Sinus DiseaseT-PRFNCT05596084
Comparison of the Use of Bovine Bone Graft and Titanium-Platelet Rich Fibrin in Maxillary Sinus Augmentation
A study testing maxillary sinus augmentation and implant placement and Maxillary sinus augmentation with bovine bone graft in people with Sinus Disease and Maxillary Sinus Disease, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Sinus Disease, Maxillary Sinus Disease
- What is being tested?
- maxillary sinus augmentation and implant placement and Maxillary sinus augmentation with bovine bone graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Mar 2022to 14 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- >18 years old
- The patient does not have any systemic disease
- Patients who need fixed implant-supported prosthesis in the bilateral maxillary posterior region
- Bilateral posterior maxilla residual bone height <5 mm
- Full mouth plaque and bleeding score ≤15%
Who cannot join
- Patients who smoke more than 10 cigarettes a day
- History of acute infection or chronic sinusitis in the Schneiderian membrane
- Having allergies involving the respiratory system
- Any contraindication for systematic periodontal surgery (Patients with bleeding platelet disorders, bisphosphonate therapy, uncontrolled diabetes (HbA1c > 6%, blood glucose level > 110 mg/dl)),
- Bilateral posterior maxilla residual bone height >5 mm
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kütahya Health Sciences University Faculty of Dentistry, Department of Periodontology
Kütahya, 43100
About this study
Official title: Clinical, Radiological and Histological Comparison of the Use of Bovine Bone Graft and Titanium-Platelet Rich Fibrin in Maxillary Sinus Augmentation: Split-Mouth Randomized Controlled Trials
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.
Read the detailed description
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
- be over 18 years old
- The patient does not have any systemic disease
- Patients who do not smoke or smoke less than 10 times a day
- Patients who need fixed implant supported prosthesis in the bilateral maxillary posterior region
- Bilateral posterior maxilla residual bone height <5 mm on current radiographs
- Full mouth plaque insertion and bleeding score ≤15%
Exclusion criteria
- Being outside the specified age range
- Patients who smoke more than 10 cigarettes a day
- History of acute infection or chronic sinusitis in the Schneiderian membrane
- Having allergies involving the respiratory system
- Any contraindication for systematic periodontal surgery (Patients with bleeding platelet disorders, bisphosphonate therapy, uncontrolled diabetes (HbA1c > 6%, blood glucose level > 110 mg/dl)),
- Bilateral posterior maxilla residual bone height >5 mm on current radiographs
- Full mouth plaque insertion and bleeding score ≥15% Bio-oss bovine bone graft on one side and platelet-rich fibrin prepared with titanium on the other side of 10 patients who require bone height increase with the maxillary sinus augmentation procedure for implant placement in the atrophic posterior maxilla with a bilateral bone height of less than 5 mm will be applied. Test group and Control group will be written in closed envelopes, and platelet-rich fibrin prepared with titanium groups and Bio-oss bovine bone graft will be selected randomly.
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:
- Plaque index (Löe\&Silness): It is obtained by measuring with a periodontal probe from 4 regions of a tooth (mesial, distal, buccal and lingual).
- Gingival index (Silness\&Löe): It is obtained by measuring with a periodontal probe from 4 regions of a tooth (mesial, distal, buccal and lingual).
- Attachment loss: The distance between the free gingiva and the base of the periodontal sulcus, based on the enamel-cementum boundary of a tooth, is measured using a periodontal probe.
- Bleeding index on probing (Ainamo \& Bay): In this index, probing is performed by gently walking around the pocket. As a result of probing, the evaluation is made by looking at the presence or absence of bleeding in the gingiva. A positive value is given if bleeding occurs within 10-15 seconds after probing in the mesial, distal, buccal and lingual gingival parts of all teeth. The ratio of the bleeding area to the examined area is expressed as %.
- Pocket depth: It is the vertical distance measured between the base of the periodontal sulcus and the gingival margin with a standard periodontal probe
- Residual bone height: It is the distance from the top of the alveolar crest to the floor of the maxillary sinus in the preoperative tomography.
- Sinus mucosal thickness: It is the measurement of the membrane's sinus floor and adjacent surfaces of the sinus cavity. Its thickness varies between 2.16-3.11.
- Sinus volume: It is the measurement of the vertical and horizontal heights of the sinus cavity.
- Fractal analysis: By placing circles of various diameters randomly in the image, the pixels of the image border inside the circles are counted. It is stated that it reflects changes in trabecular bone density and mineral loss in bone. When the panoramic radiographs were examined with fractal analysis, it was stated that the increase in the fractal size of the bone around the implant correlated with successful osteointegration and healing of the trabecular bone.
