NCT05449925

Brief Summary

To evaluate the effect injectable platelet rich fibrin (i-PRF) along with microneedling on gingival thickness in patients with thin gingival phenotype undergoing non extraction fixed orthodontic treatment

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 30, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 8, 2022

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2022

Completed
Last Updated

July 8, 2022

Status Verified

July 1, 2022

Enrollment Period

1.4 years

First QC Date

May 30, 2022

Last Update Submit

July 7, 2022

Conditions

Thin-gingiva

Outcome Measures

Primary Outcomes (1)

  • Change in Gingival tissue thickness (GTT)

    Change in Gingival tissue thickness from baseline to 6 months

    6 months

Study Arms (2)

TEST GROUP

EXPERIMENTAL

i-PRF and Microneedling Procedure in thin gingiva followed by orthodontic treatment

Procedure: Injectable PRF and Microneedling

CONTROL GROUP

NO INTERVENTION

no periodontal intervention

Interventions

Injectable PRF and MicroneedlingPROCEDURE

i-PRF and Microneedling Procedure in thin gingiva followed by orthodontic treatment

TEST GROUP

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • GT of the mandibular anterior teeth \<1mm (jepson et al. 2018) requiring labial orthodontic tooth movement without extraction.
  • Patients with \> 18 years who will be systemically healthy
  • full-mouth plaque index (PI) and full-mouth bleeding on probing (BOP) score of ≤ 15%
  • gingival index (GI) of \<1 (loe and silness) and dehiscence in mandibular anterior teeth detected in CBCT;

You may not qualify if:

  • Patients with thick gingival biotype (\>1mm gingival thickness as per Jepson et al.,2018) ;
  • Patient undergoing dental extraction for labial orthodontic tooth movement.
  • previous periodontal surgery;
  • systemic disease;
  • smokers
  • use of blood thinners;
  • use of any drugs that might lead to gingival enlargement;
  • mucogingival stress, bruxism.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Post Graduate Institute of Dental Sciences

Rohtak, Haryana, 124001, India

Location

MeSH Terms

Interventions

Percutaneous Collagen Induction

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesPuncturesRehabilitation

Study Officials

  • MRINALINI VERMA, BDS

    PGIDS, ROHTAK

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2022

First Posted

July 8, 2022

Study Start

March 1, 2021

Primary Completion

July 15, 2022

Study Completion

August 25, 2022

Last Updated

July 8, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)