An interventional study of Ozone gel placed after closed sinus lifting then implant placed simultaneously. and closed sinus lifting using osteotomes with simultaneous implant placement in Sinus Pneumatization, sponsored by Suez Canal University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-20.
Sponsored by Suez Canal University · Not applicable, Interventional, and Treatment
Purpose: The present study was conducted to evaluate the effect of using ozone gel with maxillary sinus elevation using tenting technique on the clinical and radiographic outcome of implants placed simultaneously..
Materials and Methods: A total of 30 sinuses with an average residual alveolar bone height ranging from 4-7 mm participated in this randomized controlled clinical trial. After closed sinus lift operation, patients were randomly and equally allocated into control group and ozone gel recipient group. Cone beam computed tomography was performed immediately and at 4 months postoperatively. Bone stability was measured immediately and at 3 \& 4 months postoperatively. Bone height and stability were evaluated radiographically, and bone stability was measured using the Osstell device.
Concern over biological augmentations used in bone healing has grown in recent years. One of the essential demands in sinus lifting procedure is to speed up the bone formation and enhance the quality of the formed bone in the space created after sinus elevation. Since more than 100 years medical grade ozone has been used as one of the non-medication methods of treatment. E. A. Fisch in the 1930's was the first dentist to use ozone therapy in his practice to aid in disinfection and wound healing. Current ozone uses a mixture of ozone gel and pure oxygen, with today's medical ozone generators which regulate the flow of medical grade O2 through high voltage tubes which is capable of producing pure ozone-oxygen mixtures in precise dosages.
Nevertheless, there is not enough evidence to support the use of ozone in oral and maxillofacial surgery. Ozone therapy has a therapeutic effect that promotes blood and growth factor supply, aids in wound healing, and may improve bone regeneration . However up till now, no studies were conducted to assess the impact of using ozone gel on bone formation in case maxillary sinus elevation.
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Exclusion Criteria:
Full thickness mucoperiosteal flap was elevated.• The pilot drill of the implant system was used to create an osteotomy 1 mm short of the subantral floor. • The insertion of the osteotome were repeated several times until the required membrane lift was achieved then the osteotome corresponding in size to the last drill was used.After that, placement of the implant was done .Healing abutment was placed to allow for multiple times measurements of implant stability and primary closure was done and the flap was sutured in an interrupted manner using 4/0 prolene suture .
Procedure: closed sinus lifting using osteotomes with simultaneous implant placement
Full thickness mucoperiosteal flap was elevated.• The pilot drill of the implant system was used to create an osteotomy 1 mm short of the subantral floor. • The insertion of the osteotome were repeated several times until the required membrane lift was achieved then the osteotome corresponding in size to the last drill was used.Ozone gel was delivered into the osteotomy . To obtain the ozone gel, pure olive oil was blasted with 25 μ/ml O3 gas for two days, or until the oil changed from a greenish-colored liquid to a whitish gel. The longevity Ext 120 ozone generator executed out this process. After that, placement of the implant was done .Healing abutment was placed to allow for multiple times measurements of implant stability and primary closure was done and the flap was sutured in an interrupted manner using 4/0 prolene suture .
Drug: Ozone gel placed after closed sinus lifting then implant placed simultaneously.
The patient received closed sinus lifting using osteotomes then ozone gel is prepared. Pure olive oil was blasted with 25 μ/ml O3 gas for two days, or until the oil changed from a greenish-colored liquid to a whitish gel. The longevity Ext 120 ozone generator executed out this process then implants were placed.
The patient received closed sinus lifting using osteotomes with implant placed simultaneously.
Implant stability
- Resonance frequency analysis was performed to assess implant stability. The implant stability was measured using the Osstell ISQ scale "immediate postoperative then after 3 and 4 months . The readings were taken along the three surfaces of the implant (perpendicular to the implant axis, mesial surface and distal surface). Finally, the averages of these readings were taken as a representative value for each implant .
Time frame: Immediate postoperative,3 months and 4 months postoperative
Bone Density
The bone density was evaluated using CBCT. To minimize the error from radiographic image alignment, the On Demand 3D fusion module software was used to generate a superimposed image at the sagittal and coronal planes of each implant to compare each parameter .
Time frame: Immediate postoperative and 4 months postoperative
Bone height gain
Cone beam computed tomography (CBCT was taken to evaluate the accuracy of implant placement and to represent the baseline measurement for evaluation. The bone height gain was evaluated along the surface of each implant.
Time frame: Immediate postoperative and 4 months postoperative
Plan to share: Yes — It will be available upon request
Supporting information: Study protocol, Sap, Icf
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Suez Canal University