Coronally Advanced Flap With Alloderm Versus Coronally Advanced Flap With Micro-needling on RT1 Gingival Recession

Cairo University (CU)

Status: Not yet enrolling

Conditions: Recession, Gingival; Gingival Recession; Thin-gingiva

Treatments: Procedure: coronally advanced flap combined with Alloderm; Procedure: Root coverage using coronally advanced flap combined with micro-needling

Study type: Interventional

Funder types: Other

Identifiers

NCT05470660

PER331

Details and patient eligibility

About

This study aims to assess the effect of micro-needling together with coronally advanced flap procedure on the gain of gingival thickness (GT) and keratinized tissue width (KTW) and compare it to Alloderm with coronally advanced flap procedure in the management of thin periodontal phenotype associated with recession type 1 (RT1)

Full description

Gingival or periodontal diseases were found to occur more likely in patients with a thin gingival biotype. The periodontal phenotype was also found to show stronger correlation with gingival thickness rather than keratinized tissue width and papilla height. Moreover, the thin gingiva was usually found to be associated with thin bony plate with potential for dehiscence and fenestration and hence was thought to be at risk for recession after trauma.

Several techniques have been recommended for the treatment of gingival recession. One of the most predictable outcome is associated with the use of a coronally advanced flap and acellular dermal matrix graft.

Treatment of thin periodontal phenotype through the conjunction of i-PRF and micro-needling may be a first move of the non-surgical approach for improving the gingival thickness. Micro-needling was proved to be generally an effective and safe therapeutic option for numerous dermatologic conditions as clinical improvement of scars, striae, and rhytids with appropriate recovery and limited side effects. The controlled dermal wounding and stimulation of the wound healing cascade through Micro-needling was found to enhance collagen production and thus was responsible for the clinical results obtained.

Therefore, this study will be aiming to compare the effect of micro-needling on the gingival thickness in root coverage procedures. It will also provide an insight of its effect on the patient related factors and the root coverage parameters.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patient consulting in the outpatient clinic.

  • Able to tolerate the study procedures.
  • Patient ready to perform oral hygiene instructions.
  • Compliance with the maintenance program.
  • Provide informed consent.
  • Accepts the 6 months follow-up period

• Mature permanent tooth.

• Full-mouth plaque index (PI) and full-mouth bleeding on probing (BOP) score of ≤ 15%.

• Presence of identifiable Cemento-enamel Junction.

• RT1 facial recession defect of ≥3 mm.

• Clinical indication and/or patient request for recession coverage

Exclusion criteria

• Medically compromised patients.

  • use of any drugs that might lead to gingival enlargement
  • Pregnant or nursing women.
  • Uncooperative patients.
  • Smokers.

• Teeth with malocclusion, crowding, fillings, missing or supernumerary mandibular anterior teeth.

  • Cairo Recession Type 3 (RT3) recession defects.
  • Teeth with active orthodontic treatment.
  • Previous periodontal surgery.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Root coverage using coronally advanced flap combined with micro-needling

Experimental group

Description:

modified coronally advanced flap will be performed in sites of recession defects, then micro-needling will be performed after 1 month from the coronally advanced flap procedure to ensure the initial flap healing

Treatment:

Procedure: Root coverage using coronally advanced flap combined with micro-needling

coronally advanced flap combined with Alloderm

Active Comparator group

Description:

modified coronally advanced flap will be performed in sites of recession defects in Association with alloderm to cover the exposed root and 3 mm of connective tissue mesial and distal to it.

Treatment:

Procedure: coronally advanced flap combined with Alloderm