Periodontal DiseaseNCT07634250
Mental Health and Periodontitis in Probable Bruxers
An observational study of Periodontal Disease, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
The goal of this observational study is to learn how mental health affects periodontal health in people having teeth grinding (bruxism). The main questions it aims to answer are: Does poor mental health increase the risk of periodontitis in people with teeth grinding? Does stress link teeth grinding and periodontitis?… Read more about this study
- Who is it for?
- Ages 30 to 50 months
- Conditions the study is for
- Periodontal Disease
- How many people
- 110 participants
- Where
- 1 siteIndia
- Study dates
- Jun 2026to Sep 2026
- 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 50 months
- All sexes
- No healthy volunteers
- Child
Study population: The study population will be drawn from patients reporting to the outpatient clinic of department of Periodontics at PGIDS, Rohtak on the basis of strict inclusion and exclusion criteria.
Who may be able to join
- Adult periodontitis patients with age group 30-50 years diagnosed with probable bruxism.
- Presence of minimum 20 teeth excluding third molars.
Who cannot join
- History of systemic disease such as diabetes or autoimmune disease
- History of drugs having the potential impact on periodontal status like phenytoin, cyclosporin, calcium-channel blockers or antidepressant drugs.
- Pregnant or lactating females.
- Post-menopausal women.
- Patients diagnosed with temporomandibular disorders- pain and tenderness in the masticatory muscles
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Association Between Mental Health Status and Periodontitis Among Probable Bruxers
The goal of this observational study is to learn how mental health affects periodontal health in people having teeth grinding (bruxism).
The main questions it aims to answer are:
Read more
Does poor mental health increase the risk of periodontitis in people with teeth grinding? Does stress link teeth grinding and periodontitis?
Participants are people who likely have teeth grinding(bruxism) and periodontitis
Participants will:
Answer questions about their mental health, including stress Get a periodontal health status check
Teeth grinding(Bruxism) can occur due to stress, smoking, alcohol use, and bite problems. Stress may affect muscle activity and lead to teeth grinding. It can also weaken the body's defense and lead to poor oral care. This may worsen periodontal health.
Read the detailed description
Stress is related to emotional and physiological reactions when there is a lifetime event conflict that exceeds the individual's ability to deal effectively with the situation.
Psychological stress is generally recognized as a potential cofactor in the pathogenesis of infectious disease. It can trigger immune responses that favor the occurrence or exacerbation of changes in the oral cavity, such as periodontitis. It can directly impair the periodontal status through various biological mechanisms: variation in the gingival fluid, production of interleukin IL1, IL-6, reduction of polymorphonuclear leukocytes and phagocytosis, and decreased lymphocyte production and antibody production, as well as through changes in behavior related to health, such as oral hygiene, smoking habit and diet.
Stress evokes emotional and physiologic reactions and is an important modifiable risk factor for both mental and physical illnesses.
Periodontitis is characterized by progressive destruction of the tooth-supporting apparatus causing loss of support which manifests through clinical attachment loss (CAL), radiographically assessed alveolar bone loss, presence of periodontal pocket and gingival bleeding.
Based on the ecologic plaque hypothesis, periodontal diseases result from environmental changes to the oral habitat. Marsh considers that the selection of ''pathogenic'' bacteria is directly coupled to changes in the environment.
A sound understanding of the psychosocial pathways of the behaviors strongly linked to periodontal diseases, and how psychological factors affect the response of the periodontal tissues to pathogens, is essential for diagnosis and improving interventions.
One of the stress manifestations is bruxism, or gnashing and grinding of the teeth. Theories about the origin of bruxism have hypothesized different types of factors: peripheral, connected to teeth occlusion interferences, central, connected to neurotransmission from brain to chewing muscles and psychosocial, associated to stress.
"Although extensive research has investigated the associations between stress and bruxism, as well as stress and periodontitis, there remains a notable gap in the literature examining the combined relationship among stress, bruxism, and periodontitis."
- Conditions
- Periodontal Disease
- Keywords
- mental health status, probable bruxism
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| single group(probable bruxers) | This study will be evaluating the association between mental health status and periodontitis in individuals with probable bruxism. |
What is being measured
The primary outcome is the main question the study is designed to answer.
mental health status
Assessment of mental health status in each participant using mental health questionnaire (MHI-38). Score range from 38 to 226, with higher score indicating better mental health
Measured: baseline
Secondary outcomes (5)
pocket probing depth
Pocket probing depth will be measured in millimeters from gingival margin to base of pocket at 6 sites per tooth using UNC-15 probe
Measured: baseline
Clinical Attachment Level
Clinical attachment level will be measured in millimeters from cemento-enamel junction to base of periodontal pocket at 6 sites per tooth using UNC-15 probe.
Measured: Baseline
Bleeding on probing
Bleeding on probing will be scored as 0=no bleeding and 1= bleeding at six sites per tooth after gentle probing with UNC-15 probe
Measured: baseline
Gingival Index
Gingival Index will be assessed using the Loe and Silness criteria. Each site will be scored from 0 to 3, where 0= normal gingiva, 1= mild inflammation with slight color change and edema but no bleeding on probing, 2= moderate inflammation with redness, edema, and bleeding on probing, and 3= severe inflammation with marked redness, edema, ulceration and a tendency for spontaneous bleeding. The scores are averaged to obtain the gingival index for an individual tooth or entire dentition.
