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.: PACTR201611001338358 Date of Approval: 03/11/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title effect of two superstructure materials on crestal bone loss
Official scientific title The effect of two superstructure materials on the crestal bone loss of implant supported restorations (Randomized Clinical Trial)
Brief summary describing the background and objectives of the trial my objective is to evaluate the effect of 2 superstructure materials on crestal bone loss, implant stability and patient satisfaction in implant supported restorations
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied crestal bone loss, patient satisfaction, peri-implant tissue success,Oral Health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/10/2015
Actual trial start date 01/01/2017
Anticipated date of last follow up 01/01/2018
Actual Last follow-up date 01/03/2018
Anticipated target sample size (number of participants) 20
Actual target sample size (number of participants) 20
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 coin tossing determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group all ceramic superstructures single tooth replacements 12 months monolithic ceramic crowns will be cemented on the implant abutments 10
Experimental Group resin nanoceramic superstructures single tooth replacements 12 months resin nanoceramic (vita enamic) will be cemented on the implant abutments 10
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1.Patients > 18 yrs. 2.Patients with missing teeth in the maxillary premolar region. 3.Absence of any pathological condition in the recipient site. 4.Stabilization phase will be performed including: ¿Scaling. ¿Debridement. ¿Elimination of all carious cavities and root canal treatment if needed. ¿Elimination of overhanging restorations. 5.Systemic condition of the subjects was evaluated according to dental modification of the Cornell medical index (Kerr and Millard 1966). 6.Patients who are cooperative, motivated, and hygiene conscious. 7.Patients should have adequate ridge width (>5mm). 1.Patients unable to undergo minor surgical procedure. 2.Patients with history of drug abuse or catabolic drugs. 3.Patients with history of psychiatric disorder. 4.Patients with insufficient bone. 5.Patients with insufficient vertical inter-arch space, upon centric occlusion, to accommodate the available restorative components. 6.Patients with any systemic condition that may contraindicate implant therapy. 7.Patients that may have any habits that may jeopardize the osseointegration process, such as heavy smoking and alcoholism. 8.Patients with para-functional habits that produce overload on the implant such as bruxism and clenching. 18 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
No 01/12/2015 Evidence Based Dentistry
Ethics Committee Address
Street address City Postal code Country
Al Manial Giza 002 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome crestal bone loss baseline 3 months 6 months 9 months 12 months
Secondary Outcome Implant stability baseline 3 months 6 months 9 months 12 months
Secondary Outcome Patient satisfaction 3 months 9 months 12 months
Secondary Outcome soft tissue parameters baseline 3 months 6 months 9 months 12 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo University Al manial Giza 002 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Sally Edward Fekry 6th of october city Giza 002 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Dr. Zayad Rabie al manial Giza 002 Egypt Hospital
Primary Sponsor Dr. Gihan el naggar al manial Giza 002 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Dr. Gihan el naggar al manial Giza 002 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Gihan el naggar drgigielnagar@yahoo.com 01006607978 al manial
City Postal code Country Position/Affiliation
giza 002 Egypt
Role Name Email Phone Street address
Public Enquiries Ziad Rabie ziadhassanm@gmail.com 01200003325 El Obour
City Postal code Country Position/Affiliation
Cairo 002 Egypt
Role Name Email Phone Street address
Scientific Enquiries Sally Edward sally.armol@gmail.com 01093993387 21st street
City Postal code Country Position/Affiliation
Giza 002 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