Assessment of Masticatory Performance in Periodontitis

Inflammation Clinical Trial

Official title:

Assessment of Masticatory Performance in Various Stages of Periodontitis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06426069
• Other study ID #: JANVIPERIO2024
• Status: Not yet recruiting
• Start date: June 2024
• Est. completion date: January 2025

Study information

• Verified date: May 2024
• Source: Postgraduate Institute of Dental Sciences Rohtak
• Contact: Rajinder K Sharma, MDS
• Phone: 09416358222
• Email: rksharmamds[@]yahoo.in
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 555
• Est. completion date: January 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Chewing Problem
• Chronic Periodontitis
• Inflammation
• Periodontitis
• Periodontitis, Chronic

Intervention

Other:
• Masticatory efficiency assessment
Masticatory efficiency will be assessed for each group.

Locations

Country	Name	City	State
India	Post Graduate Institute of Dental Sciences	Rohtak	Haryana

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Dental Sciences Rohtak

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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