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IRCT20201012049004N1 IRCT 2020-11-01 Mashhad University of Medical Sciences The effect of amniotic membrane and collagen membrane in guided bone regeneration in implant treatment Comparison of effects of amniotic membrane with collagen membrane in guided bone regeneration in dental implant surgery: a randomized clinical trial 2018-09-23 anticipated 20 Complete https://irct.ir/trial/51561 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization was used using a random number table taken from randomization.com which consisted of disordered numbers and even numbers were used for the intervention group and odd numbers for the control group. For concealment, based on the sample size, 20 opaque envelopes were prepared and a card containing a random sequence was inserted in which the random sequence was created by the method described. Cards with random sequences were placed in order. In order to maintain a random sequence, numbering was done in the same way on the outer surface of the envelopes. Finally, the envelopes were sealed and placed inside a box.Based on the order of entry of eligible participants in the study, one of the envelopes of the order was opened and the assigned group of that participant was revealed, Blinding description: The patient was informed verbally and in writing through a written consent letter that one of the two membranes examined in the study would be used, but ultimately the patient and the researcher were unaware of the type of membranes used in implant surgery. N/A 3-wall intrabony defects in jaws. Intervention 1: Intervention group (amniotic membrane group): The bone defect was filled with bone graft (Cerabone, GmbH, Germany) before placing the implant (Biohorizons, BioHorizons IPH ),then it was covered with amniotic membrane (AmniPatch, TRC, Iran).finally the flap was initially sewn on the membrane without hatching the periosteum. Patients were prescribed antibiotics for up to 5 days (clindamycin 300 mg four times a day), analgesics for up to 3 days (ibuprofen 400 mg three times a day) and chlorhexidine 0.12% mouthwash twice a day for 2 weeks. Intervention 2: Control group (collagen membrane group): The bone defect was filled with bone graft (Cerabone, GmbH, Germany) before placing the implant (Biohorizons, BioHorizons IPH ) and then covered with collagen membrane (Jason membrane, bottis, Germany) with a size of 2cm*1.5cm . Finally the flap was initially sewn on the membrane without hatching the periosteum. Patients were prescribed antibiotics for up to 5 days (clindamycin 300 mg four times a day), analgesics for up to 3 days (ibuprofen 400 mg three times a day) and chlorhexidine 0.12% mouthwash twice a day for 2 weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is was not anticipated in the proposal
public Mahdi Gholami
Mashhad University of Medical Sciences; Azadi square
Mashhad Iran (Islamic Republic of) 9177948959 +98 51 3882 9501 GholamiMH@mums.ac.ir Mashhad University of Medical Sciences scientific Mahdi Gholami
Dental School; Mashhad University of Medical Sciences; Azadi square
Mashhad Iran (Islamic Republic of) 9177948959 +98 51 3882 9501 GholamiMH@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Patient referred to the implant department of the Mashhad Dental School Candidate for dental implant Having 3-wall intrabony defect no limit no limit Both The presence of any kind of systemic diseases The presence of any kind of local factors that might impede the natural healing process of the tissue M27.61 Osseointegration failure of dental implant Treatment - Surgery Treatment - Surgery Intervention group (amniotic membrane group): The bone defect was filled with bone graft (Cerabone, GmbH, Germany) before placing the implant (Biohorizons, BioHorizons IPH ),then it was covered with amniotic membrane (AmniPatch, TRC, Iran).finally the flap was initially sewn on the membrane without hatching the periosteum. Patients were prescribed antibiotics for up to 5 days (clindamycin 300 mg four times a day), analgesics for up to 3 days (ibuprofen 400 mg three times a day) and chlorhexidine 0.12% mouthwash twice a day for 2 weeks. Control group (collagen membrane group): The bone defect was filled with bone graft (Cerabone, GmbH, Germany) before placing the implant (Biohorizons, BioHorizons IPH ) and then covered with collagen membrane (Jason membrane, bottis, Germany) with a size of 2cm*1.5cm . Finally the flap was initially sewn on the membrane without hatching the periosteum. Patients were prescribed antibiotics for up to 5 days (clindamycin 300 mg four times a day), analgesics for up to 3 days (ibuprofen 400 mg three times a day) and chlorhexidine 0.12% mouthwash twice a day for 2 weeks. The amount of bone formed on the implant. Timepoint: Intervals of 12 weeks (in the mandible) and 16 weeks (in the maxilla) after stage 2 surgery. Method of measurement: Clinically determined by the percentage of exposed implant threads in the second stage of surgery. Implant success rate. Timepoint: At intervals of 12 weeks (in the mandible) and 16 weeks (in the maxilla) after surgery. Method of measurement: Implant success rate is determined by reflection frequency analysis (RFA) test using Osstell Mentor (Integration Diagnostics Ltd., Göteborg, Sweden) as well as the application of a reverse torque force of 35 N / cm by the reverse mode of the implant surgery engine and angle 20: 1, It is measured during the second stage of implant surgery. In the osstell mentor device, according to osseointegration a number between 1 and 100 is shown. This number is the Implant Stability Quotient(ISQ) . The higher the ISQ displayed by the device, the higher the degree of integration. In evaluation by reverse torque force, success is expressed as stable and implant failure as unstable. Periodontal tissue healing rate on implant. Timepoint: At 1, 2 and 4 weeks after surgery. Method of measurement: periodontal tissue healing rate is expressed as the absence of membrane and bone graft exposure(A), only membrane exposure (B), or membrane and bone graft exposure (C). The incidence of infection in the surgical area. Timepoint: At 1, 2 and 4 weeks after surgery. Method of measurement: The incidence of infection in the area is measured and expressed as the presence (+) or absence (-) of infection according to the symptoms of infection in the area (swelling, pain, persistent erythema and secretion of pus). Patients' postoperative pain. Timepoint: In the first, third and tenth day after surgery. Method of measurement: The amount of pain after surgery of the patient is recorded using a VAS scale in a questionnaire designed for this purpose. In this scale, the amount of pain is classified from 0 to 10 based on the severity of pain.0 is the absence of pain and 10 is the presence of the most severe pain possible. Mashhad University of Medical Sciences Approved 2016-06-01 Ethics committee of Mashhad University of Medical Sciences Mashhad University of Medical Sciences; Azadi square Mashhad Razavi Khorasan Iran (Islamic Republic of)