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IRCT20131205015665N3 IRCT 2020-05-04 Esfahan University of Medical Sciences Evaluation of Antibacterial Suture Efficacy on Reduction of Bacterial Adhesion in Impacted Lower Third Molar Surgery Evaluation of the Bacterial Species and the Mean Number of Bacterial Colonies on Vicryl and Antibacterial Vicryl Sutures Used In Mandibular Third Molar Surgery 2019-05-10 anticipated 30 Complete https://irct.ir/trial/46725 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: pseudorandomization will be done in this study. after considering an ID for each patient number from 1 to 27, in patients with an odd ID number, vicryl suture is placed in the mesial part and antibacterial vicryl suture in the distal part of the flap. in patients with an even ID number, the antibacterial suture is placed in the mesial part of the flap, while the vicryl suture is placed in the distal part, Blinding description: for blinding the participants: they will not be aware of the exact location of the vicryl and vicryl plus sutures in the mesial and distal part of the flap. for blinding the surgeon: both violet-colored suture materials will be peeled open out of the sight of the surgeon and then given o him for placing the sutures in the mesial and distal part of the flap. for blinding the technician of the microbiological laboratory: tubes containing the suture materials, will be coded as (1) for vicryl and (2) for vicryl plus . N/A comparison of mean number of bacterial colonies and predominant species on antibacterial vicryl and vicryl sutures. Intervention 1: Intervention group 1: 27 patients selected between May and July 2019 and January 2019 among patients in the dentistry faculty of Isfahan university of medical sciences, Isfahan, Iran. After achieving local anesthesia by lidocaine 2% with epinephrine1:80000, a mucoperiosteal flap is elevated and the third molar tooth is extracted. After that, an interrupted vicryl suture is randomly placed in the mesial or distal part of the flap. Location of each suture for each patient is mentioned in patient’s form (i.e. “1M” means vicryl suture in mesial and “2D" means antibacterial vicryl suture in distal) After 1 week, the suture is removed and sent to the microbiological laboratory in less than 1 hour, while protected in saline. the suture is transferred to the thioglycolate culture media and processed within 1 hour. For each sample, a one-tenth diluted solution with 0.9% NaCl is made and 100µL of it was used on blood agar culture medium and then Incubation is done in 37 degrees of temperature for 2-4 days. Gram coloring is done and cellular morphology is assessed under an optical microscope. Intervention 2: Intervention group 2: 27 patients selected between May and July 2019 and January 2019 among patients in the dentistry faculty of Isfahan university of medical sciences, Isfahan, Iran. After achieving local anesthesia by lidocaine 2% with epinephrine1:80000, a mucoperiosteal flap is elevated and the third molar tooth is extracted. After that, an interrupted antibacterial vicryl suture is randomly placed in the mesial or distal part of the flap. Location of each suture for each patient is mentioned in patient’s form (i.e. “1M” means vicryl suture in mesial and “2D" means antibacterial vicryl suture in distal) After 1 week, the suture is removed and sent to the microbiological laboratory in less than 1 hour, while protected in saline. the suture is transferred to the thioglycolate culture media and processed within 1 hour. For each sample, a one-tenth diluted solution with 0.9% NaCl is made and 100µL of it was used on blood agar culture medium and then Incubation is done in 37 degrees of temperature for 2-4 days. Gram coloring is done and cellular morphology is assessed under an optical microscope. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Milad Etemadi Shalamzari
Department of oral and maxillofacial surgery, dentistry faculty, Isfahan university of medical sciences, Hezar-jerib st., Isfahan, Iran.
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3792 5581 etemadi@dnt.mui.ac.ir Esfahan University of Medical Sciences scientific Milad Etemadi Shalamzari
Department of oral and maxillofacial surgery, dentistry faculty, Isfahan university of medical sciences, Hezar-jerib st., Isfahan, Iran.
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3792 5581 etemadi@dnt.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) having type A mesioangular mandibular third molar indicated for surgical removal having appropriate radiographic imaging age between 18-30 absence of obvious infection and/or extensive caries lesion in the oral cavity 18 years 30 years Both systemic health problems systemic or oral medication affecting normal oral microbial flora and colonization smoking and drug addiction alcohol addiction presence of intraoral inflammation before the surgery pregnancy and lactation known or suspected allergy to suture and other materials using in this study presence of removable prosthesis in the oral cavity loss of sutures before suture removal appointment presence of infection after surgery or any other situation with the need for antibiotic therapy Treatment - Other Treatment - Other Intervention group 1: 27 patients selected between May and July 2019 and January 2019 among patients in the dentistry faculty of Isfahan university of medical sciences, Isfahan, Iran. After achieving local anesthesia by lidocaine 2% with epinephrine1:80000, a mucoperiosteal flap is elevated and the third molar tooth is extracted. After that, an interrupted vicryl suture is randomly placed in the mesial or distal part of the flap. Location of each suture for each patient is mentioned in patient’s form (i.e. “1M” means vicryl suture in mesial and “2D" means antibacterial vicryl suture in distal) After 1 week, the suture is removed and sent to the microbiological laboratory in less than 1 hour, while protected in saline. the suture is transferred to the thioglycolate culture media and processed within 1 hour. For each sample, a one-tenth diluted solution with 0.9% NaCl is made and 100µL of it was used on blood agar culture medium and then Incubation is done in 37 degrees of temperature for 2-4 days. Gram coloring is done and cellular morphology is assessed under an optical microscope. Intervention group 2: 27 patients selected between May and July 2019 and January 2019 among patients in the dentistry faculty of Isfahan university of medical sciences, Isfahan, Iran. After achieving local anesthesia by lidocaine 2% with epinephrine1:80000, a mucoperiosteal flap is elevated and the third molar tooth is extracted. After that, an interrupted antibacterial vicryl suture is randomly placed in the mesial or distal part of the flap. Location of each suture for each patient is mentioned in patient’s form (i.e. “1M” means vicryl suture in mesial and “2D" means antibacterial vicryl suture in distal) After 1 week, the suture is removed and sent to the microbiological laboratory in less than 1 hour, while protected in saline. the suture is transferred to the thioglycolate culture media and processed within 1 hour. For each sample, a one-tenth diluted solution with 0.9% NaCl is made and 100µL of it was used on blood agar culture medium and then Incubation is done in 37 degrees of temperature for 2-4 days. Gram coloring is done and cellular morphology is assessed under an optical microscope. Mean number of bacterial colonies (cfu/ml) on vicryl and antibacterial vicryl suture materials. Timepoint: 1 week after surgery. Method of measurement: calculation of mean number of bacterial colonies grown in blood agar culture medium. Determining the predominant species. Timepoint: 1 week after surgery. Method of measurement: gram coloring. Esfahan University of Medical Sciences Approved 2019-05-07 Ethics committee of Isfahan university of medical sciences oral and maxillofacial surgery department, dentistry faculty, Isfahan university of medical sciences,Hezar-jerib st., Isfahan, Iran. Isfahan Isfehan Iran (Islamic Republic of)