Clinical trial NCT05596084: Comparison of the Use of Bovine Bone Graft and Titanium-Platelet Rich Fibrin in Maxillary Sinus Augmentation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sinus Disease
Maxillary Sinus Disease
Keywords: maxillary sinus augmentation
xenograft
platelet-rich fibrin prepared with titanium
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2022-10-27
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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. 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

1. be over 18 years old
2. The patient does not have any systemic disease
3. Patients who do not smoke or smoke less than 10 times a day
4. Patients who need fixed implant supported prosthesis in the bilateral maxillary posterior region
5. Bilateral posterior maxilla residual bone height \<5 mm on current radiographs
6. Full mouth plaque insertion and bleeding score ≤15%

Exclusion criteria

1. Being outside the specified age range
2. Patients who smoke more than 10 cigarettes a day
3. History of acute infection or chronic sinusitis in the Schneiderian membrane
4. Having allergies involving the respiratory system
5. Any contraindication for systematic periodontal surgery (Patients with bleeding platelet disorders, bisphosphonate therapy, uncontrolled diabetes (HbA1c \> 6%, blood glucose level \> 110 mg/dl)),
6. Bilateral posterior maxilla residual bone height \>5 mm on current radiographs
7. 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:

1. Plaque index (Löe\&Silness): It is obtained by measuring with a periodontal probe from 4 regions of a tooth (mesial, distal, buccal and lingual).
2. Gingival index (Silness\&Löe): It is obtained by measuring with a periodontal probe from 4 regions of a tooth (mesial, distal, buccal and lingual).
3. 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.
4. 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 %.
5. Pocket depth: It is the vertical distance measured between the base of the periodontal sulcus and the gingival margin with a standard periodontal probe
6. 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.
7. 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.
8. Sinus volume: It is the measurement of the vertical and horizontal heights of the sinus cavity.
9. 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.
10. 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

Eligibility criteria: Inclusion Criteria:

1. \>18 years old
2. The patient does not have any systemic disease
3. Patients who need fixed implant-supported prosthesis in the bilateral maxillary posterior region
4. Bilateral posterior maxilla residual bone height \<5 mm
5. Full mouth plaque and bleeding score ≤15%

Exclusion Criteria:

1. Patients who smoke more than 10 cigarettes a day
2. History of acute infection or chronic sinusitis in the Schneiderian membrane
3. Having allergies involving the respiratory system
4. Any contraindication for systematic periodontal surgery (Patients with bleeding platelet disorders, bisphosphonate therapy, uncontrolled diabetes (HbA1c \> 6%, blood glucose level \> 110 mg/dl)),
5. Bilateral posterior maxilla residual bone height \>5 mm

Primary outcomes:
measure: Bone gain change radiologically
timeFrame: Postoperatively 6th month
measure: Histomorphometric bone changes
timeFrame: Postoperatively 6th month
Secondary outcomes:
measure: Bone density changes
timeFrame: Postoperatively 6th month
measure: Primary Stabilization Value
timeFrame: Immediately after dental implant placement,
measure: Secondary Implant Stabilization
timeFrame: At healing cap session, following dental implant placement 3rd month
Other outcomes:
Locations:
city: Kütahya
country: Turkey
facility: Kütahya Health Sciences University Faculty of Dentistry, Department of Periodontology
Study officials:
affiliation: Kütahya Health Sciences University
name: Berceste Güler
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Corbella 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.
citation: Adali 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.
citation: Tunali 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.
citation: Olgun 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.