Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201411000595327 Date of Approval: 16/07/2013
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of Single Implant Versus Two Implants Mandibular Retained Overdenture on Patient Satisfaction and Biting Force of Completely Edentulous Patien
Official scientific title Effect of Single Implant Versus Two Implants Mandibular Retained Overdenture on Patient Satisfaction and Biting Force of Completely Edentulous Patients
Brief summary describing the background and objectives of the trial In the recent years, single implant overdentures have gained popularity due to their lowered costs and minimal tissue trauma and there are many articles and case reports that supported a single implant as reliable successful alternative treatment to two implant overdenture but more evidence studies are needed to validate this treatment modality
Type of trial RCT
Acronym (If the trial has an acronym then please provide) parallel groups
Disease(s) or condition(s) being studied Completely edentulous patients
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/09/2013
Actual trial start date 01/09/2013
Anticipated date of last follow up 01/10/2014
Actual Last follow-up date 15/10/2014
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 28
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
63 protocol number
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised computer generated randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group single implant overdenture one implant for each patient 9 months single implant in mandible midline and overdenture will retained to implant via locator attachment 14
Control Group Two implant retained mandibular overdentures Two implants per patient 9 months Standard treatment 14 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1-Completely edentulous patients. 2-Adult patients with age range 40-70 years. 3-Patients suffer from mandibular conventional denture complaints related to retention or stability due to bone resorption. 4-Cooperative patient. 1-Patients with TMG disorders. 2-Systemic disease patients. 3-Partially edentulous patients. 4-Smoking patients. 5-Uncooperative patients. 6-Patient with surgical operation in maxillofacial region 40 Year(s) 70 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 15/08/2013 research ethic commette
Ethics Committee Address
Street address City Postal code Country
12 Saray El Manial st.¿ KASR EL AINY cairo 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome patient satisfaction baseline time (befor implant placement) one month 3 months 6 months
Secondary Outcome Biting measurement by i-load sensore device baseline; one, 3 and 6 months after implants
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of oral and dental medicine cairo university 12 Saray El Manial st.¿ KASR EL AINY cairo 02 23635329 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self fuunding 6 ali ata st. hadaege almaadi cairo 11728 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor ibb university salabt alsayeda st. Ibb Yemen University
COLLABORATORS
Name Street address City Postal code Country
nadia abbas cario Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Adnan Abdullah Naje Al-Fahd adnan.alfahd@dentistry.cu.edu.eg 00201142228430 6 Ali Ata Street
City Postal code Country Position/Affiliation
Adaeage Almaadi, Cairo 11728 Egypt Lecturer Prsothodontics, Prosthodontics Dept, Faculty Dentistry, Ibb Univ Yemen
Role Name Email Phone Street address
Public Enquiries Adnan Abdullah Naje Al-Fahd adnan.alfahd@denstistry.eu.edu.eg 00201142228430 6 Ali Ata Street Hadayek Almaadi
City Postal code Country Position/Affiliation
Cairo 11728 Egypt Lecturer Prosthodontics, Faculty Dentistry, Ibb Univ Yemen
Role Name Email Phone Street address
Scientific Enquiries Mohamed Farouk Abdullah mfaroukabdulla@yahoo.com 00201006781407 87 St. 9 2nd Floor Almaadi
City Postal code Country Position/Affiliation
Cairo 11742 Egypt Assoc Prof Removable Prosthodontics, Faculty Oral Dental Med, Univ Cairo
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information