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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 3 August 2020
Main ID:  ISRCTN10251727
Date of registration: 28/09/2015
Prospective Registration: No
Primary sponsor: Albaha University
Public title: Complete dentures base materials and teeth types and phonetics
Scientific title: Effect of different complete dentures base materials and teeth types on short-term phonetics
Date of first enrolment: 01/01/2015
Target sample size: 50
Recruitment status: Completed
URL:  http://isrctn.com/ISRCTN10251727
Study type:  Interventional
Study design:  A parallel design experimental study. (Treatment)  
Phase:  Not Applicable
Countries of recruitment
Egypt
Contacts
Name: Khalid    Arafa
Address:  Faculty of Applied Medical Sciences Albaha University P.O. Box: 7273-Unit No.: 2 65536 - 3047 Al-Baha Saudi Arabia
Telephone:
Email:
Affiliation: 
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria:
1. Male, aged 55 years or older
2. Completely edentulous
3. Normal occlusion class one
4. Free from disabilities or chronic conditions, such as diabetes

Exclusion criteria:
1. Diabetic patients
2. Participants that are partially edentulous,
3. Participants that have neglected oral hygiene


Age minimum:
Age maximum:
Gender: Male
Health Condition(s) or Problem(s) studied
Dentures and phonetics
Oral Health
Intervention(s)
The patients enrolled in the study (n=50) were divided into two main batches (three groups in batch one and two groups in batch two), with a total of ten patients in each group. The patients were randomly assigned into groups. The three groups in the first batch received three different denture base materials for the constructed palatal plate and rouge area of the complete dentures, (flexible acrylic resin, heat cure acrylic resin, and chrome cobalt metallic base). Another batch (twenty patients) divided into two groups received different teeth types: acrylic teeth and porcelain teeth.
Primary Outcome(s)
The evaluation of the speech quality was made by measuring the phonetics. The patients were connected to a spectrogram and were asked to verbalize Arabic pronunciation letters (?? ?? ???). The mean of the sound levels was calculated for each patient, and subsequently tabulated and analyzed. The evaluation was made immediately following denture insertion: three weeks, and ten weeks following the insertion of dentures by a computerized speech lab (spectrogram). This measurement protocol was implemented for two batches. The level of sound in patients with complete dentures made from different base materials or different teeth was assessed via a spectrogram. (it was measured at insertion, 3 weeks later and after 10 weeks)
Secondary Outcome(s)
Secondary ID(s)
N/A
Source(s) of Monetary Support
Albaha University (Saudi Arabia)
Secondary Sponsor(s)
Ethics review
Status:
Approval date:
Contact:
Dental Health Department of the Faculty of Applied Medical Sciences, Albaha University.
Results
Results available: Yes
Date Posted:
Date Completed: 09/04/2015
URL:
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