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Clinical Trials/NCT06024447
NCT06024447
Recruiting
Not Applicable

Impact of Subgingival Instrumentation on Masticatory Performance and Psychological Distress in Periodontitis: Stage III and IV

Postgraduate Institute of Dental Sciences Rohtak1 site in 1 country92 target enrollmentSeptember 15, 2023
ConditionsPeriodontitis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Periodontitis
Sponsor
Postgraduate Institute of Dental Sciences Rohtak
Enrollment
92
Locations
1
Primary Endpoint
Depression Anxiety and Stress Scale 21
Status
Recruiting
Last Updated
last year

Overview

Brief 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.

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 : 1. Adult patients with age group 30-50 years diagnosed with stage III/IV generalized periodontitis. 2. Presence of minimum 20 teeth (Eichner group A1, A2, A3) excluding third molars. Exclusion Criteria: Patients with 1. Systemic diseases that may affect periodontal disease progression or outcome of treatment (diabetes, autoimmune diseases) 2. Systemic diseases that may affect masticatory ability of the patient (sarcopenia, TMJ disorders, Xerostomia, Acute Pulpitis) 3. History of periodontal treatment within the 6 months 4. Patients wearing orthodontic appliances 5. Diagnosed psychiatric disorder 6. History of antibiotic use within the previous 3 months 7. History of use of Steroid, immunosuppressive and psychiatric drugs 8. Pregnant and lactating women 9. Smoking or substance abuse 10. 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.

Registry
clinicaltrials.gov
Start Date
September 15, 2023
End Date
October 15, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

  • Pocket Probing Depth(Baseline, 2 months, 3 months)
  • Clinical attachment level(Baseline, 2 months, 3 months)

Study Sites (1)

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