]>
IRCT20211121053131N1 IRCT 2022-01-18 Tehran University of Medical Sciences Comparison of effectiveness of two types of suture during intraoral incisions healing - Comparison of effectiveness of Simple continuous suture and Reciprocal continuous suture in healing intraoral incisions: double blind, split mouth randomized clinical trial 2022-01-02 anticipated 14 Complete https://irct.ir/trial/60171 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study there are 4 randomized interventions. Right side first or left side, and each one is first can be sutured either with Reciprocal continuous suture or Simple continuous suture. 1) Right side first, suturing with Reciprocal continuous technique. 2) Right side first, suturing with Simple continuous technique. 3) Left side first, suturing with Reciprocal continuous technique. 4) Left side first, suturing with Simple continuous technique. There are 14 patients in this study. In this method we write down these 4 interventions in 4 similar sealed envelopes (there is 1 intervention in each envelope). For each 4 patients we have 4 envelopes, for first patient we choose one envelope randomly. For second patient we choose one envelope from 3 remaining envelopes and so on until the last patient. In the end this process will be done 3 times for 12 patients. For 2 remaining patients we have 2 new envelopes that are sealed and similar. In each 2 envelopes we write one of the interventions, it means that for each intervention we have a separate envelope. This method is called Balanced Block Randomization, Blinding description: Patients do not know which type of suture is performed on which side of the maxilla. With Balanced Block Randomization method surgeon will decide to do which suture technique on each side. Also impact assessor does not know which type of suture is performed on which side of the maxilla because he evaluates the photographs that is taken after suture removal. N/A This study evaluates the effectiveness of a new suturing technique that has been invented by researcher. This technique name is Reciprocal continuous suture which is a type of continuous suture.. Intervention 1: Intervention group: The side of Maxilla that receives Reciprocal continuous suture is intervention group. First, each side of the Maxilla is anesthetized with approximately 2 carpules of Lidocaine anesthetic and infiltration technique. With a razor number 15 (Morris Company), the Crestal incision is done, envelope flap is prepared and the flap is retracted mucoperioceally. The most posterior region of the maxilla where the implant is placed is first maxillary molar. One implant system is used for all patients and all implants are placed with 2 stage technique. After implant placement, one side of the maxilla is sutured with Simple continuous suture technique (control group) and the opposite side is sutured with the Reciprocal continuous suture technique (intervention group). The suturing process on each side is completely random (Balanced Block Randomization method) and it means that the surgeon didn’t apply his personal opinion for suturing (which side first and which suturing technique first). The point where the needle enters the tissue is far 3 mm from the edge of the wound. The surgical site is sutured with 0.3 Vikril absorbable (slowly absorb) suture (brand name: SUPABON made in Iran / SUPA company) with a 19 mm reverse cutting needle and a 3.8 gauge. Both side sutures will be remove 7 days after surgery. On surgery day, 7 days and 14 days after surgery intraoral photograph is taken. In the end intraoral photographs will be evaluate by impact assessor with AutoCAD software. Intervention 2: Control group: The side of Maxilla that receives Simple continuous suture is control group. First, each side of the Maxilla is anesthetized with approximately 2 carpules of Lidocaine anesthetic and infiltration technique. With a razor number 15 (Morris Company), the Crestal incision is done, envelope flap is prepared and the flap is retracted mucoperioceally. The most posterior region of the maxilla where the implant is placed is first maxillary molar. One implant system is used for all patients and all implants are placed with 2 stage technique. After implant placement, one side of the maxilla is sutured with Simple continuous suture technique (control group) and the opposite side is sutured with the Reciprocal continuous suture technique (intervention group). The suturing process on each side is completely random (Balanced Block Randomization method) and it means that the surgeon didn’t apply his personal opinion for suturing (which side first and which suturing technique first). The point where the needle enters the tissue is far 3 mm from the edge of the wound. The surgical site is sutured with 0.3 Vikril absorbable (slowly absorb) suture (brand name: SUPABON made in Iran / SUPA company) with a 19 mm reverse cutting needle and a 3.8 gauge. Both side sutures will be remove 7 days after surgery. On surgery day, 7 days and 14 days after surgery intraoral photograph is taken. In the end intraoral photographs will be evaluate by impact assessor with AutoCAD software. 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 Because the participants have not been determined yet.
