]>
IRCT20131205015665N6 IRCT 2022-09-09 Esfahan University of Medical Sciences Efficacy of Vicryl Rapide suture on the reduction of the scar formation after genioplasty Clinical Evaluation of scar formation using VICRYL® RAPIDE and VICRYL® suture materials in genioplasty : A Thriple-blinded Randomized Clinical Trial 2022-03-06 anticipated 26 Complete https://irct.ir/trial/64119 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 mandibullar canin 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.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 mandibullar canin to the mid-line is sutured with vicryl or vicryl rapide suture as mentioned in the randomization plan by continuous lock technique and in a tension-free mannerand and the left half with the other suture material, Blinding description: Patient: patients are not aware of the exact location of the suture materials and dissociation of suture material is not possible because the apparent feature of them are same . 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 mucosal scar in mandibular vestibule after Genioplasty. Intervention 1: Intervention group 1: Considering an ID number from 1 to 26 for each patient,After randomization , 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". Genioplasty is done using Sliding technique and The initial cut is perpendicular to mucosa. Then, as muscle is transected, the angle of the cut is altered perpendicular to the bone and continued through the periosteum.At least 5 mm of attached periosteum and muscle are left between the inferior border of the symphysis and the subperiosteal dissection . before suturing the incision line, mentalis mussle each side sutured. 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 right mandibular canin 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 group2: Considering an ID number from 1 to 26 for each patient,After randomization , 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". Genioplasty is done using Sliding technique and The initial cut is perpendicular to mucosa. Then, as muscle is transected, the angle of the cut is altered perpendicular to the bone and continued through the periosteum.At least 5 mm of attached periosteum and muscle are left between the inferior border of the symphysis and the subperiosteal dissection . before suturing the incision line, mentalis mussle each side sutured. 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 left mandibular canin 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 isn’t further information
public Milad Etemadi
Department of oral and maxillofacial surgery, Dentistry Faculty, Isfahan University of Medical sciences, Hezar-jerib st., Isfahan, Iran.
Isfahan Iran (Islamic Republic of) 817467361 +98 31 9237 8155 Etemadi@dnt.mui.ac.ir Esfahan University of Medical Sciences scientific Milad Etemadi-Shalamzari
Hezar-jerib st., Esfahan
Esfahan Iran (Islamic Republic of) 8174673461 +98 31 1391 3237 etemadi@dnt.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) patients undergoing Genioplasty 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 Y81.3 General- and plastic-surgery devices associated with adverse incidents : surgical instruments, materials and devices (including sutures) Treatment - Other Treatment - Other Intervention group 1: Considering an ID number from 1 to 26 for each patient,After randomization , 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". Genioplasty is done using Sliding technique and The initial cut is perpendicular to mucosa. Then, as muscle is transected, the angle of the cut is altered perpendicular to the bone and continued through the periosteum.At least 5 mm of attached periosteum and muscle are left between the inferior border of the symphysis and the subperiosteal dissection . before suturing the incision line, mentalis mussle each side sutured. 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 right mandibular canin 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 group2: Considering an ID number from 1 to 26 for each patient,After randomization , 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". Genioplasty is done using Sliding technique and The initial cut is perpendicular to mucosa. Then, as muscle is transected, the angle of the cut is altered perpendicular to the bone and continued through the periosteum.At least 5 mm of attached periosteum and muscle are left between the inferior border of the symphysis and the subperiosteal dissection . before suturing the incision line, mentalis mussle each side sutured. 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 left mandibular canin 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 2022-02-21 Ethics Committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences,Hezar-jerib st., Isfahan, Iran. Isfahan Isfehan Iran (Islamic Republic of)