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IRCT20181027041476N1 IRCT 2019-10-06 Islamic Azad University In vivo comparison between the effect of GC composite without primer and conventional composite on white spot lesion around orthodontic brackets : A randomized clinical trial In vivo comparison between the effect of GC composite without primer and conventional composite on white spot lesion around orthodontic brackets : A randomized clinical trial 2018-10-14 anticipated 50 Complete https://irct.ir/trial/42657 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: selection of patients is based on sequence number of files. Odd numbers were given to right side of maxilla and left side of mandible and even numbers were given to left side of maxilla and right side of mandible were case group, Blinding description: bonding info and groups record by dentist but patient and 2 dental student assessor dont know this information. 3 Caries , White spot lesion. Intervention 1: Intervention group: first clean buccal surface with pumice powder and prophylactic cap to remove plaques. then etch buccal surface with phosphoric acid 37% (Reliance , Itasca , lll) for 20 seconds and then rinse it with water and dry it up to rise a chalky white appearance. Then According to the manufacturer's brochure, we dont put primer and only put GC without primer composite (GC Ortho Connect 90-1100-000) with bracket on the dental surface with light pressure and remove the extras with a scaler, then cure for 20 seconds (10s mesial and 10s distal). Intervention 2: Control group: first clean buccal surface with pumice powder and prophylactic cap to remove plaques. then etch buccal surface with phosphoric acid 37% (Reliance , Itasca , lll) for 20 seconds and then rinse it with water and dry it up to rise a chalky white appearance. Then we put primer and cure for 20 seconds and then put Transbond XT composite with bracket on the dental surface with light pressure and remove the extras with a scaler, then cure for 20 seconds (10s mesial and 10s distal). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is after completing the project we will decide about presenting
public Elmira Asadi
No 9, Neiestan 9 , Pasdaran
Tehran Iran (Islamic Republic of) 1946853314 +98 21 2204 2304 elmiraasadi@yahoo.com Islamic Azad University scientific Elmira Asadi
No 9, Neiestan 9 , Pasdaran
Tehran Iran (Islamic Republic of) 1946853314 +98 21 2204 2304 elmiraasadi@yahoo.com Islamic Azad University Iran (Islamic Republic of) similar crowding in lateral and first pre molar in each arch 3 mm or more distance between brackets and gingiva without history of fixed orthodontic treatment no wsl, caries, crowns and restoration in lateral and first pre molar no limit no limit Both smoking without systemic disease and drugs that occur xerostomia history of fixed orthodontic treatment K02 Dental caries Prevention Prevention Intervention group: first clean buccal surface with pumice powder and prophylactic cap to remove plaques. then etch buccal surface with phosphoric acid 37% (Reliance , Itasca , lll) for 20 seconds and then rinse it with water and dry it up to rise a chalky white appearance. Then According to the manufacturer's brochure, we dont put primer and only put GC without primer composite (GC Ortho Connect 90-1100-000) with bracket on the dental surface with light pressure and remove the extras with a scaler, then cure for 20 seconds (10s mesial and 10s distal). Control group: first clean buccal surface with pumice powder and prophylactic cap to remove plaques. then etch buccal surface with phosphoric acid 37% (Reliance , Itasca , lll) for 20 seconds and then rinse it with water and dry it up to rise a chalky white appearance. Then we put primer and cure for 20 seconds and then put Transbond XT composite with bracket on the dental surface with light pressure and remove the extras with a scaler, then cure for 20 seconds (10s mesial and 10s distal). White spot lesion. Timepoint: 6 and 9 months after bonding. Method of measurement: with ICDAS 2 Criteria , use ball end explorer. Islamic Azad University Approved 2018-10-13 Ethics committee of Tehran Azad University of Medical Sciences NO 9 , neiestan 9 , pasdaran tehran Tehran Iran (Islamic Republic of)