An interventional study of maxillary sinus augmentation and implant placement and Maxillary sinus augmentation with bovine bone graft in Sinus Disease and Maxillary Sinus Disease, sponsored by Kutahya Health Sciences University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-30.
Sponsored by Kutahya Health Sciences University · Not applicable, Interventional, and Treatment
Before placement of the dental implant in the posterior maxilla where the maxillary sinus is pneumatized, it is necessary to elevate of the sinus mucosa from the sinus floor (sinus lift) and to provide new bone formation by using bone-forming graft materials (maxillary sinus augmentation) in the space obtained. In the bilateral maxillary posterior region with insufficient bone height with tooth deficiency, two-stage sinus lift and placement of platelet-rich fibrin prepared with titanium on one side and bovine bone graft on the other side in the implant surgery will affect the primary stability of the implant, the obtained bone histology, volume, height and density is the evaluation of its effect on it. Ten patients who required a maxillary sinus augmentation procedure for implant placement in the bilateral atrophic maxilla were included. Bio-Oss bovine bone graft was made on one side of the patients and randomly assigned to the control group, and the other side was randomly assigned to the test group using platelet-rich fibrin prepared with titanium.
In addition to insufficient bone height with bone resorption of the posterior maxilla after tooth loss, the pneumatization of the maxillary sinus is one of the factors that prevent implant placement in the posterior maxilla. For this, it is necessary to raise the sinus mucosa from the sinus floor (sinus lift) and to provide new bone formation by using bone graft materials (maxillary sinus augmentation) in the resulting sinüs cavity. Two-stage sinus augmentation and implant placement have been recognized as a good clinical model for evaluating the performance of graft materials. Because bone formation takes place in a closed area and with minimal intervention of external factors. Platelet-rich fibrin (T-PRF) prepared with titanium from autologous thrombocyte concentrates showed a tighter polymerized fibrin structure and a long dissolution process, and it was reported that new bone formation started on the 15th day with the placed T-PRF and was effective in 30 days. In a study, comparing the use of allograft and T-PRF in maxillary sinus augmentation, the group in which only T-PRF was applied showed successful clinical and histological results, and new bone formation was accelerated up to 4 months compared to allografts. The primary stability of the implants placed was similar in both groups.
The primary stability of the implant, the bone histology, volume, height and density of the two-stage sinus lift in the bilateral maxillary posterior region with insufficient bone height with tooth deficiency, and the placement of platelet-rich fibrin prepared with titanium on one side and bovine bone graft on the other side in implant surgery, evaluation of its effect.
Bilateral atrophic maxilla dental implant placement and who needed maxillary sinus augmentation, and who did not smoke or smoked at most 10 cigarettes will be included in the study. Before the operation, systemic and dental anamnesis will be taken from the patient and clinical measurements and radiographic images will be recorded.
Inclusion criteria
Exclusion criteria
The operation date will be given after the patient is given oral hygiene training and 4 weeks after receiving Phase I routine periodontal treatment. The data to be obtained preoperatively and postoperatively are as follows:
43 studies on the registry are indexed under Paranasal Sinus Diseases; 14 are open to participants now.
This study's enrollment of 10 is below the median of 80 across 27 interventional studies indexed under Paranasal Sinus Diseases.
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Exclusion Criteria:
A 2 cc Bio-oss bovine bone graft will be used for maxillary sinus augmentation before placing an implant on one side of the bilateral atrophic maxillary posterior regions. Then, 6 months after the surgery, the implant will be placed in accordance with the standard protocol
Procedure: Maxillary sinus augmentation with bovine bone graft
A Titanium-Platelet Rich Fibrin will be used for maxillary sinus augmentation before placing an implant on other side of the bilateral atrophic maxillary posterior regions. Titanium platelet-rich fibrin was prepared by centrifugation at 2700 rpm for 14 minutes in accordance with standard protocols. Then, 6 months after the surgery, the implant will be placed in accordance with the standard protocol
Procedure: maxillary sinus augmentation and implant placement
For maxillary sinus augmentation, the area will be prepared by lifting a full-thickness flap. The sinus membrane will be carefully elevated by opening a window through the lateral wall of the sinus on both sides.platelet-rich fibrin prepared with titanium on the other side will be placed in the space prepared in the sinus region by random selection. For Platelet-rich fibrin prepared with titanium (T-PRF), the blood taken from the patient to a 20 cc injektor was put into titanium tubes and prepared by centrifugation at 2700 rpm for 14 minutes according to the standard protocol. Then, 6 months after the surgery, histological sample will be taken with a trephine bur in both groups and the implant will be placed in accordance with the standard protocol. The stability value (ISQ) of the placed implant will be measured with the Ostell device at the time the implant is placed and 3 months after it is placed.
Also known as: Platelet-rich fibrin prepared with titanium
For maxillary sinus augmentation, the area will be prepared by lifting a full-thickness flap. The sinus membrane will be carefully elevated by opening a window through the lateral wall of the sinus on both sides. Bio-oss bovine bone graft on one side will be placed in the space prepared in the sinus region by random selection. For Platelet-rich fibrin prepared, the blood taken from the patient to a 20 cc injektor was put into titanium tubes and prepared by centrifugation at 2700 rpm for 13 minutes according to the standard protocol. Then, 6 months after the surgery, histological sample will be taken with a trephine bur in both groups and the implant will be placed in accordance with the standard protocol. The stability value (ISQ) of the placed implant will be measured with the Ostell device at the time the implant is placed and 3 months after it is placed.
Bone gain change radiologically
Change of the distance from the top of the alveolar crest to the floor of the maxillary sinus in the cone beam computerized tomography at between baseline and postoperatively 6th month.
Time frame: Postoperatively 6th month
Histomorphometric bone changes
Following at 6th month from sinus augmentation, histological samples will be evaluated new bone formation.
Time frame: Postoperatively 6th month
Bone density changes
Bone density will be evaluated on cone beam computerized tomography at 6 months after surgery with Hounsfield Units. Primary stability 3 months after implant placement (T2): Resonance frequency analysis is the unit of measurement in determining the stability of the implant. It gives the resonance frequency (kHz) on a clinically usable scale from 1-100 ISQ. It will be measured 3 months after the implant is placed. Sinus volume change (T0-T1): The measurement of the vertical and horizontal heights of the sinus cavity on tomography before and 6 months after surgery will be compared.
Time frame: Postoperatively 6th month
Primary Stabilization Value
Resonance frequency analysis is the unit of measurement in determining the stability of the implant. It gives the resonance frequency (kHz) on a clinically usable scale from 1-100 ISQ.
Time frame: Immediately after dental implant placement,
Secondary Implant Stabilization
Resonance frequency analysis is the unit of measurement in determining the stability of the implant. It gives the resonance frequency (kHz) on a clinically usable scale from 1-100 ISQ.
Time frame: At healing cap session, following dental implant placement 3rd month
Plan to share: Yes — Individual participant data can be shared if the principal investigator is contacted
Supporting information: Csr
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Kutahya Health Sciences University