Measured: Baseline
Plaque Index
The Silness and Loe plaque index (PI) is a clinical index used to assess the thickness of dental plaque at the gingival area of teeth. scored from 0 to 3: 0 = no plaque, 1 = a thin film of plaque adhering to the free gingival margin and adjacent tooth surface, detectable only by probing or disclosing agent, 2 = moderate accumulation of plaque visible to the naked eye within the gingival pocket or on the tooth and gingival margin, and 3 = abundant soft deposits covering the tooth surface and gingival margin. The scores are averaged to obtain the plaque index for an individual tooth or the entire mouth, providing a measure of oral hygiene
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseaseStudies 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
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Rajinder Kumar Sharma, MDS, Study director, PGIDS, ROHTAK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07634250
- Sponsor's protocol ID
- VARSHA PERIO
- Status last verified
- Jun 2026
- First submitted
- 22 May 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Mental Health Status and Periodontitis Among Probable Bruxers
- ClinicalTrials.gov ID
- NCT07634250
- Acronym / sponsor ID
- VARSHA PERIO
- Conditions
- Periodontal Disease
- Keywords
- mental health status, probable bruxism
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 8 Jun 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.
The goal of this observational study is to learn how mental health affects periodontal health in people having teeth grinding (bruxism).
The main questions it aims to answer are:
Does poor mental health increase the risk of periodontitis in people with teeth grinding? Does stress link teeth grinding and periodontitis?
Participants are people who likely have teeth grinding(bruxism) and periodontitis
Participants will:
Answer questions about their mental health, including stress Get a periodontal health status check
Teeth grinding(Bruxism) can occur due to stress, smoking, alcohol use, and bite problems. Stress may affect muscle activity and lead to teeth grinding. It can also weaken the body's defense and lead to poor oral care. This may worsen periodontal health.
Detailed description
Stress is related to emotional and physiological reactions when there is a lifetime event conflict that exceeds the individual's ability to deal effectively with the situation.
Psychological stress is generally recognized as a potential cofactor in the pathogenesis of infectious disease. It can trigger immune responses that favor the occurrence or exacerbation of changes in the oral cavity, such as periodontitis. It can directly impair the periodontal status through various biological mechanisms: variation in the gingival fluid, production of interleukin IL1, IL-6, reduction of polymorphonuclear leukocytes and phagocytosis, and decreased lymphocyte production and antibody production, as well as through changes in behavior related to health, such as oral hygiene, smoking habit and diet.
Stress evokes emotional and physiologic reactions and is an important modifiable risk factor for both mental and physical illnesses.
Periodontitis is characterized by progressive destruction of the tooth-supporting apparatus causing loss of support which manifests through clinical attachment loss (CAL), radiographically assessed alveolar bone loss, presence of periodontal pocket and gingival bleeding.
Based on the ecologic plaque hypothesis, periodontal diseases result from environmental changes to the oral habitat. Marsh considers that the selection of ''pathogenic'' bacteria is directly coupled to changes in the environment.
A sound understanding of the psychosocial pathways of the behaviors strongly linked to periodontal diseases, and how psychological factors affect the response of the periodontal tissues to pathogens, is essential for diagnosis and improving interventions.
One of the stress manifestations is bruxism, or gnashing and grinding of the teeth. Theories about the origin of bruxism have hypothesized different types of factors: peripheral, connected to teeth occlusion interferences, central, connected to neurotransmission from brain to chewing muscles and psychosocial, associated to stress.
"Although extensive research has investigated the associations between stress and bruxism, as well as stress and periodontitis, there remains a notable gap in the literature examining the combined relationship among stress, bruxism, and periodontitis."
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single group(probable bruxers) | – | –This study will be evaluating the association between mental health status and periodontitis in individuals with probable bruxism. |
Who may qualify
- Ages
- 30 to 50 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study population will be drawn from patients reporting to the outpatient clinic of department of Periodontics at PGIDS, Rohtak on the basis of strict inclusion and exclusion criteria.
Key inclusion criteria (2 listed)
- Adult periodontitis patients with age group 30-50 years diagnosed with probable bruxism.
- Presence of minimum 20 teeth excluding third molars.
Key exclusion criteria (5 listed)
- History of systemic disease such as diabetes or autoimmune disease
- History of drugs having the potential impact on periodontal status like phenytoin, cyclosporin, calcium-channel blockers or antidepressant drugs.
- Pregnant or lactating females.
- Post-menopausal women.
- Patients diagnosed with temporomandibular disorders- pain and tenderness in the masticatory muscles
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
mental health status
Time frame: baseline
Assessment of mental health status in each participant using mental health questionnaire (MHI-38). Score range from 38 to 226, with higher score indicating better mental health
5 secondary outcomes
pocket probing depth
Time frame: baseline
Clinical Attachment Level
Time frame: Baseline
Bleeding on probing
Time frame: baseline
Gingival Index
Time frame: Baseline
Plaque Index
Time frame: Baseline
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 8 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Dr. Rajinder Kumar Sharma, MDS study director
PGIDS, ROHTAK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontal Disease, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
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 2 inclusion and 5 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 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Varsha kapoor, BDS (+91 99991802339, varsha.kapoor045@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mental health status (time frame: baseline). 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 8 Jun 2026.