Twelve patients (24 sinuses)will be selected from those presenting to periodontology department of Dental Faculty of Tehran University of Medical Sciences who desiring to receive maxillary posterior implants and did not have sufficient bone as determined on cone beam computerized scan (CBCT) for dental implant placement. Procedures will done under local anesthesia with different anesthetic agents depending on patient medical history and investigator preference. By a full thickness flap reflection, the lateral sinus wall will be exposed and osteotomy will perform with rotary burs. The sinus membrane will be elevated. zenograft alone will be placed in one side and zenograft + simvastatin will be placed in the contralateral side. Randomization by toss of a coin will be used to determine the test and control sites. A resorbable collagen membrane will be hydrated in sterile saline and will be placed over the lateral window. A postoperative CBCT will take to ensure that all graft material was in place. Appropriate antibiotics, analgesics for 7-10 days and chlorhexidine gluconate 0.2% for two weeks, will prescribe. After 6 months, a trephine with 2.3 mm internal diameter and 10 mm length will be used to harvest a bone core for histomorphometric analysis as the first step in the implant osteotomy. The cores will will be harvested from both test and control site by investigators in a manner which will not compromise the implant receptor sites .The reference points will be determined by these landmark points and used for measurements of bone height and density for all CBCTs in each patient.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016062527240N1
Registration date:2016-07-16, 1395/04/26
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-07-16, 1395/04/26
Registrant information
Name
Sahar Rafiei
Name of organization / entity
Dental Faculty of Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 3300 5539
Email address
s_rafiei@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Dental Faculty of Tehran University of Medical Sciences
Expected recruitment start date
2016-08-31, 1395/06/10
Expected recruitment end date
2017-04-30, 1396/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of Simvastatin in maxillary sinus augmenttion: a randomized controlled trial (histomorphometric and radiographic evaluation)
Public title
The efficacy of Simvastatin in maxillary sinus augmenttion: a randomized controlled trial (histomorphometric and radiographic evaluation)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who desiring to receive maxillary posterior implants and did not have sufficient bone as determined on cone beam computerized scan (CBCT) for dental implant placement; patients will be partially or completely edentulous in the posterior maxilla, all of them will need bilateral maxillary sinus augmentation surgeries.
Exclusion criteria:
Patients needing antibiotic prophylaxis for dental procedures; any sinus pathology (acute or chronic) contraindicating the sinus grafting;patients with systemic disease that contraindicating any oral surgeries; patients who smoked more than 10 cigarettes daily; women who were pregnant or wished to become pregnant during the period of the study; patients under 18 years of old; patients with diseases or use of medications known to affect bone metabolism ,tissue regeneration and repair such as corticosteroids, bisphosphonates and etc.; patients with a history of alcoholism or recreational drug abuse; patients who had a history of cancer, radiation to the head and neck in the last 18 months.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization by toss of a coin will be used to determine the test and control sites.
Secondary Ids
1
Registry name
Ethics committee of Tehran University of Medical Sciences
Secondary trial Id
IR.TUMS.REC.1394.2203
Registration date
2016-03-09, 1394/12/19
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Keshavarz Bulvar, Tehran, Iran
City
Tehran
Postal code
Approval date
2016-03-09, 1394/12/19
Ethics committee reference number
IR.TUMS.REC.1394.2203
Health conditions studied
1
Description of health condition studied
alveolar bone deficiency-maxillary sinus pneumatization
ICD-10 code
XIII
ICD-10 code description
Diseases of the musculoskeletal system and connective tissue
Primary outcomes
1
Description
Human maxillary sinus bone augmentation by zenograft with or without simvastatin
Timepoint
Preoperatively ,immediately after surgery and at 6 months after sinus graft
Method of measurement
Histomorphometric and radiographic evaluation
Secondary outcomes
1
Description
New bone formation
Timepoint
At 6 months after sinus graft
Method of measurement
Histomorphometric analysis percent
2
Description
Connective tissue
Timepoint
At 6 months after sinus graft
Method of measurement
Histomorphometric analysis percent
3
Description
Residual graft material
Timepoint
At 6 months after sinus graft
Method of measurement
Histomorphometric analysis percent
4
Description
Bone height analysis
Timepoint
Preoperatively ,immediately after surgery and at 6 months after sinus graft