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IRCT20240928063195N1 IRCT 2024-12-09 Mazandaran University of Medical Sciences Evaluation of the Effect of Mespilus germanica L. Fruit Extract on the Control of Alveolar Socket Bleeding after Mandibular Molars Extraction Evaluation of the Effect of Hydroalcoholic Extract of Mespilus germanica L. Fruit on the Control of Alveolar Socket Bleeding after Mandibular Molars Extraction 2025-04-03 anticipated 90 Complete https://irct.ir/trial/79724 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: People who met the entry criteria were placed in two treatment groups and one control group. sterile gauzes soaked with extract of 20 % and 40 % Mespilus germanica L. were used for treatment group and sterile gauzes soaked with normal saline were used for control group. random block method will be used to allocate samples to three groups. For this purpose, patients will receive the number 1 to 90 according to the selection order. The randomization unit will be individually and by number with blocks of three people. The selection of the group type for each person will be done through random allocation2 statistical software. In order to construct a random sequence, codes A, B and C will be generated from the software, where code A means applying the the first intervention group (20% extract) and code B means applying the second intervention group (40% extract) and Code C means applying the control group to each person. Finally, the codes will be placed in the sealed envelope and the number of each patient will be written on the envelope. As each patient enters, the doctor will open the envelope and apply the desired treatment, Blinding description: Due to the homogenization of the color of the normal saline solution and the extracts with each other, the evaluator, the patient and the statistical consultant are involved in blinding. 3 Control of Alveolar Socket Bleeding after Mandibular Molars Extraction. Intervention 1: The first intervention group: gauze impregnated with a 20% extract of Mespilus germanica L. : The tooth is extracted by simple extraction without flap removal, bone removal, and odontotomy. After cleaning the socket, sterile gauze soaked in 20% Mespilus germanica L. extract is given to the maxillofacial surgeon by the student and used for the first treatment group. After the gauze is placed in the patient's mouth, the dried gauze is moistened with normal saline and the patient is asked to press the gauze so that the opposing tooth or ridge touches the gauze and the light and acceptable contact is confirmed by the maxillofacial surgeon. At this stage, the patient is instructed to avoid any activity that may increase bleeding, such as opening the mouth, emptying saliva, or talking. In each group, gauze is removed from the patient's mouth every 5 minutes and bleeding or cessation is recorded. To prevent the formed clot from dislodging, gas removal is performed gently by an oral and maxillofacial surgeon. Intervention 2: The second intervention group: gauze impregnated with a 40% extract of Mespilus germanica L. : The tooth is extracted by simple extraction without flap removal, bone removal, and odontotomy. After cleaning the socket, sterile gauze soaked in 40% Mespilus germanica L. extract is given to the maxillofacial surgeon by the student and used for the first treatment group. After the gauze is placed in the patient's mouth, the dried gauze is moistened with normal saline and the patient is asked to press the gauze so that the opposing tooth or ridge touches the gauze and the light and acceptable contact is confirmed by the maxillofacial surgeon. At this stage, the patient is instructed to avoid any activity that may increase bleeding, such as opening the mouth, emptying saliva, or talking. In each group, gauze is removed from the patient's mouth every 5 minutes and bleeding or cessation is recorded. To prevent the formed clot from dislodging, gas removal is performed gently by an oral and maxillofacial surgeon. Intervention 3: Control group: gauze impregnated with normal saline. : The tooth is extracted by simple extraction without flap removal, bone removal, and odontotomy. After cleaning the socket, sterile gauze soaked in normal saline is given to the maxillofacial surgeon by the student and used for control group. After the gauze is placed in the patient's mouth, the dried gauze is moistened with normal saline and the patient is asked to press the gauze so that the opposing tooth or ridge touches the gauze and the light and acceptable contact is confirmed by the maxillofacial surgeon. At this stage, the patient is instructed to avoid any activity that may increase bleeding, such as opening the mouth, emptying saliva, or talking. In each group, gauze is removed from the patient's mouth every 5 minutes and bleeding or cessation is recorded. To prevent the formed clot from dislodging, gas removal is performed gently by an oral and maxillofacial surgeon. 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 "No more information"
