Assessment of Masticatory Performance in Periodontitis

Not yet recruiting

• Conditions: Chewing Problem; Inflammation; Periodontitis, Chronic
• Interventions: Other: Masticatory efficiency assessment

• Registration Number: NCT06426069
• Lead Sponsor: Postgraduate Institute of Dental Sciences Rohtak

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.

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 Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-17
• Study First Submitted QC: 2024-05-17
• Last Update Submitted: 2024-05-17
• Study First Posted: 2024-05-23
• Last Update Posted: 2024-05-23
• Study Start: 2024-06
• Primary Completion: 2024-12
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 555

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Stage IV Periodontitis	Masticatory efficiency assessment	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.
Stage III Periodontitis	Masticatory efficiency assessment	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.
Periodontally Healthy	Masticatory efficiency assessment	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.
Stage II Periodontitis	Masticatory efficiency assessment	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.
Stage I Periodontitis	Masticatory efficiency assessment	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.

Primary Outcome Measures

Name	Time	Method
Objective masticatory performance	Baseline	Objective Masticatory Performance will be evaluated using colour mixing ability of a chewing gum, through optoelectronic analysis using a software.

Secondary Outcome Measures

Name	Time	Method
Subjective masticatory performance	Baseline	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.

Trial Locations

Locations (1)

Post Graduate Institute of Dental Sciences; 🇮🇳 Rohtak, Haryana, India