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

NCT05869136 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-02-07

No results posted yet for this study

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

Interventions

PROCEDURE

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

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.

PROCEDURE

microneedling for increasing gingival thickness in thin gingival phenotype

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

Sponsors & Collaborators

  • Postgraduate Institute of Dental Sciences Rohtak

    lead OTHER

Principal Investigators

  • Dr Nishi Tanwar, MDS · Post graduate institute of dental sciences,Rohtak,Haryana,India

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-16
Primary Completion
2024-12-31
Completion
2025-04-30

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05869136 on ClinicalTrials.gov