Maxillary sinus augmentation using different osseodensification protocols: a retrospective study with 3-year follow-up
| ISRCTN | ISRCTN17397796 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17397796 |
- Submission date
- 24/09/2025
- Registration date
- 06/10/2025
- Last edited
- 06/10/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
The rehabilitation of atrophic jaws may require sinus floor elevation procedures before or simultaneously with implant placement. Several surgical procedures have been documented for maxillary sinus elevation to overcome this bone resorption, and more recently, conservative and minimally invasive protocols using the osseodensification (OD) technique have been described. This study aims to determine the relationship between Insertion torque (IT) and resonance frequency analysis (RFA) on the day of implant placement. And how the ISQ varied over 36 months of follow-up.
Who can participate?
Patients at least 18 years old with healed edentulous sites in the posterior maxilla with residual bone height between 2 and 8 mm to facilitate the placement of implants requiring sinus grafting procedures
What does the study involve?
The study involves the use of a novel osseous technique in the rehabilitation of atrophic maxillae.
What are the possible benefits and risks of participating?
The use of osseodensification technique differs from other maxillary sinus elevation techniques, which use subtractive instrumentation method to perform the implant bed to the desired diameter, increasing the risk of perforation of the maxillary sinus membrane.
Where is the study run from?
Cooperativa de Ensino Superior Politécnico e Universitário (Portugal)
When is the study starting and how long is it expected to run for?
February 2019 to February 2022
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Prof. Marco Câmara, marco.camara@iucs.cespu.pt
Contact information
Public, Scientific
Rua Central de Gandra
Gandra
4585-116
Portugal
 ORCID ID |
0000-0003-2462-4734 |
|---|---|
| Phone | +351 (0)914240555 |
| rosana.costa@iucs.cespu.pt |
Principal investigator
Rua Central de Gandra
Gandra
4585-116
Portugal
| ORCID ID |
0000-0002-9551-5407 |
|---|---|
| Phone | +351 (0)914112775 |
| marco.camara@iucs.cespu.pt |
Study information
| Study design | Retrospective observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Sinus floor elevation using osseodensification protocols I, II and III: a retrospective study with 36 months follow-up |
| Study objectives | To determine the relationship between insertion torque (IT) and resonance frequency analysis (RFA) on the day of implant placement, and how the implant stability quotient (ISQ) varied over 36 months of follow-up. |
| Ethics approval(s) |
Approved 05/02/2019, Ethics Committee of the University Institute of Health Sciences (Rua Central de Gandra, Gandra, 4585-116, Portugal; +351 (0)224 157 100; sec.ce@cespu.pt), ref: 02/CE-IUCS/2019 |
| Health condition(s) or problem(s) studied | Dental implant stability |
| Intervention | The participants provided their informed consent after being thoroughly enlightened about the goal and methods of the study both orally and in writing. A meticulous clinical examination, an assessment of oral hygiene, and a detailed analysis of the patients’ medical and dental histories comprised the initial evaluation of each patient. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Insertion torque (IT) measured using a manual torque wrench (Straumann®, Basel, Switzerland) and resonance frequency analysis (RFA) on the day of implant placement |
| Secondary outcome measures | The implant stability quotient (ISQ) value was recorded as the average of buccal, lingual, mesial, and distal measurements using Osstell® IDX (Osstell, W&H, Gothenburg, Sweden) immediately after implant placement (T1); 1 year after implant placement (T2); 2 years of follow-up (T3); 3 years of follow-up (T4) |
| Overall study start date | 05/02/2019 |
| Completion date | 15/02/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | All |
| Target number of participants | 190 |
| Total final enrolment | 105 |
| Key inclusion criteria | 1. At least 18 years old 2. Healed edentulous sites in the posterior maxilla with residual bone height between 2 and 8 mm to facilitate the placement of implants requiring sinus grafting procedures after prior analysis with Cone Beam computer Tomography (CBCT, New Tom® Go 3D, CEFLA S.C., Imola (BO) Italy) |
| Key exclusion criteria | 1. Irradiated patients 2. Impaired immune systems 3. Smoking, drug abuse or alcoholism 4. Diabetes 5. Heart disease 6. Bleeding disorders 7. Sinus pathology 8. Previous bone augmentation 9. Past or current usage of steroids or bisphosphonates |
| Date of first enrolment | 06/02/2019 |
| Date of final enrolment | 06/02/2022 |
Locations
Countries of recruitment
- Portugal
Study participating centre
Gandra
4585-116
Portugal
Sponsor information
Research organisation
Rua Central de Gandra
Gandra
4585-116
Portugal
| Website | https://www.cespu.pt/en/ |
|---|---|
"ROR" |
https://ror.org/00w7bj245 |
Funders
Funder type
Not defined
No information available
Results and Publications
| Intention to publish date | 01/01/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| Publication and dissemination plan | |
| IPD sharing plan | The datasets generated during the current study are stored in a non-publicly available repository (https://repositorio.cespu.pt/) |
Editorial Notes
29/09/2025: Study's existence confirmed by the Ethics Committee of the University Institute of Health Sciences.
