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

Gingival Recession, Localized Clinical Trial

Official 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06432439
• Other study ID #: Amisha perio
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: Postgraduate Institute of Dental Sciences Rohtak
• Contact: Nishi Tanwar, MDS
• Phone: 8368126310
• Email: nsh_tanwar[@]yahoo.co.in
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Gingival Recession (GR) is a common finding in 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 a covered root surface of 100%, 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.

Description:

Gingival recession 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. Cairo et al in 2018 categorised GRs into 3 types with reference to interdental clinical attachment loss as RT1, RT2 and RT3. Mid-buccal GRs have root coverage potential through periodontal plastic surgery procedures. Coronally positioned flap 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

INCLUSION CRITERIA:

• Presence of isolated (RT1) by Cairo et al 2011 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 thearpy 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.

Related Conditions & MeSH terms

• Gingival Recession
• Gingival Recession, Localized

Intervention

Procedure:
• microneedling followed by CAF procedures
microneedling will be done on gingiva of RT1 recession tooth in 4 sessions followed by CAF 2months later for root coverage
• CAF procedure
RT1 gingival recession coverage by CAF procedures alone.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Dental Sciences Rohtak

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recession Depth	recorded in mm with a periodontal probe from the cementoenamel junction to the crest of the gingival margin at mid labial region.	3 months
Primary	RECESSION WIDTH (RW)	recorded in mm with a periodontal probe from the mesial to distal gingival margin at the level of cementoenamel junction.	3 months
Primary	ROOT COVERAGE PERCENTAGE	calculated according to the formula Root Coverage percentage = Recession depth (preop-postop)*100 Recession depth preoperative	3 months
Primary	Gingival thickness(GT)	GT is 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	3 months
Secondary	CLINICAL ATTACHMENT LEVEL (CAL)	Clinical attachment level will be measured as the distance between the cemento- enamel junction and the base of pocket. Measurements will be made at 6 sites of each tooth	3 months
Secondary	Probing Pocket Depth (PPD)	Probing pocket depth will be measured as the distance from gingival margin to the base of pocket. The probing depth measurements will be assessed using the Periodontal probe	3 months
Secondary	Bleeding on Probing (BOP)	It will be measured by walking the periodontal probe at 6 sites of each tooth	3 months
Secondary	Plaque Index (PI)	For the scoring, a mouth mirror, an explorer and a light source will be used on air dried teeth and gingiva	3 months
Secondary	Gingival Index (GI	Gingival index by Loe and Silness (1963)22 will be used to assess severity of gingival inflammation	3 months
Secondary	Keratinized Tissue Width (KTW)	Keratinized tissue width will be measured with the help of UNC 15 probe with silicon stopper from the mucogingival junction to the free gingival margin and measured on vernier caliper	3 months