Comparison of the Use of Bovine Bone Graft and Titanium-Platelet Rich Fibrin in Maxillary Sinus Augmentation
Condition: Sinus Disease; Maxillary Sinus Disease
MeSH terms: Paranasal Sinus Diseases
Study type: Interventional

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
    

Intervention name(s): maxillary sinus augmentation and implant placement; Maxillary sinus augmentation with bovine bone graft
Intervention type(s): Procedure; Procedure
Intervention description(s): 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.; 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.
Other intervention name(s): Platelet-rich fibrin prepared with titanium
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: maxillary sinus augmentation; xenograft; platelet-rich fibrin prepared with titanium