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.: PACTR201909918553224 Date of Approval: 17/09/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Figaro Crowns versus Stainless Steel Crowns in Primary molars
Official scientific title Fiberglass Posterior Crowns “Figaro Crowns” versus Stainless Steel Crowns in Pulp Treated Primary Molars in Children: A Randomized Controlled Trial
Brief summary describing the background and objectives of the trial Early Childhood Caries (ECC) is a multifactorial disorder which continues to be a global health problem for decades in children, Stainless steel crowns (SSCs) have been the benchmark in providing a permanent restoration for primary molars affected by caries, decalcification in the cervical region, developmental defects like hypoplasia, and also as a full coronal restoration in case of teeth treated by pulpotomy or pulpectomy. Their advantages with strength, retention, and minimal tooth preparation could not overcome the distinct disadvantage of hampering aesthetics. Zirconia crowns made its debut in 1991 which had a paradigm shift in providing full coronal restorations in primary anterior teeth. These crowns allow the practitioners to provide patients with superior, highly polished, esthetic results. Many brands have then evolved in the manufacture of Zirconia crowns. However, all brands needed a comparatively higher tooth reduction compared to SSC resulting in more time consuming for crown preparation and insertion, which is an essential factor when dealing with kids. Another limitation for zirconia crows is its coast; crowns are expensive and may not be affordable by many patients. Fiberglass crowns were recently introduced in 2018 It is composed of fiberglass and also contains titanium oxide and ferrous oxide which synergistically add unsurpassed strength and enhanced cosmetic value. Figaro crowns are all white, metal-free, BPA free, autoclavable crowns. The manufacturer claimed that Figaro crowns are white crowns that are very similar to SSC in preparation and that they are based on flex- Fit technology which allow the crowns to be placed with minimal tooth reduction saving time and providing tight margins similar to SSC. This study aims to evaluate the clinical performance of Figaro crowns compared to SSC in pulpotomized primary molars in children.
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 01/10/2019
Actual trial start date
Anticipated date of last follow up 31/05/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 32
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 Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Fiberglass Figaro Crowns From the insertion of crown till the end of follow up Figaro crowns are all white, metal-free, BPA free, autoclavable crowns. The manufacturer claimed that Figaro crowns are white crowns that are very similar to SSC in preparation and that they are based on flex- Fit technology 16
Control Group Stainless Steel Crowns From the insertion of crown till the end of follow up Stainless steel crowns have been the benchmark in providing a permanent restoration for primary molars 16 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Healthy children who need complete oral rehabilitation under general anesthesia Each child should have at least one pair or 2 pairs of their primary molars that need pulpotomy and crown restoration, Teeth selected were with deep carious lesion, vital with healthy periodontium and restorable crowns. Un-restorable teeth due to massive crown destruction Massive sub-gingival decay that may interfere with crown preparation and retention Clinical signs or symptoms suggesting a non-vital tooth such as suppurating sinus, soft tissue swelling, mobility. Radiographic signs showing: widening of periodontal ligament (PDL), internal root resorption (IRR), pathological external root resorption, periapical or inter radicular radiolucency. Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 4 Year(s) 6 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 20/08/2019 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 Crown retention At 3 months and 6 months postoperative
Primary Outcome Marginal integrity At 3 months and 6 months postoperative
Secondary Outcome Parents preference to type of crown At 3 months and 6 months postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Department of Pediatric Dentistry Faculty of Dentistry Alexandria university Champolion St., Azarita Alexandria 21521 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Laila Moustafa El Habashy 132 Abd El Salam Aref Alexandria 21532 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Pediatric dentistry Department Faculty of Dentistry Alexandria university Champolion St., Azarita Alexandria 21521 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Laila Moustafa El Habashy 132 Abd el salan Aref Alexandria 21532 Egypt
Nadia Aziz 305 el horeya avenue alexandria Alexandria 21523 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Laila El Habashy lmhabashy@Hotmail.com 00201206241076 132 Abd el salan Aref
City Postal code Country Position/Affiliation
Alexandria 21532 Egypt Associate Professor In Pediatric Dentistry Department Faculty of Dentistry Alexandria university
Role Name Email Phone Street address
Scientific Enquiries Nadia Aziz drnadiawahba@gmail.com 00201228400050 305 el horeya avenue alexandria
City Postal code Country Position/Affiliation
Alexandria 21523 Egypt Professor In Pediatric Dentistry Department 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
Yes Full excel sheet of data will be available upon completing the recruitment Informed Consent Form,Study Protocol 1 year Open access will be permitted to get the data please send e-mail to elsayedamr@yahoo.com (public relation) Researchers decided to send data when requested No quality of request is required
URL Results Available Results Summary Result Posting Date First Journal Publication Date
N/A 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