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

Masticatory Efficiency in Implant-fixed Complete Dentures Compared to the Conventional Dentures: a Randomized Clinical Trial by Color Mixing Analysis Test.

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

Study Overview

• Status: Completed
• Conditions: Mastication
• Intervention / Treatment: Behavioral: mixing analysing test

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon
    • Saint Joseph University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: conventional denture; 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; The chewed gum is retrieved scanned and weighted to quantify masticatory efficiency; Other Names: gum weight; hubba bubba
Experimental: implant fixed denture; 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; The chewed gum is retrieved scanned and weighted to quantify masticatory efficiency; Other Names: gum weight; hubba bubba

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
weight reduction	gum is weighted before each chewing cycle than dried and weighted after chewing.weight reduction is the secondary outcome for mastication efficiency analyzing	from 5 up to 20 second

Collaborators and Investigators

• Sponsor: St Joseph University, Beirut, Lebanon
• Investigators: Principal Investigator: Elie Jasser, DSD, Master student in aesthetic and prosthetic dentistry

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): September 1, 2018
• Study Completion (Actual): February 1, 2019

Study Registration Dates

• First Submitted: May 22, 2019
• First Submitted That Met QC Criteria: May 25, 2019
• First Posted (Actual): May 29, 2019

Study Record Updates

• Last Update Posted (Actual): May 29, 2019
• Last Update Submitted That Met QC Criteria: May 25, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: complete denture; masticatory efficiency; implant-fixed denture; mixing ability test
• Other Study ID Numbers: USJ -2017-65

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No