Effect Of Microneedling With Coronally Advanced Flap For Management of RT1 Gingival Recession In Thin Gingival Phenotype

NCT06988839 | Not Yet Recruiting DMC

• 1 other identifier: KASHISH PERIO 25/33
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to explore the effect of microneedling to increase the gingival tissue thickness which could improve the outcome of root coverage in coronally advanced flap procedure in thin gingival phenotype. The main question it aims to answer is that : Does the use of microneedling procedure followed by coronally advanced flap has similar outcomes of root coverage in recession type 1 (RT1) gingival recession i.e. buccal gingival recessions without interdental clinical attachment loss in thin gingival phenotype as compared to coronally advanced flaps with connective tissue graft. Systemically healthy patients having isolated upper RT1 gingival recession will be assigned into two groups. Microneedling will be performed in one group (4 sessions each at a 10 days interval) followed by coronally advanced flap operation (at an interval of 2 months) and coronally advanced flap with connective tissue graft will be performed in the other group. Follow-up will be done at 1 month, 3 months and 6 months for evaluation of primary and secondary outcomes.

Conditions

Gingival Recession

Keywords

gingival recession; percutaneous collagen induction; root coverage; connective tissue graft; microneedle

Outcome Measures

Primary Outcomes (5)

• Recession depth (RD)

  It will be recorded in mm with a periodontal probe from the CEJ to the crest of the gingival margin at the mid-labial region

  Baseline,1,3,6 months

• Recession width (RW)

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

  Baseline, 1 , 3 and 6 months

• Root coverage percentage (RC%)

  It will be calculated according to formula Root coverage percentage= RD (preop -postop) \*100 /RD preoperative

  Baseline ,1,3 and 6 months

• Root Esthetic Score (RES)

  The RES system evaluates 5 variables 6 months following surgery: gingival margin, marginal tissue contour (MTC), soft tissue texture (STT), Mucogingival junction alignment, and gingival color (GC). 0, 3, or 6 points will be used for the position of the gingival margin, whereas a score of 0 or 1 point will be used for each of the other variables

  Baseline, 6 months

• Patient-centered outcomes

  Each patient will be questioned about his/her satisfaction with regard to following criteria: root coverage attained, dentinal hypersensitivity, shape and contour of gums, surgical procedure, and post-surgical phase and it will be assessed using a three-point rating scale.

  Baseline,1,3 and 6 months

Secondary Outcomes (5)

• Clinical Attachment level (CAL)

  Baseline, 1 , 3 ,6 months

• Probing pocket depth

  Baseline,1 ,3 and 6 months

• Plaque index

  Baseline, 1 ,3 and 6 months

• Gingival index

  Baseline,1,3 and 6 months

• Gingival thickness

  Baeline, 1 ,3 and 6 months

Study Arms (2)

Microneedling with coronally advanced flap

EXPERIMENTAL

In this group, microneedling will be performed using a 30 gauge lancet needles, inserted until hard tissue is felt. It will be performed in 4 sessions at 10 day intervals, followed by coronally advanced flap procedure, 2 months post microneedling.

Procedure: Microneedling followed by coronally advanced flap

Coronally advanced flap with connective tissue graft

ACTIVE COMPARATOR

Coronally advanced flap operation will be performed with connective tissue graft harvested from palate after phase 1 therapy.

Procedure: Coronally advanced flap with connective tissue graft

Interventions

Microneedling followed by coronally advanced flap PROCEDURE

Microneedling will be performed using a 30 gauge lancet needles, inserted until hard tissue is felt. It will be performed in 4 sessions at 10 day intervals, followed by coronally advanced flap procedure, 2 months post microneedling.

Microneedling with coronally advanced flap

Coronally advanced flap with connective tissue graft PROCEDURE

Coronally advanced flap operation will be performed with connective tissue graft harvested from palate after phase 1 therapy.

Coronally advanced flap with connective tissue graft

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Presence of isolated RT1 buccal maxillary gingival recessions in esthetic zone with thin gingival phenotype (Gingival thickness≤1mm) associated with esthetic complaints and/or dental sensitivity and otherwise systemically healthy.
• Gingival Recession ≥2mm , Keratinized tissue width≥2mm and clinically identifiable cementoenamel junction
• 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)

Department of Periodontology, Post Graduate Institute of Dental Sciences

Rohtak, Haryana, 124001, India

Location

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Nishi Tanwar, MDS

CONTACT

8368126310; nsh_tanwar@yahoo.co.in

Kashish, BDS

CONTACT

+919996944522; kashish.21999@gmail.com

Study Design

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

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: May 25, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)