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IRCT20230603058370N1 IRCT 2023-06-20 Islamic Azad University Investigating the effect of tranexamic acid in preventing dry socket syndrome Investigating the effect of tranexamic acid in preventing dry socket syndrome following surgical extraction of the impacted third molar of the mandible 2023-06-20 anticipated 72 Complete https://irct.ir/trial/70497 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, we used the restricted randomization method randomization (block randomization type) We will use randomization. . The size of all the blocks is equal and we are in this Single-group trial of 4 blocks (including 4 participants in We will have an intervention group and a control). The randomization tool is also from sequence generation software Random (random software allocation) is used that this Random sequence generation software is capable of simple randomization They are used to generate random sequences using the block method. To hide We use Concealment Allocation We use the method used to execute the sequence Randomization is applied to the participants in the study, in a way Before assigning the individual, the assigned group is not clear. With from sealed opaque envelopes with random sequence (envelopes opaque, sealed, numbered Sequentially (which in In this method, each random sequence is created on a card It is registered and the cards are placed in the envelopes in order become In order to preserve the random sequence on the outer surface of the envelope Numbering is done in the same order. Finally, the envelope door The letters are glued and placed in a box in order. At The time of starting the registration of participants, based on the order of entry of the company Eligible candidates to study, one of the letter envelopes in open order and the assigned group of that participant is revealed, Blinding description: The evaluator does not know the type of intervention and the study is conducted in a single blind manner. 3 Dry socket. Intervention 1: All patients undergo wisdom tooth extraction surgery by one person. The type of cut in all operations is similar and buccal flap type with distobuccal releasing, along with sulcular cut to the mesial of tooth seven. After giving anesthesia, making a cut, and setting aside the flap, some of the bone covering the tooth will be removed with a surgical burr, and after sectioning the tooth and removing it, on the side of the intervention area, wash the cavity with tranexamic acid 250 mg capsule powder. Iran Daro is filled, then it is stitched using 0.3 chromic thread and 26 mm needle.And then a sterile gauze is placed in the area for half an hour. For better control and elimination of the effect of infection, amoxicillin 250 mg capsules will be prescribed every 8 hours for all patients, and Gelofen 500 mg tablets will be prescribed every 6 hours for possible pain control. The patient is asked to do the following in the first 24 to 48 hours: 1- Use cold and liquid food such as: cold milk, cold soup, cold fruit juice, ice cream, etc. 2- Do not eat hot or chewy food in any way. 3- Avoid brushing the area of ​​the extracted tooth. 4- Avoid smoking and do not spit out your saliva in any way. 5- Avoid stimulating the area of ​​the extracted tooth with hand or tongue. 6- Avoid heavy sports and physical work and give priority to rest. • After one day of surgery, normal saline solution at least five times a day for one It should be used as a mouthwash for a week. Two or three days after the extraction of the impacted third molar tooth, the visit time for the clinical examination of the dry cavity or the absence of a dry cavity is determined for the patient, and the examination is performed by another maxillofacial surgeon and the symptoms of the posterior cavity Clinical examination will be recorded. Intervention 2: Control group: On the control side, all the patients were subjected to surgery to remove the mandibular wisdom teeth by one person. The type of cut in all operations is similar and buccal flap type with distobuccal releasing, along with sulcular cut to the mesial of tooth seven. After giving anesthesia, making the incision, and setting aside the flap, some of the bone covering the tooth will be removed with a surgical burr, and after sectioning the tooth and removing it, on the control side of the washing area and the cavity without using any local coagulant with Using a 0.3 chromic thread and a 26 mm needle, stitches are made, and then a sterile gauze is placed in the area for half an hour. For better control and elimination of the effect of infection, amoxicillin 250 mg capsules will be prescribed every 8 hours for all patients, and Gelofen 500 mg tablets will be prescribed every 6 hours for possible pain control. The patient is asked to do the following in the first 24 to 48 hours: 1- Use cold and liquid food such as: cold milk, cold soup, cold fruit juice, ice cream, etc. 2- Do not eat hot or chewy food in any way. 3- Avoid brushing the area of ​​the extracted tooth. 4- Avoid smoking and do not spit out your saliva in any way. 5- Avoid stimulating the area of ​​the extracted tooth with hand or tongue. 6- Avoid heavy sports and physical work and give priority to rest. • After one day of surgery, normal saline solution at least five times a day for one It should be used as a mouthwash for a week. Two or three days after the extraction of the impacted third molar tooth, the visit time for the clinical examination of the dry cavity or the absence of a dry cavity is determined for the patient, and the examination is performed by another maxillofacial surgeon and the symptoms of the posterior cavity Clinical examination will be recorded. 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 It should be further investigated
