Impact of Microneedling on Coverage of RT1 Gingival Recession in Thin Phenotype.

NCT ID: NCT06432439

Last Updated: 2024-05-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2025-12-31

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.

Conditions

Gingival Recession, Localized

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

TEST GROUP

Isolated RT1 gingival recession treated by microneedling followed by Coronally Advanced Flap procedures

Group Type: EXPERIMENTAL

microneedling followed by CAF procedures

Intervention Type: PROCEDURE

microneedling will be done on gingiva of RT1 recession tooth in 4 sessions followed by CAF 2months later for root coverage

CONTROL GROUP

Isolated RT1 gingival recession treated by Coronally Advanced Flap procedures alone.

Group Type: ACTIVE_COMPARATOR

CAF procedure

Intervention Type: PROCEDURE

RT1 gingival recession coverage by CAF procedures alone.

Interventions

microneedling followed by CAF procedures

microneedling will be done on gingiva of RT1 recession tooth in 4 sessions followed by CAF 2months later for root coverage

Intervention Type: PROCEDURE

CAF procedure

RT1 gingival recession coverage by CAF procedures alone.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Postgraduate Institute of Dental Sciences Rohtak

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amisha Goyal, BDS

Role: PRINCIPAL_INVESTIGATOR

PGIDS

Central Contacts

Nishi Tanwar, MDS

Role: CONTACT

nsh_tanwar@yahoo.co.in

8368126310

Amisha Goyal, BDS

Role: CONTACT

amishagoyal97@gmail.com

9718413637

Other Identifiers

Amisha perio

Identifier Type: -

Identifier Source: org_study_id