Impact of Subgingival Instrumentation on Jaw Symptoms of Probable Bruxers Among Patients With Periodontitis
1 other identifier
interventional
60
1 country
1
Brief Summary
This study aims to explore the mechanisms by which periodontal disease affects the bruxers and to assess the impact of subgingival instrumentation on jaw symptoms of probable bruxers among patients with periodontitis .
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 Aug 2024
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 21, 2024
CompletedFirst Posted
Study publicly available on registry
May 28, 2024
CompletedStudy Start
First participant enrolled
August 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2025
CompletedMay 28, 2024
May 1, 2024
1 year
May 21, 2024
May 21, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Jaw symptoms
Improvement in frequency and intensity of Jaw Symptoms (pain, unpleasantness, sensitivity, tiredness, tension and stiffness) as perceived by the patient.
baseline , 2 months , 3 months and 6 months
Secondary Outcomes (4)
Bleeding on probing
baseline , 2 months , 3 months and 6 months
Gingival index
baseline , 2 months , 3 months and 6 months
Probing pocket depth
baseline , 2 months , 3 months and 6 months
tooth mobility
baseline , 2 months , 3 months and 6 months
Study Arms (1)
Periodontitis with bruxism
OTHERAll the participants will undergo subgingival instrumentation with hand scalers, curettes and ultrasonic scaler. Parameters will be recorded at baseline and two, three and six months of time points after subgingival instrumentation.
Interventions
All the participants will undergo subgingival instrumentation with hand scalers, curettes and ultrasonic scaler. Parameters will be recorded at baseline and two, three and six months of time points after subgingival instrumentation.
Eligibility Criteria
You may qualify if:
- \. Systemically healthy patients 2. Patient having habit of bruxism diagnosed with periodontitis 3. Age between 30-40 years 4. Minimum 20 teeth present in oral cavity
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
- Patients receiving interventions for bruxism.
- History of Psychological disorders
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
VARSHA KAPOOR, 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 21, 2024
First Posted
May 28, 2024
Study Start
August 1, 2024
Primary Completion
August 1, 2025
Study Completion
September 1, 2025
Last Updated
May 28, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share