]>
IRCT20131205015665N5 IRCT 2020-08-25 Esfahan University of Medical Sciences Efficacy of Vicryl Rapide suture on the reduction of the scar formation after upper jaw surgery Evaluation of the scar formation using Vicryl rapide and Vicryl suture materials in Le-fort I osteotomy: A triple-blinded randomized clinical trial 2020-08-31 anticipated 26 Complete https://irct.ir/trial/47708 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Split-mouth design: the right half of the incision (from the maxillary first molar to the mid-line) will be sutured with one suture material (vicryl or vicryl rapide based on randomization plan) and the left side with the other suture material, Randomization description: simple randomization using online computer-based software (http://www.randomization.com) leading to a randomized plan in which the first suture will be used in the right side and the second suture on the left side of the surgery. unit of randomization is individual and by using a sealed envelop for each patient consisting of the order of suturing and suture materials, the right half of the incision (from the maxillary first molar to the mid-line) will be sutured with one suture material (vicryl or vicryl rapide based on randomization plan) and the left half with the other suture material, Blinding description: Patient: patients are not aware of the exact location of the suture materials. Outcome assessor: assessors are not aware of the exact location of the suture materials during the examination of the scar tissue. Investigator: The researcher will not be aware of the exact location of the suture materials and they will be only informed by the surgeons' registrations in the patients' form using "A" and "B" codes for suture materials. Data analyzer: analyzer won't be aware of the exact location of the suture materials and data is given to him/her coded as "A" and "B". N/A Clinical evaluation of mucosal scar in maxillary vestibule using vicryl and vicryl rapide suture materials after Le-fort I osteotomy. Intervention 1: Intervention group 1: Considering an ID number from 1 to 26 for each patient, randomization is done using online computer-based software (http://www.randomization.com). The randomization plan is used as follows: "the first suture name is placed on the right side while the second one on the left side of the incision line". Le-fort I Osteotomy is done using a V-shaped incision in vestibular mucosa of the maxilla; 5 mm superior to the mucogingival junction from maxillary right first molar to the maxillary left first molar. after osteotomy and before suturing the incision line, alar base cinch technique using 3-0 nylon (Ethicon Inc., Johnson and Johnson Company, Somerville, New Jersey) suture material for preventing the widening of the base of the nose. due to the split-mouth design, the sealed envelop related to the patient's ID number is peeled open and the right side of the incision line from the maxillary right first molar to the mid-line is sutured with vicryl (Ethicon Inc., Johnson and Johnson Company, Somerville, New Jersey) or vicryl rapide (Ethicon Inc., Johnson and Johnson Company, Somerville, New Jersey) suture as mentioned in the randomization plan by continuous lock technique and in a tension-free manner. Intervention 2: Intervention group 2: Considering an ID number from 1 to 26 for each patient, randomization is done using online computer-based software (http://www.randomization.com). The randomization plan is used as follows: "the first suture name is placed on the right side while the second one on the left side of the incision line". Le-fort I Osteotomy is done using a V-shaped incision in vestibular mucosa of the maxilla; 5 mm superior to the mucogingival junction from maxillary right first molar to the maxillary left first molar. after osteotomy and before suturing the incision line, alar base cinch technique using 3-0 nylon (Ethicon Inc., Johnson and Johnson Company, Somerville, New Jersey) suture material for preventing the widening of the base of the nose. due to the split-mouth design, the sealed envelop related to the patient's ID number is peeled open and the left side of the incision line from the maxillary left first molar to the mid-line, is sutured with vicryl (Ethicon Inc., Johnson and Johnson Company, Somerville, New Jersey) or vicryl rapide (Ethicon Inc., Johnson and Johnson Company, Somerville, New Jersey) suture as mentioned in the randomization plan by continuous lock technique and in a tension-free manner. 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) Iran (Islamic Republic of) patients undergoing Le-fort I osteotomy for correction of skeletal deformity 18 years 40 years Both age less than 18 or more than 40 pre-existing scar in vestibular area or history of surgery in maxillary vestibule any systemic and chronic disease which can interfere with wound healing process (i.e. diabetes, kidney and liver diseases) long-term corticosteroid or antibiotic therapy, or immunosuppressor drugs (specially in the last 6 month) congenital or acquired compromising immune system dehydration and malnutrition and associated neural defects (especially vitamin C and zinc deficiency) history of radiotherapy and using cytotoxic drugs tobacco use and alcoholism Fitzpatrick skin classification types I, IV, V, VI Maxillary advancement more than 6 mm history of allergic reaction (known or suspected) to suture materials Y74.3 Surgical instruments, materials and general hospital and personal-use devices (including sutures) associated with adverse incidents Treatment - Other Treatment - Other Intervention group 1: Considering an ID number from 1 to 26 for each patient, randomization is done using online computer-based software (http://www.randomization.com). The randomization plan is used as follows: "the first suture name is placed on the right side while the second one on the left side of the incision line". Le-fort I Osteotomy is done using a V-shaped incision in vestibular mucosa of the maxilla; 5 mm superior to the mucogingival junction from maxillary right first molar to the maxillary left first molar. after osteotomy and before suturing the incision line, alar base cinch technique using 3-0 nylon (Ethicon Inc., Johnson and Johnson Company, Somerville, New Jersey) suture material for preventing the widening of the base of the nose. due to the split-mouth design, the sealed envelop related to the patient's ID number is peeled open and the right side of the incision line from the maxillary right first molar to the mid-line is sutured with vicryl (Ethicon Inc., Johnson and Johnson Company, Somerville, New Jersey) or vicryl rapide (Ethicon Inc., Johnson and Johnson Company, Somerville, New Jersey) suture as mentioned in the randomization plan by continuous lock technique and in a tension-free manner. Intervention group 2: Considering an ID number from 1 to 26 for each patient, randomization is done using online computer-based software (http://www.randomization.com). The randomization plan is used as follows: "the first suture name is placed on the right side while the second one on the left side of the incision line". Le-fort I Osteotomy is done using a V-shaped incision in vestibular mucosa of the maxilla; 5 mm superior to the mucogingival junction from maxillary right first molar to the maxillary left first molar. after osteotomy and before suturing the incision line, alar base cinch technique using 3-0 nylon (Ethicon Inc., Johnson and Johnson Company, Somerville, New Jersey) suture material for preventing the widening of the base of the nose. due to the split-mouth design, the sealed envelop related to the patient's ID number is peeled open and the left side of the incision line from the maxillary left first molar to the mid-line, is sutured with vicryl (Ethicon Inc., Johnson and Johnson Company, Somerville, New Jersey) or vicryl rapide (Ethicon Inc., Johnson and Johnson Company, Somerville, New Jersey) suture as mentioned in the randomization plan by continuous lock technique and in a tension-free manner. Mean score of mucosal scarring index from 0 to 10. Timepoint: 4 months after surgery. Method of measurement: using mucosal scarring index consisting of 5 parts of Width, Height or Contour, Color, Suture mark, and Overall appearance; each range from 0 to 2 scores. For reach patient, 3 surgeons will evaluate the tissue and the mean of scores will be reported for the left and right sides for each patient. Esfahan University of Medical Sciences Approved 2020-08-05 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)