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The complete upper or lower set of teeth replacement with four dental implants

Immediate loading of fixed full-arch prostheses supported by four implants: a retrospective cohort study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN16104700
Enrollment
60
Registered
2022-02-10
Start date
2010-01-10
Completion date
Unknown
Last updated
2022-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complete arch edentate Oral Health

Interventions

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 scre

Sponsors

Sapienza University of Rome
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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 0.5mm) beyond crestal bone level changes resulting from initial bone remodeling (T1).

Secondary

MeasureTime frame
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 calibrate

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026