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IRCT20221127056634N1 IRCT 2023-01-23 Esfahan University of Medical Sciences Evaluation of the effect of royal jelly on post extraction socket healing Evaluation of the effect of royal jelly on post extraction socket healing ; A randomized triple blind clinical trial 2023-02-04 anticipated 52 Complete https://irct.ir/trial/67095 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, in order to balance the number of patients assigned to each of the two study groups, the permuted block randomization method is used. Also In order not to reveal the last allocation in each block, the size of the blocks is chosen randomly. For this purpose, random blocks with sizes of 4, 6, or 8 are used. This information is given to the random allocation software and the classification of patients is determined. Since all the patients of this study are not selected at the same time and also in order to observe the blinding process as much as possible, before starting the study, 52 empty files are numbered from 1 to 52 and one file is randomly selected for each patient. Based on the patient's file number and its match with the output of the random allocation software, the patient's group is determined. In order to blindness, the patients will not know about the group in which they are placed, Blinding description: In order to blindness, the patients will not know about the group (intervention or control) in which they are placed. After tooth extraction by first dentist, the variables are evaluated by second dentist (who has no knowledge of the patient's study group for the purpose of blindness). The statistician who analyzes the results will not know about the patient's study groups. 3 Post extraction socket healing. Intervention 1: Intervention group: In this group, after tooth extraction and washing the tooth socket with injectable sterile normal saline, pure royal jelly powder (prepared from the pharmaceutical department of Amin Pharmaceutical Co. Isfahan, Iran) which is sterilized through gamma radiation and will be going through Freeze drying process (the inside water will be removed and it becomes a powder); is mixed to a concentration of five percent in sterile normal saline (Sodium Chloride 0.9% for injection, Iranian Parenteral and Pharmaceutical Co. Tehran, Iran). Then the gelatamp smeared with this mixture will be applied on the tooth socket. Intervention 2: Control group: In this group, after tooth extraction and washing the tooth socket with injectable sterile normal saline, gelatamp smeared with sterile normal saline (Sodium Chloride 0.9% for injection, Iranian Parenteral and Pharmaceutical Co. Tehran, Iran) will be applied on the tooth socket. Yes - There is a plan to make this available What will be shared: Some of the data including information about main outcome and study variables after making study cases (patients) not identifiable, will be shared. When: Beginning of accessibility period is 6 months after publishing the article. To whom: Researchers working in academic and scientific institutes and professionals occupied in pharmaceutics departments of pharmacy companies and they have an approved research plan that has a ethical approval. Conditions: If the research plan is to be carried out in the continuation of the current study or in the completion of this study, it is possible to use the data Where to obtain: For getting access to data, requests should be sent to study administrators Ali Mazdak or Peiman Mazaheri to email addresses of alimazdak@res.mui.ac.ir or peimanarman1378@gmail.com . How to obtain: After checking the identity information of requester and the correctness of the mentioned ethical approval code and checking the job or academic position data will be shared. Comments:
public Ali Mazdak
Hezarjerib Ave.
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 0048 alimazdak@res.mui.ac.ir Esfahan University of Medical Sciences scientific Ali Mazdak
Hezarjerib Ave.
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 0048 alimazdak@res.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) All patients who refer for extraction of non-impacted molar teeth At least 18 years old Without any systemic disease 18 years no limit Both History of the long-term use of non-steroidal anti-inflammatory drugs or corticosteroids or bisphosphonates or chemotherapy drugs or immunosuppressive drugs The need for antibiotic prophylaxis before tooth extraction Known allergy to honey or its products Continuous use of royal jelly in the last 6 months Severe untreated periodontal disease Being under dental treatment Compulsion to use any type of mouthwash or any type of medicine from the time of tooth extraction until ten days later Smoking Addiction to alcohol, drugs, medicine or a certain substance Acute infection or presence of pus in the tooth area Pregnancy Treatment - Drugs Placebo Intervention group: In this group, after tooth extraction and washing the tooth socket with injectable sterile normal saline, pure royal jelly powder (prepared from the pharmaceutical department of Amin Pharmaceutical Co. Isfahan, Iran) which is sterilized through gamma radiation and will be going through Freeze drying process (the inside water will be removed and it becomes a powder); is mixed to a concentration of five percent in sterile normal saline (Sodium Chloride 0.9% for injection, Iranian Parenteral and Pharmaceutical Co. Tehran, Iran). Then the gelatamp smeared with this mixture will be applied on the tooth socket. Control group: In this group, after tooth extraction and washing the tooth socket with injectable sterile normal saline, gelatamp smeared with sterile normal saline (Sodium Chloride 0.9% for injection, Iranian Parenteral and Pharmaceutical Co. Tehran, Iran) will be applied on the tooth socket. Wound size of tooth socket. Timepoint: Measurement of wound size at the beginning of the study (immediately after tooth extraction and washing the socket with normal saline) and seven days later. Method of measurement: Using a caliper (ae JUYA instruments, Istanbul, Turkey). Bleeding after palpation of the tooth socket. Timepoint: Examination of bleeding after palpation at the beginning of the study (immediately after tooth extraction and washing the socket with normal saline) and seven days later. Method of measurement: Visually. The presence or absence of pus in the tooth socket. Timepoint: At the beginning of the study (immediately after tooth extraction and washing the socket with normal saline) and seven days later. Method of measurement: Visually. Presence or absence of granulation tissue in the tooth socket. Timepoint: At the beginning of the study (immediately after tooth extraction and washing the socket with normal saline) and seven days later. Method of measurement: Visually. Tissue color of the tooth socket. Timepoint: At the beginning of the study (immediately after tooth extraction and washing the socket with normal saline) and seven days later. Method of measurement: Visually. Amount of pain. Timepoint: At the beginning of the study (immediately after tooth extraction and washing the socket with normal saline) and seven days later. Method of measurement: Visual Analogue Scale. Esfahan University of Medical Sciences Approved 2022-11-07 Ethics committee of Isfahan University of Medical Sciences Faculty of Dentistry, Isfahan University of Medical Sciences, Hezarjerib Ave. Isfahan Isfehan Iran (Islamic Republic of)