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IRCT20181021041404N1 IRCT 2018-11-14 Research center of Semnan Dental School Comparison of Innovative Suture with Conventional Suture on Severity of Complications Following Mandibular fully Impacted third molar Surgery Comparison of newly Presented Suturing technique with Conventional Suturing on Severity of Complications Following Mandibular fully Impacted third molar Surgery 2018-11-07 anticipated 40 Complete https://irct.ir/trial/34789 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In order to randomize, patients are divided into two groups using the blocks of six that made by statistical software: In the first group, the first surgery is on the lower right jaw, and in the second group, the first surgery is performed on the lower left jaw. All surgeries will be performed by an oral and maxillofacial surgeon and in one room with an assistant. The suture pattern will be selected randomly in the first surgery and will not be shown to the surgeon prior to the start of suturing and finishing the surgical procedure, Blinding description: The suture pattern will not be shown to the surgeon(main researcher) prior to the start of suturing and finishing the surgical procedure. The patient and measurer will be blind about the type of suture. N/A Condition 1: Mandibular fully impacted third molar surgery. Condition 2: Postoperative facial swelling after mandibular fully impacted third molar surgery. Condition 3: Trismus after mandibular fully impacted third molar surgery. Condition 4: Dehiscence after mandibular fully impacted third molar surgery. Condition 5: Dry socket after mandibular fully impacted third molar surgery. Intervention 1: Intervention group:first the thread will be twisted around the needle holder in clockwise direction A)Then, with the aid of the needle holder the middle of the loose thread is taken and passed around the needle holder through the twisted thread to form a loop B)The needle holder is passed through the loop into the free end of the thread and pulled to complete the knot C)same process is repeated for the second time. Intervention 2: Control group:A suture will be made on the releasing incision and two sutures will be implemented on 7th tooth distal and mesial papillae with a common knot. 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 No more information exist
public Mohammad Esmaeelnejad
Semnan Dental School, 17 Shahrivar Blvd
Semnan Iran (Islamic Republic of) 35198-99951 +98 23 3333 4657 Esmaeelnejad@gmail.com Semnan University of Medical Sciences scientific Mohammad Esmaeelnejad
Semnan Dental School, 17 Shahrivar Blvd
Semnan Iran (Islamic Republic of) 35198-99951 +98 23 3333 4657 Esmaeelnejad@gmail.com Semnan University of Medical Sciences Iran (Islamic Republic of) Both-sided and symmetrical impaction of mandibular third molar tooth that are classified in the same class by Pell & Gregory Meeting ASA1 systemic conditions Non-smokers patients Collaborative patients with frequent visits for follow up Patients without periodontal disease patients with proper oral hygiene patients aged between 20 and 30 20 years 30 years Both Pathologic lesion in the impacted tooth Difference in follicle size around the crown of each person's sides Surgical time exceeding 25 minutes More than 5 minutes of surgical difference on both sides Taking steroids, drugs, alcohol, contraceptives Pregnancy and lactation History of delayed wound healing Failure to complete follow up sessions K01.1 R22.9 S03.4 T81.31 K10.3 Impacted teeth Localized swelling, mass and lump, unspecified Sprain of jaw Disruption of external operation (surgical) wound, not elsewhere classified Alveolitis of jaws Treatment - Surgery Treatment - Surgery Intervention group:first the thread will be twisted around the needle holder in clockwise direction A)Then, with the aid of the needle holder the middle of the loose thread is taken and passed around the needle holder through the twisted thread to form a loop B)The needle holder is passed through the loop into the free end of the thread and pulled to complete the knot C)same process is repeated for the second time Control group:A suture will be made on the releasing incision and two sutures will be implemented on 7th tooth distal and mesial papillae with a common knot. Pain. Timepoint: Before starting surgery, it is assessed that there is no pain at the surgical site.pain of the patient 12 hours after surgery and on days 7, 1, 2, 3, 4, 5, 6 after surgery will be measured. Method of measurement: Visual Analogue Scale. Swelling. Timepoint: Before starting surgery, 24 hours after surgery and the days 3rd and 7th after surgery. Method of measurement: Facial width will be measured by ticking three facial distances on a thread and then measuring it by a ruler. Horizontal: The distance between the corners of the lip to the attachment of the ear lobe on same side and the thread is subject to the cheeks. Vertical: The distance between the outer eye cantos and the mandibular angle of the same side and the thread is subject to the cheeks. Oblique: The distance from the corners of the lip and the mandibular angle of the same side and the thread is subject to the possible facial swelling (post-operative swelling). Maximal oral opening rate. Timepoint: Before starting surgery, 24 hours after surgery and the days 3rd and 7th after surgery. Method of measurement: It will be calculated by measuring the distance between the central margin of the upper jaw and the central edge of the lower jaw (or left in the absence of the right central) by the digital caliper (Mitutoyo, Illinois, USA). Dry socket. Timepoint: 24 hours after surgery and the days 3rd and 7th after surgery. Method of measurement: Blums criteria. Dehiscence. Timepoint: 24 hours after surgery and the days 3rd and 7th after surgery. Method of measurement: The self-opening of sutures without patient’s intervention that define with observations. Clinical attachment loss in 7th tooth distal. Timepoint: Before starting surgery, six months after surgery. Method of measurement: The distance between CEJ and the pocket bottom will be measured by william probe (Juya Instruments PVT, Tehran, Iran). The 7th tooth distal pocket depth. Timepoint: Before starting surgery, six months after surgery. Method of measurement: The distance between the gingival margin and pocket bottom will be measured by the william probe (Juya Instruments PVT, Tehran, Iran). Research center of Semnan Dental School Approved 2018-10-17 Ethics committee of Semnan University of Medical Sciences Vice chancellor for research, Setad building, Basij Blvd Semnan Semnan Iran (Islamic Republic of)