Impact of Subgingival Instrumentation on Psychological Distress and Mental Health Status in Bruxers With Periodontitis
1 other identifier
interventional
45
1 country
1
Brief Summary
Bruxism is a non-functional repetitive jaw-muscle activity characterized by grinding or clenching the teeth. Bruxism, characterized by the involuntary grinding or clenching of teeth, is a prevalent parafunctional habit affecting individuals of all ages. Stress, anxiety, and depression are the psychological factors most commonly associated with the presence of bruxism.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2024
Shorter than P25 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
May 17, 2024
CompletedFirst Posted
Study publicly available on registry
May 30, 2024
CompletedStudy Start
First participant enrolled
July 4, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2025
CompletedJuly 8, 2024
July 1, 2024
5 months
May 17, 2024
July 4, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Psychological distress
Assessment of psychological distress will be done by using Kessler Psychological distress(K10)
BASELINE,2 MONTHS ,3 MONTHS
Mental Health Status
Assessment of mental health status will be done by using mental health inventory 38
Baseline, 2 months, 3 months
Secondary Outcomes (2)
periodontal parameter
Baseline, 2 month, 3 month
periodontal inflammation
Baseline, 2 month, 3 month
Study Arms (1)
PERIODONTITIS BRUXISM
EXPERIMENTALsubgingival instrumentation will be done in all participants
Interventions
All the participants will undergo scaling and root planning with hand scalers, curettes and ultrasonic scaler.
Eligibility Criteria
You may qualify if:
- Systemically healthy patients
- Patient having periodontitis with bruxism
- Age between 30-50 years
You may not qualify if:
- History of mental health disorder
- History of systemic disease
- History of drugs having the potential impact on periodontal status like phenytoin, cyclosporin, calcium-channel blockers or antidepressant drugs
- Pregnant or lactating females
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Post Graduate Institute of Dental Sciences
Rohtak, Haryana, 124001, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Priyanka Chandela, BDS
PGIDS , ROHTAK
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2024
First Posted
May 30, 2024
Study Start
July 4, 2024
Primary Completion
December 1, 2024
Study Completion
February 1, 2025
Last Updated
July 8, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share