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IRCT20240607062028N1 IRCT 2024-08-28 Mashhad University of Medical Sciences Evaluating the effect of NeoPUTTY as an apical plug used in 6th tooth of lower jaw in postoperative pain Evaluating the effect of NeoPUTTY as an apical plug used in mandibular first molar in postoperative pain and flare up; a randomized clinical trial 2024-11-05 anticipated 30 Complete https://irct.ir/trial/77393 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are entered into the study according to the inclusion criteria and are randomly assigned to one of the two study groups using double blocks and tap/line (coin toss). In order to ensure an equal number of intervention and control group samples in each of the mesial and distal root subgroups, first, the sample in odd sequences is assigned to the intervention or control group in the form of tap/line, and in even sequences as The reverse is done with the odd sequence of allocation. If there is a need to put a plug in both roots of the first molar of the mandible, first one of the roots is selected as a tap/line and the other root will be in the same group as the first root, Blinding description: In this study, the participants, the evaluators for the follow-up of the patient's pain, and the statistical data analysts will not know about the study groups. Only the operator who performs the treatment process of the patients will be aware of the participants' grouping after the allocation and immediately before the treatment. As for the patients blinding, the preparation of the substance will be done away from the patient's sight. N/A Flare-up and pain. Intervention 1: Intervention group: NeoPUTTY (Avalon Biomed Inc., Bradenton, USA). A bioceramic, bioactive MTA is premixed in a syringe. This material is placed at the apical end of the roots as a plug by MAP One (Produits Dentaires S. A., Vevey, Switzerland). Using a suitable plugger, it will be compacted in the form of a plug to reach a thickness of 3-5 mm at the apical end of the root canal. After the MTA has solidified, the excess MTA on the canal wall is gently wiped off with wet cotton. According to the manufacturer's brochure, the setting time of this material is 4 hours. Therefore, a wet paper point will be placed on it and the canal is temporarily dressed with Cavit (3M ESPE, Seefeld, Germany). At the end of this session, a periapical radiograph is prepared to ensure the thickness of the placed plug. The next session, after 24 hours, if there is no pain and symptoms, under local anesthesia and rubber dam isolation, temporary dressing and wet cotton balls are removed. . The MTA setting is slowly checked with a #40k file. Obturation of the canal will be done by the hot vertical compression technique with AH 26 sealer, and the patient's root canal treatment will be completed. In total, 2 treatment sessions will take about 90 minutes each. Intervention 2: Control group: OrthoMTA (BioMTA, Seoul, Korea). An MTA is a powder that needs to be mixed with normal saline to achieve a sandy/creamy consistency. This material is placed at the apical end of the roots as a plug by MAP One (Produits Dentaires S. A., Vevey, Switzerland). Using a suitable plugger, it will be compacted in the form of a plug to reach a thickness of 3-5 mm at the apical end of the root canal. After the MTA has solidified, the excess MTA on the canal wall is gently wiped off with wet paper point. According to the manufacturer's brochure, the setting time of this material is 3 hours. Therefore, a wet paper point will be placed on it and the canal is temporarily dressed with Cavit (3M ESPE, Seefeld, Germany). A periapical radiograph is prepared at the end of this session to ensure the thickness of the plug. In the next session, after 24 hours, if there is no pain and symptoms, under local anesthesia and isolation of Ruberdem, the temporary dressing and wet cotton balls are removed. The MTA setting is slowly checked with a #40k file. Obturation of the canal will be done by the hot vertical compression technique with AH 26 sealer, and the patient's root canal treatment will be completed. In total, 2 treatment sessions will take about 90 minutes each. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more info is available
public Maryam Khorasanchi
No43, South Khayyam1, Khayyam Blv.
