Impact of Subgingival Instrumentation on Psychological Distress and Mental Health Status in Bruxers With Periodontitis

July 4, 2024 updated by: Postgraduate Institute of Dental Sciences Rohtak
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • India
    • Haryana
      • Rohtak, Haryana, India, 124001
        • Recruiting
        • Post Graduate Institute of dental sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PERIODONTITIS BRUXISM
subgingival instrumentation will be done in all participants
Other: Subgingival instrumentation
All the participants will undergo scaling and root planning with hand scalers, curettes and ultrasonic scaler.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychological distress
Time Frame: BASELINE,2 MONTHS ,3 MONTHS
Assessment of psychological distress will be done by using Kessler Psychological distress(K10)
BASELINE,2 MONTHS ,3 MONTHS
Mental Health Status
Time Frame: Baseline, 2 months, 3 months
Assessment of mental health status will be done by using mental health inventory 38
Baseline, 2 months, 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
periodontal parameter
Time Frame: Baseline, 2 month, 3 month
periodontal probing depth
Baseline, 2 month, 3 month
periodontal inflammation
Time Frame: Baseline, 2 month, 3 month
bleeding on probing
Baseline, 2 month, 3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Postgraduate Institute of Dental Sciences Rohtak

Investigators

  • Principal Investigator: Priyanka Chandela, BDS, PGIDS , Rohtak

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 4, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

May 17, 2024

First Submitted That Met QC Criteria

May 23, 2024

First Posted (Actual)

May 30, 2024

Study Record Updates

Last Update Posted (Actual)

July 8, 2024

Last Update Submitted That Met QC Criteria

July 4, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRIYANKAPERIO2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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