- Hounsfield unit: System computers assign a number to all voxels in the images obtained by computed tomography according to this scale. It is to paint voxels that have received numerical values with black, white and gray tones in between that match the numbers they receive. Changes in bone can be observed
- Conditions
- Sinus Disease, Maxillary Sinus Disease
- Being tested
- maxillary sinus augmentation and implant placement, Maxillary sinus augmentation with bovine bone graft
- Keywords
- maxillary sinus augmentation, xenograft, platelet-rich fibrin prepared with titanium
- Medical subject headings
- Paranasal Sinus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
maxillary sinus augmentation and implant placementProcedure or surgery
Also called 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.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.
Maxillary sinus augmentation with bovine bone graftProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Bio-oss bovine bone graft with maxillary sinus augmentation and implant placement | Experimental | 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 Receives: Procedure: Maxillary sinus augmentation with bovine bone graft |
| Titanium-Platelet Rich Fibrin with maxillary sinus augmentation and implant placement | Experimental | 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 Receives: Procedure: maxillary sinus augmentation and implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postoperatively 6th month
Histomorphometric bone changes
Following at 6th month from sinus augmentation, histological samples will be evaluated new bone formation.
Measured: Postoperatively 6th month
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: At healing cap session, following dental implant placement 3rd month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start14 Mar 2022
- Primary completion14 Apr 2023
- Study completion14 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Sinus DiseaseStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The maxillary sinus augmentation procedure has been a common treatment method since the 1980s. In patients who have insufficient bone height in the maxillary posterior edentulous region and who want implant placement, materials that provide bone formation are placed in the sinus cavity. When the bone height is 4 mm or less, it is necessary to provide bone formation with maxillary sinus augmentation surgery 6 months before implant placement. The aim of this study is to determine the primary stability of the implant by placing a titanium-rich fibrin on one side and a bovine bone graft on the other side with a sinus lift applied 6 months before the implant in bilateral maxillary posterior region with insufficient bone height with tooth deficiency. is the evaluation of the effect on the obtained bone histology, volume, height and density.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berceste Guler, Kutahya Health Sciences University
- Investigators
- Berceste Güler, Study director, Kütahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05596084
- Sponsor's protocol ID
- 2022-03/05
- Acronym
- T-PRF
- Status last verified
- Jan 2024
- First submitted
- 23 Oct 2022
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data can be shared if the principal investigator is contacted
Publications
Irinakis T. Efficacy of injectable demineralized bone matrix as graft material during sinus elevation surgery with simultaneous implant placement in the posterior maxilla: clinical evaluation of 49 sinuses. J Oral Maxillofac Surg. 2011 Jan;69(1):134-41. doi: 10.1016/j.joms.2010.07.028. Epub 2010 Nov 2.
PubMed 21050634Corbella S, Taschieri S, Del Fabbro M. Long-term outcomes for the treatment of atrophic posterior maxilla: a systematic review of literature. Clin Implant Dent Relat Res. 2015 Feb;17(1):120-32. doi: 10.1111/cid.12077. Epub 2013 May 8.
PubMed 23656352Adali E, Yuce MO, Gunbay T, Gunbay S. Does Concentrated Growth Factor Used With Allografts in Maxillary Sinus Lifting Have Adjunctive Benefits? J Oral Maxillofac Surg. 2021 Jan;79(1):98-108. doi: 10.1016/j.joms.2020.07.217. Epub 2020 Aug 5.
PubMed 32866488Tunali M, Ozdemir H, Kucukodaci Z, Akman S, Yaprak E, Toker H, Firatli E. A novel platelet concentrate: titanium-prepared platelet-rich fibrin. Biomed Res Int. 2014;2014:209548. doi: 10.1155/2014/209548. Epub 2014 Jan 21.
PubMed 24563860Olgun E, Ozkan SY, Atmaca HT, Yalim M, Hendek MK. Comparison of the clinical, radiographic, and histological effects of titanium-prepared platelet rich fibrin to allograft materials in sinus-lifting procedures. J Investig Clin Dent. 2018 Nov;9(4):e12347. doi: 10.1111/jicd.12347. Epub 2018 Jun 12.
PubMed 29893477Eken S, Guler Ayyildiz B, Altay B, Ari NS, Ozatik O. Clinical, Radiological, and Histomorphometric Comparison of the Use of Deproteinized Bovine Bone Mineral and Titanium-Prepared Platelet-Rich Fibrin in Maxillary Sinus Augmentation: A Split-Mouth Randomized Controlled Clinical Study. J Oral Maxillofac Surg. 2025 Mar;83(3):322-331. doi: 10.1016/j.joms.2024.11.006. Epub 2024 Nov 19.
