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.: PACTR201507001169125 Date of Approval: 09/06/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Impact of Single Implant Versus Two Implants Mandibular Retained Overdenture on Denture Retention and Implant Success Rate in Completely Edentulous
Official scientific title Impact of Single Implant Versus Two Implants Mandibular Retained Overdenture on Denture Retention and Implant Success Rate in Completely Edentulous Patients (RCT)
Brief summary describing the background and objectives of the trial The aim of this study is to evaluate the impact of single implant versus two implant mandibular overdenture on denture retention and implant success rate of completely edentulous patients.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied IMPLANT OVERDENTURE,Oral Health,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/10/2015
Actual trial start date 01/12/2015
Anticipated date of last follow up 01/06/2016
Actual Last follow-up date 01/06/2016
Anticipated target sample size (number of participants) 18
Actual target sample size (number of participants) 18
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
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 Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group 2 IMPLANT OVERDENTURE 2 IMPLANT 6 MONTH 2 IMPLANT OVERDENTURE PLACED IN CANINE AREAS 9 Active-Treatment of Control Group
Experimental Group 1 IMPLANT OVERDENTURE 1 IMPLANT 6 MONTH SINGLE IMPLANT OVERDENTURE PLACED IN MIDLINE AREAS 9
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All subjects were required: 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 patients. 1. Patients with TMJ disorders. Because it will interfere with the prosthetic outcomes. 2. Medically compromised patients. Because it will affect the surgical placement of the implants. 3. Partially edentulous patients. Because it make differences in the value of the study regarding the retention and overall prosthesis. 4. Smoking patients. Because it will affect the healing process. 5. Uncooperative patients. Because it will not return for follow-up, examinations and evaluation. 6. Patient with surgical operation in maxillofacial region. Because it affect the prosthesis. 35 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 15/07/2015 Ethics Committee, Faculty of Oral and Dental Medicine -Cairo University
Ethics Committee Address
Street address City Postal code Country
11 saray almanial cairo 311 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Denture retention The denture retention measures will DONE AT BASE LINE AND repeat after three, six MONTH
Secondary Outcome Implant success rate, Marginal bone loss, Gingival index implant success rate will be evaluated using implant success criteria including marginal bone loss and gingival index. The measurements undertake at baseline after implant placement and at one, three, six and nine months thereafter.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
prosthodontic departments - cairo university 11 saray almanial cairo 311 Egypt
out patients clinics - cairo university 11 saray almanial cairo 311 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Oral and Dental Medicine -Cairo University 11 saray almanial cairo 311 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Oral and Dental Medicine -Cairo University 11 saray almanial cairo 311 Egypt University
Secondary Sponsor Faculty of Oral and Dental Medicine -IBB University 43 ALMALAKH STREET IBB 541 Yemen University
COLLABORATORS
Name Street address City Postal code Country
Faculty of Oral and Dental Medicine -IBB University 11 saray almanial cairo 311 Egypt
Faculty of Oral and Dental Medicine -IBB University 43 ALMALAKH STREET IBB 541 Yemen
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ali Alsourori ali234792@gmail.com 00201200851511 11 saray almanial
City Postal code Country Position/Affiliation
cairo 311 Egypt assistant lecturer
Role Name Email Phone Street address
Public Enquiries ahmed fayad ahmedfyad@yahoo.com 00201005185211 11 saray almanial
City Postal code Country Position/Affiliation
cairo 311 Egypt Lecturer of Prosthodontics Faculty of Oral and Dental Medicine Cairo University
Role Name Email Phone Street address
Scientific Enquiries amal kaddah amalkaddah@yahoo.com 00201112181818 11 saray almanial
City Postal code Country Position/Affiliation
cairo 311 Egypt Professor and Head of Prosthodontics, Faculty of Oral and Dental Medicine Cairo University.
REPORTING
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Changes to trial information