Impact of Subgingival Instrumentation on Masticatory Performance and Psychological Distress (NCT06024447) | Clinical Trial Compass
UnknownNot Applicable
Impact of Subgingival Instrumentation on Masticatory Performance and Psychological Distress
India92 participantsStarted 2023-09-15
Plain-language 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. 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.
Who can participate
Age range
30 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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:
* 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
* Steroid, immunosuppressive and psychiatric drug use
* Pregnant and lactating women
* History of menopause
* Smoking or substance abuse
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Masticatory performance
Timeframe: Baseline, 2 months, 3 months
2
Hospital Anxiety and Depression Scale 14
Timeframe: Baseline, 2 months, 3 months
3
Depression Anxiety and Stress Scale 21
Timeframe: Baseline, 2 months, 3 months
Trial details
NCT IDNCT06024447
SponsorPostgraduate Institute of Dental Sciences Rohtak