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IRCT20250204064639N1 IRCT 2025-06-04 Islamic Azad University Investigating the effect of Eugenol by gelfoam carrier in preventing dry socket syndrome Investigating the effect of Eugenol by gelfoam carrier in preventing dry socket syndrome following surgical extraction of the impacted third molar of the mandible 2025-04-16 anticipated 72 Complete https://irct.ir/trial/82897 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The randomization method in this study is block randomization with a fixed block size of 2. This study is designed as a split-mouth trial, meaning that in each participant, one side of the mouth (right or left) will be randomly assigned to the intervention group (application of Eugenol with Gel Foam), and the opposite side will be assigned to the control group (no pharmaceutical intervention). For the random allocation of the intervention side, Random Allocation Software version 1.0 (RAS, ©M. Saghaei, 2004, Isfahan University of Medical Sciences) will be used. The random sequence will be prepared before the start of the study, placed in opaque, sealed, and sequentially numbered envelopes, and used in order of participant enrollment to ensure allocation concealment, Blinding description: The evaluator is unaware of the type of intervention performed, and the study is conducted as a single-blind trial. 3 Dry socket. Intervention 1: Intervention group: All patients underwent mandibular wisdom tooth extraction by the same surgeon. The type of incision in all procedures was 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 and the socket will be filled with one piece of Hemospan gel foam soaked with one drop of eugenol (manufactured by Golchai Company). 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 surgical extraction of the lower third molar by the same surgeon. The type of incision is the same in all procedures: a buccal flap with a distobuccal releasing incision, along with a sulcular incision extending to the mesial of the second molar. After administering anesthesia, making the incision, and reflecting the flap, a surgical bur is used to remove part of the bone covering the tooth. After sectioning and removing the tooth, the control site is irrigated and sutured using 3/0 chromic gut suture with a 26 mm needle. A sterile gauze is then placed at the site for 30 minutes. To better control and eliminate the effect of infection, all patients are prescribed amoxicillin 250 mg capsules every 8 hours and ibuprofen 500 mg tablets every 6 hours for pain control. Patients are instructed to follow postoperative care guidelines during the first 24 to 48 hours. 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 underwent mandibular wisdom tooth extraction by the same surgeon. The type of incision in all procedures was 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 and the socket will be filled with one piece of Hemospan gel foam soaked with one drop of eugenol (manufactured by Golchai Company). 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 surgical extraction of the lower third molar by the same surgeon. The type of incision is the same in all procedures: a buccal flap with a distobuccal releasing incision, along with a sulcular incision extending to the mesial of the second molar. After administering anesthesia, making the incision, and reflecting the flap, a surgical bur is used to remove part of the bone covering the tooth. After sectioning and removing the tooth, the control site is irrigated and sutured using 3/0 chromic gut suture with a 26 mm needle. A sterile gauze is then placed at the site for 30 minutes. To better control and eliminate the effect of infection, all patients are prescribed amoxicillin 250 mg capsules every 8 hours and ibuprofen 500 mg tablets every 6 hours for pain control. Patients are instructed to follow postoperative care guidelines during the first 24 to 48 hours. Dry socket syndrome Incidence. Timepoint: 1,3 And 7 days after the intervention 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)