CClinicalTrials.gg
Status unknownNCT04259034Updated Feb 11, 2020

Periodontal Status in Oral Lichen Planus Patients

An observational study in Periodontitis, sponsored by Postgraduate Institute of Dental Sciences Rohtak. Status unknown at 1 site in India. Open to participants aged 40 Years to 50 Years. Per ClinicalTrials.gov, last updated 2020-02-11.

Sponsored by Postgraduate Institute of Dental Sciences Rohtak · Observational

The sponsor has not verified this record recently (last verified Feb 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
134
Ages
40 Years to 50 Years
Sex
All
01

Study summary

The aim is to investigate the influence of oral lichen planus on periodontal status of systemically healthy individuals.

Read the detailed description

Lichen planus, a chronic immune-mediated inflammatory disease affects the skin and mucous membranes. Oral lichen planus is the mucosal counterpart of cutaneous lichen planus. It was reported first described in 1866 as white papular eruptions in the oral cavity. The prevalence of OLP varies from 0.1% to 4%. OLP mostly occurs in middle aged and elderly patients, with female to male ratio of 3:2. OLP is characterized by lesions consisting of radiating white, grey, velvety, thread-like papules in a linear, annular and retiform arrangement forming typical lacy, reticular patches, rings and streaks. The lesions are most common on buccal mucosa, tongue, lips, gingiva, floor of mouth, palate. Clinically OLP has six clinical presentations namely reticular, erosive, atrophic, plaque-like, papular, bullous.

Reticular form, the most common clinical form presents as fine, asymptomatic intertwined lace-like pattern called "Wickham striae" in a bilateral symmetrical form. It mainly involves the posterior mucosa of the cheek. Erosive OLP represents symptomatic lesions. Atrophic lesions may resemble the combination of two clinical forms, such as the presence of white striae characteristic of the reticular type surrounded by an erythematous area. Plaque-like form mainly found on dorsum of the tongue and the mucosa of the cheek reveals whitish homogeneous irregularities similar to leukoplakia. Papular form presents with small white papules with fine striae in its periphery. Bullous form is the most unusual clinical form, exhibiting blisters that increase in size and tend to rupture, leaving the surface ulcerated and painful.

The pathogenesis of the disease is characterized by cytotoxic CD8+ T lymphocytes migration to the epithelium inducing apoptosis of basal keratinocytes. A number of etiological factors in OLP have been proposed such as local and systemic inducers of cell-mediated hypersensitivity, drugs, dental materials, infectious agents, and stress. The existence of a local cell-mediated immune disorder has been postulated as a factor underlying development of the lesions specifically, a delayed cellular hypersensitivity response probably triggered by some exogenous agent. Periodontal diseases are the most prevalent oral microbial infections that lead to chronic inflammation of the supporting tissues of teeth. Periodontal disease has a complex pathogenesis involving host microbiome interactions. It has an impact on both local and systemic health. The pathogenesis of periodontal disease involves a local inflammatory reaction and the activation. Thus, it is possible to speculate that some interference could exist and that the potential effect arising from these shared mechanisms⁄ mediators could be localized to sites where OLP lesions are present and alteration of host immune response in OLP may have an impact on periodontal health. With this consideration, the present study is aimed to assess periodontal status in systemically healthy individuals with and without oral lichen planus.

02

Conditions studied

03

In context

Periodontitis

1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.

This study's planned enrollment of 134 is above the median of 90 across 428 observational studies indexed under Periodontitis.

Browse Periodontitis studies →

Lead sponsor

Postgraduate Institute of Dental Sciences Rohtak is the lead sponsor of 209 studies on the registry; 71 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 50 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

systemically healthy individuals with and without oral lichen planus

Inclusion criteria

Individuals aged 40-50 yrs. Clinically diagnosed and histo-pathologically confirmed cases of oral Lichen Planus

Exclusion criteria

Exclusion Criteria:

History of periodontal therapy in last one year. Drug-induced lichenoid reaction or any other red or white lesions in the oral cavity.

The presence of any tooth restoration near the lesions. Smokers or patients with history of smoking. systemic diseases or conditions that are reported to be associated with periodontal diseases, including diabetes mellitus, osteoporosis, rheumatoid arthritis Pregnant and lactating women. Patients with history of systemic treatment for oral Lichen Planus Patients with cutaneous lichen planus

05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
134 participants (estimated)
Patient registry
No

Groups and cohorts

  • systemically healthy individuals with oral lichen planus

    systemically healthy individuals diagnosed with oral lichen planus on clinical and histopathological basis.

    Other: diagnosis of periodontitis in oral lichen planus patients

  • systemically healthy individuals without oral lichen planus

    systemically healthy individuals without any clinical feature of oral lichen planus.

    Other: diagnosis of periodontitis in systemically healthy individuals without oral lichen planus

Interventions

  • Otherdiagnosis of periodontitis in oral lichen planus patients

    diagnosis of periodontitis in oral lichen planus patients

  • Otherdiagnosis of periodontitis in systemically healthy individuals without oral lichen planus

    diagnosis of periodontitis in systemically healthy individuals without oral lichen planus

06

What researchers measure

Primary outcomes

  1. Clinical attachment level

    CAL will be measured from cementoenamel junction to the base of the pocket using a periodontal probe at 6 sites

    Time frame: 6 months

Secondary outcomes

  1. Bleeding on probing

    BOP will be measured using a periodontal probe at 4 sites

    Time frame: 6 months

  2. PLAQUE INDEX

    PI will be measured using a periodontal probe at 4 sites

    Time frame: 6 months

  3. Gingival index

    Gingival index will be measured using a periodontal probe at 4 sites

    Time frame: 6 months

  4. Probing pocket depth

    Probing pocket depth will be measured from gingival margin to the base of the pocket using a periodontal probe at 6 sites

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
  • Post Graduate Institute of Dental Sciences
    Rohtak, Haryana 124001, India
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — study protocol

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04259034
Lead sponsor
Postgraduate Institute of Dental Sciences Rohtak
Responsible party
Sponsor
First posted
Feb 6, 2020
Start date
Jan 1, 2020
Primary completion
Apr 30, 2021 (estimated)
Completion
Apr 30, 2021 (estimated)
Last update
Feb 11, 2020

Study contacts

Satish Narula, MDS
Contact
scnarula@gmail.com
01262283876
TEWARI, MDS
Contact
principalpgids@yahoo.in
01262283876
RMA ARYA
principal investigator · POST GRADUATE INSTITUTE OF DENTAL SCIENCES, ROHTAK

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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