Using platelet-rich fibrin prepared with titanium tubes in external sinus lift
| ISRCTN | ISRCTN11300231 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11300231 |
- Submission date
- 08/05/2025
- Registration date
- 09/05/2025
- Last edited
- 27/05/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English Summary
Background and study aims
This study aims to evaluate the effectiveness of a material called T-PRF as a solo filler in sinus lifting procedures. The goal is to compare T-PRF to traditional bone grafts (allografts and xenografts) when placing dental implants either at the same time as the sinus lift or after a delay.
Who can participate?
Participants should be in good oral health, have missing teeth in the upper jaw (premolars or molars), and meet specific bone height and width requirements. They should be aged between 30 and 60 years.
What does the study involve?
Participants will be divided into four groups:
1. Two groups will have a sinus lift and dental implant placed at the same time. One group will use T-PRF, and the other will use traditional bone grafts.
2. Two groups will have a sinus lift first and the dental implant placed after six months. One group will use T-PRF, and the other will use traditional bone grafts.
What are the possible benefits and risks of participating?
The potential benefits include gaining bone and support for dental implants in a safe, easy, and cost-effective way. There are no known risks associated with this technique.
Where is the study run from?
Damascus University (Syria)
When is the study starting and how long is it expected to run for?
September 2023 to February 2025
Who is funding the study?
Damascus University (Syria)
Who is the main contact?
Dr Zakaria Awad, awadzakaria31@gmail.com
Contact information
Public, Principal Investigator
Faculty of Dentistry
Damascus
-
Syria
 ORCID ID |
0000-0002-1190-9151 |
|---|---|
| Phone | +963 964314346 |
| zakaria31.awad@damascusuniversity.edu.sy |
Scientific
Faculty of Dentistry
Damascus
-
Syria
| Phone | +963 944594323 |
|---|---|
| zavengarabed@damascusuniversity.edu.sy |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | University/medical school/dental school |
| Study type | Treatment |
| Scientific title | The use of titanium-prepared platelet-rich fibrin in sinus lifting with simultaneous and delayed implantation comparative clinical radiographic study |
| Study acronym | T-PRF lateral window approach |
| Study hypothesis | Using T-PRF instead of bone grafts in sinus augmentation because of there are disadvantages related with bone grafts like infection,transmitting diseases, high economic cost, immune response, length period of its absorption |
| Ethics approval(s) |
Approved 15/04/2025, Ethical Approval for Biomedical Researches (Damascus University, Damascus, -, Syria; +963 964314346; dl.srd@damascusuniversity.edu.sy), ref: DN-150425-425 |
| Condition | Bone gain to dental implants placement |
| Intervention | The study includes 4 groups 2 groups sinus lift with simultaneous implant placement, experimental group we use T-PRF as s solo filler, control group we use allograft + xenograft 2 groups sinus lift with delayed implant placement, experimental group we use T-PRF, control group we use allograft + xenograft and implant placement after 6 months of surgery |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Bone gain height is measured using CBCT imaging at baseline and 6 months 2. Bone gain volume is measured using CBCT imaging at baseline and 6 months 3. Implant stability (ISQ) is measured using MegaISQ II (RAF) at immediate implantation, 3 months, and 6 months 4. Bone density (HU) is measured using CBCT imaging at immediate post-surgery and 6 months 5. Complications (membrane perforation, sinusitis) measured using patient records |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 15/09/2023 |
| Overall study end date | 22/02/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 30 Years |
| Upper age limit | 60 Years |
| Sex | Both |
| Target number of participants | 28 cases of sinus lift divided into 4 groups , 7 cases in each group |
| Participant inclusion criteria | 1. Good oral health 2. Have missing teeth in the premolars or molars of maxillary 3. Residual bone height between 4-6 mm for first two groups and less than 4 mm for second two groups 4. Minimum width (buccal-palatal) 6mm 5. Aged between 30-60 years |
| Participant exclusion criteria | 1. Systematic disease(diabetes-hyperthyroidism) 2. Contraindication of surgery 3. Patient refuses treatment 4. Bad oral health |
| Recruitment start date | 01/01/2024 |
| Recruitment end date | 15/02/2025 |
Locations
Countries of recruitment
- Syria
Study participating centre
Damascus
-
Syria
Sponsor information
University/education
Faculty of Dentistry
Damascus
-
Syria
| Phone | +963 944594323 |
|---|---|
| zavengarabed@damascusuniversity.edu.sy | |
| Website | https://www.damascusuniversity.edu.sy/ |
"ROR" |
https://ror.org/03m098d13 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- University of Damascus, جَامِعَةُ دِمَشْقَ, DU
- Location
- Syria
Results and Publications
| Intention to publish date | 20/06/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. awadzakaria31@gmail.com |
Editorial Notes
09/05/2025: Trial's existence confirmed by Damascus University.
