NCT04259034

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
134

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 4, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 6, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

February 11, 2020

Status Verified

February 1, 2020

Enrollment Period

1.3 years

First QC Date

February 4, 2020

Last Update Submit

February 8, 2020

Conditions

Outcome Measures

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

    6 months

Secondary Outcomes (4)

  • Bleeding on probing

    6 months

  • PLAQUE INDEX

    6 months

  • Gingival index

    6 months

  • Probing pocket depth

    6 months

Study Arms (2)

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

diagnosis of periodontitis in oral lichen planus patients

systemically healthy individuals with oral lichen planus

diagnosis of periodontitis in systemically healthy individuals without oral lichen planus

systemically healthy individuals without oral lichen planus

Eligibility Criteria

Age40 Years - 50 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

systemically healthy individuals with and without oral lichen planus

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Post Graduate Institute of Dental Sciences

Rohtak, Haryana, 124001, India

RECRUITING

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • RMA ARYA

    POST GRADUATE INSTITUTE OF DENTAL SCIENCES, ROHTAK

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Satish Narula, MDS

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2020

First Posted

February 6, 2020

Study Start

January 1, 2020

Primary Completion

April 30, 2021

Study Completion

April 30, 2021

Last Updated

February 11, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will share

study protocol

Shared Documents
STUDY PROTOCOL

Locations