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IRCT20230202057309N1 IRCT 2023-03-16 Islamic Azad University Evaluation of post-op complications of envelope flap and comma flap for impacted third molar Evaluation of post-op complications of two different flap designs for impacted third mandibular molar surgery 2023-04-21 anticipated 25 Complete https://irct.ir/trial/68415 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Crossover, Purpose: Supportive, Randomization description: The impacted tooth will assigned into two lingually based comma flap(group A) and envelope flap(group B), by flipping a coin. For choosing which quadrant to start with, also there will be a coin flipping, Blinding description: It will be explained to the patients that one distinct flap design will be used for every impacted mandibular third molar on each quadrant. But they will be not informed, which one of those two flap designs will be used on which quadrant. N/A Post-op complications comparison of two comma and envelope flap design in impacted third mandibualr surgery. Intervention 1: Control group:The impacted tooth will assigned into two lingually based comma flap(group A) and envelope flap(group B), by flipping a coin. For choosing which quadrant to start with, also there will be a coin flipping. Intervention 2: Intervention group: The impacted tooth will assigned into two lingually based comma flap(group A) and envelope flap(group B), by flipping a coin. For choosing which quadrant to start with, also there will be a coin flipping. Yes - There is a plan to make this available What will be shared: all of the patients' data except their name and contact information, will be shared. When: 6 months after publishing of the results. To whom: People who practice in medical field, like medical doctors and dentists. Conditions: Access permit to data will only be allowed in case of evaluating the exactitude of the study and using its benefits for treating patients. Where to obtain: 1) Farid Ghasemi f.gh1372@gmail.com (+98)9134728100 Skype: f.gh1372 2) Yousef Kananizadeh dr.kananizadehy@gmail.com How to obtain: Please contact with one of the two person mentioned, by e-mail or phone. after evaluating the request, in 2 weeks the data will be sent. Comments:
public Farid Ghasemi
No. 76, Ladan alley, Farabi 6 street, Tohid Sharghi street, Sepahan Shahr, Esfahan
Esfahan Iran (Islamic Republic of) 8179993583 +98 31 3651 6267 f.gh1372@gmail.com Islamic Azad University scientific Farid Ghasemi
No. 76, Ladan alley, Farabi 6 street, Tohid Sharghi street, Sepahan Shahr, Esfahan
Esfahan Iran (Islamic Republic of) 8179993583 +98 31 3651 6267 f.gh1372@gmail.com Islamic Azad University Iran (Islamic Republic of) Patients who have bilateral and symmetrical impacted mandibular third molar Patients who have class 1,2,A,B impacted mandibular third molar, based on Pell and Gregory classification Patients who have not any systemic or underlying disease Patients whom impacted mandibular third molar has no symptom such as pain, edema and trismus Patients whom root of impacted mandibular third molar has developed more than one-third Patients who have no acute periodontal disease no limit no limit Both K01.1 Impacted teeth Treatment - Surgery Treatment - Surgery Control group:The impacted tooth will assigned into two lingually based comma flap(group A) and envelope flap(group B), by flipping a coin. For choosing which quadrant to start with, also there will be a coin flipping. Intervention group: The impacted tooth will assigned into two lingually based comma flap(group A) and envelope flap(group B), by flipping a coin. For choosing which quadrant to start with, also there will be a coin flipping. Pain: post-operative pain will be measured by Visual Analog Scale. In this scale, the patients will be asked to show the intensity of the pain which is experienced by choosing a number(between 0-10) on a horizontal line. Pain in this descriptive scale is categorized to 6 levels: 0= no pain, 1-3= mild pain, 4-5= moderate pain, 6-7= painful, 7-8= sever pain and 10= unbearable pain. The paitients will be asked to report the pain score on its worst severity time on a day. Timepoint: Will be measured on the first, third and seventh post-operative day. Method of measurement: Visual Analog Scale. Edema: the severity of post-operative edema will be measured by the pre-operative difference between the two fixed mandibular angle and lip commissure points on the patients' face and the post-operative one. Timepoint: Will be measured on the first, third and seventh post-operative day. Method of measurement: The pre-operative difference between the two fixed mandibular angle and lip commissure points on the patients' face and the post-operative one (in milimeter). Trismus: will be measured post-operatively. for this purpose the inter-incisal distance will be measured. if the distance is less than 25 milimiter, the presence of trismus will be considered. Timepoint: Will be measured on the first, third and seventh post-operative day. Method of measurement: the maximum inter-incisal distance (in milimeter). Wound dehiscence: to a dehiscence more than 1.5 centimeter square, number 3, less than 1 centimeter square, number 2 and less than 0.5 centimeter square, number 1 will be assigned. in case of no dehiscence number 0 will be considered. Timepoint: Will be measured on the first, third and seventh post-operative day. Method of measurement: the amount of post-operative wound dehiscence (in centimeter square). Alveolar osteitis: will be considered post-operative pain in or around the socket of the extracted impacted tooth or partial/total loss of the blood clot in the socket (yes or no). Timepoint: Will be measured on the first, third and seventh post-operative day. Method of measurement: post-operative pain in or around the socket of the extracted impacted tooth or partial/total loss of the blood clot in the socket (yes or no). Lingual nerve paraesthesia: in order to evaluate any post-operative injury or paraesthesia to lingual nerve, changes on the lateral surface of tounge will be investigated. Timepoint: Will be measured on the first, third and seventh post-operative day. Method of measurement: any post-operative injury,paraesthesia or aneasthesia on the lateral surface of tounge (any changes in sensation , yes and no changes in sensation, no). Islamic Azad University Approved 2023-03-07 Ethics committee of Islamic Azad University Tabriz branch Tabriz Islamic Azad Medical University, Jadde Basmanj, East Azerbaijan Province, Iran Tabriz East Azarbaijan Iran (Islamic Republic of)