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IRCT20110325006105N8 IRCT 2024-02-08 Zahedan University of Medical Sciences Different Aspects of Two Adjacent Primary Molars Treatment Evaluation of Physiologic and non physiologic Effects of Two Adjacent Primary Molars Treatment in One Single Session in5-7 years old children 2024-01-21 anticipated 58 Complete https://irct.ir/trial/74633 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Supportive, Other design features: A split-mouth design is used to investigate the effect of treating two adjacent teeth on the variables. Two molars on the experimental side and one molar on the control side are treated. All children in the pediatric department are treated by two dental resident under the supervision of a pediatric specialist. For each participant, both sides of the jaw will be treated by a single operator in two separate consecutive sessions with a two-week interval between the treatment sessions. This time interval between sessions is planned to eliminate the effects of the first encounter on the outcomes of the second encounter. Additionally, to eliminate any unknown treatment effect from the first session to the second session, children will be randomly divided into two groups using a random block method. One group will receive single-tooth pulpotomy treatment and stainless steel crown (SSC) initially, while the other group will receive pulpotomy treatment for the adjacent molars and SSC in one session initially. Furthermore, depending on which dental arch (right or left) will receive the first treatment, two subgroups from each of the initial groups will be extracted using a random block method. For both sides, treatments are performed as a single session of complete treatment, Randomization description: Allocation of samples will be done using quadruple blocks, where half of the individuals are assigned to group one and the other half to group two. All possible quadruple scenarios are as follows: Where 'A' belongs to group one and 'B' belongs to group two. 1. A A B B 2. A B A B 3. A B B A 4. B B A A 5. B A B A 6. B A A B In the next step, each of these quadruple combinations will be assigned a number from 1 to 6. Following that, approximately 15 random quadruple blocks will be selected based on the total sample size and the sample size for each group. The order of these selected blocks will be determined, and the allocation of individuals to groups one and two will be based on these chosen orders. By continuing this process, we ensure that the difference between the two groups will not exceed two individuals at most, Blinding description: The assessor of the physiological and non-physiological measures is currently blinded to which side (adjacent treatment of two decayed primary molars in one session under the experimental group and treatment of one decayed primary molar in one session under the control group) is being performed. The participant is unaware of how to check the sequence of sessions. N/A pulpotomy. Intervention 1: Intervention side: Prior to injection, local gel will be used at the injection site. A volume of 1.8 milliliters of 2% lidocaine with 1/80000 epinephrine solution at room temperature will be slowly administered using a regular syringe (1 milliliter per minute, only one cartridge). For anesthesia of the upper and lower jaw, participants will receive infiltration and inferior alveolar nerve block sequentially using a 21-gauge needle with a 27-gauge and 35-gauge needle with a 27-gauge respectively. Intrapapillary anesthesia will be performed for complete anesthesia. After 15 minutes have elapsed since the administration of anesthesia, treatment will begin. All dental procedures will be performed using rubber dam isolation. After performing pulp treatment, the adjacent tooth will be restored using light-cured glass ionomer cement for crown restoration. Then, SSCs will be adjusted and cemented using glass ionomer cement. Intervention 2: Control side: Intervention Group 1: Before injection, local gel will be used at the injection site. A volume of 1.8 milliliters of 2% lidocaine with 1/80000 epinephrine solution at room temperature will be slowly administered using a regular syringe (1 milliliter per minute, only one cartridge). For anesthesia of the upper and lower jaw, participants will receive infiltration and inferior alveolar nerve block sequentially using a 21-gauge needle with a 27-gauge and 35-gauge needle with a 27-gauge respectively. Intrapapillary anesthesia will be performed for complete anesthesia. After 15 minutes have elapsed since the administration of anesthesia, treatment will begin. All dental procedures will be performed using rubber dam isolation. After performing pulp treatment, a primary molar tooth will be restored using light-cured glass ionomer cement for crown restoration. Then, SSCs will be adjusted and cemented using glass ionomer cement. Yes - There is a plan to make this available What will be shared: information about the main outcome and its comparison with different groups can be shared. When: Access period starts 6 months after the results are published. To whom: Researchers working in academic and scientific institutes, dental students, dentists. Conditions: The ultimate goals are providing adequate dental services, creating a good experience, consolidating good communication between the individual child and dental team and avoiding any fear and anxiety throughout future life and improve treatment results. all dental researchers will be able to access the data. Where to obtain: Dr.nahid ramazani ramazani77@gmail.com +989155009085 How to obtain: please send an email to the respondent and state the resume and purpose of accessing the data for the respondent.The respondent will respond to the initial email within a week, and if documents need to be sent, the documents will be sent to the applicant within a month. Comments:
