Assessment of Masticatory Performance in Periodontitis

Assessment of Masticatory Performance in Various Stages of Periodontitis

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Inflammation; Chewing Problem; Periodontitis, Chronic
• Intervention / Treatment: Other: Masticatory efficiency assessment

Detailed Description

Periodontal disease manifestations include gingival bleeding, halitosis, tooth mobility and loss of teeth in advanced cases. The loss of periodontal attachment contributes to reduced masticatory performance and has a negative impact on general health. Loss of periodontium leads to reduced ability of tooth to withstand masticatory loads. Thus, biting abilities of subjects with healthy periodontium are significantly greater than those of chronic periodontitis patients. Even though the new periodontitis classification includes masticatory dysfunction in stage 4, but clinical periodontal parameters do start influencing objective masticatory efficiency in early stages. Since the masticatory function is an important point for the classification of periodontitis, standardized procedures with corresponding reference values are needed to consider these parameters in the assessment of periodontitis and to be able to make specific therapy recommendations.

This clinical trial aims to assess the changes in masticatory performance among periodontitis patients of all stages and healthy individuals using test methods easily applicable in daily practice.

• Study Type: Observational
• Enrollment (Estimated): 555

Contacts and Locations

• Study Contact: Name: Rajinder K Sharma, MDS; Phone Number: 09416358222; Email: rksharmamds@yahoo.in
• Study Contact Backup: Name: Janvi Janvi, BDS; Phone Number: 09416183623; Email: janvisahu75@gmail.com

Study Locations

• India
  • Haryana
    • Rohtak, Haryana, India, 124001
      • Post Graduate Institute of Dental Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

Inclusion Criteria:

1. Adult patients with age group 30-50 years diagnosed with generalized periodontitis
2. 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)
• Grade C periodontitis (evaluated indirectly by radiographic bone loss/age criteria)
• Smoking or substance abuse
• Pregnant and lactating women

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Masticatory efficiency will be assessed for each group.
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; Masticatory efficiency will be assessed for each group.
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; Masticatory efficiency will be assessed for each group.
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; Masticatory efficiency will be assessed for each group.
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; Masticatory efficiency will be assessed for each group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective masticatory performance	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

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Dental Sciences Rohtak
• Investigators: Principal Investigator: Janvi Janvi, BDS, pgids rohtak

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: May 17, 2024
• First Submitted That Met QC Criteria: May 17, 2024
• First Posted (Actual): May 23, 2024

Study Record Updates

• Last Update Posted (Actual): May 23, 2024
• Last Update Submitted That Met QC Criteria: May 17, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Chronic Disease; Periodontitis; Inflammation; Chronic Periodontitis
• Other Study ID Numbers: JANVIPERIO2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No