PubMed 39638292
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Radiological and Histological Comparison of the Use of Bovine Bone Graft and Titanium-Platelet Rich Fibrin in Maxillary Sinus Augmentation: Split-Mouth Randomized Controlled Trials
- ClinicalTrials.gov ID
- NCT05596084
- Acronym / sponsor ID
- T-PRF / 2022-03/05
- Conditions
- Sinus Disease, Maxillary Sinus Disease
- Keywords
- maxillary sinus augmentation, xenograft, platelet-rich fibrin prepared with titanium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 14 Apr 2023 (actual)
- Study completion
- 14 Apr 2023 (actual)
- First posted
- 27 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
- be over 18 years old
- The patient does not have any systemic disease
- Patients who do not smoke or smoke less than 10 times a day
- Patients who need fixed implant supported prosthesis in the bilateral maxillary posterior region
- Bilateral posterior maxilla residual bone height <5 mm on current radiographs
- Full mouth plaque insertion and bleeding score ≤15%
Exclusion criteria
- Being outside the specified age range
- Patients who smoke more than 10 cigarettes a day
- History of acute infection or chronic sinusitis in the Schneiderian membrane
- Having allergies involving the respiratory system
- Any contraindication for systematic periodontal surgery (Patients with bleeding platelet disorders, bisphosphonate therapy, uncontrolled diabetes (HbA1c > 6%, blood glucose level > 110 mg/dl)),
- Bilateral posterior maxilla residual bone height >5 mm on current radiographs
- Full mouth plaque insertion and bleeding score ≥15% Bio-oss bovine bone graft on one side and platelet-rich fibrin prepared with titanium on the other side of 10 patients who require bone height increase with the maxillary sinus augmentation procedure for implant placement in the atrophic posterior maxilla with a bilateral bone height of less than 5 mm will be applied. Test group and Control group will be written in closed envelopes, and platelet-rich fibrin prepared with titanium groups and Bio-oss bovine bone graft will be selected randomly.
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:
- Plaque index (Löe\&Silness): It is obtained by measuring with a periodontal probe from 4 regions of a tooth (mesial, distal, buccal and lingual).
- Gingival index (Silness\&Löe): It is obtained by measuring with a periodontal probe from 4 regions of a tooth (mesial, distal, buccal and lingual).
- Attachment loss: The distance between the free gingiva and the base of the periodontal sulcus, based on the enamel-cementum boundary of a tooth, is measured using a periodontal probe.
- Bleeding index on probing (Ainamo \& Bay): In this index, probing is performed by gently walking around the pocket. As a result of probing, the evaluation is made by looking at the presence or absence of bleeding in the gingiva. A positive value is given if bleeding occurs within 10-15 seconds after probing in the mesial, distal, buccal and lingual gingival parts of all teeth. The ratio of the bleeding area to the examined area is expressed as %.
- Pocket depth: It is the vertical distance measured between the base of the periodontal sulcus and the gingival margin with a standard periodontal probe
- Residual bone height: It is the distance from the top of the alveolar crest to the floor of the maxillary sinus in the preoperative tomography.
- Sinus mucosal thickness: It is the measurement of the membrane's sinus floor and adjacent surfaces of the sinus cavity. Its thickness varies between 2.16-3.11.
- Sinus volume: It is the measurement of the vertical and horizontal heights of the sinus cavity.
- Fractal analysis: By placing circles of various diameters randomly in the image, the pixels of the image border inside the circles are counted. It is stated that it reflects changes in trabecular bone density and mineral loss in bone. When the panoramic radiographs were examined with fractal analysis, it was stated that the increase in the fractal size of the bone around the implant correlated with successful osteointegration and healing of the trabecular bone.
- Hounsfield unit: System computers assign a number to all voxels in the images obtained by computed tomography according to this scale. It is to paint voxels that have received numerical values with black, white and gray tones in between that match the numbers they receive. Changes in bone can be observed
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The maxillary sinus augmentation procedure has been a common treatment method since the 1980s. In patients who have insufficient bone height in the maxillary posterior edentulous region and who want implant placement, materials that provide bone formation are placed in the sinus cavity. When the bone height is 4 mm or less, it is necessary to provide bone formation with maxillary sinus augmentation surgery 6 months before implant placement. The aim of this study is to determine the primary stability of the implant by placing a titanium-rich fibrin on one side and a bovine bone graft on the other side with a sinus lift applied 6 months before the implant in bilateral maxillary posterior region with insufficient bone height with tooth deficiency. is the evaluation of the effect on the obtained bone histology, volume, height and density.
