CONTACTJosé A Moreno-Rodríguez, DDS
joseantonio171087@hotmail.com+34 620538483

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026