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Role of Subgingival Instrumentation in Oral Lichen Planus

Impact of Subgingival Instrumentation on Clinical and Immunohistochemical Presentation of Oral Lichen Planus With Gingival Involvement

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07381595
Enrollment
30
Registered
2026-02-02
Start date
2026-03-01
Completion date
2028-12-31
Last updated
2026-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Lichen Planus

Keywords

Subgingival instrumentation, Immunohistochemistry, CD4 and CD8 lymphocytes, Clinical parameters

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

Detailed description

Title: Impact of subgingival instrumentation on clinical and immunohistochemical presentation of Oral Lichen Planus with gingival involvement. It aims to answer whether subgingival instrumentation will lead to a reduction in clinical signs and symptoms, as well as a decrease in the immunohistochemical expression of Cluster of Differentiation (CD) 4+ and CD8+T lymphocytes. P-(Population)- Oral Lichen Planus patients with gingival involvement. I (Intervention)- Root planing and scaling. C (Comparison)- Same cases after 4 weeks. O (Outcome)- Assessment of clinical symptoms, pain and gingival index at baseline and after 4 weeks. Quantitative assessment of CD4+ and CD8+T lymphocytes at baseline and after 4 weeks. Periodontitis is an irreversible plaque-induced microbial disease that leads to the destruction of the periodontal ligament and alveolar bone. Its etiopathogenesis is multifactorial and controversial. Oral lichen planus is a T-cell mediated chronic mucocutaneous disease of unknown etiology with an impact of 0.1-4% of the general adult population. Despite various pharmacological advances, the medical management of oral lichen planus remains a daunting task. This could be attributed to the fact that the etiopathogenesis of this disease remains unascertained. Recent evidence does show interactions between these two diseases, where some researchers found that periodontal status in oral lichen planus cases was significantly worse than in healthy controls. Other reports stated that in gingival atrophic-erosive-type oral lichen planus lesions, there was a significant increase in dental plaque and calculus deposits, associated with a higher incidence of periodontal deterioration. Cumulative evidence supports the role of immune dysregulation mediated by the release of cytokines by activated T cells. There is evidence that effective plaque control diminishes the gingival lesions of oral lichen planus, which could be improved by the maintenance of proper oral hygiene and periodontal treatment. However, whether this change in symptoms also makes any histological difference is yet to be known. To date, no study has evaluated the role of T lymphocytes (CD 8+ cytotoxic & 4+ helper) pre and post scaling and root planing in cases of oral lichen planus with gingival involvement. This study was conceived to evaluate the change in clinical signs and symptoms in oral lichen planus with gingival involvement, as well as a reduction in the number of CD4+ and CD8+T lymphocytes pre and post-treatment.

Interventions

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

Sponsors

Postgraduate Institute of Dental Sciences Rohtak
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Change in clinical signs and symptoms in cases of oral lichen planusAt baseline and after end of treatment at 4 weeksClinical signs and symptoms will be recorded using oral disease severity score criteria

Secondary

MeasureTime frameDescription
Change in the number of CD4+ and CD8+T lymphocyte count pre and post-treatment in cases of oral lichen planusAt baseline and after end of treatment at 4 weeksEach case will be biopsied, the tissue will be processed and quantified for CD4 and CD8 lymphocytes by immunohistochemistry

Countries

India

Contacts

CONTACTMala Kamboj, MDS
malskam@gmail.com+919466902477

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026