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IRCT20221110056464N1 IRCT 2023-01-15 Tabriz University of Medical Sciences The difference in full mouth implant placement in one session and multiple visits Evaluation of clinical and serological responses after post full mouth implantation in single visit versus multiple visits 2022-12-31 anticipated 60 Complete https://irct.ir/trial/67743 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Random sampling will be done among the patients referred to the Faculty of Dentistry in Tabriz who are eligible for the study. The randomization method is simple, and its unit is individual. Our tool for randomizing a table of random numbers. Based on this, the type of treatment is marked with codes A (intervention) and B (control) and placed inside the sealed envelopes. The envelopes are placed in a bag and mixed. Then it is randomly selected from the bag, and treatment is given to the patient by observing the code, Blinding description: This study is single-blind, both the patient and the attending physician will know the type of treatment. The evaluating researcher will not know about the type of intervention performed. N/A Dental Implant. Intervention 1: Intervention group: Surgery and implant placement will be done in one session. The flap and the drilling protocol and placement will be done as standard and the healing abutment will be closed as much as possible. The type of implants used will be the same for all people, and the Korean implant of Deo Company is used. All implants will be surgically implanted in the patient's mouth following the principles of infection control and based on the manufacturer's instructions. One day before implant placement and 2 and 7 days after surgery, inflammatory biomarkers, serum WBC and CRP will be measured by blood tests in the medical diagnosis laboratory. 24 hours after the operation, 48 hours, and 7 days after implant placement, the pain level will be measured by a ten-point Visual Analogue Scale (VAS). The rate of wound healing will be evaluated according to the method mentioned in measuring outcomes through three indices of clinical signs of re-epithelialization (CSR), clinical signs of homeostasis (CSH), and clinical signs of inflammation (CSI). Intervention 2: Control group: Surgery and implant placement will be done in two or three sessions. The flap and the drilling and placement protocol will be done as standard and the healing abutment will be closed as much as possible. The type of implants used will be the same in all people, and the Korean implant of Deo Company is used. All implants will be surgically implanted in the patient's mouth following the principles of infection control and based on the manufacturer's instructions. One day before implant placement and 2 and 7 days after surgery, inflammatory biomarkers, serum WBC and CRP will be measured by blood tests in the medical diagnosis laboratory. 24 hours after the operation, 48 hours and 7 days after implant placement, the pain level will be measured by a ten-point Visual Analogue Scale (VAS). The rate of wound healing will be evaluated according to the method mentioned in measuring outcomes through three indices of clinical signs of re-epithelialization (CSR), clinical signs of homeostasis (CSH) and clinical signs of inflammation (CSI). 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 There is no further information
public Atabak Kashefi Mehr
Faculty of Dentistry, Tabriz University of Medical Sciences, Golgasht St., Tabriz.
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3344 4598 kashefimehr.perio@gmail.com Tabriz University of Medical Sciences scientific Atabak Kashefi Mehr
Faculty of Dentistry, Tabriz University of Medical Sciences, Golgasht St., Tabriz.
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3344 4598 kashefimehr.perio@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Patients who need a full mouth implant Healthy gum condition 18 years no limit Both Pregnant and lactating women Having any systemic diseases such as diabetes Patients receiving antibiotics in the last six months Patients receiving corticosteroid drugs Use of non-steroidal anti-inflammatory drugs for osteoarthritis rheumatism Addiction to drugs, smoking or alcohol History of head and neck radiotherapy Z96.5 Presence of tooth-root and mandibular implants Treatment - Other Treatment - Other Intervention group: Surgery and implant placement will be done in one session. The flap and the drilling protocol and placement will be done as standard and the healing abutment will be closed as much as possible. The type of implants used will be the same for all people, and the Korean implant of Deo Company is used. All implants will be surgically implanted in the patient's mouth following the principles of infection control and based on the manufacturer's instructions. One day before implant placement and 2 and 7 days after surgery, inflammatory biomarkers, serum WBC and CRP will be measured by blood tests in the medical diagnosis laboratory. 24 hours after the operation, 48 hours, and 7 days after implant placement, the pain level will be measured by a ten-point Visual Analogue Scale (VAS). The rate of wound healing will be evaluated according to the method mentioned in measuring outcomes through three indices of clinical signs of re-epithelialization (CSR), clinical signs of homeostasis (CSH), and clinical signs of inflammation (CSI). Control group: Surgery and implant placement will be done in two or three sessions. The flap and the drilling and placement protocol will be done as standard and the healing abutment will be closed as much as possible. The type of implants used will be the same in all people, and the Korean implant of Deo Company is used. All implants will be surgically implanted in the patient's mouth following the principles of infection control and based on the manufacturer's instructions. One day before implant placement and 2 and 7 days after surgery, inflammatory biomarkers, serum WBC and CRP will be measured by blood tests in the medical diagnosis laboratory. 24 hours after the operation, 48 hours and 7 days after implant placement, the pain level will be measured by a ten-point Visual Analogue Scale (VAS). The rate of wound healing will be evaluated according to the method mentioned in measuring outcomes through three indices of clinical signs of re-epithelialization (CSR), clinical signs of homeostasis (CSH) and clinical signs of inflammation (CSI). Serum CRP and WBC levels. Timepoint: One day before implant placement and 48 hours after surgery and 7 days after surgery. Method of measurement: It will be done through blood tests of patients. The amount of pain. Timepoint: 48 hours after surgery and 7 days after surgery. Method of measurement: Visual Analogue Scale. Wound healing rate. Timepoint: One week after surgery. Method of measurement: EHS (EARLY WOUND HEALING) evaluation will be done through three indicators: 1. Clinical signs of re-epithelialization (CSR) (score 0: visible distance between cut edges, score 3: contact between cut edges, score 6: Sticky cutting edges) 2. Clinical signs of hemostasis (CSH) (score 0: bleeding at the cut edge, score 1: the presence of fibrin at the cut edge, score 2: absence of fibrin at the cut edge) 3. Clinical signs of inflammation (CSI) (score 0: redness in More than 50% of the cut length and/or clear swelling, score 1: redness in less than 50% of the cut length, score 2: absence of redness during the cut). The sum of the scores of these three parameters will form the EHS score. Therefore, the EHS score for the ideal wound healing will be ten points, and a score of zero will indicate the worst EHS condition. The wound will be ten points. And a score of zero will indicate the worst EHS condition. Tabriz University of Medical Sciences Approved 2022-10-31 Ethics Committee of Tabriz University of Medical Sciences 3rd Floor, Central Building No. 2, Tabriz University of Medical Sciences, Golgasht St.Tabriz. Tabriz East Azarbaijan Iran (Islamic Republic of)