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.: PACTR201801002987317 Date of Registration: 19/01/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Enamel remineralization after amorphous casein phosphopeptide
Official scientific title Enamel remineralization in children after two regimens of application of amorphous casein phosphopeptide: A randomised controlled trial
Brief summary describing the background and objectives of the trial Demineralization of enamel is a natural phenomenon that can not be prevented but rather controlled. Organic acids can dissolve enamel by removing calcium from enamel and its diffusion into plaque. Remineralization of enamel is a natural component of the dynamic caries process causing the lesion to heal by deposition of minerals on damaged enamel crystals thus causing demineralization to reverse. Remineralization can be enhanced by providing low levels of calcium , phosphorus and fluorides. Minimal intervention dentistry is concerned with the earliest detection and earliest possible cure of dental caries. The diagnodent is a laser fluorescence device that can measure enamel demineralization utilizing a diode laser at wave length of 655nm inducing fluorescence in the red and near infra red region and in presence of caries, fluorescence increases. The anti cariogenic effect of fluoride is well documented in the literature by inhibiting deminerlization and promoting remineraliaztion. Casein phosphate peptides-amorphous calcium phosphate complexes (CPP-ACP) are dairy products effective in preventing caries. It increases the concentration of calcium and phosphorus in dental plaque. The primary objective of the study is to measure and compare clinically the remineralizing effect of amorphous casen phosphopeptides with and without fluoride on enamel of children following two regimens of application
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Dental caries,Oral Health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/01/2011
Actual trial start date 01/03/2011
Anticipated date of last follow up 30/09/2011
Actual Last follow-up date 15/12/2011
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Completed
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 randomisation (variable block size) 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 MI paste plus 5 days 10% CPP-ACP 900 ppm Fl 5 days Application of agent for 5 days Final reading One month post treatment reading 3months post operative reading 15
Experimental Group GC Tooth mousse 5 days 10% CPP-ACP 5 days Application of agent for 5 days Final reading One month post treatment reading 3months post operative reading 15
Experimental Group MI paste plus 10 days 10% CPP-ACP 900 ppm Fl 10 days Application of agent for 10days Final reading One month post treatment reading 3months post operative reading 15
Experimental Group GC tooth mousse 10 days 10% CPP-ACP 10 days Application of agent for 10 days Final reading One month post treatment reading 3months post operative reading 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Child with at least one white spot enamel lesion on smooth surface - Non cavitated white chalky spot lesion - Readings on diagnodent 15-20 - Child allergic to milk proteins - Uncooperative child 7 Year(s) 10 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 17/11/2010 IRB: Faculty of dentistry, University of Alexsndria
Ethics Committee Address
Street address City Postal code Country
Champollion street, E Messalah Alexandria 21521 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Remineralization of tooth enamel following treatment as measured by Diagnodent Baseline After application of materials One month post treatment Three months post treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Pediatric Dentistry Department, Faculty of Dentistry, University of Alexsndria Chamblion street, el azareeta Alexandria 21521 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Pediatric department, Faculty of Medicine, Alexandria University Chamblion street, el azareeta Alexandria 21521 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Dentistry, University of Alexandria Chamblion street, el azareeta Alexandria 21521 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Aly Sharaf Chamblion street, el azareeta Alexandria 21521 Egypt
Karin Dowidar Chamblion street, el azareeta Alexandria 21521 Egypt
Amal El Zayat Medical Research Institute, Gamal Abdel Nasr Street Alexandria 21524 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Aly Sharaf Dr.alysharaf@hotmail.com 002-03-5853556 Sharaawy street
City Postal code Country Position/Affiliation
Alexandria 21527 Egypt Professor of Pediatric Dentistry, Faculty of Dentistry, University of Alexsndria
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
Role Name Email Phone Street address
Scientific Enquiries Karin Dowidar karindowidar55@gmail.com 01222154965 Champollion street, Azareta
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Professor of Pediatric Dentistry, Faculty of Dentistry, University of Alexsndria
REPORTING
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Result URL Hyperlinks Link To Protocol
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Changes to trial information