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IRCT20250204064640N1 IRCT 2025-04-26 Islamic Azad University Investigating the effect of dexamethasone by gelfoam carrier in preventing dry socket syndrome Investigating the effect of dexamethasone by gelfoam carrier in preventing dry socket syndrome following surgical extraction of the impacted third molar of the mandible 2025-04-09 anticipated 72 Complete https://irct.ir/trial/81740 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. Blocking is usually used in order to Creating a balance in the number of samples assigned to each of the groups be used for study. This feature helps researchers to Cases that require intermediate analyzes during the sampling process be the number of samples assigned to each of the case groups The study is equal. 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 is unaware of the type of intervention, and the study is conducted in a single-blind manner. 3 Dry socket. Intervention 1: Intervention group: All patients undergo mandibular wisdom tooth extraction by the same surgeon. The type of incision in all procedures is the same: a buccal flap with distobuccal release, along with a sulcular incision to the mesial of the seventh tooth. After anesthesia, incision, and flap removal, a portion of the bone covering the tooth will be removed with a surgical bur. After sectioning the tooth and removing it, the area on the intervention side is rinsed, and the cavity is filled with dexamethasone-impregnated gel foam. Then, it is sutured using 3/0 chromic thread and a 26mm needle, and then a sterile gauze is placed in the area for half an hour. For better control and elimination of the effect of the infectious agent, all patients will be prescribed Amoxicillin 250 mg capsules every 8 hours and Gelofen 500 mg tablets every 6 hours to control possible pain. The patient is asked to do the following in the first 24 to 48 hours: 1- Consume cold foods and liquids such as cold milk, cold soup, cold fruit juice, ice cream, etc. 2- Do not consume hot or chewy foods. 3- Avoid brushing the area where the tooth was extracted. 4- Avoid smoking and do not spit (spit) your saliva. 5- Avoid irritating the area where the tooth was extracted with your hands or tongue. 6- Avoid heavy exercise and physical work and prioritize rest. One day after surgery, normal saline solution should be used as a mouthwash at least five times daily for one week. One day, three days, and seven days after the extraction of the impacted third molar, the patient is contacted for clinical assessment of dry socket or absence of dry socket. Intervention 2: Control group: All patients undergo mandibular wisdom tooth extraction by the same surgeon. The type of incision in all procedures is the same, a buccal flap with distobuccal releasing, along with a sulcular incision to the mesial of the seventh tooth. After anesthesia, incision, and flap removal, a portion of the bone covering the tooth will be removed with a surgical bur. After sectioning the tooth and removing it, the area on the intervention side is rinsed. Then, it is sutured using 3/0 chromic thread and a 26mm needle, and then a sterile gauze is placed in the area for half an hour. For better control and elimination of the effect of the infectious agent, all patients will be prescribed Amoxicillin 250 mg capsules every 8 hours and Gelofen 500 mg tablets every 6 hours to control possible pain. The patient is asked to do the following in the first 24 to 48 hours: 1- Consume cold foods and liquids such as cold milk, cold soup, cold fruit juice, ice cream, etc. 2- Do not consume hot or chewy foods. 3- Avoid brushing the area where the tooth was extracted. 4- Avoid smoking and do not spit (spit) your saliva. 5- Avoid irritating the area where the tooth was extracted with your hands or tongue. 6- Avoid heavy exercise and physical work and prioritize rest. One day after surgery, normal saline solution should be used as a mouthwash at least five times daily for one week. One day, three days, and seven days after the extraction of the impacted third molar, the patient is contacted for clinical assessment of dry socket or absence of dry socket. 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 no further information.
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 impacted third molars of the mandible bilaterally placed in class I, II and III, level A, B and C based on the classification of Paul and Gary Gouri need to remove the tooth surgically 18 years 35 years Both Uncontrolled systemic conditions M27 Other diseases of jaws Prevention Prevention Intervention group: All patients undergo mandibular wisdom tooth extraction by the same surgeon. The type of incision in all procedures is the same: a buccal flap with distobuccal release, along with a sulcular incision to the mesial of the seventh tooth. After anesthesia, incision, and flap removal, a portion of the bone covering the tooth will be removed with a surgical bur. After sectioning the tooth and removing it, the area on the intervention side is rinsed, and the cavity is filled with dexamethasone-impregnated gel foam. Then, it is sutured using 3/0 chromic thread and a 26mm needle, and then a sterile gauze is placed in the area for half an hour. For better control and elimination of the effect of the infectious agent, all patients will be prescribed Amoxicillin 250 mg capsules every 8 hours and Gelofen 500 mg tablets every 6 hours to control possible pain. The patient is asked to do the following in the first 24 to 48 hours: 1- Consume cold foods and liquids such as cold milk, cold soup, cold fruit juice, ice cream, etc. 2- Do not consume hot or chewy foods. 3- Avoid brushing the area where the tooth was extracted. 4- Avoid smoking and do not spit (spit) your saliva. 5- Avoid irritating the area where the tooth was extracted with your hands or tongue. 6- Avoid heavy exercise and physical work and prioritize rest. One day after surgery, normal saline solution should be used as a mouthwash at least five times daily for one week. One day, three days, and seven days after the extraction of the impacted third molar, the patient is contacted for clinical assessment of dry socket or absence of dry socket. Control group: All patients undergo mandibular wisdom tooth extraction by the same surgeon. The type of incision in all procedures is the same, a buccal flap with distobuccal releasing, along with a sulcular incision to the mesial of the seventh tooth. After anesthesia, incision, and flap removal, a portion of the bone covering the tooth will be removed with a surgical bur. After sectioning the tooth and removing it, the area on the intervention side is rinsed. Then, it is sutured using 3/0 chromic thread and a 26mm needle, and then a sterile gauze is placed in the area for half an hour. For better control and elimination of the effect of the infectious agent, all patients will be prescribed Amoxicillin 250 mg capsules every 8 hours and Gelofen 500 mg tablets every 6 hours to control possible pain. The patient is asked to do the following in the first 24 to 48 hours: 1- Consume cold foods and liquids such as cold milk, cold soup, cold fruit juice, ice cream, etc. 2- Do not consume hot or chewy foods. 3- Avoid brushing the area where the tooth was extracted. 4- Avoid smoking and do not spit (spit) your saliva. 5- Avoid irritating the area where the tooth was extracted with your hands or tongue. 6- Avoid heavy exercise and physical work and prioritize rest. One day after surgery, normal saline solution should be used as a mouthwash at least five times daily for one week. One day, three days, and seven days after the extraction of the impacted third molar, the patient is contacted for clinical assessment of dry socket or absence of dry socket. The occurrence or absence of dry socket syndrome. Timepoint: 1, 3 and 7 days after surgery on both the intervention and control sides. Method of measurement: Evaluation through clinical observation by an oral and maxillofacial surgeon. Islamic Azad University Approved 2024-10-14 Ethics committee of Dentistry Faculty - Islamic Azad University of Medical Sciences No. 9, Pasdaran St., Nistan 9th Tehran Tehran Iran (Islamic Republic of)