Clinical trial NCT05470660: Coronally Advanced Flap With Alloderm Versus Coronally Advanced Flap With Micro-needling on RT1 Gingival Recession
Official title: The Effect of Coronally Advanced Flap With Acellular Dermal Matrix (Alloderm) Versus Coronally Advanced Flap With Micro-needling on RT1 Gingival Recession: A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gingival Recession
Recession, Gingival
Thin-gingiva
Keywords: RT1
Recession
micro-needling
micro-needles
Coronally Advanced Flap
Alloderm
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-07-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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)

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Gingival thickness (GT) in mm
timeFrame: 6 months
Secondary outcomes:
measure: Keratinized tissue width (KTW) in mm
timeFrame: 6 months
measure: Clinical Attachment Level (CAL) in mm
timeFrame: 6 months
measure: Gingival Recession Depth (RD) in mm
timeFrame: 6 months
measure: Gingival Recession Width (RW) in mm
timeFrame: 6 months
measure: Percentage of root coverage
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry - Cairo University
Study officials:
References:
citation: Alster TS, Graham PM. Microneedling: A Review and Practical Guide. Dermatol Surg. 2018 Mar;44(3):397-404. doi: 10.1097/DSS.0000000000001248.
citation: Cairo F, Pagliaro U, Nieri M. Treatment of gingival recession with coronally advanced flap procedures: a systematic review. J Clin Periodontol. 2008 Sep;35(8 Suppl):136-62. doi: 10.1111/j.1600-051X.2008.01267.x.
citation: Cortes Ade Q, Martins AG, Nociti FH Jr, Sallum AW, Casati MZ, Sallum EA. Coronally positioned flap with or without acellular dermal matrix graft in the treatment of Class I gingival recessions: a randomized controlled clinical study. J Periodontol. 2004 Aug;75(8):1137-44. doi: 10.1902/jop.2004.75.8.1137.