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IRCT20190514043585N3 IRCT 2021-12-29 Tabriz University of Medical Sciences Evaluation of the effect of ozone gel on the clinical and radiographic success of ferric sulfate primary molar pulpotomy Evaluation of the effect of ozone gel on the clinical and radiographic success of ferric sulfate primary molar pulpotomy 2021-12-28 anticipated 25 Complete https://irct.ir/trial/60664 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The sampling method is randomly Available among Individuals referring to the pediatric department of Tabriz Dental faculty. The randomization method is simple. Our Tool for randomization is the randomized Number Chart. Furthermore, the Allocation of treatment to Patients is done Randomly. To do this, the types of treatment are identified with code A (control) and B (case) and then the sealed envelopes that will be placed in a box and stirred. Then they are randomly chosen from the Box and after observing the code, the treatment is given to the Patient. One person's tooth was considered as a control and another tooth for treatment, Blinding description: The pediatrician is unaware of the outcome of the treatment and the type of disinfectant used for each patient. N/A Primary tooth caries. Intervention 1: Intervention group: In the experimental group, the procedure will be as follows: The desired tooth will be anesthetized and isolated with a Rubber Dam. After removing all caries and debris, an access cavity will be created. The contents of the coronary pulp tissue will be removed and then ozone gel (Vitomex) will be placed for disinfection After a few minutes of melting the gel, 15.5% ferric sulfate (UltraDent Astingedent) is placed in place and finally, zonalin (Zoliran) will be applied. and the final restoration will be done in the same meeting. This gel can stay at room temperature for months, but to maintain the highest performance, it must be stored in the refrigerator at 15 degrees Celsius or less. All steps will be performed by the student participating in the study under the supervision of the supervisor. Clinical success will be assessed by a pediatrician during a 6-month clinical follow-up. The pediatrician is unaware of the type of treatment given to each patient. Intervention 2: Control group: Normal pulpotomy using ferric sulfate. In the control group, the procedure will be as follows: The desired tooth will be anesthetized and isolated with a Rubber Dam. After removing all caries and debris, an access cavity will be created. The contents of the coronal pulp tissue will be extracted. 15.5% ferric sulfate (UltraDent Astingedent) will be placed in place and finally, zonalin (Zoliran) will be placed and the final repair will be done in the same session. In the control group, all the steps performed for the experimental group will be repeated, except Ozone gel will not be used for disinfection and eventually the crown of the teeth will be regenerated. All steps will be performed by the student participating in the study under the supervision of the supervisor. Clinical success will be assessed by a pediatrician during a 6-month clinical follow-up. The pediatrician is unaware of the type of treatment given to each patient. 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 There is not more data
public Seyedeh Arezou Ghoreyshizadeh
Tabriz University of Medical Sciences, Golgasht St.
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3335 5965 ghoreyshizadeha@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Seyedeh Arezou Ghoreyshizadeh
Tabriz University of Medical Sciences, Golgasht St.
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3335 5965 ghoreyshizadeha@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Ages 4 to 8 years The ability to cooperation for treatment Double sided molar with irreversible pulpitis requires pulpectomy Lack of symptoms of necrosis or inflammation of the root pulp in radiography Lack of symptoms of external root resorption in radiography Having primary radiography Possibility of crown restoration Parental satisfaction for participation in the study 4 years 8 years Both Deficiency of glucose 6 phosphate dehydrogenase or favism Hyperthyroidism Anemia Ozone sensitivity Hemorrhagic disease K02 Dental caries Treatment - Other Treatment - Other Intervention group: In the experimental group, the procedure will be as follows: The desired tooth will be anesthetized and isolated with a Rubber Dam. After removing all caries and debris, an access cavity will be created. The contents of the coronary pulp tissue will be removed and then ozone gel (Vitomex) will be placed for disinfection After a few minutes of melting the gel, 15.5% ferric sulfate (UltraDent Astingedent) is placed in place and finally, zonalin (Zoliran) will be applied. and the final restoration will be done in the same meeting. This gel can stay at room temperature for months, but to maintain the highest performance, it must be stored in the refrigerator at 15 degrees Celsius or less. All steps will be performed by the student participating in the study under the supervision of the supervisor. Clinical success will be assessed by a pediatrician during a 6-month clinical follow-up. The pediatrician is unaware of the type of treatment given to each patient. Control group: Normal pulpotomy using ferric sulfate. In the control group, the procedure will be as follows: The desired tooth will be anesthetized and isolated with a Rubber Dam. After removing all caries and debris, an access cavity will be created. The contents of the coronal pulp tissue will be extracted. 15.5% ferric sulfate (UltraDent Astingedent) will be placed in place and finally, zonalin (Zoliran) will be placed and the final repair will be done in the same session. In the control group, all the steps performed for the experimental group will be repeated, except Ozone gel will not be used for disinfection and eventually the crown of the teeth will be regenerated. All steps will be performed by the student participating in the study under the supervision of the supervisor. Clinical success will be assessed by a pediatrician during a 6-month clinical follow-up. The pediatrician is unaware of the type of treatment given to each patient. Clinical success. Timepoint: 6 months. Method of measurement: A checklist containing information -1 No pain, 2-No sensitivity to Percussion 3-Missing or increased mobility 4- No opening of the sinus 5. No withdrawal of pushy exudates from the gingival margin. Tabriz University of Medical Sciences Approved 2021-08-30 Ethics committee of Tabriz University of Medical Sciences Floor2, Central Building No.2, Tabriz University of Medical Sciences, Golgasht St Tabriz East Azarbaijan Iran (Islamic Republic of)