Impact of Subgingival Instrumentation on Masticatory Performance and Psychological Distress

NCT06024447 | Recruiting DMC

• 1 other identifier: JANVIPERIO2023
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (2)

• Pocket Probing Depth

  Baseline, 2 months, 3 months

• Clinical attachment level

  Baseline, 2 months, 3 months

Study Arms (1)

Stage III and Stage IV Periodontitis

OTHER

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

Procedure: Subgingival Instrumentation

Interventions

Subgingival Instrumentation PROCEDURE

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

Stage III and Stage IV Periodontitis

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

Post Graduate Institute of Dental Sciences

Rohtak, Haryana, 124001, India

RECRUITING

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Janvi Janvi, BDS

  PGIDS Rohtak

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sanjay Tewari, MDS

CONTACT

91-1262-283876; principalpgids@yahoo.in

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2023
• First Posted: September 6, 2023
• Study Start: September 15, 2023
• Primary Completion: September 15, 2024
• Study Completion: October 15, 2024
• Last Updated: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)