Evaluation Of Microneedling Alone vs Microneedling Along With Hyaluronic Acid In Thin Gingival Phenotype

NCT05869136 | Recruiting DMC

• 1 other identifier: Nishi Tanwar
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The periodontal phenotype has been defined as the combination of gingival phenotype and buccal bone plate thickness (bone morphotype).Periodontal phenotype cannot be fully assessed but gingival phenotype can be evaluated through a standard and reproducible way. Gingival recession is usually observed in the presence of trauma and inflammation in individuals with thin phenotypes, whereas pocket formation has been reported in individuals with thick phenotypes. Various soft tissue augmentation procedures include: sub-epithelial connective tissue graft, free gingival graft, modified roll technique and use of acellular dermal matrix. The drawbacks of these techniques include second surgical site creation, post-operative discomfort, time consuming procedure, etc. Recent studies have shown i-PRF, microneedeling and hyaluronic acid procedures to be effective in increasing gingival tissue thickness. HA has been widely used in the dental field, specially periodontology, due to its bacteriostatic, fungistatic, anti-inflammatory, anti-edematous, osteoinductive, and pro-angiogenetic properties. HA's role in tissue regeneration and wound healing has gained huge interest in recent studies. Microneedling (MN) is also known as "percutaneous collagen induction therapy." Microinjuries created by MN 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.Study has shown a statistically significant increase in gingival thickness when microneedling was performed along with i-PRF in comparison to standalone i-PRF. Few human trials have been conducted using MN and Hyaluronic acids in literature for gingival augmentation in thin periodontal phenotype. Considering the effects of MN and hyaluronic acid on the biological potential, neoangiogenesis, neocollagenesis and wound, the present Randomized clinical trial is designed to evaluate the effects of MN alone and MN along with hyaluronic acid in thin gingival phenotype.

Conditions

Thin-gingiva

Outcome Measures

Primary Outcomes (1)

• Measurement of gingival thickness (GT)

  To measure GT from the apical 1.5 mm of the gingival margin, a No:15 endodontic spreader with a 3-mm-diameter silicone disc will be placed in the centre and will be measured on Vernier caliper.

  9 months

Study Arms (2)

Test group

EXPERIMENTAL

Microneedling along with hyaluronic acid in thin gingival phenotype

Procedure: microneedling and hyaluronic acid for increasing gingival thickness in thin gingival phenotype

Control group

ACTIVE COMPARATOR

Microneedling in thin gingival phenotype

Procedure: microneedling for increasing gingival thickness in thin gingival phenotype

Interventions

microneedling and hyaluronic acid for increasing gingival thickness in thin gingival phenotype PROCEDURE

All the participants will undergo phase-I therapy. Oral hygiene instructions will be imparted and will be reinforced at each appointment. Local anaesthesia in the form of xylocaine spray will be administered. Hyaluronic acid: HA will be injected in the attached gingiva and MN will be carried out 1mm below the gingival margin on the keratinized gingiva of the tooth to be treated with thirty-gauge (0.255 mm) lancet needles in the test group.

Test group

microneedling for increasing gingival thickness in thin gingival phenotype PROCEDURE

All the participants will undergo phase-I therapy. Oral hygiene instructions will be imparted and will be reinforced at each appointment. Local anaesthesia in the form of xylocaine spray will be administered and microneedling alone will be performed in control group

Control group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Thin gingival phenotype with gingival tissue thickness \<1mm in mandibular anteriors
• All the patients will be subjected to phase-I therapy and will be included after achieving healthy gingiva with Plaque index (Silness \& Loe) \<1, gingival index (Loe \& Silness) \<1 and showing adequate compliance and willing to participate in the study.

You may not qualify if:

• Patients having systemic diseases such as hypertension, diabetes, hyperthyroidism or on medications that influence the outcome of periodontal procedure
• Smokers, tobacco users
• Previous periodontal surgery
• No haematological disorders.
• Use of blood thinners
• Use of any drugs that might lead to gingival enlargement
• Stress, bruxism

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

Post Graduate Institute of Dental Sciences

Rohtak, Haryana, 124001, India

RECRUITING

MeSH Terms

Interventions

Percutaneous Collagen Induction; Hyaluronic Acid

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Punctures; Rehabilitation; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Dr Nishi Tanwar, MDS

  Post graduate institute of dental sciences,Rohtak,Haryana,India

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Sanjay Tewari, MDS

CONTACT

9416259534; principalpgids@yahoo.in

Dr Nishi Tanwar, MDS

CONTACT

8368126310; nsh_tanwar@yahoo.co.in

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2023
• First Posted: May 22, 2023
• Study Start: October 16, 2023
• Primary Completion: December 1, 2024
• Study Completion: April 1, 2025
• Last Updated: February 7, 2024

Record last verified: 2024-02

Locations

IN (1)