Mashhad Iran (Islamic Republic of) 9185714715 +98 915 119 9667 khorasanchim4011@mums.ac.ir Mashhad University of Medical Sciences scientific Maryam Gharechahi
Endodontics Department, Mashhad School of Dentistry, University Campus, Azadi Square
Mashhad Iran (Islamic Republic of) 9177948959 +98 51 3882 9501 gharechahim@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients in the age range of 6 to 15 years Necrotic immature mandibular first molar with open apex (size 60 to 100) A tooth with chronic apical periodontitis with the presence of a radiolucency greater than 3 mm2 in periapical radiography Tooth without sinus tract, no drainage from the canal, no swelling and no acute apical periodontitis Patients should not have pain in the area of ​​the target tooth before starting the root canal treatment Patients should have not received any medical treatment before starting the root canal treatment Teeth without root deviation, root resorption or calcification Tooth without previous root canal treatment or crown Teeth without any root fracture or craze lines 6 years 15 years Both Necrotic immature mandibular first molar with open apex (larger than size 100) Teeth with root fracture, craze lines, root deviation, resorption or calcifications lack of child cooperation Teeth with compromised periodontal structure, severe mobility Teeth with previous root canal treatment, post or crown Teeth with open apex and severe destruction that are unrestorable Patient unwillingness to participate Major systemic disease (ASA 3 or higher) The patient's severe pain that led to the use of analgesic K04.5 Chronic apical periodontitis Treatment - Other Treatment - Other Intervention group: NeoPUTTY (Avalon Biomed Inc., Bradenton, USA). A bioceramic, bioactive MTA is premixed in a syringe. This material is placed at the apical end of the roots as a plug by MAP One (Produits Dentaires S. A., Vevey, Switzerland). Using a suitable plugger, it will be compacted in the form of a plug to reach a thickness of 3-5 mm at the apical end of the root canal. After the MTA has solidified, the excess MTA on the canal wall is gently wiped off with wet cotton. According to the manufacturer's brochure, the setting time of this material is 4 hours. Therefore, a wet paper point will be placed on it and the canal is temporarily dressed with Cavit (3M ESPE, Seefeld, Germany). At the end of this session, a periapical radiograph is prepared to ensure the thickness of the placed plug. The next session, after 24 hours, if there is no pain and symptoms, under local anesthesia and rubber dam isolation, temporary dressing and wet cotton balls are removed. . The MTA setting is slowly checked with a #40k file. Obturation of the canal will be done by the hot vertical compression technique with AH 26 sealer, and the patient's root canal treatment will be completed. In total, 2 treatment sessions will take about 90 minutes each. Control group: OrthoMTA (BioMTA, Seoul, Korea). An MTA is a powder that needs to be mixed with normal saline to achieve a sandy/creamy consistency. This material is placed at the apical end of the roots as a plug by MAP One (Produits Dentaires S. A., Vevey, Switzerland). Using a suitable plugger, it will be compacted in the form of a plug to reach a thickness of 3-5 mm at the apical end of the root canal. After the MTA has solidified, the excess MTA on the canal wall is gently wiped off with wet paper point. According to the manufacturer's brochure, the setting time of this material is 3 hours. Therefore, a wet paper point will be placed on it and the canal is temporarily dressed with Cavit (3M ESPE, Seefeld, Germany). A periapical radiograph is prepared at the end of this session to ensure the thickness of the plug. In the next session, after 24 hours, if there is no pain and symptoms, under local anesthesia and isolation of Ruberdem, the temporary dressing and wet cotton balls are removed. The MTA setting is slowly checked with a #40k file. Obturation of the canal will be done by the hot vertical compression technique with AH 26 sealer, and the patient's root canal treatment will be completed. In total, 2 treatment sessions will take about 90 minutes each Flare-up and pain. Timepoint: 3, 6, 12, 24, 48 and 72 hours postoperative. Method of measurement: Visual Analogue Scale. Mashhad University of Medical Sciences Approved 2024-03-09 School of Dentistry - Mashhad University of Medical Sciences (Ethics Committee) Azadi square Mashhad Razavi Khorasan Iran (Islamic Republic of)