Fully edentulous mandibles Oral Health Complete loss of teeth
Conditions
Interventions
The study will be conducted at the Department of Oral and Maxillofacial Sciences, Oral Surgery Unit, “Sapienza” University of Rome, Italy.
The study sample will be composed of patients presenting at t
Sponsors
Sapienza University of Rome
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age =18 years 2. Committed to participate for at least a 36 months follow-up period 3. Provide signed informed consent according to the World Medical Association’s Declaration of Helsinki 4. Complete edentulism of the mandible, to allow placement of six dental implants 5. Full or partial dentition opposing the implants 6. Implant site edentulous for more than 3 months and healed with absence of local inflammation 7. The minimal residual bone height should be appropriate in the canine and posterior sector to allow implant placement
Exclusion criteria
Exclusion criteria: Systemic: 1. Uncontrolled systemic disease 2. Smokers (>10 cigarettes/day) 3. History of mental disorders 4. Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance or unreliability 5. Patients with HIV and/ or Hepatitis infection Local: 6. Mucosal disease or local inflammation 7. Previous failed implant placement or bone grafting in the site 8. Need for major augmentation procedure 9. Poor oral hygiene (Plaque Score > 25)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 11/08/2025: Marginal bone level at baseline, 6, 12, and 36 months after surgery Standardized (Rinn, Dentsply, York, PA) periapical radiographs will be taken for each implant placed, bone levels will be calculated by measuring the distance from the implant shoulder to the first bone to implant contact, mean bone loss will be then digitally evaluated. Mesial and distal implant crestal bone levels will be measured on the periapical radiographs. The radiographs will be evaluated by an independent investigator and expert in the field. The reference point for the bone level measurement is the implant shoulder. The bone level will be evaluated by measuring the distance between the implant chamfer and the first visible bone contact on the implant. The bone level measurements will be recorded on the mesial and distal aspect of each implant. Measurements will take into account distortion based on changes on the radiograph from the true dimension of the implant or if the implant is not on its whole length on the periapical radiographs. The distance of the threads or the implant length will be measured to calculate the true dimension of the implant Previous primary outcome measure: Marginal bone level at baseline, 7, 14, and 28 days after surgery and then every thirty days for the following months. Standardized (Rinn, Dentsply, York, PA) periapical radiographs will be taken for each implant placed, bone levels will be calculated by measuring the distance from the implant shoulder to the first bone to implant contact, mean bone loss will be then digitally evaluated. Mesial and distal implant crestal bone levels will be measured on the periapical radiographs. The radiographs will be evaluated by an independent investigator and expert in the field. The reference point for the bone level measurement is the implant shoulder. The bone level will be evaluated by measuring the distance between the implant chamfer and the first visible bone co | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 11/08/2025: 1. Implant survival. An implant in place at the respective follow-up visit will be considered a surviving implant 2. Implant success. Implant success will be documented according to the following criteria: 2.1. Absence of persistent subjective complaints, such as pain, foreign body sensation and/ or dysaesthesia 2.2. Absence of recurrent peri-implant infection with suppuration 2.3. Absence of mobility 2.4. Absence of a continuous radiolucency around the implant 3. Patient-centred outcomes: 3.1. The Oral Health Impact Profile for Edentulous Patients (OHIP 20E) will be provided to patients for completion before treatment and at 6 months, 1 year, 2 years and 3 years from delivery of final restorations. 3.2. The Denture Satisfaction Index focuses on the ease of cleaning, general satisfaction, speech, comfort, aesthetics, stability, chewing ability, function and the general oral condition. The patients will be provided with a Visual Analogue Scale (VAS) to complete the questionnaire. 4. Implant Stability Quotient (ISQ). Resonance frequency analysis method with an Osstell device at implant surgery and during the 3-year follow-up period 5. The insertion torque at implant placement will be recorded 6. Soft tissue assessment: 6.1. Plaque Index determined on the mesial, buccal, distal, and palatal surfaces of the implant. 6.2. Sulcus Bleeding Index determined on the mesial, buccal, distal, and palatal surfaces of the implant according to Mombelli et al. 6.3. Probing pocket depth - the distance from the gingival margin to the bottom of the probable pocket at 4 sites (mesial, buccal, distal and palatal) of the implant 7. Prosthetic success: 7.1. A “successful prosthesis” is a prosthesis that is stable and in good function: Absence of abutment mobility 7.2. Absence of corrective measurements to the prosthesis 7.3. Absence of reparations to either prosthesis or abutment 7.4. An “unsatisfactory prosthesis” is in which the patie | — |
Countries
Italy
Outcome results
None listed