Assessment of Masticatory Performance in Periodontitis

NCT06426069 | Not Yet Recruiting DMC

• 1 other identifier: JANVIPERIO2024
• Study Type: observational
• Target: 555
• Locations: 1 country
• Sites: 1

Brief Summary

The loss of periodontal attachment contributes to reduced masticatory performance and has a negative impact on general health.This clinical trial aims to assess the status of masticatory performance among patients with stage I, stage II, stage III and stage IV periodontitis, along with those with healthy periodontium.

Conditions

Periodontitis, Chronic; Chewing Problem; Inflammation

Outcome Measures

Primary Outcomes (1)

• Objective masticatory performance

  Objective Masticatory Performance will be evaluated using colour mixing ability of a chewing gum, through optoelectronic analysis using a software.

  Baseline

Secondary Outcomes (1)

• Subjective masticatory performance

  Baseline

Study Arms (5)

Periodontally Healthy

Complete periodontal examination will be done comprising of recording pocket probing depth (PPD), clinical attachment level (CAL) at six sites per tooth, bleeding on probing (BOP), plaque index (PI) and gingival index (GI) and mobility. Objective Masticatory Performance will be evaluated using colour mixing ability of a chewing gum. Subjective masticatory performance will be calculated using The Quality of Masticatory Function Questionnaire.

Other: Masticatory efficiency assessment

Stage I Periodontitis

Complete periodontal examination will be done comprising of recording pocket probing depth (PPD), clinical attachment level (CAL) at six sites per tooth, bleeding on probing (BOP), plaque index (PI) and gingival index (GI) and mobility. Objective Masticatory Performance will be evaluated using colour mixing ability of a chewing gum. Subjective masticatory performance will be calculated using The Quality of Masticatory Function Questionnaire.

Other: Masticatory efficiency assessment

Stage II Periodontitis

Complete periodontal examination will be done comprising of recording pocket probing depth (PPD), clinical attachment level (CAL) at six sites per tooth, bleeding on probing (BOP), plaque index (PI) and gingival index (GI) and mobility. Objective Masticatory Performance will be evaluated using colour mixing ability of a chewing gum. Subjective masticatory performance will be calculated using The Quality of Masticatory Function Questionnaire.

Other: Masticatory efficiency assessment

Stage III Periodontitis

Complete periodontal examination will be done comprising of recording pocket probing depth (PPD), clinical attachment level (CAL) at six sites per tooth, bleeding on probing (BOP), plaque index (PI) and gingival index (GI) and mobility. Objective Masticatory Performance will be evaluated using colour mixing ability of a chewing gum. Subjective masticatory performance will be calculated using The Quality of Masticatory Function Questionnaire.

Other: Masticatory efficiency assessment

Stage IV Periodontitis

Complete periodontal examination will be done comprising of recording pocket probing depth (PPD), clinical attachment level (CAL) at six sites per tooth, bleeding on probing (BOP), plaque index (PI) and gingival index (GI) and mobility. Objective Masticatory Performance will be evaluated using colour mixing ability of a chewing gum. Subjective masticatory performance will be calculated using The Quality of Masticatory Function Questionnaire.

Other: Masticatory efficiency assessment

Interventions

Masticatory efficiency assessment OTHER

Masticatory efficiency will be assessed for each group.

Periodontally Healthy; Stage I Periodontitis; Stage II Periodontitis; Stage III Periodontitis; Stage IV Periodontitis

Eligibility Criteria

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

Study Population

A total of 555 patients will be recruited from the out patient department of periodontics, PGIDS, Rohtak based on the inclusion and exclusion criteria. The study design will be explained to eligible candidates and all study participants will be required to provide informed consent. Subjects will be grouped based on stage of periodontitis and a healthy control group.

You may qualify if:

• Adult patients with age group 30-50 years diagnosed with 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)
• Grade C periodontitis (evaluated indirectly by radiographic bone loss/age criteria)
• Smoking or substance abuse
• Pregnant and lactating women

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

Post Graduate Institute of Dental Sciences

Rohtak, Haryana, 124001, India

Location

MeSH Terms

Conditions

Chronic Periodontitis; Inflammation

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Janvi Janvi, BDS

  PGIDS Rohtak

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rajinder K Sharma, MDS

CONTACT

09416358222; rksharmamds@yahoo.in

Janvi Janvi, BDS

CONTACT

09416183623; janvisahu75@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: May 23, 2024
• Study Start: June 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: May 23, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)