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IRCT20120127008830N5 IRCT 2018-02-23 Vice chancellor for Research and Technology, Tehran University of Medical Sciences The efficacy of Simvastatin in maxillary sinus augmentation Radiographic analysis of the efficacy of Simvastatin in combination with bone graft with bovis origin in maxillary sinus augmentation: A randomized controlled clinical trial 2018-02-09 anticipated 12 Complete https://irct.ir/trial/29017 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Flipping a coin is used for randomization, Blinding description: Surgeons are not blind to the materials used in the site of surgery. However, examiner who performs the radiographic evaluations is blind to the treatment and doesn't conduct or supervise the surgery. 4 bone loss in the posterior maxillary edentulous ridge. Intervention 1: Control side: Each subject takes 2 gr amoxicillin or 600 mg clindamycin as antibiotic prophylaxis one hour before surgery. Clinical photographs are taken before, during and post-surgery. Procedures carry out under local anesthesia with different anesthetic. By reflection a full thickness flap, the lateral wall of the sinus is exposed. Osteotomy of the lateral sinus wall is performed with rotary burs. The wall and sinus membrane are elevated. Bovine bone substitute alone is placed. A resorbable collagen membrane is hydrated in sterile saline before to insertion and is placed over the lateral window. Primary flap closure will be obtained with silk or vicryl yarn. A postoperative CBCT is taken to ensure that all graft materials are in place. Appropriate antibiotics and analgesics will be prescribed for 7-10 days and chlorhexidine gluconate 0.2% will be prescribed for two weeks. The patients will be asked to return to the clinic 7-10 days after surgery for suture removal and postoperative assessment. Intervention 2: Intervention side: Each subject takes 2 gr amoxicillin or 600 mg clindamycin as antibiotic prophylaxis one hour before surgery. Clinical photographs are taken before, during and post-surgery. Procedures carry out under local anesthesia with different anesthetic. By reflection a full thickness flap, the lateral wall of the sinus is exposed. Osteotomy of the lateral sinus wall is performed with rotary burs. The wall and sinus membrane are elevated. Simvastatin solution (8 mg SMV in 0.5 cc ethanol 70%), 0.5 cc, is mixed with 1 cc bovine bone substitute and is placed in the intervention site. The same ratios of SMV to bovine bone substitute are used if any additional materials require filling sinuses. A resorbable collagen membrane is hydrated in sterile saline before to insertion and is placed over the lateral window. Primary flap closure will be obtained with silk or vicryl yarn. A postoperative CBCT is taken to ensure that all graft materials are in place. Appropriate antibiotics and analgesics will be prescribed for 7-10 days and chlorhexidine gluconate 0.2% will be prescribed for two weeks. The patients will be asked to return to the clinic 7-10 days after surgery for suture removal and postoperative assessment. 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 No more information
public Shakiba Farahani
Dentistry School, Tehran University of Medical Science, North Karegar Street
Tehran Iran (Islamic Republic of) 14399-55991 +98 21 8801 5950 farahanishakiba@yahoo.com Dentistry School, Tehran University of medical Science scientific Siamak Yaghobee
Dentistry School, Tehran University of Medical Science, North Karegar Street
Tehran Iran (Islamic Republic of) 14399-55991 +98 21 8801 5950 Yaghobee@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Patients with age over 18 Desiring to receive maxillary posterior implants Not having sufficient bone determined on CBCT for dental implant The patients are partially or completely toothless in the posterior maxilla Patients who need bilateral maxillary sinus augmentation surgeries 18 years no limit Both Needing antibiotic prophylaxis for dental procedures Any sinus pathology (acute or chronic) contraindicating the sinus graft surgery Patients with systemic disease contraindicating any oral surgeries Patients who smoke more than 10 cigarettes daily Women who are pregnant or wish to become pregnant during the period of the study Diseases or medications known to affect bone metabolism ,tissue regeneration and repair such as corticosteroids, bisphosphonates and etc Patients with a history of alcoholism or drug abuse Patients who have a history of cancer or radiation to the head and neck Treatment - Surgery Treatment - Drugs Control side: Each subject takes 2 gr amoxicillin or 600 mg clindamycin as antibiotic prophylaxis one hour before surgery. Clinical photographs are taken before, during and post-surgery. Procedures carry out under local anesthesia with different anesthetic. By reflection a full thickness flap, the lateral wall of the sinus is exposed. Osteotomy of the lateral sinus wall is performed with rotary burs. The wall and sinus membrane are elevated. Bovine bone substitute alone is placed. A resorbable collagen membrane is hydrated in sterile saline before to insertion and is placed over the lateral window. Primary flap closure will be obtained with silk or vicryl yarn. A postoperative CBCT is taken to ensure that all graft materials are in place. Appropriate antibiotics and analgesics will be prescribed for 7-10 days and chlorhexidine gluconate 0.2% will be prescribed for two weeks. The patients will be asked to return to the clinic 7-10 days after surgery for suture removal and postoperative assessment. Intervention side: Each subject takes 2 gr amoxicillin or 600 mg clindamycin as antibiotic prophylaxis one hour before surgery. Clinical photographs are taken before, during and post-surgery. Procedures carry out under local anesthesia with different anesthetic. By reflection a full thickness flap, the lateral wall of the sinus is exposed. Osteotomy of the lateral sinus wall is performed with rotary burs. The wall and sinus membrane are elevated. Simvastatin solution (8 mg SMV in 0.5 cc ethanol 70%), 0.5 cc, is mixed with 1 cc bovine bone substitute and is placed in the intervention site. The same ratios of SMV to bovine bone substitute are used if any additional materials require filling sinuses. A resorbable collagen membrane is hydrated in sterile saline before to insertion and is placed over the lateral window. Primary flap closure will be obtained with silk or vicryl yarn. A postoperative CBCT is taken to ensure that all graft materials are in place. Appropriate antibiotics and analgesics will be prescribed for 7-10 days and chlorhexidine gluconate 0.2% will be prescribed for two weeks. The patients will be asked to return to the clinic 7-10 days after surgery for suture removal and postoperative assessment. Alveolar bone height on Cone Beam Computed Tomograghy. Timepoint: Preoperative, immediately and 9 months after sinus graft. Method of measurement: Cone Beam Computed Tomography:Two lines which are the mesial and distal limits of the augmented area and a center point between these two lines were selected on Cone Beam Computed Tomographys that were taken. Alveolar bone height in these three lines measured and the average of these measurements was reported as mean alveolar bone height. Alveolar bone density on Cone Beam Computed Tomograghy. Timepoint: preoperatively, immediately and at 9 months after sinus graft. Method of measurement: Cone Beam Computed Tomography. Vice chancellor for Research and Technology, Tehran University of Medical Sciences Approved 2018-01-13 Ethics committe of Tehran University of Medical Sciences Dentistry School, Tehran University of Medical Science, North Karegar Street Tehran Tehran Iran (Islamic Republic of)