PeriodontitisNCT07615153
Impact of Distress Level, Sleep Quality and Occlusal Trauma on Periodontal Status Among Bruxers
An observational study of Periodontitis and Bruxism, run by Postgraduate Institute of Dental Sciences Rohtak.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 45 years
- Conditions the study is for
- Periodontitis, Bruxism, Sleep Quality
- What is being tested?
- Pittsburgh Sleep Quality Index (PSQI)
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- 22 Jun 2026to 27 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 45 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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:
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Periodontitis, Bruxism, Sleep Quality, Distress Level, Occlusal Trauma
- Being tested
- Pittsburgh Sleep Quality Index (PSQI)
- Keywords
- periodontits, bruxism, sleep quality, distress level, occlusal trauma
- Medical subject headings
- Periodontitis, Bruxism, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pittsburgh Sleep Quality Index (PSQI)Other
Also called Depression Anxiety Stress Scales-21
these scale were assessed using questionnaires in both the groups
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Pittsburgh Sleep Quality Index (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 Receives: Other: Pittsburgh Sleep Quality Index (PSQI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start22 Jun 2026 (estimated)
- Primary completion27 Dec 2027 (estimated)
- Study completion27 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Postgraduate Institute of Dental Sciences RohtakThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rajinder Kumar Sharma, MDS, Study director, Post Graduate Institute Of Dental Sciences, Rohtak
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07615153
- Sponsor's protocol ID
- Shubham Singh perio 26/56
- Status last verified
- May 2026
- First submitted
- 22 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Distress Level, Sleep Quality and Occlusal Trauma on Periodontal Status Among Bruxers - a Cross Sectional Study
- ClinicalTrials.gov ID
- NCT07615153
- Acronym / sponsor ID
- Shubham Singh perio 26/56
- Conditions
- Periodontitis, Bruxism, Sleep Quality, Distress Level, Occlusal Trauma
- Keywords
- periodontits, bruxism, sleep quality, distress level, occlusal trauma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 22 Jun 2026 (estimated)
- Primary completion
- 27 Dec 2027 (estimated)
- Study completion
- 27 Dec 2027 (estimated)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| probable bruxers according to bruxscreen-q with periodontitis | – | Other: Pittsburgh Sleep Quality Index (PSQI)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 | – | Other: Pittsburgh Sleep Quality Index (PSQI)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 |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (10 listed)
- 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
- Adults aged 30-45 years
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pittsburgh Sleep Quality Index (PSQI)Also: Depression Anxiety Stress Scales-21these scale were assessed using questionnaires in both the groups | Other | patient who are non bruxers according to bruxscreen-q, probable bruxers according to bruxscreen-q with periodontitis |
Primary outcome
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).
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rajinder Kumar Sharma, MDS study director
Post Graduate Institute Of Dental Sciences, Rohtak
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontitis and Bruxism, run by Postgraduate Institute of Dental Sciences Rohtak.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shubham Singh Kaur, BDS (+91 8168143428, kaurqismat1511@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburgh Sleep Quality Index (PSQI) (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.