Skip to main content
OpenTrials
Completed

NCT Number: NCT06432439

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

post graduate institute of dental sciences (PGIDS)

Rohtak, Haryana, 124001, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

microneedling followed by CAF procedures

Procedure

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

CAF procedure

Procedure

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

Primary outcomes

  1. Recession Depth

    Time frame: 6 months

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

  2. RECESSION WIDTH (RW)

    Time frame: 6 months

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

  3. ROOT COVERAGE PERCENTAGE

    Time frame: 6 months

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

  4. Gingival thickness(GT)

    Time frame: 6 months

    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

Secondary outcomes

  1. CLINICAL ATTACHMENT LEVEL (CAL)

    Time frame: 6 months

    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

  2. Probing Pocket Depth (PPD)

    Time frame: 6 months

    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

  3. Bleeding on Probing (BOP)

    Time frame: 6 months

    It will be measured by walking the periodontal probe at each site of each tooth and recorded as 0 or 1.

  4. Plaque Index (PI)

    Time frame: 6 months

    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.

  5. Gingival Index (GI

    Time frame: 6 months

    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. Keratinized Tissue Width (KTW)

    Time frame: 6 months

    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

Sponsors and collaborators

Lead sponsor

Postgraduate Institute of Dental Sciences Rohtak

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 29, 2024
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.