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IRCT20130710013938N5 IRCT 2021-08-10 Tabriz University of Medical Sciences The effect of using a new material (porous gelfum) on the tooth cavity when extracting impacted wisdom teeth Incidence of the dry socket with and without the use of porous gelfum containing curcumin following extraction of impacted wisdom teeth 2021-07-02 anticipated 38 Complete https://irct.ir/trial/57831 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Thirty-eight patients who refer to the Department of Surgery of the School of Dentistry for their wisdom tooth surgery agree to carry out this research project and complete informed consent and form our study community. Patients are randomly selected and in each patient, the selection of one side tooth as control or test will be by simple randomization using coins in the form of taps/lines. Each patient who enters the study will be assigned a code from 1 to 38. N/A Impacted wisdom tooth. Intervention 1: Control group: All patients were randomly selected and after completing the questionnaire, they were approved by at least two professors of the surgical department. Before the operation, chlorhexidine mouthwash was prescribed and gelofen was administered to them. Extraction of both teeth will be performed by a surgeon under the same conditions. To anesthetize patients, 3 carpol lidocaine containing epinephrine 1 in 80,000 was used and performed with lower alveolar block and long buccal technique. In patients in this group, teeth are extracted normally. To unify the patients, if the time difference between the two operations (from the beginning of the operation to the moment of the last suture) is more than 10 minutes, the patient will be excluded from the study. Silent examination (pain, unpleasant odor and lack of proper clot formation in the extracted tooth cavity) are examined; Patients are given questionnaires that indicate their pain on the first, second and ... days until the 7th day in the form of numbers from 1 to 10. Clinical examination of the patient and completion of information forms are used to collect information and VAS method is used to assess pain. Intervention 2: Intervention group: All patients were randomly selected and after completing the questionnaire, they were approved by at least two professors of the surgical department. Before the operation, chlorhexidine mouthwash was prescribed and gelofen was administered to them. Extraction of both teeth will be performed by a surgeon under the same conditions. To anesthetize patients, 3 carpol lidocaine containing epinephrine 1 in 80,000 was used and performed with lower alveolar block and long buccal technique. After tooth extraction, an antimicrobial porous gelatin gel (containing curcumin nanoparticles) is placed inside the cavity. The prepared gelfomes were cut into 1: 1 by 1 cm dimensions and sterilized by gamma rays. Zelfum has a spongy structure with pores of 200 nm and a loading percentage of 96% curcumin and a slow release pattern of curcumin. To unify the patients, if the time difference between the two operations (from the beginning of the operation to the moment of the last suture) is more than 10 minutes, the patient will be excluded from the study. Silent examination (pain, unpleasant odor and lack of proper clot formation in the extracted tooth cavity) are examined; Patients are given questionnaires that indicate their pain on the first, second and ... days until the 7th day in the form of numbers from 1 to 10. Clinical examination of the patient and completion of information forms are used to collect information and VAS method is used to assess pain. 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 Mohammadali Ghavimi
3rd floor, No 2 Central Building , Tabriz University of Medical Sciences, Golgasht St
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3335 5921 Ghavimim@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Mohammadali Ghavimi
3rd floor, No 2 Central Building , Tabriz University of Medical Sciences, Golgasht St
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3335 5921 Ghavimim@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Having two wisdom teeth with the similar mesioangular position in the mandible No addiction to drugs and smoking Lack of systemic and bone diseases Women are not pregnant Age 18 to 35 years 18 years 35 years Both Failure to refer the patient for extraction of the other side tooth and subsequent evaluations Smoking and drug use after and during the study Undergoing medical treatment taking medication Sensitivity to study therapies K01.1 Impacted teeth Treatment - Drugs Treatment - Drugs Control group: All patients were randomly selected and after completing the questionnaire, they were approved by at least two professors of the surgical department. Before the operation, chlorhexidine mouthwash was prescribed and gelofen was administered to them. Extraction of both teeth will be performed by a surgeon under the same conditions. To anesthetize patients, 3 carpol lidocaine containing epinephrine 1 in 80,000 was used and performed with lower alveolar block and long buccal technique. In patients in this group, teeth are extracted normally. To unify the patients, if the time difference between the two operations (from the beginning of the operation to the moment of the last suture) is more than 10 minutes, the patient will be excluded from the study. Silent examination (pain, unpleasant odor and lack of proper clot formation in the extracted tooth cavity) are examined; Patients are given questionnaires that indicate their pain on the first, second and ... days until the 7th day in the form of numbers from 1 to 10. Clinical examination of the patient and completion of information forms are used to collect information and VAS method is used to assess pain. Intervention group: All patients were randomly selected and after completing the questionnaire, they were approved by at least two professors of the surgical department. Before the operation, chlorhexidine mouthwash was prescribed and gelofen was administered to them. Extraction of both teeth will be performed by a surgeon under the same conditions. To anesthetize patients, 3 carpol lidocaine containing epinephrine 1 in 80,000 was used and performed with lower alveolar block and long buccal technique. After tooth extraction, an antimicrobial porous gelatin gel (containing curcumin nanoparticles) is placed inside the cavity. The prepared gelfomes were cut into 1: 1 by 1 cm dimensions and sterilized by gamma rays. Zelfum has a spongy structure with pores of 200 nm and a loading percentage of 96% curcumin and a slow release pattern of curcumin. To unify the patients, if the time difference between the two operations (from the beginning of the operation to the moment of the last suture) is more than 10 minutes, the patient will be excluded from the study. Silent examination (pain, unpleasant odor and lack of proper clot formation in the extracted tooth cavity) are examined; Patients are given questionnaires that indicate their pain on the first, second and ... days until the 7th day in the form of numbers from 1 to 10. Clinical examination of the patient and completion of information forms are used to collect information and VAS method is used to assess pain. Occurrence of silent drift (pain, unpleasant odor and lack of proper clot formation in the extracted tooth cavity). Timepoint: 3 days and 7 days later. Method of measurement: Patients are given questionnaires that indicate their pain on the first, second, and ... days until the 7th day in the form of numbers from 1 to 10. Clinical examination of the patient and completion of information forms are used to collect information and the Visual Analogue Scale method is used to assess pain. Tabriz University of Medical Sciences Approved 2021-02-22 Ethics committe of Tabriz University of Medical Sciences 3rd floor, No2 Centeral Building , Tabriz University of Medical Sciences, ,Golgasht street Tabriz East Azarbaijan Iran (Islamic Republic of)