NCT07381595

Brief Summary

The goal of this interventional study is to assess the clinical and histopathological changes in Oral Lichen Planus patients with gingival involvement pre and post subgingival instrumentation. Objective- Primary objective: To observe and evaluate the clinical signs and symptoms in Oral Lichen Planus with gingival involvement. Secondary objective: To observe and evaluate the Cluster of Differentiation (CD) 4+ and 8+T lymphocytes in Oral Lichen Planus with gingival involvement. Study group: 30 cases of Oral Lichen Planus with gingival involvement

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
33mo left

Started Mar 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress7%
Mar 2026Dec 2028

First Submitted

Initial submission to the registry

December 4, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 2, 2026

Completed
27 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

1.8 years

First QC Date

December 4, 2025

Last Update Submit

February 4, 2026

Conditions

Oral Lichen Planus

Keywords

Subgingival instrumentationImmunohistochemistryCD4 and CD8 lymphocytesClinical parameters

Outcome Measures

Primary Outcomes (1)

  • Change in clinical signs and symptoms in cases of oral lichen planus

    Clinical signs and symptoms will be recorded using oral disease severity score criteria

    At baseline and after end of treatment at 4 weeks

Secondary Outcomes (1)

  • Change in the number of CD4+ and CD8+T lymphocyte count pre and post-treatment in cases of oral lichen planus

    At baseline and after end of treatment at 4 weeks

Study Arms (1)

Oral Lichen Planus

EXPERIMENTAL

Scaling and root planing will be conducted on Oral Lichen Planus cases with gingival involvement.

Procedure: subgingival instrumentation

Interventions

subgingival instrumentationPROCEDURE

Subgingival instrumentation like scaling and root planing of the recruited subject shall be done.

Oral Lichen Planus

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinically and histopathologically confirmed cases of OLP.
  • OLP predominantly involving the gingiva.
  • Consent obtained.

You may not qualify if:

  • Cases which does not fulfil either clinical or histopathological criteria.
  • Unwilling to participate in the study.
  • Patients with recorded history of factors that might modify immune response (such as patient on corticosteroids or medically compromised patients or suffering from heart diseases).
  • Cases undergoing treatment of OLP within past 6 months.
  • Biopsies with inadequate or non-representative samples
  • Cases histopathologically diagnosed as Lichenoid Dysplasia or Oral Lichenoid Lesions.
  • Cases diagnosed with autoimmune disorders.

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

Conditions

Lichen Planus, Oral

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesLichen PlanusLichenoid EruptionsSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Mala Kamboj, MDS

CONTACT

+919466902477malskam@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2025

First Posted

February 2, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Last Updated

February 6, 2026

Record last verified: 2026-02

Locations

IN(1)