An interventional study of Microneedling followed by coronally advanced flap and Coronally advanced flap with connective tissue graft in Gingival Recession, sponsored by Postgraduate Institute of Dental Sciences Rohtak. Recruiting at 1 site in India. Open to participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-06-12.
Sponsored by Postgraduate Institute of Dental Sciences Rohtak · Not applicable, Interventional, and Treatment
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.
The gingival phenotype affects the choice of mucogingival surgical technique for coverage of the root surface in gingival recession. It has been reported 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 coronally advanced flap procedure for Miller class I or II root coverage. Thus connective tissue graft (CTG) use is advocated in thin phenotype cases, for improved clinical and esthetic outcomes. Connective tissue graft increases the predictability of coronally advanced flap. Treatment by addition of connective tissue graft has some drawbacks like creation of a second surgical site, postoperative discomfort and long chair side time, leading the researchers to explore techniques less invasive in nature.
Microneedling (MN), also known as "percutaneous collagen induction therapy." It creates microinjuries that result in minimal superficial bleedings and create a wound-healing cascade from which various growth factors, such as platelet-derived growth factors, transforming growth factors, connective tissue growth factor and fibroblast growth factors, are released. In microneedling, the tissue responds as if experiencing minor trauma and the body's own collagen production is induced to preserve skin integrity. Microneedling as opposed to connective tissue grafts is a non-surgical approach to increase gingival thickness, that results in significant changes in the gingival thickness and keratinized tissue width of individuals with thin gingival phenotype. It is associated with higher patient acceptance, lesser surgical site co-morbidities and is a minimally invasive yet an effective approach to augment the gingiva. The histological analysis performed one year post microneedling sessions, showed increased collagen and elastic fiber accumulation in the reticular dermis, a thickened epidermis and a normal stratum corneum, showing its greater effect on gingival thickness.
The present study aims to increase the gingival thickness by microneedling procedures to enhance root coverage by coronally advanced flap procedures in thin gingival phenotype. This technique is proposed to improve thin gingival phenotype by minimally invasive and non-surgical means.
402 studies on the registry are indexed under Gingival Recession; 98 are open to participants now.
This study's planned enrollment of 36 is above the median of 30 across 368 interventional studies indexed under Gingival Recession.
Browse Gingival Recession studies →Postgraduate Institute of Dental Sciences Rohtak is the lead sponsor of 209 studies on the registry; 71 are open to participants now.
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Exclusion Criteria:
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 operation will be performed with connective tissue graft harvested from palate after phase 1 therapy.
Procedure: Coronally advanced flap with connective tissue graft
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 operation will be performed with connective tissue graft harvested from palate after phase 1 therapy.
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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: Baseline,1,3 and 6 months
Clinical Attachment level (CAL)
Clinical attachment level will be measured as the distance between the CEJ and the base of pocket. Measurements will be made at 6 sites of each tooth using periodontal probe.
Time frame: Baseline, 1 , 3 ,6 months
Probing pocket depth
Probing pocket depth will be measured as the distance from gingival margin to the base of pocket. Measurements will be noted at 6 sites of a tooth.
Time frame: Baseline,1 ,3 and 6 months
Plaque index
Plaque index will be measured on buccal and lingual surface with Periodontal probe.
Time frame: Baseline, 1 ,3 and 6 months
Gingival index
Gingival index will be used to assess severity of gingival inflammation with the help of periodontal probe at 4 sites.
Time frame: Baseline,1,3 and 6 months
Gingival thickness
A No:15 endodontic spreader with silicon disc as stopper will be inserted perpendicularly at 1.5mm apical to gingival margin, till the hard tissue will be felt. The depth of penetration will be noted using digital calliper measuring the distance between the tip of the spreader and silicon disc.
Time frame: Baeline, 1 ,3 and 6 months
Plan to share: No
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Postgraduate Institute of Dental Sciences Rohtak