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.: PACTR201811913815126 Date of Approval: 27/11/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Assessment of Mandibular Immediately Loaded Fixed Detachable Restorations Retained by Four Axial Implants
Official scientific title Assessment of Mandibular Immediately Loaded Fixed Detachable Restorations Retained by Four Axial Implants
Brief summary describing the background and objectives of the trial Rehabilitation of edentulous patients with complete arch screw-retained prostheses has been considered an optimal treatment choice. The “All-on-4” technique has been well-established in the clinical practice, and favorable survival rates and clinical results of immediate rehabilitation of fully edentulous jaws have been reported in the literature. Regardless of the high success rate of the all -on -four concept, numerous limitations and disadvantages were reported in the literature. The placement of four vertically parallel implants between the mental foramina is easier approach with high success rate. Also, it was considered a safe and predictable technique that consistently preserves the marginal bone and promotes implant stability. The aim of the study is to assess and compare the clinical and radiographic outcomes of implants supporting mandibular immediately loaded fixed detachable restorations retained by four axial implants in the interforaminal region versus implants placed using the all- on-four concept.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Oral Health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/12/2018
Actual trial start date
Anticipated date of last follow up 31/12/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 14
Actual target sample size (number of participants)
Recruitment status Not yet 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 Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Axial Implants 12 months Will receive mandibular screw retained restorations supported by four axial implants (12 mm in length and 3.6 mm in diameter) placed in the inter-foramina region. 7
Control Group All On four 12 months Will receive mandibular screw retained restorations supported by four implants placed in the inter-foramina space of the jaw - two mesial axial implants (12 mm in length and 3.6 mm in diameter) and two distal implants (14 mm in length and 3.6 mm in diameter) tilted at about 45◦ 7 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Completely edentulous patients with skeletal Class I maxilla-mandibular relationship. - Adequate inter-arch space (22 mm), (by using the "try in" as a measure before any intervention taking place). - Maxillary and mandibular ridges with no history of recent extraction. - Mandibular ridge should be ≥15 mm height and ≥ 6 mm width to house four implants in the intra-foramina area of mandibular arch this will be verified by using cone beam computed tomography (CBCT). - History of radiotherapy in head and neck region. - History of hard tissue augmentation. - Presence of any intra-oral pathological condition. - Any medical disorder that could complicate the surgical phase or affect osseo-integration as osteoporosis, uncontrolled diabetes and hypertension. - Heavy smokers (more than 20 cigarette / day). Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 40 Year(s) 65 Year(s) Both
- Completely edentulous patients with skeletal Class I maxilla-mandibular relationship. - Adequate inter-arch space (22 mm), (by using the "try in" as a measure before any intervention taking place). - Maxillary and mandibular ridges with no history of recent extraction. - Mandibular ridge should be ≥15 mm height and ≥ 6 mm width to house four implants in the intra-foramina area of mandibular arch this will be verified by using cone beam computed tomography (CBCT). History of radiotherapy in head and neck region. - History of hard tissue augmentation. - Presence of any intra-oral pathological condition. - Any medical disorder that could complicate the surgical phase or affect osseointegration as osteoporosis, uncontrolled diabetes and hypertension. - Heavy smokers (more than 20 cigarette / day). Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 40 Year(s) 65 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 12/06/2018 Institutional Review Boards IRB at the faculty of dentistry Alexandria University IRB NO 00010556 IORG 0008839
Ethics Committee Address
Street address City Postal code Country
Champollion St., Azarita Alexandria 21521 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Implant Stability Initial stability will to be checked at the insertion time then it will be evaluated regularly, 3 months, 6 months and 12 months.
Primary Outcome Clinical Periodontal Parameters Gingival index Plaque index Attachment level Probing depth. The patients will be recalled regularly 3 months, 6 months and 12months after implants placement.
Secondary Outcome Radiographic Evaluation Bone measurements will to be evaluated at the insertion time then it will be evaluated regularly, 3 months, 6 months and 12 months.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Department of Removable Prosthodontics Faculty of Dentistry Alexandria University Champolion St., Azarita Alexandria 21521 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Removable Prosthodontics Department Faculty of Dentistry Alexandria University Champolion St., Azarita Alexandria 21521 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohamed Moataz Khamis 20 Amin Fekry St mehatet el raml Alexandria 21521 Egypt
Ahlam EL Sharkawy 19 Zaki Ragab Street City Stars Tower Smouha Alexandria 21615 Egypt
Rania Abd el Aziz Fahmy 17 Champolion St., Azarita Alexandria 21521 Egypt
Yara Aly Abdelhamid Kammoun 10 Amin Hassouna Street Syouf Shamaa El Montazza Alexandria 21919 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Moataz Khamis Moataz_khamis@yahoo.com 00201001634254 20 Amin Fekry Street mehatet el raml
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Professor of Prosthodontics Faculty of Dentistry Alexandria University
Role Name Email Phone Street address
Scientific Enquiries Yara Kammoun Yara_kammoun@yahoo.com 0201114390957 10 Amin Hassouna Street Syouf Shamaa El Montazza
City Postal code Country Position/Affiliation
Alexandria 21919 Egypt Assistant lecturer Prosthodontics department Faculty of Dentistry Damanhur University
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Patient Information Manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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