Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05596084
Other study ID # 2022-03/05
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 14, 2022
Est. completion date April 14, 2023

Study information

Verified date January 2024
Source Kutahya Health Sciences University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Description:

Read more »
Read more »

Study Design


Intervention

Read more »

Locations

Country Name City State
Turkey Kütahya Health Sciences University Faculty of Dentistry, Department of Periodontology Kütahya

Sponsors (1)

Lead Sponsor Collaborator
Kutahya Health Sciences University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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. — View 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. — View 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. d — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Histomorphometric bone changes Following at 6th month from sinus augmentation, histological samples will be evaluated new bone formation. Postoperatively 6th month
Secondary 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.
Postoperatively 6th month
Secondary 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. Immediately after dental implant placement,
Secondary 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. At healing cap session, following dental implant placement 3rd month
See also
  Status Clinical Trial Phase
Recruiting NCT05494099 - Extended Endoscopic Approaches to Non-malignant Maxillary Sinus Lesions Comparative
Active, not recruiting NCT03046173 - Concentrated Growth Factors Applied in Maxillary Sinus Floor Elevation Via a Lateral Window Approach N/A
Not yet recruiting NCT06071416 - Biphasic Material With PRF in Lateral Sinus Floor Augmentation Phase 1
Not yet recruiting NCT04702867 - Association Between Periodontal Bone Loss and Maxillary Sinus Changes.
Not yet recruiting NCT05411510 - Evaluation of Bone Height Gain Following Trans-crestal Sinus Floor Elevation N/A