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Main
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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. |
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Register:
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ISRCTN |
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Last refreshed on:
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17 October 2016 |
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Main ID: |
ISRCTN27154312 |
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Date of registration:
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05/03/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Clinical wear and incidence of temporomandibular disorders among complete denture patients
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Scientific title:
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Effect of clinical wear in incidence of temporomandibular disorders among complete denture patients: a randomized clinical trial |
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Date of first enrolment:
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15/01/2014 |
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Target sample size:
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64 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN27154312 |
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Study type:
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Interventional |
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Study design:
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Randomized clinical trial, parallel arm design (Treatment)
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Phase:
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Countries of recruitment
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Sudan
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Contacts
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Name:
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Yahya
Ahmed |
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Address:
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Khartoum
00249
Khartoum
Sudan |
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Telephone:
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Email:
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Affiliation:
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Name:
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Khalid
Arafa |
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Address:
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Albaha University
Faculty of Applied Medical Sciences
00966
Al-Baha
Saudi Arabia |
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Telephone:
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+966 (0)553 388 866 |
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Email:
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drkhalidarafa@yahoo.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Edentulous patients in need of complete dentures
Exclusion criteria: 1. Patients with severe malocclusion
2. Patients with systematic diseases affecting the temporomandibular joint like generalized fibromyaligia, rheumatoid arthritis or post-traumatic stress disorder
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Temporomandibular disorder
Oral Health
Temporomandibular joint disorders
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Intervention(s)
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The patients who agreed to participate in this study were assigned randomly using random table numbers into two groups:
Group 1 (intervention group) patients received upper and lower complete dentures with teeth made of heat cure acrylic resin (Meliodent- Bayer dental, Germany batch no 54105L-2).
Group 2 (control group) patients received upper and lower complete dentures with teeth made of porcelain (dent supply, Germany batch no 43105L-1).
The patients were followed up for two years at 6, 12, 18 and 24 months for assessment of clinical wear and incidence of TMD.
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Primary Outcome(s)
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Clinical wear measured using computerized imaging measuring system at 6, 12, 18 and 24 months
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Secondary Outcome(s)
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Incidence of TMD measured using Helkimo clinical dysfunction index at 6, 12, 18 and 24 months
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Source(s) of Monetary Support
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Albaha University (Saudi Arabia)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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