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IRCT20180714040460N2 IRCT 2018-12-26 Islamic Azad University Effect of HA/β-TCP on new bone formation after tooth extraction Effect of healing time on new bone formation after tooth extraction with HA/β-TCP 2017-10-22 anticipated 40 Complete https://irct.ir/trial/35840 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Dividing the samples completely randomly into two groups of case and control by dropping the coin and dividing it into two groups of 3 months (case) and 4 months (control) and hiding the card until the patients were re-referenced, Blinding description: All individuals involved in this research, such as clinicians, outcome evaluators, data analyzers, safety committees, and data monitoring, have been unaware of the randomization process of samples, and only researchers and therapists in this study have compared the time Sampling and referral of patients are well known. 3 Evaluation of bone formation with HA/β-TCP after tooth extraction. Intervention 1: Intervention group: This group includes 20 dental samples need to be extracted and required Implant treatment. The dental socket (after tooth extraction) is filled with OSTEON, from Dentium company, Korea, and its entry is covered with Collagen from brand called Auto Plug. The specimens are randomly divided into this group (3 months) and after the prescribed time, they are called for sampling. The bone sample is taken to examine the condition of the bone and is delivered to the Pathology Laboratory. The OSTEON is an 70% TCP Synthetic Bone Graft material with 30% Hydroxyapatite coated on it. The powder contains particles of 500-1000 microns. Intervention 2: Control group: This group includes 20 dental samples need to be extracted and required implant treatment. The dental socket (after tooth extraction) is filled with OSTEON, from Dentium company, Korea, and its entry is covered with Collagen from brand called Auto Plug. The specimens are randomly divided into this group (4 months) , and after the prescribed time, they are called for sampling. The bone sample is taken to examine the condition of the bone and is delivered to the Pathology Laboratory. The OSTEON is an 70% TCP Synthetic Bone Graft material with 30% Hydroxyapatite coated on it. The powder contains particles of 500-1000 microns. Yes - There is a plan to make this available What will be shared: Comparison of short-term effects (3 months, case group) and long-term (4 months, control group) Application of synthetic HA / β-TCP on histopathology of bone formation following tooth extraction in patients referring to the dental unit of Islamic Azad University of Tehran in 1396-1397 . When: 6 months after printing the results To whom: All people who need data Conditions: Analyzes that do not damage the outcome of our data analysis are allowed. Where to obtain: Faculty of Dentistry Islamic Azad University of Tehran How to obtain: Visit the Faculty of Dentistry, Islamic Azad University of Tehran and request there, and will access the data within 1 week. Comments:
public Nima Nadaf Pour
Tehran, Pasdaran Street , Ninth Neyestan avenue
Tehran Iran (Islamic Republic of) 1946853314 +98 21 2256 4571 n_nadaf@dentaliau.ac.ir Islamic Azad University scientific Nima nadaf Pour
Tehran , Pasdaran street , Ninth Neyestan avenue
Tehran Iran (Islamic Republic of) 1946853314 +98 21 2256 4571 n_nadaf@dentaliau.ac.ir Islamic Azad University Iran (Islamic Republic of) Single-rooted teeth needing extraction Patient desiring restoration with a dental implant Adequate space for restoration no limit no limit Both Patients not fulfilling inclusion criteria or not compliant with necessary procedural follow-up Pregnancy Active systemic/local infection not including periodontitis Medical conditions or medications known to alter soft tissue or bony healing (poorly controlled diabetes mellitus [DM], bisphosphonates, immunosuppressives, etc.) Teeth with short roots or roots that were malpositioned such that the core biopsy might include bone along the socket wall. Females of childbearing age without tubal ligation, menopause, or hysterectomy were required to have a negative pregnancy test prior to surgery. K08.2 Atrophy of edentulous alveolar ridge Treatment - Surgery Treatment - Surgery Intervention group: This group includes 20 dental samples need to be extracted and required Implant treatment. The dental socket (after tooth extraction) is filled with OSTEON, from Dentium company, Korea, and its entry is covered with Collagen from brand called Auto Plug. The specimens are randomly divided into this group (3 months) and after the prescribed time, they are called for sampling. The bone sample is taken to examine the condition of the bone and is delivered to the Pathology Laboratory. The OSTEON is an 70% TCP Synthetic Bone Graft material with 30% Hydroxyapatite coated on it. The powder contains particles of 500-1000 microns. Control group: This group includes 20 dental samples need to be extracted and required implant treatment. The dental socket (after tooth extraction) is filled with OSTEON, from Dentium company, Korea, and its entry is covered with Collagen from brand called Auto Plug. The specimens are randomly divided into this group (4 months) , and after the prescribed time, they are called for sampling. The bone sample is taken to examine the condition of the bone and is delivered to the Pathology Laboratory. The OSTEON is an 70% TCP Synthetic Bone Graft material with 30% Hydroxyapatite coated on it. The powder contains particles of 500-1000 microns. The amount of Bone Formation. Timepoint: 3 months and 4 months. Method of measurement: Calculated by optical microscope. Amount of Residual graft. Timepoint: 3 months and 4 months. Method of measurement: Calculated by optical microscope. Amount of Connective Tissue and Inflammation Rate. Timepoint: 3 months and 4 months. Method of measurement: Calculated by optical microscope. Islamic Azad University Approved 2017-06-18 Faculty of Dentistry Islamic Azad University, Tehran Branch Tehran, Pasdaran Street, Ninth Neyestan Avenue Tehran Tehran Iran (Islamic Republic of)