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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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06432439
Enrollment
36
Registered
2024-05-29
Start date
2024-06-01
Completion date
2025-12-31
Last updated
2026-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingival Recession, Localized

Keywords

microneedling, phenotype, gingival recession, coronally advanced flap

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.

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.

Interventions

PROCEDUREmicroneedling followed by CAF procedures

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

PROCEDURECAF procedure

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

Sponsors

Postgraduate Institute of Dental Sciences Rohtak
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Recession Depth6 monthsrecorded in mm with a periodontal probe from the cementoenamel junction to the crest of the gingival margin at mid labial region.
RECESSION WIDTH (RW)6 monthsrecorded in mm with a periodontal probe from the mesial to distal gingival margin at the level of cementoenamel junction.
ROOT COVERAGE PERCENTAGE6 monthscalculated in % according to the formula Root Coverage percentage = Recession depth (preop-postop)\*100 Recession depth preoperative
Gingival thickness(GT)6 monthsGT 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

MeasureTime frameDescription
CLINICAL ATTACHMENT LEVEL (CAL)6 monthsClinical 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
Probing Pocket Depth (PPD)6 monthsProbing 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
Bleeding on Probing (BOP)6 monthsIt will be measured by walking the periodontal probe at each site of each tooth and recorded as 0 or 1.
Plaque Index (PI)6 monthsFor 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.
Gingival Index (GI6 monthsGingival 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.
Keratinized Tissue Width (KTW)6 monthsKeratinized 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

Countries

India

Contacts

PRINCIPAL_INVESTIGATORAmisha Goyal, BDS

PGIDS

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 8, 2026