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.: PACTR201809736563842 Date of Approval: 25/09/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Biological Performance of Custom CAD /CAM Abutments for Single Dental Implants Restoring Mandibular First Molars: RCT
Official scientific title Biological Performance of Custom CAD /CAM Abutments for Single Dental Implants Restoring Mandibular First Molars (A Randomized Controlled Trial)
Brief summary describing the background and objectives of the trial Multiple manufacturing techniques have been recently developed for the purpose of implant abutment customization. These manufacturing techniques have not been thoroughly investigated for precision and seal at the implant /abutment interface and accordingly their effect on biological and clinical parameters. This study aims to assess the effect of in-house CAD/CAM manufacturing technique on Matrix Metalloproteinase 8 level in the periimplant sulcular fluid as a biomarker of inflammation, as well as clinical parameters including plaque index, gingival index and probing depth.
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 01/10/2018
Actual trial start date
Anticipated date of last follow up 31/03/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 30
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
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Custom CAD CAM Placed 3 months after surgical placement of dental implants, and follow up will be up to one year Custom CAD/CAM titanium dental implant abutment, milled from titanium blank. 15
Control Group Premachined stock titanium Placed 3 months after surgical placement of dental implants, and follow up will be up to one year Premachined stock titanium dental implant abutment 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients with a missing mandibular first molar, with natural tooth antagonist. Good oral hygiene with attitude for compliance to perform strict oral hygiene measures (Plaque index score = 0-1). Adequate bone quantity and quality for placement of dental implants. Systemic or local diseases that might contraindicate surgical implant placement, or interfere with proper osseointegration. Parafunctional habits or any sign and symptom of pathological occlusion. Smoking. Pregnancy Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 25 Year(s) 50 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 03/07/2018 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 MMP-8 level in peri-implant sulcular fluid around custom titanium CAD CAM and pre-machined stock titanium dental implant abutments. Baseline, Three months, Six months and Twelve months
Secondary Outcome Evaluation of periodontal clinical parameters (Plaque Index, Gingival Index, and Probing Depth) of soft tissues around both types of abutments. Baseline, Three months, Six months and Twelve months
Secondary Outcome Assessment of crestal bone level through digital bitewing radiographs. Baseline, Three months, Six months and Twelve months
Secondary Outcome Assessment of mechanical complications related to abutment screw or the crown restoration. Baseline, Three months, Six months and Twelve months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Department of Conservative Dentistry 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 Faculty of Dentistry Alexandria University Champolion St., Azarita Alexandria 21521 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Islam Mahmoud Gad Abdel Raheem 57 Idfu street Al Ibrahemeya Alexandria 21524 Egypt
Ihab Adel Hammad 17 Champolion St., Azarita Alexandria 21521 Egypt
Sanaa Hussein Abdel Kader 17 Champolion St., Azarita Alexandria 21521 Egypt
Abeer Shawky El hadidi 17 Champolion St., Azarita Alexandria 21521 Egypt
Rania Abdel Aziz Fahmy 17 Champolion St., Azarita Alexandria 21521 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Islam Abdel Raheem islamgad1986@yahoo.com 00201000497739 57 Idfu street Al Ibrahemeya
City Postal code Country Position/Affiliation
Alexandria 21524 Egypt Assistant Lecturer Department of Conservative Dentistry Faculty of Dentistry Alexandria University
Role Name Email Phone Street address
Scientific Enquiries Ihab Hammad hammadfp@yahoo.com 00201099486177 17 Champollion St., Azarita
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Professor Department of Conservative Dentistry Faculty of Dentistry Alexandria 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