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.: PACTR201606001620344 Date of Approval: 06/05/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Evaluation of marginal adaptation, esthetics and patients' satisfaction of lithium disilicate and nano hybrid resin ceramic crowns over zirconia impla
Official scientific title Evaluation of marginal adaptation, esthetics and patients' satisfaction of lithium disilicate and nano hybrid resin ceramic crowns over zirconia implant abutments in anterior esthetic zone (Randomized controlled clinical trial)
Brief summary describing the background and objectives of the trial The trial tests the clinical performance of two different dental ceramic materials ( lithium disilicate versus Enamic) regarding their marginal adaptation over dental implant abutments, their esthetic results and which one of them achieves more patients' satisfaction
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Missed teeth in anterior esthetic area,Oral Health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/09/2016
Actual trial start date 15/09/2016
Anticipated date of last follow up 02/09/2017
Actual Last follow-up date 01/10/2017
Anticipated target sample size (number of participants) 16
Actual target sample size (number of participants) 16
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 participants will be allocated in to two groups with 1:1 allocation ratio by using computerized Sequence generation (www.randomizer.org) The number for each member in each group will be written on a white paper sheet. The sheet will be saved inside opaque well sealed envelope in which the inner content will not be visible for the naked eye. Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group E-Max ceramic material 8 1 year E-Max is a glass ceramic material composed ofSiO2. Li2O, K2O, P2O5, ZrO2,ZnO,other oxides and coloring oxides. It is used for fabrication of dental crowns and bridges due to its high strength and good esthetics 8 Uncontrolled
Experimental Group Enamic 8 1 year hybrid material composed of a network which is a combination between ceramic and composite so that benifits of both material can be obtained when used for the fabrication of crown and bridges dental superstructures 8
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
subjects were required to be 1-Age above 18 years with at least one tooth missing in the esthetic area 2- Anterior area available for implant placement 3- Patient with good oral hygiene 4- Lack of excessive parafunctional activity leading to Implant failure 5-Articles published in English language. 6- Human studies. 7- Randomized clinical trials or quasi-randomized clinical trial. 8- Controlled clinical trials 1- Animal and in vitro study 2- Articles published other than English 3- Case reports studies, cohort studies and case series studies. 4- Young patients in whom the jaws are still growing. 5- General or local contraindications - such as systemic medical conditions, drug abuse or local 6-Jaw pathology. 18 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
Yes 20/07/2015 Centre of evidence based dentistry-cairo University
Ethics Committee Address
Street address City Postal code Country
El-Manyal Cairo Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome whaite esthetic score T4 T5 T6 TX
Secondary Outcome Pink Esthetic Score T4 T5 T6 TX
Secondary Outcome Marginal Adaptation T4 T5 T6 TX
Secondary Outcome Patients' Satisfaction T4 T5 T6 TX
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Outpatient clinic-Cairo University EL-Manyal Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Self funded Torail El-Mansoura Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Oral and Dental Medicine-Cairo University EL-Manyal Cairo Egypt University
COLLABORATORS
Name Street address City Postal code Country
Nehal Samra Torail El-Mansoura Egypt
Gylan El-Guindy Mohandessein Cairo Egypt
Hani El-Nahass Mohandessin Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nehal Samra nehal_samra@hotmail.com 00201006789321 Torail
City Postal code Country Position/Affiliation
El-Mansoura Egypt Assistant lecturer-Faculty of Oral and Dental Medicine-Delta University
Role Name Email Phone Street address
Public Enquiries Hani El-Nahass hani.elnahass@dentistry.cu.edu.eg 00201000252603 Mohandessin
City Postal code Country Position/Affiliation
Cairo Egypt Professor of periodontology-Faculty of Oral and Dental Medicine-Cairo University
Role Name Email Phone Street address
Scientific Enquiries Jylan El-Guindy dr_Jul@hotmail.com 00201001671419 Mohandessin
City Postal code Country Position/Affiliation
Cairo Egypt Professor of fixed prosthodontics-Faculty of Oral and Dental Medicine-Cairo University
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