PeriodontitisNCT06429917
Impact of Subgingival Instrumentation on Jaw Symptoms of Probable Bruxers Among Patients With Periodontitis
A study testing Subgingival instrumentation in people with Periodontitis and Bruxism, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
This study aims to explore the mechanisms by which periodontal disease affects the bruxers and to assess the impact of subgingival instrumentation on jaw symptoms of probable bruxers among patients with periodontitis . Read more about this study
- Who is it for?
- Ages 30 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Bruxism
- What is being tested?
- Subgingival instrumentation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- 5 Aug 2024to 16 Sep 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Systemically healthy patients 2. Patient having habit of bruxism diagnosed with periodontitis 3. Age between 30-40 years 4. Minimum 20 teeth present in oral cavity
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
- Patients receiving interventions for bruxism.
- History of Psychological disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Subgingival Instrumentation on Jaw Symptoms of Probable Bruxers Among Patients With Periodontitis- An Interventional Study
This study aims to explore the mechanisms by which periodontal disease affects the bruxers and to assess the impact of subgingival instrumentation on jaw symptoms of probable bruxers among patients with periodontitis .
Read the detailed description
Patients with chronic periodontitis usually describe itching and persistent pain of moderate intensity. Applying masticatory pressure provides relief in these symptoms. However, this practice may lead to the development of bruxism habits in patients over time.
A deeper comprehension of the dynamic interplay between periodontal health and bruxism is crucial for crafting holistic treatment approaches aimed at addressing both symptoms and root causes effectively.
Till now, there has been no report examining the effect of subgingival instrumentation on probable bruxers in periodontitis patients.
. This study aims to assess the impact of subgingival instrumentation on jaw symptoms of probable bruxers in patients with periodontitis
- Conditions
- Periodontitis, Bruxism
- Being tested
- Subgingival instrumentation
- Keywords
- Inflammation
- Medical subject headings
- Periodontitis, Bruxism, Inflammation
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 subgingival instrumentation with hand scalers, curettes and ultrasonic scaler. Parameters will be recorded at baseline and two, three and six months of time points after subgingival instrumentation.
| Study group | Role | What they receive |
|---|---|---|
| Periodontitis with bruxism | Other | All the participants will undergo subgingival instrumentation with hand scalers, curettes and ultrasonic scaler. Parameters will be recorded at baseline and two, three and six months of time points after subgingival instrumentation. Receives: Other: Subgingival instrumentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Jaw symptoms
Improvement in frequency and intensity of Jaw Symptoms (pain, unpleasantness, sensitivity, tiredness, tension and stiffness) as perceived by the patient.
Measured: baseline , 2 months , 3 months and 6 months
Secondary outcomes (4)
Bleeding on probing
BOP recorded as 1 if bleeding occurs within 15 seconds of probing and 0 (absent) if no bleeding occurred. It will be calculated in %. After adding all the scores, total score will be divided by the total no. of surfaces accessed and multiplied by 100
Measured: baseline , 2 months , 3 months and 6 months
Gingival index
Gingival index by Loe and Silness (1963) will be used to assess severity of gingival inflammation.
Measured: baseline , 2 months , 3 months and 6 months
Probing pocket depth
Probing Pocket Depth (PPD): Probing pocket depth will be measured as the distance from gingival margin to the base of pocket. The probing depth measurements will be assessed using the Periodontal probe. The probe will be inserted in the bottom of pocket and maintained parallel to vertical axis of the tooth. Measurements will be noted at 6sites of a tooth (mesio-buccal, mid-buccal, disto- buccal, mesio-lingual, mid-lingual and disto- lingual). Measurements will be rounded to the nearest whole millimeter.
Measured: baseline , 2 months , 3 months and 6 months
tooth mobility
Tooth mobility is assessed using Miller Mobility Index
Measured: baseline , 2 months , 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start5 Aug 2024
- Primary completion25 Aug 2025
- Study completion16 Sep 2025
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- VARSHA KAPOOR, BDS, Principal investigator, PGIDS, ROHTAK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06429917
- Sponsor's protocol ID
- PGIDS/BHRC/24/37
- Status last verified
- May 2026
- First submitted
- 21 May 2024
- Last updated
- 7 May 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 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Subgingival Instrumentation on Jaw Symptoms of Probable Bruxers Among Patients With Periodontitis- An Interventional Study
- ClinicalTrials.gov ID
- NCT06429917
- Acronym / sponsor ID
- PGIDS/BHRC/24/37
- Conditions
- Periodontitis, Bruxism
- Keywords
- Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 5 Aug 2024 (actual)
- Primary completion
- 25 Aug 2025 (actual)
- Study completion
- 16 Sep 2025 (actual)
- First posted
- 28 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.
This study aims to explore the mechanisms by which periodontal disease affects the bruxers and to assess the impact of subgingival instrumentation on jaw symptoms of probable bruxers among patients with periodontitis .
Detailed description
Patients with chronic periodontitis usually describe itching and persistent pain of moderate intensity. Applying masticatory pressure provides relief in these symptoms. However, this practice may lead to the development of bruxism habits in patients over time.
A deeper comprehension of the dynamic interplay between periodontal health and bruxism is crucial for crafting holistic treatment approaches aimed at addressing both symptoms and root causes effectively.
Till now, there has been no report examining the effect of subgingival instrumentation on probable bruxers in periodontitis patients.
. This study aims to assess the impact of subgingival instrumentation on jaw symptoms of probable bruxers in patients 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 with bruxism | Other | Other: Subgingival instrumentationAll the participants will undergo subgingival instrumentation with hand scalers, curettes and ultrasonic scaler. Parameters will be recorded at baseline and two, three and six months of time points after subgingival instrumentation. |
Who may qualify
- Ages
- 30 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1. Systemically healthy patients 2. Patient having habit of bruxism diagnosed with periodontitis 3. Age between 30-40 years 4. Minimum 20 teeth present in oral cavity
Key exclusion criteria (7 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subgingival instrumentationAll the participants will undergo subgingival instrumentation with hand scalers, curettes and ultrasonic scaler. Parameters will be recorded at baseline and two, three and six months of time points after subgingival instrumentation. | Other | Periodontitis with bruxism |
Primary outcome
Jaw symptoms
Time frame: baseline , 2 months , 3 months and 6 months
Improvement in frequency and intensity of Jaw Symptoms (pain, unpleasantness, sensitivity, tiredness, tension and stiffness) as perceived by the patient.
4 secondary outcomes
Bleeding on probing
Time frame: baseline , 2 months , 3 months and 6 months
Gingival index
Time frame: baseline , 2 months , 3 months and 6 months
Probing pocket depth
Time frame: baseline , 2 months , 3 months and 6 months
tooth mobility
Time frame: baseline , 2 months , 3 months and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 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. This study is not recruiting at the moment.
VARSHA KAPOOR, 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 Periodontitis 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 1 inclusion and 7 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: finished, as of the sponsor's last update on 7 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Jaw symptoms (time frame: baseline , 2 months , 3 months and 6 months). 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 7 May 2026.