Microneedling followed by coronally advanced flapCoronally advanced flap with connective tissue graft
Microneedling followed by coronally advanced flap: 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.
Coronally advanced flap with connective tissue graft: Coronally advanced flap operation will be performed with connective tissue graft harvested from palate after phase 1 therapy.
Study 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.
Eligibility
Sex
ALL
Min age
20 Years
Max age
50 Years
Healthy volunteers
No
Inclusion Criteria:
* 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.
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.
Primary outcome measure(s)
Recession depth (RD) — Baseline,1,3,6 months 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
Recession width (RW) — Baseline, 1 , 3 and 6 months It will be recorded in mm with a periodontal probe from the mesial to distal gingival margin at the level of cementoenamel junction.
Root coverage percentage (RC%) — Baseline ,1,3 and 6 months It will be calculated according to formula Root coverage percentage= RD (preop -postop) \*100 /RD preoperative
Root Esthetic Score (RES) — Baseline, 6 months 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
Patient-centered outcomes — Baseline,1,3 and 6 months 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.
Trial sites (1)
Facility
City
Region
Status
Department of Periodontology, Post Graduate Institute of Dental Sciences
Rohtak
Haryana
Recruiting
More Postgraduate Institute of Dental Sciences Rohtak trials in India
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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