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

NCT06432439 | Completed

• 1 other identifier: Amisha perio
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Gingival Recession (GR) is a common finding 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 100% root coverage, 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.

Conditions

Gingival Recession, Localized

Keywords

microneedling; phenotype; gingival recession; coronally advanced flap

Outcome Measures

Primary Outcomes (4)

• Recession Depth

  recorded in mm with a periodontal probe from the cementoenamel junction to the crest of the gingival margin at mid labial region.

  6 months

• RECESSION WIDTH (RW)

  recorded in mm with a periodontal probe from the mesial to distal gingival margin at the level of cementoenamel junction.

  6 months

• ROOT COVERAGE PERCENTAGE

  calculated in % according to the formula Root Coverage percentage = Recession depth (preop-postop)\*100 Recession depth preoperative

  6 months

• Gingival thickness(GT)

  GT is calculated in mm and measured with the help of No:15 endodontic spreaders with silicon disc as stopper was inserted perpendicularly at 1.5mm apical to gingival margin, till the hard tissue was felt. The depth of penetration was noted using digital calliper

  6 months

Secondary Outcomes (6)

• CLINICAL ATTACHMENT LEVEL (CAL)

  6 months

• Probing Pocket Depth (PPD)

  6 months

• Bleeding on Probing (BOP)

  6 months

• Plaque Index (PI)

  6 months

• Gingival Index (GI

  6 months

Study Arms (2)

TEST GROUP

EXPERIMENTAL

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

Procedure: microneedling followed by CAF procedures

CONTROL GROUP

ACTIVE COMPARATOR

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

Procedure: CAF procedure

Interventions

CAF procedure PROCEDURE

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

CONTROL GROUP

microneedling followed by CAF procedures PROCEDURE

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

TEST GROUP

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Presence of isolated Recession Type 1 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 therapy Plaque index (PI) \<1, Gingival Index (GI) \<1
• Providing a written and verbal informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

post graduate institute of dental sciences (PGIDS)

Rohtak, Haryana, 124001, India

Location

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Officials

• Amisha Goyal, BDS

  PGIDS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: May 29, 2024
• Study Start: June 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 7, 2026

Record last verified: 2026-05

Locations

IN (1)