Effect Of Microneedling With Coronally Advanced Flap For Management of RT1 Gingival Recession In Thin Gingival Phenotype

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-50
SponsorPostgraduate Institute of Dental Sciences Rohtak

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Microneedling followed by coronally advanced flap

    Procedure/Surgery

    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

    Procedure/Surgery

    Coronally advanced flap operation will be performed with connective tissue graft harvested from palate after phase 1 therapy.

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: Microneedling with coronally advanced flapExperimental treatment 1 intervention
Group B: Coronally advanced flap with connective tissue graftActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

1

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
2

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
3

Plaque index

Plaque index will be measured on buccal and lingual surface with Periodontal probe.

Time frame
Baseline, 1 ,3 and 6 months
4

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

Other outcomes

Sponsors and contacts

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