Clinical trial NCT06426069: Assessment of Masticatory Performance in Periodontitis
Official title: Assessment of Masticatory Performance in Various Stages of Periodontitis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Periodontitis, Chronic
Chewing Problem
Inflammation
Lead sponsor: Postgraduate Institute of Dental Sciences Rohtak
Sponsor class: OTHER
First posted: 2024-05-23
Enrollment: 555
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Objective masticatory performance
timeFrame: Baseline
Secondary outcomes:
measure: Subjective masticatory performance
timeFrame: Baseline
Other outcomes:
Locations:
city: Rohtak
country: India
facility: Post Graduate Institute of Dental Sciences
state: Haryana
Study officials:
affiliation: PGIDS Rohtak
name: Janvi Janvi, BDS
role: PRINCIPAL_INVESTIGATOR
References: