The complete upper or lower set of teeth replacement with four dental implants
| ISRCTN | ISRCTN16104700 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16104700 |
| Secondary identifying numbers | 4720 |
- 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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
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
Dr Paolo Carosi
Principal Investigator
Principal Investigator
Via Montpellier 1
Rome
00037
Italy
 ORCID ID |
0000-0002-2442-1091 |
|---|---|
| Phone | +39 3277998699 |
| Paolo.carosi@alumni.uniroma2.eu |
Study information
| Study design | Retrospective single cohort |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not applicable (retrospective study) |
| 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 | Based on the radiographic and clinical examination, each implant was classified as follows: 1. Successful implants, if there were no subjective complaints (e.g., pain), no mobility, no suppuration when peri-implant mucosa was pressed, absence of bleeding and/or suppuration on gentle probing, a probing Depth ≤ 5 mm, radiographic evidence of marginal bone level change (MBLC) ≤ 2 mm at 1-year post-loading of definitive prosthesis (T1) and at the latest follow-up visit (T2) 2. Survival implant, meaning they were still in place but did not fulfil the success criteria as above 3. Clinical outcomes were recorded following the classification by Berglundh et al. (Berglundh T, Armitage G, et al. 2018) at T1 and T2: 3.1 Peri-implant health: absence of erythema, bleeding on probing, swelling and suppuration; 3.2 Peri-implant mucositis: presence of bleeding on gentle probing with radiographic bone loss <2mm. Erythema, swelling and/or suppuration may also be present. 3.3 peri-implantitis: i) presence of bleeding and/or suppuration on gentle probing; ii) increased probing depth compared to previous examinations and iii) radiographic evidence of bone resorption (>0.5mm) beyond crestal bone level changes resulting from initial bone remodeling (T1). |
| Secondary outcome measures | 1. Prosthetic success Prosthodontic maintenance events such as: abutment fracture; abutment retaining screw fracture or loosening; prosthetic retaining screw fracture or loosening; acrylic teeth loosening or fracture: acrylic veneering fracture and prosthesis (framework) fracture, were recorded during the follow-up visits or at the time the patient highlighted the problem. The definitive prostheses in function without complications were considered as a “successful prosthesis” 2. Radiographic examination Periapical radiographs obtained by using the parallel technique were performed for each implant. The radiographs were analysed for the existence of continuous peri-implant radiolucency, and the position of crestal bone levels around the implants. Measurements were done on the distal and mesial aspects of the implants with a specific software (CS Imaging 7, Carestream Dental LLC, Atlanta, GA, USA) and a High-Definition Monitor (HP Pavilion 23 cw, Full HD 5.000.000:1 Dynamic Contrast, Helwett-Packard, Palo Alto, CA, USA) to measure MBL levels, defined as the distance between the implant shoulder and the first bone-to-implant contact. In case of a sub-crestal implant shoulder, as for implants installed in extraction sockets, the measurement was recorded as a positive value. Only the worst value between the mesial and distal measurements was considered for the statistical analysis. The radiographic dimension of each implant was measured and compared to the real implant length to correct dimensional distortions (Romeo, Tomasi, et al., 2009). The radiographic measurements were performed annually but the data taken into account for the statistical analysis refer at implant placement (T0 – Baseline), at 1-year post-loading of definitive prosthesis (T1) and at the last follow-up visit (T2) 3.Peri-implant Soft tissue parameters The peri-implant soft tissue evaluation was made by a trained calibrated operator (N.F.) and involved the assessment of modified plaque index (mPI), modified bleeding index (mBI), probing depth (PD) and width of keratinized mucosa (KM). mPI was assessed on the mesial, distal, buccal, and palatal/lingual surface of the implants (score 0 – 3) (Buser, Weber, & Lang, 1990; A. Mombelli, Oosten, Schürch, & Lang, 1987; Andrea Mombelli & Lang, 1994). mBI was determined at the same surfaces as for mPI: score (0 – 3) (Buser, Weber, et al., 1990; A. Mombelli et al., 1987; Andrea Mombelli & Lang, 1994). PD was measured to the nearest millimetres, from the mucosal margin to the bottom of the pocket with a periodontal probe (Hu-Friedy PGF-GFS, Hu-Friedy, Chicago, IL., USA), at the same surfaces as for mPI (Buser, Weber, et al., 1990; A. Mombelli et al., 1987; Andrea Mombelli & Lang, 1994). The reliability of each PD data collection was estimated by performing a second set of PD measurements by a second operator (P.C.). Measured at baseline (T0), T1 and T2 |
| Overall study start date | 01/01/2010 |
| Completion date | 30/06/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
University of Rome La Sapienza
Piazzale aldo moro 5
Rome
00100
Italy
Rome
00100
Italy
Sponsor information
Sapienza University of Rome
Hospital/treatment centre
Hospital/treatment centre
Piazzale Aldo moro 5
Rome
00100
Italy
| Phone | +39 3277998699 |
|---|---|
| headquarters@iti.org | |
| Website | https://web.uniroma1.it/medeodonto/it |
"ROR" |
https://ror.org/02be6w209 |
Funders
Funder type
Research organisation
International Team for Implantology
Private sector organisation / Associations and societies (private and public)
Private sector organisation / Associations and societies (private and public)
- Alternative name(s)
- ITI
- Location
- Switzerland
Results and Publications
| Intention to publish date | 30/06/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high impacted peer reviewed journal |
| IPD sharing plan | The data of the treated patients are available under request from the principal investigator (paolo.carosi@alumni.uniroma2.eu) |
Editorial Notes
09/02/2022: Trial's existence confirmed by Ethical committee of University of Rome La Sapienza