public Hassan Mesgari
No. 9, Pasdaran St., Nistan 9th
Tehran Iran (Islamic Republic of) 1946853314 +98 21 2256 4571 kmesgari@gmail.com Islamic Azad University scientific Hassan Mesgari
No. 9, Pasdaran St., Nistan 9th
Tehran Iran (Islamic Republic of) 1946853314 +98 21 2256 4571 kmesgari@gmail.com Islamic Azad University Iran (Islamic Republic of) Age between 18 and 35 years the third molar teeth of the mandible are embedded bilateral and placed in class I, II, III, level A, B, and C based on the classification of Paul and Gray Gori require surgical tooth extraction. 18 years 35 years Both Users of exogenous corticosteroids the presence of systemic disorders respiratory and digestive diseases pregnant women and lactating mothers systemic fungal infections acute infections and active or silent tuberculosis M27 Other diseases of jaws Prevention Prevention All patients undergo wisdom tooth extraction surgery by one person. The type of cut in all operations is similar and buccal flap type with distobuccal releasing, along with sulcular cut to the mesial of tooth seven. After giving anesthesia, making a cut, and setting aside the flap, some of the bone covering the tooth will be removed with a surgical burr, and after sectioning the tooth and removing it, on the side of the intervention area, wash the cavity with tranexamic acid 250 mg capsule powder. Iran Daro is filled, then it is stitched using 0.3 chromic thread and 26 mm needle.And then a sterile gauze is placed in the area for half an hour. For better control and elimination of the effect of infection, amoxicillin 250 mg capsules will be prescribed every 8 hours for all patients, and Gelofen 500 mg tablets will be prescribed every 6 hours for possible pain control. The patient is asked to do the following in the first 24 to 48 hours: 1- Use cold and liquid food such as: cold milk, cold soup, cold fruit juice, ice cream, etc. 2- Do not eat hot or chewy food in any way. 3- Avoid brushing the area of ​​the extracted tooth. 4- Avoid smoking and do not spit out your saliva in any way. 5- Avoid stimulating the area of ​​the extracted tooth with hand or tongue. 6- Avoid heavy sports and physical work and give priority to rest. • After one day of surgery, normal saline solution at least five times a day for one It should be used as a mouthwash for a week. Two or three days after the extraction of the impacted third molar tooth, the visit time for the clinical examination of the dry cavity or the absence of a dry cavity is determined for the patient, and the examination is performed by another maxillofacial surgeon and the symptoms of the posterior cavity Clinical examination will be recorded Control group: On the control side, all the patients were subjected to surgery to remove the mandibular wisdom teeth by one person. The type of cut in all operations is similar and buccal flap type with distobuccal releasing, along with sulcular cut to the mesial of tooth seven. After giving anesthesia, making the incision, and setting aside the flap, some of the bone covering the tooth will be removed with a surgical burr, and after sectioning the tooth and removing it, on the control side of the washing area and the cavity without using any local coagulant with Using a 0.3 chromic thread and a 26 mm needle, stitches are made, and then a sterile gauze is placed in the area for half an hour. For better control and elimination of the effect of infection, amoxicillin 250 mg capsules will be prescribed every 8 hours for all patients, and Gelofen 500 mg tablets will be prescribed every 6 hours for possible pain control. The patient is asked to do the following in the first 24 to 48 hours: 1- Use cold and liquid food such as: cold milk, cold soup, cold fruit juice, ice cream, etc. 2- Do not eat hot or chewy food in any way. 3- Avoid brushing the area of ​​the extracted tooth. 4- Avoid smoking and do not spit out your saliva in any way. 5- Avoid stimulating the area of ​​the extracted tooth with hand or tongue. 6- Avoid heavy sports and physical work and give priority to rest. • After one day of surgery, normal saline solution at least five times a day for one It should be used as a mouthwash for a week. Two or three days after the extraction of the impacted third molar tooth, the visit time for the clinical examination of the dry cavity or the absence of a dry cavity is determined for the patient, and the examination is performed by another maxillofacial surgeon and the symptoms of the posterior cavity Clinical examination will be recorded Occurrence or absence of dry socket syndrome. Timepoint: Two or three days after surgery on both intervention and control sides. Method of measurement: Evaluation through clinical observation by maxillofacial surgeon. Islamic Azad University Approved 2022-12-05 Ethics committee of Dentistry Faculty - Islamic Azad University of Medical Sciences, Tehran No. 9, Pasdaran St., Nistan 9th Tehran Tehran Iran (Islamic Republic of)