The utilization of a mixture containing platelet-rich fibrin and Synthetic Hydroxyapatite (Nanobone) substance in the process of enhancing the volume of the maxillary sinus for medical purposes.
| ISRCTN | ISRCTN99349253 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99349253 |
- Submission date
- 10/03/2024
- Registration date
- 18/03/2024
- Last edited
- 25/07/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Several techniques have been described for maxillary sinus graft augmentation such as the lateral window technique, or crestal approach with osteotomes or osseodensification. Platelet-rich fibrin (PRF) has been used in maxillary sinus lift procedures due to its ability to fasten the soft and hard tissue healing. PRF is an autologous platelet concentrate containing leukocyte. This study aims to evaluate the potential of PRF in combination with Synthetic hydroxyapatite Nanobone ® to enhance bone regeneration in sinus floor elevation with Lateral window technique in a split-mouth study, twelve sinus graft surgeries were carried out.
Who can participate?
Adults over the age of 18 years who attend consultation in University Institute of Health Sciences -IUCS in Portugal.
What does the study involve? (for participants)
Participants are asked to join this study in the implant consultation in Cespu University dental clinic . Participants must pass the screening the inclusion criteria. Participants must have pneumatized sinus with insufficient bone height for implant placement. Those in the first group as asked to give blood at the usual donation intervals (based on their gender). The study will last 6 months. Participants also complete informed consent and questionnaires before being choosen to participate in the study.
What are the possible benefits and risks of participating?
Potential faster bone and soft tissue healing using PRF
Where is the study run from?
University Institute of Health Sciences -IUCS Portugal in Cespu university dental clinic and Coimbra University Hard tissue Laboratory.
When is the study starting and how long is it expected to run for?
January 2023 to December 2023
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Marco Infante da Câmara DDS, MsC, PhD
m_infante2@hotmail.com
marco.camara@iucs.cespu.pt
Contact information
Public, Scientific, Principal Investigator
Rua Correia de Sá n 107
Porto
4150-229
Portugal
 ORCID ID |
0000-0002-9551-5407 |
|---|---|
| Phone | +351914112775 |
| m_infante2@hotmail.com |
Public
Rua de Gondim n221 Vale São Cosme
Vila Nova de Famalicão
4770-570
Portugal
| ORCID ID |
0000-0003-2462-4734 |
|---|---|
| Phone | +351 914240555 |
| rosana_gcosta@hotmail.com |
Scientific
Rua Correia de Sá n 107
Porto
4150-229
Portugal
| ORCID ID |
0000-0003-0713-2041 |
|---|---|
| Phone | +351 914112775 |
| marta.relvas@iucs.cespu.pt |
Public, Scientific, Principal Investigator
Rua Correia de Sá n 107
Porto
4150-229
Portugal
| Phone | +351914112775 |
|---|---|
| marco.camara@iucs.cespu.pt |
Study information
| Study design | Interventional randomized controlled (split-mouth) trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | 45160 PIS.pdf |
| Scientific title | Clinical application of platelet-rich fibrin mixed with Synthetic Hydroxyapatite (Nanobone) material in maxillary sinus augmentation - randomised clinical trial |
| Study objectives | The aim of this clinical-histological study is to evaluate the potential of PRF in combination with Synthetic hydroxyapatite Nanobone to enhance bone regeneration in sinus floor elevation with Lateral window technique. |
| Ethics approval(s) |
Approved 14/07/2023, CESPU Ethics Committee (Rua Central de Gandra, Gandra, 4585-116, Portugal; +351 224 157 100; sec.ce@cespu.pt), ref: CE/IUCS/CESPU-18/23 |
| Health condition(s) or problem(s) studied | Reduced bone height in the posterior maxilla (1-4 mm) |
| Intervention | Participants will be randomized to test or control treatment lateral window technique for sinus augmentation using Liquid PRF with Nanobone / Nanobone alone based on computer-generated random codes. The allocation will be hidden from the surgeon by opaque envelopes to be opened right before the surgical procedure. With the exception of the surgical technique used, all methodology will be similar for both groups. Patients will be followed up for 6 months after surgery and until the implants are loaded with the final restoration. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Pain perception measured using the Visual Analogue Scale during the first week after surgery |
| Secondary outcome measures | 1. Quality of life measured using the Oral Health Impact Profile 14 translated in Portuguese during the first week after surgery 2. Implant osseointegration success rate measured using clinical examination at 6 months after surgery 3. Patient registration of analgesic medication usage during the first week after surgery |
| Overall study start date | 02/01/2023 |
| Completion date | 17/12/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 60 Years |
| Sex | Both |
| Target number of participants | 50 |
| Total final enrolment | 6 |
| Key inclusion criteria | 1. At least eighteen years old 2. Have healed edentulous sites on the posterior maxillae region with 5mm or less residual bone height to place implants in need of sinus graft procedure. |
| Key exclusion criteria | 1. Alcoholism 2. Smoking 3. Drug abuse 4. Diabetes 5. Heart disease 6. Bleeding disorders 7. Weakened immune systems 8. Radiation exposure 9. Bleeding disorders 10. Past or ongoing use of steroids or bisphosphonates 11. Prior bone augmentation |
| Date of first enrolment | 15/07/2023 |
| Date of final enrolment | 28/07/2023 |
Locations
Countries of recruitment
- Portugal
Study participating centre
Gandra
4585-116
Portugal
Sponsor information
Other
Av. Central das Termas, 165 Termas de São Vicente
Penafiel
4575-375
Portugal
| Phone | +351 255 630 600 |
|---|---|
| mfranciscomc@gmail.com | |
| Website | https://www.suavemed.pt/ |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/08/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| Publication and dissemination plan | Planned publication in 2024, in a high-impact peer-reviewed journal in an ongoing study of the histological results. |
| IPD sharing plan | The data will be stored in the IUCS-CESPU repository named Repositório CESPU (https://repositorio.cespu.pt/) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 18/03/2024 | No | Yes | ||
| Results article | 25/07/2024 | 25/07/2024 | Yes | No |
Additional files
Editorial Notes
25/07/2024: Publication reference added.
01/05/2024: Contact and sponsor details updated. The intention to publish date was changed from 01/04/2024 to 01/08/2024.
18/03/2024: Trial's existence confirmed by CESPU Ethics Committee.
