Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 9:43 PM
Study NCT ID:
NCT07381595
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-06
First Post:
2025-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Subgingival Instrumentation in Oral Lichen Planus
Sponsor:
Postgraduate Institute of Dental Sciences Rohtak
Organization:
Study Overview
Official Title:
Impact of Subgingival Instrumentation on Clinical and Immunohistochemical Presentation of Oral Lichen Planus With Gingival Involvement
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: