NCT06060119

Brief Summary

The presence study is toComparison of Microneedling with Subepithelial Connective Tissue Auto Graft for Gingival Augmentation- A Randomized Case Control Trial. The trial is in accordance with the Consolidated Standards of Reporting Trials (CONSORT) criteria, 2010.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2023

Shorter than P25 for phase_2

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 29, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

November 28, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
Last Updated

September 29, 2023

Status Verified

September 1, 2023

Enrollment Period

7 months

First QC Date

September 13, 2023

Last Update Submit

September 23, 2023

Conditions

Gingival Phenotype

Outcome Measures

Primary Outcomes (1)

  • OBJECTIVES OF THE STUDY: The primary outcomes measured will be : 1) Increase in gingival augmentation with microneedling

    1. Increase in gingival augmentation with microneedling will be measured in (mm) 2. Comparison of microneedling with subepithelial connective tissue graft for gingival thickness in(mm) digital calliper and spreader file

    6 months

Secondary Outcomes (1)

  • thickness in mm

    6 months

Study Arms (2)

Comparison of Microneedling for Gingival Augmentation- A Randomized Case Control Trial

EXPERIMENTAL

1\. TEST GROUP (n = 12) - Microneedling on the selected a non-steroidal anti-inflammatory drug (Tab Ibuprofen 400mg) and antibiotic Amoxicillin 500mg thrice daily for three days after meals will be prescribed. In patients allergic to Amoxicillin, Clindamycin 300mg thrice daily is prescribed13

Device: microneedling

Comparison of Microneedling with for Gingival Augmentation- A Randomized Case Control Trial

EXPERIMENTAL

2.CONTROL GROUP (n = 12) - Subepithelial connective tissue grafting at the contralateral site non-steroidal anti-inflammatory drug (Tab Ibuprofen 400mg) and antibiotic Amoxicillin 500mg thrice daily for three days after meals will be prescribed. In patients allergic to Amoxicillin, Clindamycin 300mg thrice daily is prescribed13

Device: microneedling

Interventions

microneedlingDEVICE

The operative sites will be anaesthetized with 2% lignocaine hydrochloride with adrenaline(1:80,000).Electric microneedling pen device model THAPPINKTM is used. Microneedling is carried out on the isolated site involving one tooth mesially and distally and 1.5mm apical to marginal gingiva each for 30-40 second intermittently. When pin point bleeding observed on the area of gingiva it is irrigated with sterile saline solution. Patient will be instructed to refrain from consuming hot beverage and brushing in that area for one day to avoid mechanical trauma. A total of 4 session of micro needling procedure will be carried out in one subject at 10 days intervals upto 40days

Also known as: Derma pen
Comparison of Microneedling for Gingival Augmentation- A Randomized Case Control TrialComparison of Microneedling with for Gingival Augmentation- A Randomized Case Control Trial

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients \> 18 years of age.
  • Patients with esthetic concern .
  • Patient under going orthodontic, prosthodontic, restorative treatment where thick gingiva is necessary.
  • Systemically healthy subjects
  • Full mouth plaque index,full mouth bleeding on probing score \< or = 15
  • Patient with palatal mucosa greater than 4mm

You may not qualify if:

  • Previous periodontal surgery
  • Patients with history of coagulation disorder
  • Smoking habit
  • Pregnant and lactating females
  • Use of any

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Percutaneous Collagen Induction

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesPuncturesRehabilitation

Central Study Contacts

ANUSHA S, MDS

CONTACT

7204759280sanusha097@gmail.com

rashmi p, MDS

CONTACT

9900925844

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: SAMPLING TECHNIQUE Purposive Sampling technique will be done. All the patients meeting the criteria will be screened and then 12 patients will be randomly allotted into either of the two groups. The treatment allocation to the test and control group will be assigned by means of a sealed envelope containing a code derived from a computer generated randomized list to receive either - 1. TEST GROUP (n = 12) - Microneedling on the selected area. 2. CONTROL GROUP (n = 12) - Subepithelial connective tissue grafting at the contralateral site
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
HOD OF PERIODONTOLOGY

Study Record Dates

First Submitted

September 13, 2023

First Posted

September 29, 2023

Study Start

November 28, 2023

Primary Completion

June 30, 2024

Study Completion

July 30, 2024

Last Updated

September 29, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share