Impact of Distress Level, Sleep Quality and Occlusal Trauma on Periodontal Status Among Bruxers
1 other identifier
observational
128
0 countries
N/A
Brief Summary
Increased distress levels and impaired sleep quality are known to exacerbate bruxism by enhancing masticatory muscle activity, leading to excessive and prolonged occlusal forces. These abnormal forces may result in occlusal trauma, which can compromise the adaptive capacity of the periodontal tissues by increasing tooth mobility, widening the periodontal ligament space, and accelerating alveolar bone loss, particularly in the presence of existing periodontal inflammation. Although occlusal trauma alone may not initiate periodontal disease, it can act as an important modifying factor in disease progression. Despite the recognized individual associations of distress, sleep quality, bruxism, and periodontal health, limited evidence exists regarding their combined impact on periodontal status among bruxers. Therefore, evaluating the influence of distress level, sleep quality, and occlusal trauma on periodontal status is essential to better understand disease progression and to facilitate comprehensive, multidisciplinary management strategies for individuals with bruxism.
Trial Health
Trial Health Score
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participants targeted
Target at P50-P75 for all trials
Started Jun 2026
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 22, 2026
CompletedFirst Posted
Study publicly available on registry
May 29, 2026
CompletedStudy Start
First participant enrolled
June 22, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
December 27, 2027
Study Completion
Last participant's last visit for all outcomes
December 27, 2027
June 3, 2026
May 1, 2026
1.5 years
May 22, 2026
June 1, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) will be used to assess sleep quality in both groups. The PSQI is a self-reported questionnaire that measures sleep quality and disturbances over a 1-month time interval. It yields a global score ranging from a minimum of 0 to a maximum of 21, where higher scores indicate worse sleep quality (a score greater than 5 indicates severe difficulties in at least two areas, or moderate difficulties in more than three areas).
baseline
Depression Anxiety Stress Scales - 21
The Depression Anxiety Stress Scales - 21 (DASS-21) will be used to assess psychological distress levels among both groups. It is a 21-item self-report questionnaire designed to measure the negative emotional states across three distinct subscale: depression, anxiety, and stress. Each subscale range from a minimum of 0 to a maximum of 42, where a lesser number indicates normal emotional state and a higher number signifies a increased severity of psychological distress. Clinically, lower scores falling within the ranges of 0-9 for Depression, 0-7 for Anxiety, and 0-14 for Stress designate a "Normal" status.For Depression, scores progress through Mild (10-13), Moderate (14-20), Severe (21-27), and Extremely Severe (28+) bands. For Anxiety, elevated scores represent Mild (8-9), Moderate (10-14), Severe (15-19), and Extremely Severe (20+) levels.
baseline
Hospital Anxiety and Depression Scale - 14
The Hospital Anxiety and Depression Scale (HADS) will be used to assess psychological distress levels among both groups. The HADS is a 14-item self-report rating scale containing two distinct 7-item subscales: one for anxiety (HADS-A) and one for depression (HADS-D). For each subscale, final scores range from a minimum of 0 to a maximum of 21, where a lesser number indicates a better outcome (absence of distress) and a higher number signifies a worse outcome (increased severity of anxiety or depressive symptoms). Clinically, scores on either subscale are categorized into specific bands to interpret severity: a lower score between 0-7 represents a "Normal" or non-case state, whereas higher scores indicate elevated distress progression across Mild/Borderline abnormal (8-10), Moderate/Abnormal (11-14), and Severe/Severe abnormal (15-21) brackets.
baseline
Study Arms (2)
probable bruxers according to bruxscreen-q with periodontitis
Periodontal parameters will be assessed which include clinical attachment level (CAL), periodontal pocket depth (PPD), bleeding on probing (BOP), Gingival index (GI), Tooth mobility will be assessed using a modified Lindhe and Nyman(1975) degree classification. Stress level will be assessed by HADS 14, DASS 21, Sleep quality will be assessed with PSQI
patient who are non bruxers according to bruxscreen-q
Periodontal parameters will be assessed which include clinical attachment level (CAL), periodontal pocket depth (PPD), bleeding on probing (BOP), Gingival index (GI), Tooth mobility will be assessed using a modified Lindhe and Nyman(1975) degree classification. Stress level will be assessed by HADS 14, DASS 21, Sleep quality will be assessed with PSQI
Interventions
these scale were assessed using questionnaires in both the groups
Eligibility Criteria
Systemically healthy patients with generalized periodontitis diagnosed with bruxism, aged 30-45years will be recruited in the study from OPD of Periodontology. Recruitment of the patients for the study will be based on eligibility criteria after obtaining informed and written consent.
You may qualify if:
- Test Group:
- Adults aged 30-45 years
- Patients diagnosed with periodontitis according to the 2017 World Workshop classification of periodontal and peri-implant diseases and conditions.
- Patients who are probable bruxers according to BRUXSCREEN-Q
- Minimum of 20 natural teeth
- Control Group:
- Adults aged 30-45 years
- Patients diagnosed with periodontitis according to the 2017 World Workshop classification of periodontal and peri-implant diseases and conditions.
- Patients who are not probable bruxers according to BRUXSCREEN-Q
- Minimum of 20 natural teeth
You may not qualify if:
- Systemic conditions affecting periodontium (e.g., diabetes, auto immune disorders)
- History of drugs having the potential impact on periodontal status like phenytoin, cyclosporin, calcium-channel blockers or antidepressant drugs
- Patients with pulpal pathology
- Pregnant or lactating females
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Rajinder Kumar Sharma, MDS
Post Graduate Institute Of Dental Sciences, Rohtak
Central Study Contacts
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
May 29, 2026
Study Start (Estimated)
June 22, 2026
Primary Completion (Estimated)
December 27, 2027
Study Completion (Estimated)
December 27, 2027
Last Updated
June 3, 2026
Record last verified: 2026-05