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IRCT20171229038128N1 IRCT 2018-03-10 Golestan University of Medical Science The effect of Intra Masseter Dexamethasone Injection on Postoperative Complications after Impacted and Semi Impacted Third Molar Surgery TMDC The effect of Intra Masseter Dexamethasone Injection on Postoperative Complications (pain, oedema and trismus) after Impacted and Semi Impacted Third Molar Surgery: A split-mouth randomized trial 2018-02-20 anticipated 19 Complete https://irct.ir/trial/29181 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: This study is based on split-mouth randomized clinical trial and will be performed to evaluate the effect of intra -Masseter dexamethasone injection on the outcomes of post-operative bilateral third molars. The most important goal of this commonly used method in interventional studies Split-Mouth Design is the elimination of inter-subject variability, because each person is self-controlled. Therefore, in this type of study, randomization occurs on teeth or oral areas rather than on patients, Randomization description: In this type of study, randomization occurs rather than on patients, oral surgery occurs or oral areas occur. Random allocation method will be performed on a simple random type (random number list). A randomized list will be prepared by an epidemiologist who is not involved in the implementation of the interventions, Blinding description: Patients and assessing the outcomes of the study (pain, swelling and trismus) do not know the random allocation of oral areas. 3 Postoperative Complications after Impacted and Semi Impacted Third Molar Surgery. Intervention 1: Intervention group:On one side of the oral surgery, dexamethasone injection of 8 mg, half an hour before surgery, and IM into the muscle of the master and will be performed by the surgeon. Intervention 2: Control group:The other side of the mouth is not injected dexamethasone prior to the third molar surgery (all surgical conditions such as the oral side of the intervention except dexamethasone injection). Yes - There is a plan to make this available What will be shared: All data are available after Unrecognizable When: 6 month after printing To whom: Academic institutions Conditions: Research plan Where to obtain: Dental school of Golestan University of Medicine Scinces How to obtain: Submit an application to research department of dental school Comments:
public Mohamadali Rahnama
Dental clinic of Golestan University of Medical Science, Obverse Edalat 97 alley, Naharkhoran Blv, Gorgan,Iran
Gorgan Iran (Islamic Republic of) 4916953358 +98 17 3255 0565 m.rahnama@goums.ac.ir Golestan Universities of Medical Science scientific Mohamadali Rahnama
Dental clinic of Golestan University of Medical Science, Obverse Edalat 97 alley, Naharkhoran Blv, Gorgan,Iran
Gorgan Iran (Islamic Republic of) 4916953358 +98 17 3255 0565 m.rahnama@goums.ac.ir Golestan Universities of Medical Science Iran (Islamic Republic of) 20 to 45 years of age Third mandibular molar impaction in both side Kind of impaction and difficulty in both impacted tooth be even ( both semi-impacted or both impacted and situation of impaction be even) 20 years 45 years Both Using of interventionist medications with healing process Having systemic disorders Having oral and maxillofacial disease or trauma to the region Having infection of pericoronitis in field of surgery History of allergy to lidocaine or other drugs Manifestation of any allergic reaction, sensibility increase or immunosyncratic to the drugs Definition of intervention group: Another side of the mouth that surgery is performing half our before surgery is injected by intramasseter dexamethasone. Definition of control group: Another side of the moth that surgery is performing half our before surgery is not injected by dexamethasone (all situation is the same except injection of dexamethasone) Treatment - Surgery Treatment - Surgery Intervention group:On one side of the oral surgery, dexamethasone injection of 8 mg, half an hour before surgery, and IM into the muscle of the master and will be performed by the surgeon Control group:The other side of the mouth is not injected dexamethasone prior to the third molar surgery (all surgical conditions such as the oral side of the intervention except dexamethasone injection). Pain. Timepoint: 2 and 7 days after intervention. Method of measurement: VAS(Visual Analogue Scale ). Swelling. Timepoint: 2 and 7 days after intervention. Method of measurement: Swelling is measured using the reference points (lower abdomen of the lobe of the ear to the corner of the mouth and the lateral edges of the eye to the mandible corner), through a flexible ruler (a dial pad for a more accurate measurement of the curved areas) and the vignette. The caliber is made up of a combination of a dial pad and a movable veneer. The vernier ruler has two antennas, small tentacles for measuring the inside diameter and large tentacles for measuring the external diameter of the objects). Will be evaluated. (Trismus). Timepoint: 2 and 7 days after intervention. Method of measurement: The Trismus value will be measured by measuring the maximum distance between the two maxillary and maxillary maxillary incisors by the ventricular calcium. Golestan University of Medical Science Approved 2017-12-17 Ethics committee of Golestan University of Medical Sciences Dental clinic of Golestan University of Medical Science, Obverse Edalat 97 alley, Naharkhoran Blv, Gorgan,Iran Gorgan Golestan Iran (Islamic Republic of)