Masticatory Efficiency in Implant-fixed Complete Dentures Compared to the Conventional Dentures

NCT03966703 | Completed DMC

• 1 other identifier: USJ -2017-65
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose of this study is to compare the masticatory efficiency 'All on four' to 'Complete dentures on a class I ridge' with a color mixing analyzing test. Ten Patients with fixed complete dentures on implants and other ten patients with complete denture on a class I ridge (Atwood) had chewed a bicolor chewing gum (Hubba Bubba ®) for different number of cycles(5-10-15-20). The chewed gum is retrieved scanned and weighted to quantify masticatory efficiency

Conditions

Mastication

Keywords

complete denture; implant-fixed denture; masticatory efficiency; mixing ability test

Outcome Measures

Primary Outcomes (1)

• color analysis mixing test

  a two color chewing gum is chewed for a specific number of cycles, gum is scanned and color mixing is analysed by a software called View Gum

  from 5 up to 20 second

Secondary Outcomes (1)

• weight reduction

  from 5 up to 20 second

Study Arms (2)

conventional denture

EXPERIMENTAL

10 patients chewed a 2 color gum for 5 cycles 10, 15 and 20.each sample is retrieved weighted and scanned

Behavioral: mixing analysing test

implant fixed denture

EXPERIMENTAL

10 patients chewed a 2 color gum for 5 cycles 10, 15 and 20.each sample is retrieved weighted and scanned

Behavioral: mixing analysing test

Interventions

mixing analysing test BEHAVIORAL

The chewed gum is retrieved scanned and weighted to quantify masticatory efficiency

Also known as: gum weight, hubba bubba

conventional denture; implant fixed denture

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• good general health, good intraoral conditions, and dentures in satisfactory conditions over edentulous high ridge Atwood's Class I. The minimum time of complete denture use ranged from 3 to 6 months. no temporomandibular dysfunction

Sponsors & Collaborators

• St Joseph University, Beirut, Lebanon: lead

Study Sites (1)

Saint Joseph University

Beirut, Lebanon

Location

Study Officials

• Elie Jasser, DSD

  Master student in aesthetic and prosthetic dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: patients are computer sorted in each group. samples were anonymous tagged by numbers and not by patient name
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master student in aesthetic and prosthetic dentistry. Principal investigator

Model Details: 10 patients from each group

Study Record Dates

• First Submitted: May 22, 2019
• First Posted: May 29, 2019
• Study Start: July 1, 2017
• Primary Completion: September 1, 2018
• Study Completion: February 1, 2019
• Last Updated: May 29, 2019

Record last verified: 2019-05

Locations

LE (1)