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IRCT20210227050512N1 IRCT 2021-08-08 Shiraz University of Medical Sciences Effect of Nano Calcium Hydroxide in tooth pulp Regeneration Comparison of the Effect of Calcium Hydroxide and Nano Calcium Hydroxide on Regeneration of Immature Permanent Teeth : A Clinical Pilot Study 2021-09-14 anticipated 24 Complete https://irct.ir/trial/54624 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Individual Block randomization method was used for the Patient’s Allocation into two groups with a 1:1 Ratio by RANDOM.ORG Software. Participants were divided into two Groups of Pulp revitalization with calcium hydroxide and nano calcium hydroxide paste, Blinding description: Calcium hydroxide and nano calcium hydroxide pastes will give to the practitioner in a similar volume, consistency, and color, as well as a similar container. Participants ( patients) will not be aware of the type of material used in the therapy as same as the evaluators of the treatment results. The researcher is the only one who knows which medicament has been used for each patient and leads the research. 2-3 Immature tooth pulp necrosis. Intervention 1: Intervention group: Regeneration treatment of dental pulp would perform using nano-calcium hydroxide paste (Polymer and Petrochemical Institute, Tehran, Iran) with a creamy consistency obtained by a combination of nano-calcium hydroxide powder and 0.9% saline in three to one ratio, According to the American Association of Endodontics protocol. Intervention 2: Control group: Regeneration treatment of dental pulp would perform using calcium hydroxide paste (Merck, Darmstadt, Germany) with a creamy consistency obtained by a combination of calcium hydroxide powder and 0.9% saline in three to one ratio, According to the American Association of Endodontics protocol. Yes - There is a plan to make this available What will be shared: The results of the study consist of clinical and radiographic findings of participants due to the kind of materials which were used. When: 6 months after publication To whom: there is no limit. Conditions: with referencing of the article Where to obtain: the corresponding author How to obtain: the written request should be sent through an email to the corresponding author - data will give in one month after the permission of all authors Comments:
public Dr Safoora Sahebi
Shiraz Dental School, Ghasrodasht Street, Shiraz
Shiraz Iran (Islamic Republic of) 7195615878 +98 71 3194 3626 sahebisafoora@gmail.com Shiraz University of Medical Sciences scientific Dr Safoora Sahebi
Shiraz Dental School, Ghasrodasht Street, Shiraz
Shiraz Iran (Islamic Republic of) 7195615878 +98 71 3194 3626 sahebisafoora@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Non-Vital Permanent teeth with Open Apex (file size number equal or more than 60) With or Without Radiographic Radiolucency Negative Response to Pulp Vitality Test Restorable Tooth No Systemic Conditions Patients’ age between 6-16 years old 6 years 16 years Both With Radiographic Evidence of Internal or External Resorption With Root Fractures With Periodontal Involvement Those Who Do Not Cooperate Treatment - Drugs Treatment - Drugs Intervention group: Regeneration treatment of dental pulp would perform using nano-calcium hydroxide paste (Polymer and Petrochemical Institute, Tehran, Iran) with a creamy consistency obtained by a combination of nano-calcium hydroxide powder and 0.9% saline in three to one ratio, According to the American Association of Endodontics protocol. Control group: Regeneration treatment of dental pulp would perform using calcium hydroxide paste (Merck, Darmstadt, Germany) with a creamy consistency obtained by a combination of calcium hydroxide powder and 0.9% saline in three to one ratio, According to the American Association of Endodontics protocol. Pulp revitalization. Timepoint: Evaluation of pulp revitalization would perform in 3, 6, and 9 month after treatment. Method of measurement: Cold test and electrical pulp test for evaluating pulp revitalization. Root dentin diameter change. Timepoint: Evaluation of changes in root dentin diameter would perform in 3, 6, and 9 month after treatment. Method of measurement: The difference between the external root thickness and the width of the pulpal area of the canal will evaluate radiographically. Root length chages. Timepoint: Evaluation of changes in root length would perform in 3, 6, and 9 month after treatment. Method of measurement: Distance between Cemento-Enamel-Junction on the mesial portion and the mesial and distal point at the end of the apex will evaluate radiographically. Shiraz University of Medical Sciences Approved 2021-05-26 Ethics committee of shiraz university of medical science Shiraz Dental School, Ghasrodasht Street, Shiraz Shiraz Fars Iran (Islamic Republic of)