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.: PACTR201512001362107 Date of Approval: 24/11/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Different attachment system retaining overdenture
Official scientific title Retention of stud attachment versus bar clip attachment retaining mandibular overdenture
Brief summary describing the background and objectives of the trial The aim of this study is to compare between 2 attachment systems regarding patient satisfaction, retention and maintenance, Studies that compared between the two retention concepts, namely the splinted (bar clip attachment) and non-splinted (stud attachment), showed that splinted was better in retention however, the use of stud has many advantages over splinted. While the splinted required almost complete parallelism between the implants, the stud on the other hand does not require that much of parallelism. Also, fabrication of implant supported prosthesis retained by bar attachment is very technique sensitive, while implant supported prosthesis retained by stud attachment is simpler and do not require complicated lab procedure also Removable prosthesis supported by a bar are more challenging to fabricate and repair than removable prosthesis supported by individual stud attachments. Problems usually associated with bar attachment is over growth of tissues beneath the bar causing gingival inflammation, which cause patient dissatisfaction. Therefore this study is to observe after 12 month loss of retention, complains and maintenance in stud attachment compared to bar clip attachment will provide equal patient satisfaction.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied edentulous mandibular jaws
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 24/01/2016
Actual trial start date
Anticipated date of last follow up 01/04/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 22
Actual target sample size (number of participants)
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 Patients will be randomly divided to either control or study group using computer generated randomization (random.org) Each patient will be allocated a number from sequentially numbered opaque sealed envelopes when they are seen for consent and initial records. They will be then allocated into one of the set-ups using a randomization table. The randomization and sequence will be done by the co-researcher (H.A), and the patient will be enrolled by the clinical operator (M.H) the supervisor will do allocation (H.C). Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Patients will be randomly divided to either control or study group using computer generated randomization (random.org) Each patient will be allocated a number from sequentially numbered opaque sealed envelopes when they are seen for consent and initial records. They will be then allocated into one of the set-ups using a randomization table. The randomization and sequence will be done by the co-researcher (H.A), and the patient will be enrolled by the clinical operator (M.H) the supervisor will do allocation (H.C). Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group stud attachment retaining implant supported overdenture Stud attachments designed to increase retention of overdentures, supported on implants. Stud attachment provide firm retention and stabilization when used with tissue supported implant-retained overdentures 11 Active-Treatment of Control Group
Experimental Group bar clip attachment retaining implant supported overdenture prefabricated bar attached to the two implant allow splinting and increase retention to implant-retained overdentures 11
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Completely edentulous patient. Sufficient inter-arch space equals to 22 mm or more. Normal maxillo-mandibular relationship (Class I Angle classification). Adequate buccolingual width of keratinized attached mucosa >5mm over the crest of the lower ridges. Patient signing informed consent Patient requiring hard or, soft tissue grafting of the proposed implant sites. Heavy smoker (more than 20 cigarette / day) and patients with para-functional habits (e.g. clenching or bruxism, etc.). Patients with temporo-mandibular joint disorders . Patients with any systemic disease that may interfere with dental implants placement and/or osseointegration e.g. uncontrolled diabetes, hypertension, osteoporosis and irradiation. Patient unable to answer the questionnaire for any reason. 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 02/12/2015 ethics committee - Faculty of Oral and Dental Medicine ¿ Cairo University - EL Kasr El Ainy.
Ethics Committee Address
Street address City Postal code Country
11 el-saraya st. manial, cairo 11553 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome patient satisfaction initial 3 month 6 month 9 month 12 month
Secondary Outcome retention initial 3 month 6 month 9 month 12 month
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
outpatient clinic of the department of Removable Prosthodontics - Faculty of Oral and Dental Medicine ¿ Cairo University - EL Kasr El Ainy. 12 saray el manial st., kasr el ainy cairo 11553 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Self-funding cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor mohamed hatem 135 el shaikh zayed district 7 giza Egypt Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Hamdi Abou Al fetoh 12 saray el manial st., kasr el ainy cairo 11553 Egypt
Hussein El Charkawi 12 saray el manial st., kasr el ainy cairo 11553 Egypt
Hesham Alm El Deen 90 st. 5th compound new Cairo future university cairo Egypt
mohamed farouk 12 saray el manial st., kasr el ainy cairo 11553 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mohamed amin mohamedhatem1211@gmail.com 00201222431550 135 el shaikh zyaed district 7
City Postal code Country Position/Affiliation
cairo Egypt
Role Name Email Phone Street address
Public Enquiries mohamed el khashab mkhashab86@gmail.com 00201006611525 39 d4 el rabwa el sheikh zayed
City Postal code Country Position/Affiliation
cairo Egypt Assistant lecturer at prosthodontics department Cairo university
Role Name Email Phone Street address
Scientific Enquiries hesham alam el deen dr.h.alameldeen77@gmail.com 00201144446687 15 abou heaf st masr gedida
City Postal code Country Position/Affiliation
cairo Egypt lecturer at prosthodontics department Future university
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