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IRCT20221027056320N1 IRCT 2022-12-02 Mashhad University of Medical Sciences Preparation and evaluation of a new dressing aim to treat dry socket Preparation and in-vitro and in-vivo evaluation of a lipid-liquid crystal gel dressing containing eugenol and iodoform aim to treatment of alveolar osteitis 2022-11-19 anticipated 60 Complete https://irct.ir/trial/66582 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For the required number of samples, identical envelopes are prepared, half of them are marked as group one and the other half as group two, the envelopes are sealed, patients are randomly assigned to one of the two groups by choosing an envelope, Blinding description: The participant randomly chooses one of the envelopes and based on the selected code, one of the drugs (test and control) is placed in the patient's socket. Since the patient does not know which drug is the test and which is the control, and it is not posible to see the drug inside the socket, the study is blind for the participant. The clinical caregiver is selected among the nurses. The test and control drugs are delivered to them in similar containers, and they will not know which drug is the control or the test. The outcome evaluator and data analyzer receive patient information based on the code and will not know which code is related to the control drug or the test drug. 3 alveolar osteitis (dry socket). Intervention 1: Control group: applying sufficient amount of alveogel manufactured by the Turkish company "Kalsin" in the tooth socket so that it fills the socket and repeating it every 24 hours in case of pain and upon the request of the patient until the complete pain relief. Intervention 2: Intervention group: applying sufficient amount of liquid crystal gel dressing, prepared in Mashhad Faculty of Pharmacy, in the tooth socket so that it fills the socket and repeating it every 24 hours in case of pain and upon the patient's request until the complete pain relief. Yes - There is a plan to make this available What will be shared: All personal data of study participants can be shared after anonymization. When: Beginning of the access period, 6 months after the publication of the results. To whom: All applicants in academic and non-academic sectors can apply to receive data after authentication.. Conditions: For use in the academic sector, the source of the data must be mentioned and the copyright must be respected. If it is used in the industrial sector leading to product production, the royalties of the researchers involved in the study should be included. Where to obtain: To receive data, send an email containing your introduction and the reason for needing data to the following address: Amirhossein Chavoshi The first researcher of the study ahch1378@gmail.com How to obtain: 1. Sending an email containing specifications and reasons for the need for data 2. Completing the sent questionnaire form 3. Authentication and consent of all researchers to release data 4. Sending data to the applicant Comments:
public Amirhossein Chavoshi
Unit 4, No. 5, at the Hekmat sq. corner, Piroozi Blvd, Mashhad, Iran
Mashhad Iran (Islamic Republic of) 9178843100 +98 51 3890 9880 chavoshia961@mums.ac.ir Mashhad University of Medical Sciences scientific Amirhossein Chavoshi
Unit 4, No. 5, at the Hekmat sq. corner, Piroozi Blvd, Mashhad, Iran
Mashhad Iran (Islamic Republic of) 9178843100 +98 51 3890 9880 chavoshia961@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Participants' age should be between 18 to 60 years old. Patients suffering from dry socket following a tooth extraction who refer to Mashhad dentistry school. Participants should sign the informed consent. 30 years 60 years Both Smoking or addiction Pregnancy and breastfeeding History of allergy to foods and drugs Suffering from systemic diseases Active infective disease (such as hepatitis , AIDS ,TB) Taking medications which interact with healing process (such as corticosteroids , immunosuppressors , anticancer drugs , anticoagulants) Age under 18 or above 60 years old History of radiotherapy of head and neck region. K10.3 Alveolar osteitis , Dry socket Treatment - Drugs Treatment - Drugs Control group: applying sufficient amount of alveogel manufactured by the Turkish company "Kalsin" in the tooth socket so that it fills the socket and repeating it every 24 hours in case of pain and upon the request of the patient until the complete pain relief. Intervention group: applying sufficient amount of liquid crystal gel dressing, prepared in Mashhad Faculty of Pharmacy, in the tooth socket so that it fills the socket and repeating it every 24 hours in case of pain and upon the patient's request until the complete pain relief. Measuring patients' pain upon admission (according to VAS) and examining the intensity of pain after applying each type of dressing. Timepoint: At 30, 60 minutes and 6, 12, 24, 48, 72 hours and 7 days after application and it continues on a daily basis, until the patient has pain. Method of measurement: Questionnaire designed based on Visual Analog Scale (VAS). Checking the number of times the dressing is used. Timepoint: After the complete relief of pain and at the end of the follow-up. Method of measurement: Recording the frequency of dressing use in Excel by the researcher. Checking the number of Analgesic used for each patient. Timepoint: After the complete relief of pain and at the end of the follow-up. Method of measurement: Asking the patient and recording in Excel by the researcher. Mashhad University of Medical Sciences Approved 2022-04-30 Research ethics committee of Mashhad university of medical sciences Research and technology vice-chancellor, Qoreishi building, next to Hoveizeh cinema, Daneshgah street Mashhad Razavi Khorasan Iran (Islamic Republic of)