Impact of Subgingival Instrumentation on Masticatory Performance and Psychological Distress

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06024447
• Other study ID #: JANVIPERIO2023
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2023
• Est. completion date: October 15, 2024

Study information

• Verified date: May 2024
• Source: Postgraduate Institute of Dental Sciences Rohtak
• Contact: Sanjay Tewari, MDS
• Phone: 91-1262-283876
• Email: principalpgids[@]yahoo.in
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 92
• Est. completion date: October 15, 2024
• Est. primary completion date: September 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Periodontitis

Intervention

Procedure:
• Subgingival Instrumentation
Subgingival Instrumentation will be performed in patients with Stage III and IV periodontitis.

Locations

Country	Name	City	State
India	Post Graduate Institute of Dental Sciences	Rohtak	Haryana

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Dental Sciences Rohtak

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 2 months, 3 months
Primary	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.	Baseline, 2 months, 3 months
Primary	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.	Baseline, 2 months, 3 months
Secondary	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.	Baseline, 2 months, 3 months
Secondary	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.	Baseline, 2 months, 3 months