| Arm | Type | Receives |
|---|---|---|
| Bio-oss bovine bone graft with maxillary sinus augmentation and implant placement | Experimental | Procedure: Maxillary sinus augmentation with bovine bone graftA 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 |
| Titanium-Platelet Rich Fibrin with maxillary sinus augmentation and implant placement | Experimental | Procedure: maxillary sinus augmentation and implant placementA 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- >18 years old
- The patient does not have any systemic disease
- Patients who need fixed implant-supported prosthesis in the bilateral maxillary posterior region
- Bilateral posterior maxilla residual bone height <5 mm
- Full mouth plaque and bleeding score ≤15%
Key exclusion criteria (5 listed)
- Patients who smoke more than 10 cigarettes a day
- History of acute infection or chronic sinusitis in the Schneiderian membrane
- Having allergies involving the respiratory system
- Any contraindication for systematic periodontal surgery (Patients with bleeding platelet disorders, bisphosphonate therapy, uncontrolled diabetes (HbA1c > 6%, blood glucose level > 110 mg/dl)),
- Bilateral posterior maxilla residual bone height >5 mm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| maxillary sinus augmentation and implant placementAlso: Platelet-rich fibrin prepared with titaniumFor 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. | Procedure or surgery | Titanium-Platelet Rich Fibrin with maxillary sinus augmentation and implant placement |
| Maxillary sinus augmentation with bovine bone graftFor 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. | Procedure or surgery | Bio-oss bovine bone graft with maxillary sinus augmentation and implant placement |
Primary outcome
Bone gain change radiologically
Time frame: Postoperatively 6th month
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.
Histomorphometric bone changes
Time frame: Postoperatively 6th month
Following at 6th month from sinus augmentation, histological samples will be evaluated new bone formation.
3 secondary outcomes
Bone density changes
Time frame: Postoperatively 6th month
Primary Stabilization Value
Time frame: Immediately after dental implant placement,
Secondary Implant Stabilization
Time frame: At healing cap session, following dental implant placement 3rd month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Results publication: PubMed 21050634Irinakis T. Efficacy of injectable demineralized bone matrix as graft material during sinus elevation surgery with simultaneous implant placement in the posterior maxilla: clinical evaluation of 49 sinuses. J Oral Maxillofac Surg. 2011 Jan;69(1):134-41. doi: 10.1016/j.joms.2010.07.028. Epub 2010 Nov 2.
- Results publication: PubMed 23656352Corbella S, Taschieri S, Del Fabbro M. Long-term outcomes for the treatment of atrophic posterior maxilla: a systematic review of literature. Clin Implant Dent Relat Res. 2015 Feb;17(1):120-32. doi: 10.1111/cid.12077. Epub 2013 May 8.
- Results publication: PubMed 32866488Adali E, Yuce MO, Gunbay T, Gunbay S. Does Concentrated Growth Factor Used With Allografts in Maxillary Sinus Lifting Have Adjunctive Benefits? J Oral Maxillofac Surg. 2021 Jan;79(1):98-108. doi: 10.1016/j.joms.2020.07.217. Epub 2020 Aug 5.
- Results publication: PubMed 24563860Tunali M, Ozdemir H, Kucukodaci Z, Akman S, Yaprak E, Toker H, Firatli E. A novel platelet concentrate: titanium-prepared platelet-rich fibrin. Biomed Res Int. 2014;2014:209548. doi: 10.1155/2014/209548. Epub 2014 Jan 21.
- Results publication: PubMed 29893477Olgun E, Ozkan SY, Atmaca HT, Yalim M, Hendek MK. Comparison of the clinical, radiographic, and histological effects of titanium-prepared platelet rich fibrin to allograft materials in sinus-lifting procedures. J Investig Clin Dent. 2018 Nov;9(4):e12347. doi: 10.1111/jicd.12347. Epub 2018 Jun 12.
- Derived from this study: PubMed 39638292Eken S, Guler Ayyildiz B, Altay B, Ari NS, Ozatik O. Clinical, Radiological, and Histomorphometric Comparison of the Use of Deproteinized Bovine Bone Mineral and Titanium-Prepared Platelet-Rich Fibrin in Maxillary Sinus Augmentation: A Split-Mouth Randomized Controlled Clinical Study. J Oral Maxillofac Surg. 2025 Mar;83(3):322-331. doi: 10.1016/j.joms.2024.11.006. Epub 2024 Nov 19.
- Individual participant dataSharing planned: Yes. Individual participant data can be shared if the principal investigator is contacted
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Berceste Güler study director
Kütahya Health Sciences University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing maxillary sinus augmentation and implant placement and Maxillary sinus augmentation with bovine bone graft in people with Sinus Disease and Maxillary Sinus Disease, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone gain change radiologically (time frame: Postoperatively 6th month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05596084, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.