The effectiveness of a novel osseous densification approach on implants' primary and secondary stability: a clinical trial
| ISRCTN | ISRCTN15797074 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15797074 |
- Submission date
- 24/03/2024
- Registration date
- 02/04/2024
- Last edited
- 19/06/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Primary stability in dental implants is crucial for successful bone integration, and factors like the surgical procedure and bone density play key roles in achieving it. The size of the hole drilled, the design of the implant, and the amount of pressure on the bone all affect how stable the implant is.
Insertion torque and the patient's bone density also impact how well the implant stabilizes. Higher insertion torque leads to better stability compared to lower values. Where the jawbone is less dense there may be less contact between the bone and the implant, which can reduce stability. Ensuring there's enough bone during implant preparation is crucial for long-term stability. Secondary stability, which develops over time as the bone remodels around the implant, is also important. A new drilling method called osseodensification increases bone density around the implant, improves primary stability, reduces implant movement during integration and allows for immediate loading in some cases. The aim of this study is to evaluate the effectiveness of osseodensification in low-density bone.
Who can participate?
Patients over the age of 18 years who require at least two dental implants in the upper jaw
What does the study involve?
In order to compare osseodensification and conventional drilling, implants were placed side by side with both techniques and assessed at three different times: at implant placement, 6 months after implant placement, and 1-year follow-up.
What are the possible benefits and risks of participating?
Osseodensification helps increase bone density and boosts the initial stability of the implant. This is important for reducing movements of the implant during integration in low-density bone. Another benefit is that it reduces the size of the holes made during drilling when the drills are taken out.
Where is the study run from?
University Institute of Health Sciences - IUCS Portugal in CESPU - Famalicão clinical unit (Portugal)
When is the study starting and how long is it expected to run for?
January 2019 to December 2023
Who is funding the study?
Infante da Camara Dental Institute (Portugal)
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
Rua Correia de Sá
Porto
4150-229
Portugal
 ORCID ID |
0000-0002-9551-5407 |
|---|---|
| Phone | +351 (0)914112775 |
| marco.camara@iucs.cespu.pt |
Principal Investigator
Rua Central de Gandra
Gandra
4585-116
Portugal
| ORCID ID |
0000-0003-2449-6293 |
|---|---|
| Phone | +351 (0)967694939 |
| joao.pereira@iucs.cespu.pt |
Study information
| Study design | Clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | See study outputs table |
| Scientific title | The effectiveness of osseodensification drilling versus conventional surgical technique on implant stability: a clinical trial |
| Study acronym | Osseodensification |
| Study objectives | The aim of this study is to evaluate osseodensification effectiveness in low-density bone and assess insertion torque and resonance frequency analysis at three different times: 1. On the day of implant placement (T1) 2. 6 months after implant placement (T2) 3. 1-year follow-up (T3) Osseodensification provides less invasive surgeries with a lower pain perception and less post-operative morbidity. |
| Ethics approval(s) |
Approved 05/02/2019, CESPU Ethics Committee (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 in low density bone |
| Intervention | Osseodensification and conventional drilling in dental implant surgery in type IV bone. All patients underwent a preliminary assessment that included a careful analysis of their medical and dental histories and a detailed clinical examination. Patients were thoroughly informed, by means of oral and written explanations, about the purpose and procedures of the study, and informed consent was obtained from all participants. In order to perform a comparison between osseodensification and subtractive conventional drilling, implants were placed side by side with both techniques to establish a comparison in resonance frequency analysis (RFA) and torque values matched for age, gender and smoking habit. Insertion torque (IT) and resonance frequency analysis were carried out at three different times: i) surgical phase of implant placement (T1); ii) 6 months after implant placement (T2); iii) 1-year follow-up (T3). |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Insertion torque was measured at T1 using a manual torque wrench (Straumann®) and the implant stability quotient (ISQ) was registered as the average of the buccal, lingual, mesial and distal readings using the Osstell® ISQ device (Osstell, W&H, Gothenburg, Sweden) |
| Secondary outcome measures | ISQ measured using the Osstell® ISQ device at 6 months and 1 year after surgery |
| Overall study start date | 15/01/2019 |
| Completion date | 16/12/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | Both |
| Target number of participants | 120 |
| Total final enrolment | 90 |
| Key inclusion criteria | 1. At least 18 years old 2. Have healed edentulous sites on the posterior maxillae region with at least 3 months postextraction period 3. Need to receive at least two dental implants 4. Have sufficient residual bone volume for implant placement without the need for bone augmentation where the minimum ridge height and width should be ≥8 and ≥6 mm, respectively |
| 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. Past or ongoing use of steroids or bisphosphonates 10. Previous bone regenerative or augmentation procedures |
| Date of first enrolment | 06/02/2019 |
| Date of final enrolment | 10/03/2019 |
Locations
Countries of recruitment
- Portugal
Study participating centre
Gandra
4585-116
Portugal
Sponsor information
Research organisation
Rua Correia de Sá 107
Porto
4150-229
Portugal
| Phone | +351 (0)226171045 |
|---|---|
| geral@infantedacamaradentalinstitute.pt | |
| Website | https://www.infantedacamaradentalinstitute.pt/ |
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 08/06/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| Publication and dissemination plan | Finalised the data collection of 278 implants in 90 patients in T1, T2 and T3, now in statistical analysis. |
| IPD sharing plan | The datasets generated during the current study are stored in a non-publicly available repository (https://repositorio.cespu.pt/) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 15/05/2024 | 19/06/2024 | Yes | No |
Editorial Notes
19/06/2024: Publication reference added.
28/03/2024: Study's existence confirmed by the CESPU Ethics Committee.
