The complete upper or lower set of teeth replacement with four dental implants
| ISRCTN | ISRCTN16104700 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16104700 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 4720 |
| Sponsor | Sapienza University of Rome |
| Funder | International Team for Implantology |
- Submission date
- 07/02/2022
- Registration date
- 10/02/2022
- Last edited
- 09/02/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
This study looked at patients who had a complete replacement set of upper or lower teeth using a relatively new technique involving 4 dental implants.
Who can participate?
Patients requiring a complete set of upper or lower teeth
What does the study involve?
Patient records were reviewed to look at the long term outcomes of patients who were treated with the above technique.
What are the possible benefits and risks of participating?
The benefits for the treated patients are restitution of mouth and teeth function
Where is the study run from?
La Sapienza University of Rome (Italy)
When is the study starting and how long is it expected to run for?
January 2010 to June 2020
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Paolo Carosi, paolo.carosi@alumni.uniroma2.eu
Contact information
Principal investigator
Via Montpellier 1
Rome
00037
Italy
| 0000-0002-2442-1091 | |
| Phone | +39 3277998699 |
| Paolo.carosi@alumni.uniroma2.eu |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Retrospective single cohort |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | Immediate loading of fixed full-arch prostheses supported by four implants: a retrospective cohort study |
| Study acronym | BLPROARCH |
| Study objectives | To report the clinical and radiological results of the overall rehabilitation treatment with a fixed screw-retained prosthesis supported by four dental implants loaded immediately |
| Ethics approval(s) | Approved 28/09/2017, Ethical committee of University of Rome La Sapienza (Viale del Policlinico 155, Rome, Italy; +39 649979822; comitato.etico@policlinicoumberto1.it), ref: 4720 |
| Health condition(s) or problem(s) studied | Complete arch edentate |
| Intervention | For each edentate patient, a case study was performed including CBCT analysis, impressions and diagnostic wax up. Each patient was treated with the placement of 4 dental implants and an immediate screw-retained prosthesis. After 3 months, a defintive prosthesis was realized. The follow up period goes from 1 year after definitive prosthesis placement to the last follow up visit (up to June 2020). The first cases were treated 12 years ago, while the most recent were treated 3 years ago. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Based on the radiographic and clinical examination, each implant was classified as follows: |
| Key secondary outcome measure(s) |
1. Prosthetic success |
| Completion date | 30/06/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 60 |
| Total final enrolment | 103 |
| Key inclusion criteria | 1. Present completely edentulous arches or hopeless teeth requiring extraction and refusing invasive grafting procedures. 2. Absence of oral mucosal disease 3. Suitable bone dimension for the insertion of four implants |
| Key exclusion criteria | 1. Heavy smokers (more than 5 cigarettes per day) 2. Drug or alcohol abuse 3. Poor oral hygiene 4. Bruxism 5. Radiotherapy in the head and neck region 6. Patients undergoing antiblastic chemotherapy 7. Severe intermaxillary skeletal discrepancy |
| Date of first enrolment | 10/01/2010 |
| Date of final enrolment | 31/12/2017 |
Locations
Countries of recruitment
- Italy
Study participating centre
Rome
00100
Italy
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The data of the treated patients are available under request from the principal investigator (paolo.carosi@alumni.uniroma2.eu) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
09/02/2022: Trial's existence confirmed by Ethical committee of University of Rome La Sapienza