Periodontal DiseasesNCT06435208
Impact of Subgingival Instrumentation on Psychological Distress and Mental Health Status in Bruxers With Periodontitis
A study testing Subgingival instrumentation in people with Periodontal Diseases and Bruxism, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
Bruxism is a non-functional repetitive jaw-muscle activity characterized by grinding or clenching the teeth. Bruxism, characterized by the involuntary grinding or clenching of teeth, is a prevalent parafunctional habit affecting individuals of all ages. Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases, Bruxism, Periodontitis
- What is being tested?
- Subgingival instrumentation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteIndia
- Study dates
- 4 Jul 2024to 1 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Systemically healthy patients
- Patient having periodontitis with bruxism
- Age between 30-50 years
Who cannot join
- History of mental health disorder
- History of systemic disease
- History of drugs having the potential impact on periodontal status like phenytoin, cyclosporin, calcium-channel blockers or antidepressant drugs
- Pregnant or lactating females
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Post Graduate Institute of Dental Sciences
Rohtak, Haryana, 124001
RAJINDER KR SHARMA, MDS, 9416358222, rksharmamds@yahoo.in
About this study
Bruxism is a non-functional repetitive jaw-muscle activity characterized by grinding or clenching the teeth. Bruxism, characterized by the involuntary grinding or clenching of teeth, is a prevalent parafunctional habit affecting individuals of all ages. Stress, anxiety, and depression are the psychological factors most commonly associated with the presence of bruxism.
Read the detailed description
Bruxism, characterized by the involuntary grinding or clenching of teeth, is a prevalent parafunctional habit affecting individuals of all ages. Although the etiology is not known exactly, it has been suggested that bruxism is a multifactorial disorder. Periodontitis, a prevalent inflammatory condition affecting the periodontium, has been linked to bruxism in several studies. The coexistence of bruxism and periodontitis poses unique challenges in clinical management of periodontitis. Also, as periodontitis became chronic, the occurrence of depression increased. Stress, anxiety, and depression are the psychological factors most commonly associated with the presence of bruxism. Therefore, this study aims to investigate impact of subgingival instrumentation on psychological distress and mental health status in bruxers with periodontitis.
- Conditions
- Periodontal Diseases, Bruxism, Periodontitis, Distress, Emotional
- Being tested
- Subgingival instrumentation
- Medical subject headings
- Periodontal Diseases, Bruxism, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subgingival instrumentationOther
All the participants will undergo scaling and root planning with hand scalers, curettes and ultrasonic scaler.
| Study group | Role | What they receive |
|---|---|---|
| PERIODONTITIS BRUXISM | Experimental | subgingival instrumentation will be done in all participants Receives: Other: Subgingival instrumentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological distress
Assessment of psychological distress will be done by using Kessler Psychological distress(K10)
Measured: BASELINE,2 MONTHS ,3 MONTHS
Mental Health Status
Assessment of mental health status will be done by using mental health inventory 38
Measured: Baseline, 2 months, 3 months
Secondary outcomes (2)
periodontal parameter
periodontal probing depth
Measured: Baseline, 2 month, 3 month
periodontal inflammation
bleeding on probing
Measured: Baseline, 2 month, 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start4 Jul 2024
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Priyanka Chandela, BDS, Principal investigator, PGIDS , ROHTAK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06435208
- Sponsor's protocol ID
- PRIYANKAPERIO2024
- Status last verified
- Jul 2024
- First submitted
- 17 May 2024
- Last updated
- 8 Jul 2024
- 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 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Subgingival Instrumentation on Psychological Distress and Mental Health Status in Bruxers With Periodontitis
- ClinicalTrials.gov ID
- NCT06435208
- Acronym / sponsor ID
- PRIYANKAPERIO2024
- Conditions
- Periodontal Diseases, Bruxism, Periodontitis, Distress, Emotional
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 4 Jul 2024 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 30 May 2024 (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.
Bruxism is a non-functional repetitive jaw-muscle activity characterized by grinding or clenching the teeth. Bruxism, characterized by the involuntary grinding or clenching of teeth, is a prevalent parafunctional habit affecting individuals of all ages. Stress, anxiety, and depression are the psychological factors most commonly associated with the presence of bruxism.
Detailed description
Bruxism, characterized by the involuntary grinding or clenching of teeth, is a prevalent parafunctional habit affecting individuals of all ages. Although the etiology is not known exactly, it has been suggested that bruxism is a multifactorial disorder. Periodontitis, a prevalent inflammatory condition affecting the periodontium, has been linked to bruxism in several studies. The coexistence of bruxism and periodontitis poses unique challenges in clinical management of periodontitis. Also, as periodontitis became chronic, the occurrence of depression increased. Stress, anxiety, and depression are the psychological factors most commonly associated with the presence of bruxism. Therefore, this study aims to investigate impact of subgingival instrumentation on psychological distress and mental health status in bruxers with periodontitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PERIODONTITIS BRUXISM | Experimental | Other: Subgingival instrumentationsubgingival instrumentation will be done in all participants |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Systemically healthy patients
- Patient having periodontitis with bruxism
- Age between 30-50 years
Key exclusion criteria (4 listed)
- History of mental health disorder
- History of systemic disease
- History of drugs having the potential impact on periodontal status like phenytoin, cyclosporin, calcium-channel blockers or antidepressant drugs
- 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 |
|---|---|---|
| Subgingival instrumentationAll the participants will undergo scaling and root planning with hand scalers, curettes and ultrasonic scaler. | Other | PERIODONTITIS BRUXISM |
Primary outcome
Psychological distress
Time frame: BASELINE,2 MONTHS ,3 MONTHS
Assessment of psychological distress will be done by using Kessler Psychological distress(K10)
Mental Health Status
Time frame: Baseline, 2 months, 3 months
Assessment of mental health status will be done by using mental health inventory 38
2 secondary outcomes
periodontal parameter
Time frame: Baseline, 2 month, 3 month
periodontal inflammation
Time frame: Baseline, 2 month, 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- 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. This study is not recruiting at the moment.
Priyanka Chandela, BDS principal investigator
PGIDS , ROHTAK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subgingival instrumentation in people with Periodontal Diseases and Bruxism, 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 3 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: status not confirmed, as of the sponsor's last update on 8 Jul 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact RAJINDER KR SHARMA, MDS (9416358222, rksharmamds@yahoo.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological distress (time frame: BASELINE,2 MONTHS ,3 MONTHS). The study lists 2 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 8 Jul 2024.