- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06024447
Impact of Subgingival Instrumentation on Masticatory Performance and Psychological Distress
Impact of Subgingival Instrumentation on Masticatory Performance and Psychological Distress in Periodontitis: Stage III and IV
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sanjay Tewari, MDS
- Phone Number: 91-1262-283876
- Email: principalpgids@yahoo.in
Study Locations
-
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Haryana
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Rohtak, Haryana, India, 124001
- Recruiting
- Post Graduate Institute of Dental Sciences
-
Contact:
- RAJINDER KR SHARMA, MDS
- Phone Number: 9416358222
- Email: rksharmamds@yahoo.in
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Stage III and Stage IV Periodontitis
Subgingival Instrumentation will be performed in patients with Stage III and Stage IV periodontitis.
|
Subgingival Instrumentation will be performed in patients with Stage III and IV periodontitis.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, 2 months, 3 months
|
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.
|
Baseline, 2 months, 3 months
|
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.
|
Baseline, 2 months, 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pocket Probing Depth
Time Frame: Baseline, 2 months, 3 months
|
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.
|
Baseline, 2 months, 3 months
|
Clinical attachment level
Time Frame: Baseline, 2 months, 3 months
|
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.
|
Baseline, 2 months, 3 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Janvi Janvi, BDS, pgids rohtak
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JANVIPERIO2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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