public Mahsa Zare
No. 9, Haqiqat Alley, The Ninth Keshavarz, Keshavarz Blvd, Sari town, Mazandaran Province
Sari Iran (Islamic Republic of) 4813797981 +98 11 3323 7198 zaremahsa12@gmail.com Mazandaran University of Medical Sciences scientific Dr AmirHossein Moaddabi
ghu Building, Gharan Street , Sari Town
Sari Iran (Islamic Republic of) 4816895475 +98 11 3325 4135 a.moaddabi2@gmail.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Mandibular Molars Extraction Age ≥ 18 years Insensitivity to Mespilus germanica L. Fruit extract Not using complementary medical methods (herbal drugs, etc.) in the last month Not having a clotting disorder Absence of acute or uncontrolled infection at the surgical site Patients with ASA I and II and absence of any uncontrolled medical problem Not using contraceptives in the last month Not using any medication that interferes with bone repair and blood coagulation No smoking and hookah Amenorrhea during surgery 18 years no limit Both Patients with a large periapical lesion Patients with complications during surgery such as flap rupture Patients with moderate and severe periodontal disease Prevention Prevention Other The first intervention group: gauze impregnated with a 20% extract of Mespilus germanica L. : The tooth is extracted by simple extraction without flap removal, bone removal, and odontotomy. After cleaning the socket, sterile gauze soaked in 20% Mespilus germanica L. extract is given to the maxillofacial surgeon by the student and used for the first treatment group. After the gauze is placed in the patient's mouth, the dried gauze is moistened with normal saline and the patient is asked to press the gauze so that the opposing tooth or ridge touches the gauze and the light and acceptable contact is confirmed by the maxillofacial surgeon. At this stage, the patient is instructed to avoid any activity that may increase bleeding, such as opening the mouth, emptying saliva, or talking. In each group, gauze is removed from the patient's mouth every 5 minutes and bleeding or cessation is recorded. To prevent the formed clot from dislodging, gas removal is performed gently by an oral and maxillofacial surgeon. The second intervention group: gauze impregnated with a 40% extract of Mespilus germanica L. : The tooth is extracted by simple extraction without flap removal, bone removal, and odontotomy. After cleaning the socket, sterile gauze soaked in 40% Mespilus germanica L. extract is given to the maxillofacial surgeon by the student and used for the first treatment group. After the gauze is placed in the patient's mouth, the dried gauze is moistened with normal saline and the patient is asked to press the gauze so that the opposing tooth or ridge touches the gauze and the light and acceptable contact is confirmed by the maxillofacial surgeon. At this stage, the patient is instructed to avoid any activity that may increase bleeding, such as opening the mouth, emptying saliva, or talking. In each group, gauze is removed from the patient's mouth every 5 minutes and bleeding or cessation is recorded. To prevent the formed clot from dislodging, gas removal is performed gently by an oral and maxillofacial surgeon. Control group: gauze impregnated with normal saline. : The tooth is extracted by simple extraction without flap removal, bone removal, and odontotomy. After cleaning the socket, sterile gauze soaked in normal saline is given to the maxillofacial surgeon by the student and used for control group. After the gauze is placed in the patient's mouth, the dried gauze is moistened with normal saline and the patient is asked to press the gauze so that the opposing tooth or ridge touches the gauze and the light and acceptable contact is confirmed by the maxillofacial surgeon. At this stage, the patient is instructed to avoid any activity that may increase bleeding, such as opening the mouth, emptying saliva, or talking. In each group, gauze is removed from the patient's mouth every 5 minutes and bleeding or cessation is recorded. To prevent the formed clot from dislodging, gas removal is performed gently by an oral and maxillofacial surgeon. Percentage of people who have faster bleeding control with gauze impregnated with Mespilus germanica L. extract. Timepoint: Measuring the clot formation time every 5 minutes after starting to place the gauze on the socket of the extracted tooth. Method of measurement: Every 5 minutes, the formation or non-formation of a clot in the socket of the extracted tooth is confirmed by the maxillofacial surgeon. Mazandaran University of Medical Sciences Approved 2024-07-09 Ethics committee of Mazandaran University of Medical Sciences No.9, 9th Keshavarz Alley, Keshavarz Blvd, Sari Town Sari Mazandaran Iran (Islamic Republic of)