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IRCT20200919048756N4 IRCT 2022-05-02 Tabriz University of Medical Sciences Comparition of hemostatic effect, the amount of pain and the incidence of dry socket in a new gelatin sponge (dental geltamp) with commercial geltamp A double-blind split-mouth clinical trial to compare hemostatic effect, the amount of pain, and the incidence of dry socket in a new gelatin sponge (dental geltamp) with commercial geltamp in patients who need mandibular first and second molar extraction 2022-05-19 anticipated 26 Complete https://irct.ir/trial/63258 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Basic scienece, Randomization description: Commercial geltamp and the produced geltamp are both packaged and sterilized. One geltamp will be labeled as group a and the other geltamp will be labeled as group b. The dental surgeon, who is blind to geltamp type, is required to use one type a and one type b in each patient. The randomization method will be simple and will be alternate. In this way, if in the first patient the geltamp type a will be placed on the right jaw, in the second patient the geltamp type a will be placed on the left, and so on until the end. And of course on the other side the geltamp b will be placed, which will also be alternate, Blinding description: Commercial geltamp and the produced geltamp are both packaged and sterilized. One geltamp will be labeled as group a and the other geltamp will be labeled as group b. One of the researchers and also a statistician is aware of the grouping of geltumps. Both the patient and the dental surgeon who insert the geltamp into the extracted tooth cavity are blind (whether a and b are commercial or manufactured). N/A Extraction of the first and second mandibular teeth. Intervention 1: Test group: One of the two first or second mandibular of patients in which the production geltamp (a sponge made of gelatin without any drug) will be placed. How to use; In each patient, after extracting the tooth, a production geltamp will be placed in the extracted tooth cavity. Duration of use: It will remain in the place for at least 4 days (due to the patient's check on the fourth day due to the occurrence of dry socket) and after that, it can be discarded or left in the place until complete absorption (10 days). Intervention 2: Control group: One of the two first or second mandibular of patients in which the commercial geltamp (a sponge made of gelatin without any drug) will be placed. How to use; In each patient, after extracting the tooth, a commercial geltamp will be placed in the extracted tooth cavity. Duration of use: It will remain in the place for at least 4 days (due to the patient's check on the fourth day due to the occurrence of dry socket) and after that, it can be discarded or left in the place until complete absorption (10 days). 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 Not clear yet.
public Mohammad Ali Ghavimi
Tabriz University of Medical Sciences, Daneshgah Ave, Golgasht Blvd, Tabriz.
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3335 3161 m_ghavimi@yahoo.com Tabriz University of Medical Sciences scientific Mohammad Ali Ghavimi
Tabriz University of Medical Sciences, Daneshgah Ave, Golgasht Blvd, Tabriz.
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3335 3161 m_ghavimi@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Need for extraction of two mandibular first molars Age between 20-45 years No corticosteroids and antibiotics using in the last month No coagulation disorders No acute or uncontrolled infection at the dental surgery site No malignancy at the dental surgery site No site exposure Radiation surgery No contraceptives using at last month No smoking No hypertension, diabetes, thyroid disorders and blood diseases 20 years 45 years Both People taking anticoagulants Not signing the consent form Having a systemic disease Patients whose teeth do not come out normally and need surgery and sectioning M27.3 Alveolitis of jaws Prevention Prevention Test group: One of the two first or second mandibular of patients in which the production geltamp (a sponge made of gelatin without any drug) will be placed. How to use; In each patient, after extracting the tooth, a production geltamp will be placed in the extracted tooth cavity. Duration of use: It will remain in the place for at least 4 days (due to the patient's check on the fourth day due to the occurrence of dry socket) and after that, it can be discarded or left in the place until complete absorption (10 days). Control group: One of the two first or second mandibular of patients in which the commercial geltamp (a sponge made of gelatin without any drug) will be placed. How to use; In each patient, after extracting the tooth, a commercial geltamp will be placed in the extracted tooth cavity. Duration of use: It will remain in the place for at least 4 days (due to the patient's check on the fourth day due to the occurrence of dry socket) and after that, it can be discarded or left in the place until complete absorption (10 days). Blood clotting. Timepoint: The amount of bleeding will be recorded after the anesthesia is gone (within 1-4 hours after tooth extraction) and the amount of uncontrollable bleeding after 4 hours will be considered as active bleeding. Method of measurement: In the study groups, sterile gas is changed every 15 minutes to completely stop the bleeding. The difference in weight of sterile gas at the beginning and after blood absorption will indicate the amount of blood absorption of each sterile gas. The number of sterile gases consumed and the total weight of sterile blood gases absorbed in each group (test and control) will be compared. The amount of pain. Timepoint: The amount of pain will be measured in the first 12 hours after tooth extraction, as well as in the 24 hour period, 36 hours after tooth extraction. Method of measurement: And the patient will determine the amount of pain in four time periods from 1 (minimum pain) to 10 (maximum pain) by ticking. The incidence of dry socket. Timepoint: All patients will be examined 4 days later and will be evaluated for the occurrence of dry socket. Method of measurement: All patients are referred for examination 4 days later and are evaluated for dry socket. Clinical examination of the patient and completion of information forms will be used to collect information. Tabriz University of Medical Sciences Approved 2022-04-19 Ethics committee of Tabriz University of Medical Sciences Golgasht St, Daneshgah Ave, Tabriz University of Medical Sciences, Tabriz, Iran Tabriz East Azarbaijan Iran (Islamic Republic of)