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.: PACTR201704001524121 Date of Approval: 08/03/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Retention of different attachment systems for single implant mandibular overdenture
Official scientific title A comparison between the retention of mandibular complete single implant overdenture retained by ball and socket and locator attachments (Randomized Clinical Trial)
Brief summary describing the background and objectives of the trial Denture retention & stability are the main concerns for edentulous patients. Denture retention can be greatly enhanced by using dental implants.The first choice ¿standard of care¿ for edentulous mandible is a 2-implant over-denture. However, a major limiting factor for the spread of implant retained over-dentures is the high costs and the invasive nature of implant surgeries.Moreover, a systematic review (Fitzpatrick 2006) concluded that there is no sufficient evidence to support a single treatment modality for edentulous mandible. Recently, the use of a single implant over-denture has gained popularity due to their reduced cost & tissue trauma.Different types of attachment are being used to improve retention & stability of over-dentures.Ball attachments, in particular, have wide universal application since they are simple and cost effective.The Locator ¿ a self-aligning implant attachment system has been on the market since 2000. Because of the unique design of the Locator, the patrix (male) is the replaceable nylon insert on the undersurface of the over-denture. The matrix (female) is by virtue, again of its unique design, the over-denture abutment on the implant.Most of the studies comparing retentive properties of Locator & Ball attachments are In vitro one. There is no published Systematic review showing which is better. It is clear that the data regarding the use of different attachment systems with single implant over-denture is still insufficient to help in clinical decisions. Objectives:Will the retention of single implant retained over-denture differ when using a locator from that when using a ball & socket attachment?
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Edentulous mandible
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 01/12/2015
Actual trial start date 24/01/2016
Anticipated date of last follow up 01/09/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 14
Actual target sample size (number of participants) 14
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 by computer software program Sealed opaque envelopes 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 Ball attachment Attachment for overdenture retention 7
Experimental Group Locator Attachment for overdenture retention 7
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1.Completely edentulous patient 2. Patients having enough bone for an implant length of at least 10 mm 3. Sufficient inter-arch space to accommodate the denture & the attachment 4. No apparent Skeletal mal-relation 5. No intraoral soft and hard tissue pathology 6. No systemic condition that contraindicate implant placement 1. Drug or alcohol abuse 2. Smokers 3. A health condition precluding surgery, 4. Logistic or physical reasons that could affect follow-up, 5. Psychiatric problems 6. Medically compromised patients & those with neuromascular disorders 7. Disorders to the implant area related to a history of radiation therapy to the head and neck, neoplasia, or bone augmentation to the implant site. 35 Year(s) 80 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
Yes 03/12/2015 Research Ethics Committee, Faculty of oral & dental medicine, Cairo University
Ethics Committee Address
Street address City Postal code Country
El-saraya Cairo Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Retention 0 month 1 month 3 months 6 months
Secondary Outcome Soft tissue responce 1 month 3 months 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
outpatient clinic in faculty of oral and dental medicine Cairo University El-Saraya Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Self-Funded
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Prosthodontic department, Faculty of oral & dental medicine, Cairo University Al-saraya Cairo Egypt University
COLLABORATORS
Name Street address City Postal code Country
Hend Mahmoud Mohamed Hegazi 1st district, 2nd Neighboorhood 6^th of october Egypt
Maha Wagdy El-Kerdawy Morad Giza Egypt
Ahmed Emad Fayyad Maadi Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hend Hegazi H.m.hegazi@gmail.com 01006372437 1st district, 2nd neighbourhood
City Postal code Country Position/Affiliation
Cairo Egypt teaching assistant
Role Name Email Phone Street address
Public Enquiries Hend Hegazi H.m.hegazi@gmail.com 01006372437 1st district, 2nd neighbourhood
City Postal code Country Position/Affiliation
Cairo Egypt teaching assistant
Role Name Email Phone Street address
Scientific Enquiries Hend Hegazi H.m.hegazi@gmail.com 01006372437 1st district, 2nd neighbourhood
City Postal code Country Position/Affiliation
Cairo Egypt teaching assistant
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information