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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06435208
Other study ID # PRIYANKAPERIO2024
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 1, 2024
Est. completion date February 1, 2025

Study information

Verified date May 2024
Source Postgraduate Institute of Dental Sciences Rohtak
Contact RAJINDER KR SHARMA, MDS
Phone 9416358222
Email rksharmamds@yahoo.in
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Bruxism, characterized by the involuntary grinding or clenching of teeth, is a prevalent parafunctional habit affecting individuals of all ages. Although the etiology is not known exactly, it has been suggested that bruxism is a multifactorial disorder. Periodontitis, a prevalent inflammatory condition affecting the periodontium, has been linked to bruxism in several studies. The coexistence of bruxism and periodontitis poses unique challenges in clinical management of periodontitis. Also, as periodontitis became chronic, the occurrence of depression increased. Stress, anxiety, and depression are the psychological factors most commonly associated with the presence of bruxism. Therefore, this study aims to investigate impact of subgingival instrumentation on psychological distress and mental health status in bruxers with periodontitis.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 45
Est. completion date February 1, 2025
Est. primary completion date December 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years to 50 Years
Eligibility Inclusion Criteria: - Systemically healthy patients - Patient having periodontitis with bruxism - Age between 30-50 years Exclusion Criteria: - 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

Study Design


Intervention

Other:
Subgingival instrumentation
All the participants will undergo scaling and root planning with hand scalers, curettes and ultrasonic scaler.

Locations

Country Name City State
India Post Graduate Institute of Dental Sciences Rohtak Haryana

Sponsors (1)

Lead Sponsor Collaborator
Postgraduate Institute of Dental Sciences Rohtak

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary Psychological distress Assessment of psychological distress will be done by using Kessler Psychological distress(K10) BASELINE,2 MONTHS ,3 MONTHS
Primary Mental Health Status Assessment of mental health status will be done by using mental health inventory 38 Baseline, 2 months, 3 months
Secondary periodontal parameter periodontal probing depth Baseline, 2 month, 3 month
Secondary periodontal inflammation bleeding on probing Baseline, 2 month, 3 month
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