NCT07634250

Brief Summary

The goal of this observational study is to learn how mental health affects periodontal health in people having teeth grinding (bruxism). The main questions it aims to answer are: Does poor mental health increase the risk of periodontitis in people with teeth grinding? Does stress link teeth grinding and periodontitis? Participants are people who likely have teeth grinding(bruxism) and periodontitis Participants will: Answer questions about their mental health, including stress Get a periodontal health status check Teeth grinding(Bruxism) can occur due to stress, smoking, alcohol use, and bite problems. Stress may affect muscle activity and lead to teeth grinding. It can also weaken the body's defense and lead to poor oral care. This may worsen periodontal health.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
3mo left

Started Jun 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress16%
Jun 2026Sep 2026

First Submitted

Initial submission to the registry

May 22, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 8, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

June 8, 2026

Status Verified

June 1, 2026

Enrollment Period

3 months

First QC Date

May 22, 2026

Last Update Submit

June 3, 2026

Conditions

Keywords

mental health statusprobable bruxism

Outcome Measures

Primary Outcomes (1)

  • mental health status

    Assessment of mental health status in each participant using mental health questionnaire (MHI-38). Score range from 38 to 226, with higher score indicating better mental health

    baseline

Secondary Outcomes (5)

  • pocket probing depth

    baseline

  • Clinical Attachment Level

    Baseline

  • Bleeding on probing

    baseline

  • Gingival Index

    Baseline

  • Plaque Index

    Baseline

Study Arms (1)

single group(probable bruxers)

This study will be evaluating the association between mental health status and periodontitis in individuals with probable bruxism.

Eligibility Criteria

Age30 Months - 50 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

The study population will be drawn from patients reporting to the outpatient clinic of department of Periodontics at PGIDS, Rohtak on the basis of strict inclusion and exclusion criteria.

You may qualify if:

  • Adult periodontitis patients with age group 30-50 years diagnosed with probable bruxism.
  • Presence of minimum 20 teeth excluding third molars.

You may not qualify if:

  • History of systemic disease such as diabetes or autoimmune disease
  • History of drugs having the potential impact on periodontal status like phenytoin, cyclosporin, calcium-channel blockers or antidepressant drugs.
  • Pregnant or lactating females.
  • Post-menopausal women.
  • Patients diagnosed with temporomandibular disorders- pain and tenderness in the masticatory muscles

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pgids, Rohtak

Rohtak, Haryana, 124001, India

Location

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Officials

  • Dr. Rajinder Kumar Sharma, MDS

    PGIDS, ROHTAK

    STUDY DIRECTOR

Central Study Contacts

Dr. Rajinder kumar Sharma, MDS

CONTACT

Study Design

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

Study Record Dates

First Submitted

May 22, 2026

First Posted

June 8, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

June 8, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations