PeriodontitisNCT06024447
Impact of Subgingival Instrumentation on Masticatory Performance and Psychological Distress
A study testing Subgingival Instrumentation in people with Periodontitis, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
Patients of Stage III and Stage IV Periodontitis will be assessed for masticatory dysfunction and psychological distress. Subgingival Instrumentation will be done for treating periodontitis. Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- Subgingival Instrumentation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteIndia
- Study dates
- 15 Sep 2023to 15 Oct 2024
- 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
- Adult patients with age group 30-50 years diagnosed with stage III/IV generalized periodontitis.
- Presence of minimum 20 teeth (Eichner group A1, A2, A3) excluding third molars.
Who cannot join
- Systemic diseases that may affect periodontal disease progression or outcome of treatment (diabetes, autoimmune diseases)
- Systemic diseases that may affect masticatory ability of the patient (sarcopenia, TMJ disorders, Xerostomia, Acute Pulpitis)
- Periodontal treatment within the 6 months
- Patients wearing orthodontic appliances
- Any diagnosed psychiatric disorder
- Antibiotic use within the previous 3 months
Show all 10Show fewer
- Steroid, immunosuppressive and psychiatric drug use
- Pregnant and lactating women
- History of menopause
- Smoking or substance abuse
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
Official title: Impact of Subgingival Instrumentation on Masticatory Performance and Psychological Distress in Periodontitis: Stage III and IV
Patients of Stage III and Stage IV Periodontitis will be assessed for masticatory dysfunction and psychological distress. Subgingival Instrumentation will be done for treating periodontitis. Patients will be re-evaluated after 2 and 3 months in order to assess any change in masticatory dysfunction and psychological distress by improved periodontal health.
Read the detailed description
Literature reveals that there occurs masticatory dysfunction in patients with Stage III and IV Periodontitis. It has been hypothesized that masticatory dysfunction along with halitosis and aesthetics of the patient can have an effect on the psychological distress in a chronic state.
Patients of Stage III and Stage IV Periodontitis with the following criteria will be included :
- Adult patients with age group 30-50 years diagnosed with stage III/IV generalized periodontitis.
- Presence of minimum 20 teeth (Eichner group A1, A2, A3) excluding third molars.
Exclusion Criteria: Patients with
- Systemic diseases that may affect periodontal disease progression or outcome of treatment (diabetes, autoimmune diseases)
- Systemic diseases that may affect masticatory ability of the patient (sarcopenia, TMJ disorders, Xerostomia, Acute Pulpitis)
- History of periodontal treatment within the 6 months
- Patients wearing orthodontic appliances
- Diagnosed psychiatric disorder
- History of antibiotic use within the previous 3 months
- History of use of Steroid, immunosuppressive and psychiatric drugs
- Pregnant and lactating women
- Smoking or substance abuse
- History of Menopause
Periodontal clinical parameters:
Plaque Index, Gingival Index, Bleeding on Probing, Probing Pocket Depth, Clinical Attachment Level, Mobility Psychological Parameters: Hospital Anxiety and Depression Scale -14 and Depression Anxiety and Stress Scale -21 Quality of Masticatory Dysfunction Questionnaire and Objective evaluation of Masticatory Performance by mixing ability of Hubba Bubba chewing gum.
The sample of 84 patients consisting of 42 cases and 42 controls. The patients will be re-evaluated at 2 and 3 months follow up for clinical periodontal parameters, masticatory performance and psychological distress.
- Conditions
- Periodontitis
- Being tested
- Subgingival Instrumentation
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subgingival InstrumentationProcedure or surgery
Subgingival Instrumentation will be performed in patients with Stage III and IV periodontitis.
| Study group | Role | What they receive |
|---|---|---|
| Stage III and Stage IV Periodontitis | Other | Subgingival Instrumentation will be performed in patients with Stage III and Stage IV periodontitis. Receives: Procedure: Subgingival Instrumentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Masticatory performance
Objective Masticatory Performance will be evaluated using colour mixing ability of a chewing gum, through optoelectronic analysis using a software. Subjective masticatory performance will be calculated using The Quality of Masticatory Function questionnaire which consists of 29 questions related to frequency and difficulty of chewing different types of foods in the previous 2 weeks.
Measured: Baseline, 2 months, 3 months
Hospital Anxiety and Depression Scale 14
The HADS constitutes 14 items grouped into two subscales: "anxiety subscale" (HADS-A), as well as "depression subscale" (HADS-D). The responses to the items are graded from 0 (absence of manifestations) to 3 (severe manifestations). Scores are summated to yield the total score, and greater scores indicate more severe anxiety, as well as depressive indications. DASS-21 measures emotional distress in three subcategories of depression (e.g., loss of self-esteem/incentives and depressed mood), anxiety (e.g., fear and anticipation of negative events), and stress (e.g., persistent state of over arousal and low frustration tolerance). It is a self-reporting questionnaire with 21 items (seven items for each category) based on a four-point rating scale. Higher score represents more severe emotional distress.
Measured: Baseline, 2 months, 3 months
Depression Anxiety and Stress Scale 21
DASS-21 measures emotional distress in three subcategories of depression (e.g., loss of self-esteem/incentives and depressed mood), anxiety (e.g., fear and anticipation of negative events), and stress (e.g., persistent state of over arousal and low frustration tolerance). It is a self-reporting questionnaire with 21 items (seven items for each category) based on a four-point rating scale. Higher score represents more severe emotional distress.
Measured: Baseline, 2 months, 3 months
Secondary outcomes (2)
Pocket Probing Depth
The probe UNC 15 will be inserted with a firm, gentle pressure to the bottom of the pocket and maintained parallel to the vertical axis of the tooth. Measurements will be noted at 6 sites of involved tooth - mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual.
Measured: Baseline, 2 months, 3 months
Clinical attachment level
Clinical Attachment Level will be measured as a distance between from the base of the clinical pocket and the cemento-enamel junction (CEJ). Measurements will be made at 6 sites of involved tooth.
Measured: Baseline, 2 months, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start15 Sep 2023
- Primary completion15 Sep 2024 (estimated)
- Study completion15 Oct 2024 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Janvi Janvi, BDS, Principal investigator, PGIDS Rohtak
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06024447
- Sponsor's protocol ID
- JANVIPERIO2023
- Status last verified
- May 2024
- First submitted
- 10 Aug 2023
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Subgingival Instrumentation on Masticatory Performance and Psychological Distress in Periodontitis: Stage III and IV
- ClinicalTrials.gov ID
- NCT06024447
- Acronym / sponsor ID
- JANVIPERIO2023
- Conditions
- Periodontitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 15 Sep 2024 (estimated)
- Study completion
- 15 Oct 2024 (estimated)
- First posted
- 6 Sep 2023 (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.
Patients of Stage III and Stage IV Periodontitis will be assessed for masticatory dysfunction and psychological distress. Subgingival Instrumentation will be done for treating periodontitis. Patients will be re-evaluated after 2 and 3 months in order to assess any change in masticatory dysfunction and psychological distress by improved periodontal health.
Detailed description
Literature reveals that there occurs masticatory dysfunction in patients with Stage III and IV Periodontitis. It has been hypothesized that masticatory dysfunction along with halitosis and aesthetics of the patient can have an effect on the psychological distress in a chronic state.
Patients of Stage III and Stage IV Periodontitis with the following criteria will be included :
- Adult patients with age group 30-50 years diagnosed with stage III/IV generalized periodontitis.
- Presence of minimum 20 teeth (Eichner group A1, A2, A3) excluding third molars.