public Nahid Ramazani
Zahedan, East Azadegan St, School of dentistry
Zahedan Iran (Islamic Republic of) 9817699693 +98 54 3344 1814 ramazani77@gmail.com Zahedan University of Medical Sciences scientific ٔNahid Ramazani
Zahedan, East Azadegan St, School of dentistry
Zahedan Iran (Islamic Republic of) 9817699693 +98 54 3344 1824 ramazani77@gmail.com Zahedan University of Medical Sciences Iran (Islamic Republic of) Children aged 7-5 years without any physical or mental illnesses Cooperative based on the Frankl behavior rating scale (Frankl 3 or 4) Candidates for routine treatment for the first time (no previous treatment history) Having a minimum of four asymptomatic decayed primary molars requiring pulpotomy and SSC Requiring a minimum of three consecutive treatment sessions to treat all decayed teeth 5 years 7 years Both Children with a history of unfavorable medical or dental conditions Tooth pain, except for food impaction Systemic illness or medication intake Any known allergies or contraindications to anesthesia drugs Non-cooperative children (Frankl 1) Deciduous teeth without succedaneous tooth buds Treatment - Surgery Treatment - Surgery Intervention side: Prior to injection, local gel will be used at the injection site. A volume of 1.8 milliliters of 2% lidocaine with 1/80000 epinephrine solution at room temperature will be slowly administered using a regular syringe (1 milliliter per minute, only one cartridge). For anesthesia of the upper and lower jaw, participants will receive infiltration and inferior alveolar nerve block sequentially using a 21-gauge needle with a 27-gauge and 35-gauge needle with a 27-gauge respectively. Intrapapillary anesthesia will be performed for complete anesthesia. After 15 minutes have elapsed since the administration of anesthesia, treatment will begin. All dental procedures will be performed using rubber dam isolation. After performing pulp treatment, the adjacent tooth will be restored using light-cured glass ionomer cement for crown restoration. Then, SSCs will be adjusted and cemented using glass ionomer cement Control side: Intervention Group 1: Before injection, local gel will be used at the injection site. A volume of 1.8 milliliters of 2% lidocaine with 1/80000 epinephrine solution at room temperature will be slowly administered using a regular syringe (1 milliliter per minute, only one cartridge). For anesthesia of the upper and lower jaw, participants will receive infiltration and inferior alveolar nerve block sequentially using a 21-gauge needle with a 27-gauge and 35-gauge needle with a 27-gauge respectively. Intrapapillary anesthesia will be performed for complete anesthesia. After 15 minutes have elapsed since the administration of anesthesia, treatment will begin. All dental procedures will be performed using rubber dam isolation. After performing pulp treatment, a primary molar tooth will be restored using light-cured glass ionomer cement for crown restoration. Then, SSCs will be adjusted and cemented using glass ionomer cement Average systolic blood pressure. blood pressure, average diastolic blood pressure. Timepoint: in three separate times (time of completion of anesthesia administration, in the middle of the treatment and in the final moments of the treatment). Method of measurement: "Systolic blood pressure" using "digital instrument with wrist cuff Diastolic blood pressure" using ""digital instrument with wrist cuff. Average heart rate. Timepoint: In three separate times (time of completion of anesthesia administration, in the middle of the treatment and in the final moments of the treatment). Method of measurement: "heart rate" using "digital instrument with wrist cuff. Average oxygen saturation. Timepoint: In three separate times (time of completion of anesthesia administration, in the middle of the treatment and in the final moments of the treatment). Method of measurement: "oxygen saturation" using "pulse oximeter". Duration of treatment. Timepoint: The duration of the treatment is at the end of the treatment. Method of measurement: Treatment duration using cornometer. The average number of consumed painkillers. Timepoint: The dose numbers of analgesic by asking the parents in the days after the treatment. Method of measurement: The dose numbers of analgesic by asking the parents in the days after the treatment. The average behavior score. Timepoint: Average discomfort upon completion of treatment. Method of measurement: Frankle behavior rating scale. The average discomfort level. Timepoint: Average discomfort upon completion of treatment. Method of measurement: Facial image score. The average post-treatment pain. Timepoint: Average post-treatment pain as soon as the treatment is completed. Method of measurement: Wong baker faces pain. The average parental satisfaction                                                                 . Timepoint: Parental consent upon completion of treatment. Method of measurement: parental satisfaction based on a five-point response. Next appointment refusal. Timepoint: apposition to meeting at the beginning of the second and third session. Method of measurement: refusal for the second and third session appointments based on the child's report. Zahedan University of Medical Sciences Approved 2023-12-27 Ethics committee of Zahedan University of Medical Sciences Zahedan, Persian Gulf Blvd., College, resistance Research and Technology Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)