Impact of Distress Level, Sleep Quality and Occlusal Trauma on Periodontal Status Among Bruxers

June 1, 2026 updated by: Postgraduate Institute of Dental Sciences Rohtak

Impact of Distress Level, Sleep Quality and Occlusal Trauma on Periodontal Status Among Bruxers - a Cross Sectional Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
128

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

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Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

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

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Other: Pittsburgh Sleep Quality Index (PSQI)
these scale were assessed using questionnaires in both the groups
Other Names:
  • Depression Anxiety Stress Scales-21
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
Other: Pittsburgh Sleep Quality Index (PSQI)
these scale were assessed using questionnaires in both the groups
Other Names:
  • Depression Anxiety Stress Scales-21

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: baseline
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
Time Frame: baseline
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
Time Frame: baseline
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

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Postgraduate Institute of Dental Sciences Rohtak

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Rajinder Kumar Sharma, MDS, Post Graduate Institute Of Dental Sciences, 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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 22, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 27, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 27, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 22, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 29, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Shubham Singh perio 26/56

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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