Clinical trial NCT06432439: Impact of Microneedling on Coverage of RT1 Gingival Recession in Thin Phenotype.
Official title: Microneedling And Its Effect On Outcome Of Root Coverage With Coronally Advanced Flap Involving Isolated RT1 Maxillary Gingival Recession In Thin Gingival Phenotype: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gingival Recession, Localized
Keywords: microneedling
phenotype
gingival recession
coronally advanced flap
Lead sponsor: Postgraduate Institute of Dental Sciences Rohtak
Sponsor class: OTHER
First posted: 2024-05-29
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Gingival Recession (GR) is a common finding in among adults, regardless of the oral hygiene levels. When it is associated with esthetic impairment, dentin hypersensitivity, root caries, surgical treatment is indicated. Mid-buccal Gingival Recessions are an extremely prevalent condition and have root coverage potential through periodontal plastic surgery procedures.

A flap thickness of \> 0.8 mm results in a covered root surface of 100%, whereas a flap thickness of \< 0.8 mm results in partial root coverage in Coronally Advanced Flap (CAF)procedure.

The present study aims to increase the gingival thickness by microneedling procedures to enhance root coverage by CAF procedures in thin gingival phenotype.

Detailed description: Gingival recession is defined as the migration of the marginal tissue toward the apical of the cementoenamel junction. It is one of the most common mucogingival deformities requiring surgical correction. The rationale for treating buccal recessions are mainly aesthetic concerns, and clinical situations where unfavourable contour of the gingival margin might be an obstacle for proper plaque control. Cairo et al in 2018 categorised GRs into 3 types with reference to interdental clinical attachment loss as RT1, RT2 and RT3. Mid-buccal GRs have root coverage potential through periodontal plastic surgery procedures. Coronally positioned flap is a simple and predictable treatment of gingival recession defects. It has been observed that a flap thickness of \> 0.8 mm results in a covered root surface of 100%, whereas a flap thickness of \< 0.8 mm results in partial root coverage in CAF procedure. Microneedling (MN), creates microinjuries that result in minimal superficial bleedings and create a wound-healing cascade from which various growth factors are released. MN as opposed to Connective Tissue Grafts is a non-surgical approach to increase gingival thickness, that results in significant changes in the Gingival Thickness of individuals with thin gingival phenotype.

Eligibility criteria: INCLUSION CRITERIA:

* Presence of isolated (RT1) by Cairo et al 2011 buccal maxillary gingival recessions in esthetic zone including maxillary central incisors, lateral incisors and canines associated with esthetic complaints and/or dental sensitivity and otherwise systemically healthy.
* Gingival Recession ≥2mm and clinically identifiable CEJ
* Age 20years-50 years
* Patient demonstrating compliance for maintaining good oral hygiene after Phase 1 thearpy Plaque index (PI) \<1, Gingival Index (GI) \<1
* Providing a written and verbal informed consent.

EXCLUSION CRITERIA

* Patient with systemic disease that can influence the outcome of therapy.
* Pregnant females or on oral contraceptive pills or hormone replacement therapy.
* Smokers and patients undergoing orthodontic therapy
* Physically and mentally impaired patients.
* Non vital, malpositioned tooth
* Presence of cervical abrasions or restorations in the area
* Previous history of periodontal surgery on the involved sites.

Primary outcomes:
measure: Recession Depth
timeFrame: 3 months
measure: RECESSION WIDTH (RW)
timeFrame: 3 months
measure: ROOT COVERAGE PERCENTAGE
timeFrame: 3 months
measure: Gingival thickness(GT)
timeFrame: 3 months
Secondary outcomes:
measure: CLINICAL ATTACHMENT LEVEL (CAL)
timeFrame: 3 months
measure: Probing Pocket Depth (PPD)
timeFrame: 3 months
measure: Bleeding on Probing (BOP)
timeFrame: 3 months
measure: Plaque Index (PI)
timeFrame: 3 months
measure: Gingival Index (GI
timeFrame: 3 months
measure: Keratinized Tissue Width (KTW)
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: PGIDS
name: Amisha Goyal, BDS
role: PRINCIPAL_INVESTIGATOR
References: