Masticatory Efficiency in Children

Recruiting

• Conditions: Mastication Disorder
• Interventions: Other: Assesment of masticatory efficiency with optical scanning method; Diagnostic Test: body mass index

• Registration Number: NCT05000385
• Lead Sponsor: Clinical Hospital Center Rijeka

Brief Summary

This study aims to evaluate the association of masticatory efficiency with different conditions of the stomatognathic system (transitioning from primary to secondary dentition, dental caries, malocclusion, tooth loss, prosthodontic treatment) in the paediatric population. Also, to assess the correlation between masticatory efficiency and nutritional status. The study will be conducted on children between 3 and 14 years of age. Masticatory efficiency will be evaluated by the optical scanning method. Participants will chew a standardized silicone tablet controlled by the examiner for 20 masticatory strokes. By scanning the comminuted particles, data on each particle's size will be obtained. Enhanced masticatory performance is presented by a decrease in the chewed particle areas and an increase in the number of chewed particles.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-01
• Study First Submitted: 2021-07-22
• Study First Submitted QC: 2021-08-03
• Study First Posted: 2021-08-11
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-29
• Last Update Posted: 2023-08-30
• Primary Completion: 2024-05-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

• children of both genders aged 3 to 14, with:

  • full healthy dentition
  • bilateral dental caries stage 4,5 or 6 by ICDAS criteria
  • reduced number of occlusal contacts
  • dentures

• signed informed consent by participant's parents

• verbal consent of the children

Exclusion Criteria

• uncooperative behavior
• symptoms of temporomandibular joint dysfunction
• parafunctional habits
• systemic disturbances that can impact mastication
• ingestion of medicines that could interfere directly or indirectly with muscular activity
• tooth anomalies of structure, number or form
• periodontal disease
• tooth mobility

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Occlusal contacts	Assesment of masticatory efficiency with optical scanning method	occlusal contacts are lost bilaterally due to extraction, changing dentition or orthodontic anomalies; no dental caries
Healthy	body mass index	healthy complete dentition
Dental caries	Assesment of masticatory efficiency with optical scanning method	complete dentition with bilateral dental caries (ICDAS 4,5 or 6)
Occlusal contacts	body mass index	occlusal contacts are lost bilaterally due to extraction, changing dentition or orthodontic anomalies; no dental caries
Dental caries	body mass index	complete dentition with bilateral dental caries (ICDAS 4,5 or 6)
Dentures	body mass index	patients with dentures, no caries and/or missing occlusal contacts on remaining teeth
Healthy	Assesment of masticatory efficiency with optical scanning method	healthy complete dentition
Dentures	Assesment of masticatory efficiency with optical scanning method	patients with dentures, no caries and/or missing occlusal contacts on remaining teeth

Primary Outcome Measures

Name	Time	Method
level of masticatory efficiency in children	2 years	determining the masticator efficiency variable (mean area of chewed particles) with optical scanning method, data comparison between four groups
masticatory efficiency and body mass index	2 years	determining the correlation of the masticatory efficiency variable (mean area of chewed particles determined by the optical scanning method) with body mass index (weight and height will be combined to report BMI in kg/m\^2)

Secondary Outcome Measures

Name	Time	Method
occlusal contact and masticatory efficiency	2 years	determining the correlation of the masticatory efficiency (mean area of chewed particles determined by the optical scanning method) with the number of lost occlusal contacts
dental caries and masticatory efficiency	2 years	determining the correlation of the masticatory efficiency (mean area of chewed particles determined by the optical scanning method) with the number of dental caries

Trial Locations

Locations (2)

Clinical Hospital Center Rijeka; 🇭🇷 Rijeka, Primorsko-goranska Županija, Croatia

Faculty of Dental Medicine of the University of Rijeka; 🇭🇷 Rijeka, Primorsko-goranska Županija, Croatia