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.: PACTR201602001451342 Date of Registration: 04/02/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title noval rstoration for implant in smile zone
Official scientific title Esthetic evaluation,marginal gap and patients satisfaction for Lithium Disilicate and Nano hybrid Ceramic superstructures on Zirconium abutments in Anterior Esthetic Zone
Brief summary describing the background and objectives of the trial mesuring pink esthetic,white esthetic , marginal gap and patient satisfaction for two different implant superstructures;lithium di silicate and nano hybrid ceramic materials on patients receiving implants in esthetic zones
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied ,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 13/11/2016
Actual trial start date
Anticipated date of last follow up 15/04/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 24
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 computer soft ware program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group CERA smart every six months 18 months nano hybrid ceramic material 12 Dose Comparison
Control Group E-Max every six months 18 months lithium di silicate block 12 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1-patients above 18 years old 2-Patients able to read and sign the informed consent document illiterate patient will be avoided 3- Medically free patients or with controlled systemic disease that will be checked through past medical history part in the diagnostic chart 4- Patients with good environment to carry out implant procedure (good bone quality quantity that, will be evaluated using CBCT and panoramic radiograph,) 5- Willing to return for follow-up examinations and evaluation Young patients in growth stage 2. Patients with unsuitable implantation sites (patients with major boney defects that requires due to accidents or sever bone resorption or due to proximity of vital stracures) 4. Pregnant women's to avoid any complication that may occur in dental office due to pregnancy or due to injected anesthetic solution 5. Patients with uncontrolled systemic disease (hypertensive patient or uncontrolled diabetic patient) 8. Psychiatric problems or unrealistic expectations (patient that has phobia from dental treatments, needle bunch or surgical procedures) 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 06/02/2016 center for evidence based dentistry
Ethics Committee Address
Street address City Postal code Country
alkasr eleny street Cairo university giza 12435 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome white esthetic immediately after cementation after three months after six months after twelve months after eighteen months
Secondary Outcome pink esthetic immediately after cementation after three months after six months after twelve months after eighteen months
Secondary Outcome patient satisfaction immediately after cementation after three months after six months after twelve months after eighteen months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo university alkasr eleny street cairo university giza Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
islam munir forat street no4 almohandseen giza 12435 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr .Jylan Fuaad Alguindy mosadak street giza Egypt University
COLLABORATORS
Name Street address City Postal code Country
.Nihal Mahmoud Mohamed Samra monsoura Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Islam Ali simsim373@hotmail.com 01224565100 forat street no4 almohandseen
City Postal code Country Position/Affiliation
giza 12435 Egypt specialist in fixed prosthodontics
Role Name Email Phone Street address
Public Enquiries Islam Ali simsim373@hotmail.com 01224565100 forat street no4 almohandseen
City Postal code Country Position/Affiliation
giza 12435 Egypt specialist in fixed prosthodontics
Role Name Email Phone Street address
Scientific Enquiries Jylan Elguindy dr_jul@hotmail.com 01001671419 mesadak street
City Postal code Country Position/Affiliation
giza Egypt Professor of Fixed Prosthodontics- Faculty of Oral and Dental Medicine ¿Cairo 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