Comparison of the Use of Bovine Bone Graft and Titanium-Platelet Rich Fibrin in Maxillary Sinus Augmentation

NCT05596084 | Completed

• 1 other identifier: 2022-03/05
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Sinus Disease; Maxillary Sinus Disease

Keywords

maxillary sinus augmentation; xenograft; platelet-rich fibrin prepared with titanium

Outcome Measures

Primary Outcomes (2)

• 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.

  Postoperatively 6th month

• Histomorphometric bone changes

  Following at 6th month from sinus augmentation, histological samples will be evaluated new bone formation.

  Postoperatively 6th month

Secondary Outcomes (3)

• Bone density changes

  Postoperatively 6th month

• Primary Stabilization Value

  Immediately after dental implant placement,

• Secondary Implant Stabilization

  At healing cap session, following dental implant placement 3rd month

Study Arms (2)

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

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

Procedure: maxillary sinus augmentation and implant placement

Interventions

maxillary sinus augmentation and implant placement PROCEDURE

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

Titanium-Platelet Rich Fibrin with maxillary sinus augmentation and implant placement

Maxillary sinus augmentation with bovine bone graft PROCEDURE

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.

Bio-oss bovine bone graft with maxillary sinus augmentation and implant placement

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Kutahya Health Sciences University: lead

Study Sites (1)

Kütahya Health Sciences University Faculty of Dentistry, Department of Periodontology

Kütahya, 43100, Turkey (Türkiye)

Location

Related Publications (6)

• 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.

  PMID: 21050634 RESULT

• 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.

  PMID: 23656352 RESULT

• 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.

  PMID: 32866488 RESULT

• 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.

  PMID: 24563860 RESULT

• 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.

  PMID: 29893477 RESULT

• Eken 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.

  PMID: 39638292 DERIVED

MeSH Terms

Conditions

Paranasal Sinus Diseases

Interventions

Titanium

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Metals, Light; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Berceste Güler

  Kütahya Health Sciences University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Model Details: 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.

Study Record Dates

• First Submitted: October 23, 2022
• First Posted: October 27, 2022
• Study Start: March 14, 2022
• Primary Completion: April 14, 2023
• Study Completion: April 14, 2023
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Following acceptance of manuscript
• Access Criteria: Individual participant data can be shared if the principal investigator is contacted

Locations

TU (1)