public Houra Astaneh
No 4, Habibi Rad alley, Qoba street, Shariati avenue, Tehran, Iran
Tehran Iran (Islamic Republic of) 1948934511 +98 21 2284 9948 huas74@gmail.com Tehran University of Medical Sciences scientific Nima Dehghani
Tehran University of Medical Sciences, International Campus, School of Dentistry Mahan St., Zam Zam St., Navab Highway, Tehran, Iran
Tehran Iran (Islamic Republic of) 1894787545 00982155851131, 55851141, 55851149 dentistryic@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Healthy people(without systemic diseases) People who do not smoke Women who are not during pregnancy Women who are not during breastfeeding People who visit for follow-up sessions People who do not need bone grafts for implant surgery no limit no limit Both Patients with systemic disease Smokers Pregnant women Women who are breastfeeding Patients who need bone graft for implant surgery Patients who do not seek follow-up sessions Treatment - Surgery Treatment - Surgery Intervention group: The side of Maxilla that receives Reciprocal continuous suture is intervention group. First, each side of the Maxilla is anesthetized with approximately 2 carpules of Lidocaine anesthetic and infiltration technique. With a razor number 15 (Morris Company), the Crestal incision is done, envelope flap is prepared and the flap is retracted mucoperioceally. The most posterior region of the maxilla where the implant is placed is first maxillary molar. One implant system is used for all patients and all implants are placed with 2 stage technique. After implant placement, one side of the maxilla is sutured with Simple continuous suture technique (control group) and the opposite side is sutured with the Reciprocal continuous suture technique (intervention group). The suturing process on each side is completely random (Balanced Block Randomization method) and it means that the surgeon didn’t apply his personal opinion for suturing (which side first and which suturing technique first). The point where the needle enters the tissue is far 3 mm from the edge of the wound. The surgical site is sutured with 0.3 Vikril absorbable (slowly absorb) suture (brand name: SUPABON made in Iran / SUPA company) with a 19 mm reverse cutting needle and a 3.8 gauge. Both side sutures will be remove 7 days after surgery. On surgery day, 7 days and 14 days after surgery intraoral photograph is taken. In the end intraoral photographs will be evaluate by impact assessor with AutoCAD software. Control group: The side of Maxilla that receives Simple continuous suture is control group. First, each side of the Maxilla is anesthetized with approximately 2 carpules of Lidocaine anesthetic and infiltration technique. With a razor number 15 (Morris Company), the Crestal incision is done, envelope flap is prepared and the flap is retracted mucoperioceally. The most posterior region of the maxilla where the implant is placed is first maxillary molar. One implant system is used for all patients and all implants are placed with 2 stage technique. After implant placement, one side of the maxilla is sutured with Simple continuous suture technique (control group) and the opposite side is sutured with the Reciprocal continuous suture technique (intervention group). The suturing process on each side is completely random (Balanced Block Randomization method) and it means that the surgeon didn’t apply his personal opinion for suturing (which side first and which suturing technique first). The point where the needle enters the tissue is far 3 mm from the edge of the wound. The surgical site is sutured with 0.3 Vikril absorbable (slowly absorb) suture (brand name: SUPABON made in Iran / SUPA company) with a 19 mm reverse cutting needle and a 3.8 gauge. Both side sutures will be remove 7 days after surgery. On surgery day, 7 days and 14 days after surgery intraoral photograph is taken. In the end intraoral photographs will be evaluate by impact assessor with AutoCAD software. Dehiscence: Pathologic process consisting of a partial or complete disruption of the layers of a surgical wound. Timepoint: 7 days and 14 days after surgery. Method of measurement: Intraoral measuring instruments (graded bisturi handle - mm). Inflammation: A pathological process characterized by injury or destruction of tissues caused by a variety of cytologic and chemical reactions. It is usually manifested by typical signs of pain, heat, redness, swelling, and loss of function. Timepoint: 7 days and 14 days after surgery. Method of measurement: Pale pink: without inflammation, change in color from normal pale pink: inflammation. Suturing loosening. Timepoint: 7 days after surgery. Method of measurement: Intraoral measuring instruments (graded bisturi handle - mm). Tehran University of Medical Sciences Approved 2020-07-29 Ethics committee of Tehran University of Medical Sciences Tehran university of medical sciences international campus school of dentistry, Mahan St., Zam Zam St., Navab Highway, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)