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IRCT20231025059853N1 IRCT 2023-11-14 Shahre-kord University of Medical Sciences Comparative evaluation of the efficacy of calcium hydroxide with resin modified glass ionomer versus TheraCal in indirect pulp cap: a clinical trial study Comparative evaluation of the efficacy of calcium hydroxide with resin modified glass ionomer versus TheraCal in indirect pulp cap in teeth with deep caries: a clinical trial study 2023-09-13 anticipated 50 Complete https://irct.ir/trial/73349 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method of replacement blocks will be used with the size of each block equal to 6. The randomization list will be prepared by the permutation block method using Allcation Random software and will be provided to the researcher, Blinding description: This clinical trial study will be conducted in a double-blind manner so that both the patients participating in the study and the statistical analyst will be blinded. Blinding for the patients will be in such a way that theracal and calcium hydroxide materials have similar colors and the patients will not have any information about the content of the received intervention. Also, the information file will be provided to the statistical analyst in the form of group A and group B, and this person will not have any information about the content of the intervention of groups A and B, which will cause all the results to be analyzed based on groups A and B and will be provided to the main researcher. 3 Indirect pulp capping for teeth with deep decay. Intervention 1: Intervention group: People treated with TheraCal : For both intervention and control groups, local anesthesia, isolation of the investigated tooth and selective removal of caries are performed. The tooth is disinfected with chlorhexidine 2% and rinsed with normal saline. Then the teeth are randomly divided into two groups: the intervention group consists of 25 teeth and will be treated with TheraCal LC (calcium silicate liner modified with light cure resin): the material is applied to the deepest points of the cavity floor and It is then light cured according to the manufacturer's instructions. TheraCal LC from Bisco is supplied by the manufacturer as a disposable syringe and syringe head and does not require preparation before use. Intervention 2: Control group: people treated with self cure calcium hydroxide (Dycal) and light cure hybrid ionomer liner: Dycal is available as a two-paste system (a catalyst paste and a base paste). Equal amounts of catalyst and base are mixed and applied with a Dycal applicator directly to the deepest points of dentin in the cavity. Excess Dycal material will be removed from the cavity walls and enamel margins. Then Light Cure glass ionomer cement is placed in the cavity as a base. Yes - There is a plan to make this available What will be shared: The clinical study report will be published as an article When: It is possible to start accessing immediately after printing the results To whom: Access is open to the public Conditions: For more information Where to obtain: Fadak Complex, Hamedanian St. ,Hasht Behesht St. ,Isfahan Shamim Mohammadi khorshid_mohammad@yahoo.com 09134432263 How to obtain: The clinical study report will be available to the public immediately after printing. For detailed information, send an email to khorshid_mohammad@yahoo.com. The data files will reach the applicant after 1 month. Comments:
public Shamim Mohammadi
Fadak complex,hamedanian st., hasht behesht st., Isfahan
Isfahan Iran (Islamic Republic of) 8157967764 +98 31 3270 9327 khorshid_mohammad@yahoo.com Shahre-kord University of Medical Sciences scientific Shamim Mohammadi
Fadak complex,hamedanian st., hasht behesht st., Isfahan
Isfahan Iran (Islamic Republic of) 8157967764 +98 31 3270 9327 khorshid_mohammad@yahoo.com Shahre-kord University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients with mature permanent teeth with closed apex Patients with caries in the dentin more than one-half or three-quarters of the thickness of the dentin Patients with reversible pulpitis Dental samples must respond positively to the cold test no limit no limit Both Patients with irreversible pulpitis Teeth with internal and external absorption Tooth with periapical lesion Tooth with necrotic pulp Cracked teeth People with periodontitis K02.1 Caries of dentine Treatment - Other Treatment - Other Intervention group: People treated with TheraCal : For both intervention and control groups, local anesthesia, isolation of the investigated tooth and selective removal of caries are performed. The tooth is disinfected with chlorhexidine 2% and rinsed with normal saline. Then the teeth are randomly divided into two groups: the intervention group consists of 25 teeth and will be treated with TheraCal LC (calcium silicate liner modified with light cure resin): the material is applied to the deepest points of the cavity floor and It is then light cured according to the manufacturer's instructions. TheraCal LC from Bisco is supplied by the manufacturer as a disposable syringe and syringe head and does not require preparation before use. Control group: people treated with self cure calcium hydroxide (Dycal) and light cure hybrid ionomer liner: Dycal is available as a two-paste system (a catalyst paste and a base paste). Equal amounts of catalyst and base are mixed and applied with a Dycal applicator directly to the deepest points of dentin in the cavity. Excess Dycal material will be removed from the cavity walls and enamel margins. Then Light Cure glass ionomer cement is placed in the cavity as a base. The degree of pain or clinical sensitivity. Timepoint: 21 days, three months and six months after treatment. Method of measurement: Based on the Numeric Rating Scale. Vitality of the pulp or Vitality of the dental nerve, which is determined by the feeling of cold or heat after performing vitality tests. Timepoint: 21 days, three months and six months after treatment. Method of measurement: Vitality tests (cold and heat test). Widening of the periodontal ligament space around the apex in radiographs. Timepoint: 6 months after treatment in case of pain and clinical sensitivity. Method of measurement: Radiography. Shahre-kord University of Medical Sciences Approved 2023-09-13 Research Ethics Committees of School of Medicine - Shahrekord University of Medical Sciences Fadak complex,Hamedanian St.,East Haht Behesht St. Isfahan Isfehan Iran (Islamic Republic of)