Exclusion Criteria: Patients with
- Systemic diseases that may affect periodontal disease progression or outcome of treatment (diabetes, autoimmune diseases)
- Systemic diseases that may affect masticatory ability of the patient (sarcopenia, TMJ disorders, Xerostomia, Acute Pulpitis)
- History of periodontal treatment within the 6 months
- Patients wearing orthodontic appliances
- Diagnosed psychiatric disorder
- History of antibiotic use within the previous 3 months
- History of use of Steroid, immunosuppressive and psychiatric drugs
- Pregnant and lactating women
- Smoking or substance abuse
- History of Menopause
Periodontal clinical parameters:
Plaque Index, Gingival Index, Bleeding on Probing, Probing Pocket Depth, Clinical Attachment Level, Mobility Psychological Parameters: Hospital Anxiety and Depression Scale -14 and Depression Anxiety and Stress Scale -21 Quality of Masticatory Dysfunction Questionnaire and Objective evaluation of Masticatory Performance by mixing ability of Hubba Bubba chewing gum.
The sample of 84 patients consisting of 42 cases and 42 controls. The patients will be re-evaluated at 2 and 3 months follow up for clinical periodontal parameters, masticatory performance and psychological distress.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stage III and Stage IV Periodontitis | Other | Procedure: Subgingival InstrumentationSubgingival Instrumentation will be performed in patients with Stage III and Stage IV periodontitis. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Adult patients with age group 30-50 years diagnosed with stage III/IV generalized periodontitis.
- Presence of minimum 20 teeth (Eichner group A1, A2, A3) excluding third molars.
Key exclusion criteria (10 listed)
- Systemic diseases that may affect periodontal disease progression or outcome of treatment (diabetes, autoimmune diseases)
- Systemic diseases that may affect masticatory ability of the patient (sarcopenia, TMJ disorders, Xerostomia, Acute Pulpitis)
- Periodontal treatment within the 6 months
- Patients wearing orthodontic appliances
- Any diagnosed psychiatric disorder
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 InstrumentationSubgingival Instrumentation will be performed in patients with Stage III and IV periodontitis. | Procedure or surgery | Stage III and Stage IV Periodontitis |
Primary outcome
Masticatory performance
Time frame: Baseline, 2 months, 3 months
Objective Masticatory Performance will be evaluated using colour mixing ability of a chewing gum, through optoelectronic analysis using a software. Subjective masticatory performance will be calculated using The Quality of Masticatory Function questionnaire which consists of 29 questions related to frequency and difficulty of chewing different types of foods in the previous 2 weeks.
Hospital Anxiety and Depression Scale 14
Time frame: Baseline, 2 months, 3 months
The HADS constitutes 14 items grouped into two subscales: "anxiety subscale" (HADS-A), as well as "depression subscale" (HADS-D). The responses to the items are graded from 0 (absence of manifestations) to 3 (severe manifestations). Scores are summated to yield the total score, and greater scores indicate more severe anxiety, as well as depressive indications. DASS-21 measures emotional distress in three subcategories of depression (e.g., loss of self-esteem/incentives and depressed mood), anxiety (e.g., fear and anticipation of negative events), and stress (e.g., persistent state of over arousal and low frustration tolerance). It is a self-reporting questionnaire with 21 items (seven items for each category) based on a four-point rating scale. Higher score represents more severe emotional distress.
Depression Anxiety and Stress Scale 21
Time frame: Baseline, 2 months, 3 months
DASS-21 measures emotional distress in three subcategories of depression (e.g., loss of self-esteem/incentives and depressed mood), anxiety (e.g., fear and anticipation of negative events), and stress (e.g., persistent state of over arousal and low frustration tolerance). It is a self-reporting questionnaire with 21 items (seven items for each category) based on a four-point rating scale. Higher score represents more severe emotional distress.
2 secondary outcomes
Pocket Probing Depth
Time frame: Baseline, 2 months, 3 months
Clinical attachment level
Time frame: Baseline, 2 months, 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 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.
Janvi Janvi, 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, 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 10 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 17 May 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 Sanjay Tewari, MDS (91-1262-283876, principalpgids@yahoo.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Masticatory performance (time frame: Baseline, 2 months, 3 months). 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 17 May 2024.