Assessment of Masticatory Performance in Periodontitis

NCT ID: NCT06426069

Last Updated: 2024-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

555 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-30

Study Completion Date

2025-01-31

Brief Summary

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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

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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.

Conditions

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Periodontitis, Chronic Chewing Problem Inflammation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

Masticatory efficiency assessment

Intervention Type OTHER

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.

Masticatory efficiency assessment

Intervention Type OTHER

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.

Masticatory efficiency assessment

Intervention Type OTHER

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.

Masticatory efficiency assessment

Intervention Type OTHER

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.

Masticatory efficiency assessment

Intervention Type OTHER

Masticatory efficiency will be assessed for each group.

Interventions

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Masticatory efficiency assessment

Masticatory efficiency will be assessed for each group.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Postgraduate Institute of Dental Sciences Rohtak

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janvi Janvi, BDS

Role: PRINCIPAL_INVESTIGATOR

PGIDS Rohtak

Locations

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Post Graduate Institute of Dental Sciences

Rohtak, Haryana, India

Site Status

Countries

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India

Central Contacts

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Rajinder K Sharma, MDS

Role: CONTACT

09416358222

Janvi Janvi, BDS

Role: CONTACT

09416183623

Other Identifiers

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JANVIPERIO2024

Identifier Type: -

Identifier Source: org_study_id

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