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.: PACTR201411000592156 Date of Approval: 15/07/2013
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Implant-retained Mandibular Overdentures for completely edentuolus patients
Official scientific title Impact of Single versus two Implants on the Quality of Life and Muscle Activity for Patients Restored by Implant-retained Mandibular Overdentures
Brief summary describing the background and objectives of the trial There are agreements that the use of two-implant in the interforaminal area of the mandible to retained overdenture is sufficient to overcome the problems associated with conventional dentures.However, unfortunately these treatment modalities are outside the financial scope of many compromised edentulous patients. The aim of this study is to investigate the effect of single versus two implant retained overdenture on the quality of life and muscles activcity
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
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 01/12/2013
Actual trial start date 01/01/2014
Anticipated date of last follow up 01/12/2014
Actual Last follow-up date 01/07/2015
Anticipated target sample size (number of participants) 28
Actual target sample size (number of participants) 28
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 randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group two Implant-retained Mandibular Overdentures two Implant are needed for each patient 9 months(follow up) two Implant are placed in the mandible 14 Historical
Experimental Group Single implant mandibular overdenture one implant 9 months one implant placed in the mandible 14
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿ Patient with completely edentulous upper and lower arch with normal maxillomandibular relationship (angle's class I ridge ) ¿ Patient's age ranging from forty to sixty years old. ¿ Patient should have adequate interarch distance >10mm. ¿ Patient should be with good oral hygiene ¿¿Partially edentulous patient. ¿¿Patients with TMJ disorders , hemi-mandiblectomy or maxilloectomy . ¿¿Patients with any systemic disease that may interfere with dental implants placement and/or Osseo integration e.g. uncontrolled diabetes, hypertension, blood diseases, bone diseases, smoking etc. ¿¿uncooperative patients 35 Year(s) 75 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 20/07/2013 ethics committee of faculty of dentistry Cairo university
Ethics Committee Address
Street address City Postal code Country
12 saray el manial street cairo 11361 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome oral health related quality of life measured by oral health impact profile (OHIP-14) questionnaire base line before implant placements 6th month of implant placement one year after implant placement
Secondary Outcome electeromyographic activity of masseter and temporalis muscles base line before implant placements 6th month of implant placement one year after implant placement
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
outpatient clinic of the prosthodontic department Cairo university 12 saray el manial street Cairo 11361 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self funding 12 saray el manial street Cairo 11361 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor prosthodontic department Cairo university 12 saray el manial street Cairo 11361 Egypt University
COLLABORATORS
Name Street address City Postal code Country
amal kaddah 12 saray el manial street Cairo 11361 Egypt
mohamed farouk 12 saray el manial street Cairo 11361 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator ahmed alqutaibi am01012002@yahoo.com 00201144772955 18 mohamed khaleefa -hadaek almadi
City Postal code Country Position/Affiliation
cairo Yemen Assistant Lecturer, prosthodontics department, Faculty of Oral and Dental Medicine Ibb University
Role Name Email Phone Street address
Public Enquiries mohamed faruok mfarouk@yahoo.com 002011545443433 12 Saray el Manial Street
City Postal code Country Position/Affiliation
Cairo 11361 Egypt
Role Name Email Phone Street address
Scientific Enquiries amal kaddah amalkaddah@yahoo.com 00201112181818 12 Saray el manial Street
City Postal code Country Position/Affiliation
Cairo 11361 Egypt
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information