- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07615153
Impact of Distress Level, Sleep Quality and Occlusal Trauma on Periodontal Status Among Bruxers
Impact of Distress Level, Sleep Quality and Occlusal Trauma on Periodontal Status Among Bruxers - a Cross Sectional Study
Study Overview
Status
Intervention / Treatment
Detailed Description
The periodontium in sleep bruxism patients suffers from excessive occlusal force for long periods of time during sleep, the function of the periodontium in such patients may differ from that in patients without sleep bruxism.
Bruxism is associated with tooth wear, chipping, cracking, and fracture, tooth mobility, gingival recession, pain, and sensitivity. Tooth mobility can be a serious consequence of bruxism. Tooth mobility has been described as one of the common clinical signs of occlusal trauma. Progressive mobility may be suggestive of ongoing occlusal trauma, but assessments at different time points are necessary to make this determination.
Bruxism has multifactorial etiologies involving central nervous system regulation, psychosocial factors such as stress, and peripheral influences such as occlusal interferences. Psychological stress and poor sleep quality are commonly reported in individuals with sleep bruxism. Sleep disturbances have been linked to elevated muscle activity and increased parafunctional events, potentially contributing to adverse oral health outcomes. Additionally, poor sleep quality has been associated with diminished overall health and may exacerbate inflammatory responses, which are central to periodontal disease progression. These may contribute to adverse oral health outcomes by preventing the "rest and repair" cycle necessary for tissue health. Stress levels and poor sleep quality negatively affect systemic health. These effects are mediated through direct mechanisms such as systemic inflammation, oxidative stress, and immune system impairment, as well as indirect mechanisms involving associated compensatory behaviors. Given that inflammation and oxidative stress are key components in the pathogenesis of periodontitis. Previous epidemiological studies have identified high perceived stress and poor sleep quality as modifiable risk indicators for periodontitis. When stress levels remain chronically elevated and recovery is insufficient due to poor sleep quality, chronic allostatic load responses and dysregulated immune and inflammatory processes are further activated. Therefore, it can be hypothesized that the combined presence of high stress and poor sleep quality may have a more pronounced detrimental effect on the periodontium than either factor alone.
However, inconsistent and conflicting findings have been reported between relationship of stress, sleep quality, and bruxism as a result, highlighting the need for integrated evaluation of these factors within dental research.
In the context of bruxism, occlusal trauma is significant because the repetitive nature of occlusal loading may potentiate periodontal tissue destruction beyond the effects of microbial plaque alone.
Given the multifactorial nature of bruxism and periodontal disease, understanding how psychological (stress), psychological and behavioral (sleep quality), and mechanical (occlusal trauma) factors influence periodontal health in bruxers could enhance diagnostic precision and therapeutic strategies. This study aims to evaluate these relationships to clarify their impact on periodontal status.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Shubham Singh Kaur, BDS
- Phone Number: +91 8168143428
- Email: kaurqismat1511@gmail.com
Study Contact Backup
- Name: Rajinder Kumar Sharma, MDS
- Phone Number: +91 9416358222
- Email: rksharmamds@yahoo.in
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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
|
these scale were assessed using questionnaires in both the groups
Other Names:
|
|
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
|
these scale were assessed using questionnaires in both the groups
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: baseline
|
Pittsburgh Sleep Quality Index (PSQI) this scale will be used to assess sleep quality in both the groups
|
baseline
|
|
Depression Anxiety Stress Scales - 21
Time Frame: baseline
|
Depression Anxiety Stress Scales - 21 this scale is used to assess distress level among two groups
|
baseline
|
|
Hospital Anxiety and Depression Scale - 14
Time Frame: baseline
|
Hospital Anxiety and Depression Scale - 14 this scale is used to assess distress level among two groups
|
baseline
|
Collaborators and Investigators
Investigators
- Study Director: Rajinder Kumar Sharma, MDS, Post graduate institute of dental sciences, Rohtak
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Shubham Singh perio 26/56
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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