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.: PACTR201901895954408 Date of Approval: 23/01/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Evaluation of Digital smile design FOR CLOSURE OF maxillary median diastema with porcelain laminate veneers (A randomized controlled clinical trial(
Official scientific title Evaluation of Digital smile design FOR CLOSURE OF maxillary median diastema with porcelain laminate veneers
Brief summary describing the background and objectives of the trial Rehabilitation treatments protocols can clarify any discrepancy identification as well as guide subsequent decisions. Among aberrations in smile esthetics is the presence of diastema. Maxillary median diastema (MMD) is a common esthetic complaint of patients. To ensure the prosthodontic treatment meets the patient’s aesthetic demand, diagnostic wax-up is strongly recommended prior to the definitive treatment. Digital smile design (DSD) seems to be a useful diagnosis tool for dentogingival alterations. Nowadays, computer aided design and computer aided milling technology (CAD/CAM) requires nothing more than few keyboard clicks in order to design and fabricate accurate restorations. This study aims to Clinical evaluation of using digital smile design (DSD) versus conventional wax up technique to close maxillary median diastema (MMD) with ceramic veneers according to Esthetic parameters of Dentofacial analysis, Occlusal analysis and Phonetic analysis and to evaluate invitro the Asymmetry percentage before and after treatment with digital smile design versus conventional wax up smile design to close maxillary median diastema.
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: Other
Anticipated trial start date 02/02/2019
Actual trial start date 02/02/2019
Anticipated date of last follow up 31/07/2020
Actual Last follow-up date 31/07/2020
Anticipated target sample size (number of participants) 36
Actual target sample size (number of participants) 36
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 Digital smile 1 day The photographs and videos will be downloaded and inserted into the DSD software. Smile analysis and smile simulation with DSD software 18
Control Group wax up 1 day Conventional Smile analysis and smile simulation will proceed. On a duplicate caste diagnostic wax-up closing the diastema will be made and Slight preparation will be done on another duplicate cast and Composite mockup will be built to see if it will create a solution that will pleased the patient 18 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patient with 2-3 mm median diastema of maxillary central incisors. Maxillary six anterior teeth are caries free. Healthy gingival tissue surrounds the tooth. The patient has to be healthy and willing to return at regular intervals for evaluation. Patients with parafunction habits. Patients with major malocclusions. Patients with mobile teeth. Patients with badly destructed teeth. Anterior teeth with little or no enamel present due to erosion, attrition or hypocalcification. Swelling of associated gingival tissue. Medically compromised patients. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 20 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 14/01/2019 IRB Faculty of Denistry Alexandria University
Ethics Committee Address
Street address City Postal code Country
Champlion Street Raml Station Alexandria 21521 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Maxillary median diastema immediate postoperative and at 1, 3, 6, 12, 18 months
Secondary Outcome patient’s esthetic demand immediate postoperative and at 1, 3, 6, 12, 18 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Conservative Dentistry Department Faculty of Dentistry Alexandria University Champlion street, Raml Station., Alexandria Egypt Alexandria 21521 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mohamed Hussein Abd Elrahman Hussein Champlion Street, Azarita Alexandria 21521 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of Conservative Dentistry Faculty of Dentistry Alexandria University Champilon street, Azarita Alexandria 21521 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ahmed Safwat ELkady Champollion St. , El Azareta - Alexandria - Egypt. Alexandria 21521 Egypt
Mahmoud Mohamed Alsharkawy Champollion St. , El Azareta - Alexandria - Egypt. Alexandria 21521 Egypt
Mohamed Hussein Abd Elrahman Hussein Champollion St. , El Azareta - Alexandria - Egypt. Alexandria 21521 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Safwat Prof.a.safwat@hotmail.com 00201222231043 Champollion St. , El Azareta - Alexandria - Egypt.
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Professor of Operative Dentistry Faculty of Dentistry Alexandria University
Role Name Email Phone Street address
Scientific Enquiries Mahmoud Mohamed drmahmoud666@gmail.com 00201223447131 Champollion St. , El Azareta - Alexandria - Egypt.
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Professor of Operative 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
No
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