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NCT Number: NCT05851248

Free Mucogingival Graft for Isolated Root Coverage

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.

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Key information

Conditions

Free Mucogingival Grafts Gingival Diseases Gingival Recession Mouth Diseases Periodontal Atrophy Periodontal Diseases Periodontal Plastic Surgery Root Coverage Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. buccal Recession (bREC)

    Time frame: 12 months

    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.

Secondary outcomes

  1. buccal Clinical Attachment Level (bCAL)

    Time frame: 12 months

    bCAL will be assessed with a periodontal probe, measured in mm from the CEJ to the bottom of the pocket, on the buccal aspect.

  2. interproximal Clinical Attachment Level (iCAL)

    Time frame: 12 months

    iCAL will be assessed with a periodontal probe, measured in mm from the CEJ to the bottom of the pocket, on the interproximal aspect.

  3. Interproximal papilla tip location (PT)

    Time frame: 12 months

    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.

  4. keratinized tissue width (KT)

    Time frame: 12 months

    KT will be assessed with a periodontal probe, measured in mm on the buccal aspect, from the gingival margin to the mucogingival line.

  5. vestibule depth (VD)

    Time frame: 12 months

    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.

  6. Soft tissue attached to alveolar bone (STAB)

    Time frame: 12 months

    STAB will be measured from the gingival margen to the perpendicular mucosal insertion. The measure will be assessed with a periodontal probe in mm.

Other outcomes

  1. Root Coverage (RC percentage)

    Time frame: 12 months

    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.

  2. Complete root coverage (CRC)

    Time frame: 12 months

    It will assessed if the gingival margen is at or above the CEJ. The measure will be assessed with a periodontal probe in mm.

Study contacts

Contact information is provided by the study sponsor or research team.

Antonio J Ortiz-Ruiz, MD

CONTACT

[email protected]

+34 868888581

José A Moreno-Rodríguez, DDS

CONTACT

[email protected]

+34 620538483

Sponsors and collaborators

Lead sponsor

Universidad de Murcia

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
May 9, 2023
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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