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IRCT20150613022697N4 IRCT 2018-06-16 Mashhad University of Medical Sciences Post-operative pain amount in tapered versus cylindrical implants The comparison of tapered versus cylindrical implants in post-operative pain amount after dental implant surgery in posterior maxilla. 2018-06-22 anticipated 60 Complete https://irct.ir/trial/31810 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: The randomized triple blind clinical trial without the placebo, Randomization description: ُSimple individual randomization using the table of random numbers would be used. Allocation concealment of random codes would be carried out, Blinding description: The participants (patients), investigator who collects data and assessors the outcome and the statistician who will analyse the data would be blind to the study. the patients who participated in this study do not know which kind of same size implants whether cylindrical or taper would be used for them. the pain assessor would be another surgeon who is blind to the study. N/A Condition 1: Dental implant surgery. Condition 2: Post-operative pain. Intervention 1: Intervention group 1: Tapered implant with 4mm diameter from Biohorizone system which needs drilling regarding the tapered system protocol. Intervention 2: Intervention group 2: Cylindrical implant with 4mm diameter from Biohorizone system which needs drilling regarding the straight system protocol. Yes - There is a plan to make this available What will be shared: All collected deindetified data would be shared for all researchers. When: The access to data will be started 6 months after publication. To whom: The data would only be available for people working in academic institutions. Conditions: It is allowed to use the data for meta-analysis and systematic reviews. Where to obtain: The data can be obtained via email, from the corresponding researches (Dr Sahand samiee rad). E-mail: samieerads@mums.ac.ir How to obtain: The new research proposal and the processes details should be e-mailed to corresponding researcher in order to get the access permission. Comments:
public Sahand Samiee rad
Mashhad dental school, Vakil abad street.
Mashhad Iran (Islamic Republic of) 9176813111 +98 51 3882 9501 samieerads@mums.ac.ir Mashhad University of Medical Sciences scientific Sahand Samiee rad
Mashhad dental school, Vakil abad street
Mashhad Iran (Islamic Republic of) 9176813111 +98 51 3883 7289 samieerads@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) The age between 20-50 years old The healthy systemic physical status (ASA I,II) Without the history of analgesic and sedative drugs in the past 1 year. Candidates for 1 or 2 units implantation in posterior maxilla region Existing the sufficient bone width and height in posterior maxilla region lack of need for bone graft and sinus lift during implantation 20 years 50 years Both Patients who would not attend for follow up sessions. The arbitrary usage of analgesic drugs except Gelofen by patients, because of intolerable severe pain. M27.69 G89.11 Other endosseous dental implant failure Acute pain due to trauma Treatment - Surgery Treatment - Surgery Intervention group 1: Tapered implant with 4mm diameter from Biohorizone system which needs drilling regarding the tapered system protocol. Intervention group 2: Cylindrical implant with 4mm diameter from Biohorizone system which needs drilling regarding the straight system protocol. The post-operative pain amount. Timepoint: In 3,6 and 12 hours after the surgery and also in 1,2,3 and 7 days post-operatively. Method of measurement: The score of 0 to 10 by VAS system (Visual Analog Scale). Mashhad University of Medical Sciences Approved 2018-04-18 Ethics committee of Mashhad university of medical sciences Ghoreishi building, Daneshghah avenue Mashhad Razavi Khorasan Iran (Islamic Republic of)