Role of Subgingival Instrumentation in Oral Lichen Planus
ConditionOral Lichen Planus
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPostgraduate Institute of Dental Sciences Rohtak
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Clinically and histopathologically confirmed cases of OLP.
OLP predominantly involving the gingiva.
Consent obtained.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
subgingival instrumentation
Procedure/SurgerySubgingival instrumentation like scaling and root planing of the recruited subject shall be done.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Oral Lichen PlanusExperimental treatment 1 intervention
Trial outcomes
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
Time frame
At baseline and after end of treatment at 4 weeksSecondary outcomes
1
Change in the number of CD4+ and CD8+T lymphocyte count pre and post-treatment in cases of oral lichen planus
Each case will be biopsied, the tissue will be processed and quantified for CD4 and CD8 lymphocytes by immunohistochemistry
Time frame
At baseline and after end of treatment at 4 weeksSponsors and contacts
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Source ClinicalTrials.gov
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