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

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

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.

Study Overview

• Status: Completed
• Conditions: Gingival Recession, Localized
• Intervention / Treatment: Procedure: microneedling followed by CAF procedures; Procedure: CAF procedure

Detailed Description

Gingival recession (GR) 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. GRs are of 3 types with reference to interdental clinical attachment loss as Recession Type (RT) RT1, RT2 and RT3. Mid-buccal GRs have root coverage potential through periodontal plastic surgery procedures. Coronally positioned flap (CAF) 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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Haryana
    • Rohtak, Haryana, India, 124001
      • post graduate institute of dental sciences (PGIDS)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

INCLUSION CRITERIA:

• 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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TEST GROUP; Isolated RT1 gingival recession treated by microneedling followed by Coronally Advanced Flap procedures	Procedure: microneedling followed by CAF procedures; Isolated RT1 gingival recession treated by microneedling followed by Coronally Advanced Flap procedures
Active Comparator: CONTROL GROUP; Isolated RT1 gingival recession treated by Coronally Advanced Flap procedures alone.	Procedure: CAF procedure; Isolated RT1 gingival recession treated by Coronally Advanced Flap procedures alone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
CLINICAL ATTACHMENT LEVEL (CAL)	Clinical attachment level will be measured in mm using a periodontal probe as the distance between the cemento- enamel junction and the base of pocket. Measurements will be made at 3 sites of each tooth	6 months
Probing Pocket Depth (PPD)	Probing pocket depth will be measured as the distance from gingival margin to the base of pocket in mm. The probing depth measurements will be assessed using the Periodontal probe	6 months
Bleeding on Probing (BOP)	It will be measured by walking the periodontal probe at each site of each tooth and recorded as 0 or 1.	6 months
Plaque Index (PI)	For the scoring, a mouth mirror, an explorer and a light source will be used on air dried teeth and gingiva. 0=no plaque, 1= plaque present on explorer and not visible to naked eye, 2= moderate layer of plaque visible to naked eye, 3= abundant plaque along gingival margin. Lesser score, better outcome.	6 months
Gingival Index (GI	Gingival index (GI) will be used to assess severity of gingival inflammation. 0= no inflammation, 1= mild inflammation, no bleeding. 2= inflammation with delayed bleeding. 3= spontaneous bleeding. lower score, better outcome.	6 months
Keratinized Tissue Width (KTW)	Keratinized tissue width will be measured in mm with the help of UNC 15 probe with silicon stopper from the mucogingival junction to the free gingival margin and measured on vernier caliper	6 months

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Dental Sciences Rohtak
• Investigators: Principal Investigator: Amisha Goyal, BDS, PGIDS

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Actual): December 31, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: May 22, 2024
• First Submitted That Met QC Criteria: May 22, 2024
• First Posted (Actual): May 29, 2024

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 2, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: gingival recession; phenotype; coronally advanced flap; microneedling
• Additional Relevant MeSH Terms: Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Gingival Diseases; Gingival Recession
• Other Study ID Numbers: Amisha perio

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No