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Recruiting NCT05851248

Free Mucogingival Graft for Isolated Root Coverage

No phase Interventional Free Mucogingival Grafts Gingival Recession Root Coverage Periodontal Plastic Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Buccal muco-gingival tissue graft, Palatal connective tissue graft.
Who it may be relevant to
Registry conditions: Free Mucogingival Grafts, Gingival Recession, Root Coverage, Periodontal Plastic Surgery. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • 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 incision
  • 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

Primary outcome measures

  • buccal Recession (bREC) [Time frame: 12 months]
Secondary outcome measures (6)
  • buccal Clinical Attachment Level (bCAL) [Time frame: 12 months]
  • interproximal Clinical Attachment Level (iCAL) [Time frame: 12 months]
  • Interproximal papilla tip location (PT) [Time frame: 12 months]
  • keratinized tissue width (KT) [Time frame: 12 months]
  • vestibule depth (VD) [Time frame: 12 months]
  • Soft tissue attached to alveolar bone (STAB) [Time frame: 12 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Spain · 1 center
  • Centro Odontologico Del Sureste Slp — Murcia

Identifiers

NCT: NCT05851248 · 4157/2022

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