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IRCT20230530058338N1 IRCT 2023-06-11 Tehran University of Medical Sciences Pulp effect with silver diamine fluoride and calcium hydroxide in primary teeth Comparative study of clinical and radiographic outcomes of indirect pulp treatment with silver diamine fluoride versus calcium hydroxide in primary teeth: a randomized controlled clinical trial. 2023-07-06 anticipated 66 Complete https://irct.ir/trial/70430 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Since the two groups are supposed to have the same sample size, limited randomization and block randomization will be used in this study. Random block units will usually be used in order to balance the number of samples allocated to each of the studied groups. The size of the blocks will be chosen randomly and in each block there is an equal number of each group. The way to make the random sequence will be by the computer software "Random Allocation Software". Concealment of random allocation will be done by using opaque sealed and waxed envelopes in a random sequence by an independent person who is not aware of the study process, Blinding description: The outcome assessor and the statistical analyst will not know about the study groups. In the case of patients, blinding is such that patients do not know which material was used to cover the pulp. In the case of the assessor, the person who completes the study checklist, they do not know the patients group. The data analyst will be blinded and all data will be coded. 3 Large caries of primary teeth. Intervention 1: Intervention group: A deep injection of local anesthesia is performed using lidocaine and the tooth is isolated with a cotton roll. The caries removal of the outer walls of the cavity is completely performed by a diamond process bur using a high speed handpiece with plenty of water. In the inner walls, the infected caries are completely removed and some of the affected caries remain to prevent pulp exposure. After removing the caries, in one group, self-cure calcium hydroxide from Dycal Calcium Hydroxide brand (Dentsply sirona-USA)) is placed in the deepest part of the cavity with a minimum thickness of 1.5 mm by using a Dykal applicator. Intervention 2: Intervention group: A deep injection of local anesthesia is performed using lidocaine and the tooth is isolated with a cotton roll. The caries removal of the outer walls of the cavity is completely performed by a diamond process bur using a high speed handpiece with plenty of water. In the inner walls, the infected caries are completely removed and some of the affected caries remain to prevent pulp exposure. After removing the caries, In the other group, SDF Cariestop 30% (Biodinamica-Brazil) was applied to the cavity floor with a microtip applicator. 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 I have not decided yet
public Shahram Mosharrafian
Tehran university of medical sciences, corner of Qods, Keshavarz Blvd
Tehran Iran (Islamic Republic of) 1416633591 +98 21 8889 6696 shahramosharrafian@yahoo.com Tehran University of Medical Sciences scientific Shahram Mosharrafian
Tehran university of medical sciences, corner of Qods, Keshavarz Blvd
Tehran Iran (Islamic Republic of) 1416633591 +98 21 8889 6696 shahramosharrafian@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Children without systemic disease who are cooperative according to Frankel classification, Frankel 3 and 4. On clinical examination, large carious lesions involving the occlusal or proximal surfaces, with normal gingival appearance and having at least one decayed deciduous molar on each side of the mandible or maxilla. In the radiographic examination, the observation of caries close to the pulp that involved about two-thirds of the thickness of the dentin, normal lamina dura, normal periodontal ligament space, root length more than two-thirds, absence of periapical changes, absence of external or internal pathological analysis. 3 years 7 years Both A history of sharp, piercing pulpal pain that persists after removal of the stimulus, as well as spontaneous pain and nocturnal pain Clinical examination showing tooth mobility, tooth discoloration, sinus tract or tooth abscess Radiographic examination showing a carious lesion with intermittent exposure of the pulp, interrupted lamina dura, widening of the periodontal ligament space, periapical radiolucency and internal or external pathological degeneration. Children with absolute sensitivity to any kind of anesthetic K08.43 Partial loss of teeth due to caries Treatment - Drugs Treatment - Drugs Intervention group: A deep injection of local anesthesia is performed using lidocaine and the tooth is isolated with a cotton roll. The caries removal of the outer walls of the cavity is completely performed by a diamond process bur using a high speed handpiece with plenty of water. In the inner walls, the infected caries are completely removed and some of the affected caries remain to prevent pulp exposure. After removing the caries, in one group, self-cure calcium hydroxide from Dycal Calcium Hydroxide brand (Dentsply sirona-USA)) is placed in the deepest part of the cavity with a minimum thickness of 1.5 mm by using a Dykal applicator. Intervention group: A deep injection of local anesthesia is performed using lidocaine and the tooth is isolated with a cotton roll. The caries removal of the outer walls of the cavity is completely performed by a diamond process bur using a high speed handpiece with plenty of water. In the inner walls, the infected caries are completely removed and some of the affected caries remain to prevent pulp exposure. After removing the caries, In the other group, SDF Cariestop 30% (Biodinamica-Brazil) was applied to the cavity floor with a microtip applicator. Normal gums. Timepoint: After 3 and 6 months. Method of measurement: Clinical assessment. Absence of abscess and fistula. Timepoint: After 3 and 6 months. Method of measurement: Clinical assessment. Absence of desired toothache. Timepoint: After 3 and 6 months. Method of measurement: Clinical assessment. No internal and external degeneration. Timepoint: After 6 months. Method of measurement: Radiographic evaluation. Lack of widening of the periodontal ligament space. Timepoint: After 6 months. Method of measurement: Radiographic evaluation. No furca involvement. Timepoint: After 6 months. Method of measurement: Radiographic evaluation. Tehran University of Medical Sciences Approved 2023-06-10 Ethics committee of dentistry faculty, Tehran university of medical sciences Deputy of Research and Technology of Tehran university of medical sciences, corner of Qods, Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)