Comparative Evaluation of Microneedling and Injectable Platelet Rich Fibrin in Thin Periodontal Phenotype

NCT05055765 | Unknown DMC

• 1 other identifier: Anjali Yadav perio
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of microneedling vs injectable -platelet rich fibrin on gingival phenotype in thin periodontal phenotype.

Conditions

Thin Gingiva

Keywords

periodontal phenotype

Outcome Measures

Primary Outcomes (1)

• Gingival thickness (GT)

  GT was determined at a mid-buccal location about 1mm apical to the Pocket Depth with a #15 endodontic reamer.

  6 months

Secondary Outcomes (2)

• Keratinized tissue width (KTW)

  6 months

• Pocket Probing Depth (PD)

  6 months

Study Arms (2)

TEST GROUP I

EXPERIMENTAL

Thin periodontal phenotype will be treated with microneedling. A total of 4 sessions will be done with an interval of 10 days each. And all the parameters will be measured.

Procedure: Microneedling

TEST GROUP II

ACTIVE COMPARATOR

Thin periodontal phenotype will be treated with i-PRF procedure. A total of 4 sessions will be done with an interval of 10 days each. And all the parameters will be measured.

Procedure: injectable- platelet rich fibrin

Interventions

Microneedling PROCEDURE

MN will be carried out 1mm below of the gingival margin on the gingiva of the tooth to be treated with thirty-gauge (0.255 mm) lancet needles.

TEST GROUP I

injectable- platelet rich fibrin PROCEDURE

I-PRF will be prepared according to Choukroun PRF method.

TEST GROUP II

Eligibility Criteria

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

You may qualify if:

• GT of the mandibular and maxillary anterior teeth \< 1 mm, gingival index (GI) of \< 1
• Age 18-40 years and otherwise systemically healthy
• Patients who had completed etiological periodontal therapy with Plaque index \<1, gingival index \<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
• Pregnant and lactating women
• 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

Location

MeSH Terms

Interventions

Percutaneous Collagen Induction

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Punctures; Rehabilitation

Study Officials

• ANJALI YADAV

  PGIDS,ROHTAK

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SANJAY TEWARI

CONTACT

01262-283876; principalpgids@yahoo.in

NISHI TANWAR

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Single blinding will be adopted where the investigator analysing the results will be unaware to which group the patient belongs.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: September 24, 2021
• Study Start: November 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: September 1, 2022
• Last Updated: November 17, 2021

Record last verified: 2021-11

Locations

IN (1)