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Randomized Controlled Trial of Full-Arch Rehabilitation

Clinical Evaluation of Immediate Loading Full Arch Rehabilitation Made With Methodology for Computer Guided Implant Planning With Software Polyvalent vs Free Hand Implants Placement

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01905306
Enrollment
20
Registered
2013-07-23
Start date
2013-01-31
Completion date
Unknown
Last updated
2013-07-23

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

Conditions

Bone-to-implant Contact, Success Rate, Survival Rate

Keywords

dental implants, immediate loading, full-arch, computer guided implant surgery

Brief summary

This clinical study has the objective to compare the radiographic evaluations after 3 years of follow-up of immediate loaded implant-prosthetic rehabilitation, carried out randomly using the methodology for computer guided implant planning with software polyvalent or free hand implants placement.

Interventions

PROCEDUREcomputer guided implant planning
PROCEDUREfree hand implants placement

Sponsors

University of Siena
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Edentulous patients with an adequate area: at least two teeth in the posterior area * Age over 18 years * Adequate width of the bone crest without the need for bone regeneration * Consensus to participate in a oral hygiene maintenance program * Consensus to participate in a long-term study * Availability to provide their free and informed consensus.

Exclusion criteria

* Systemic diseases that preclude participation in the study * History of radiation therapy * Bone lesions * Cigarette smoking (more than 10 cigarettes per day) * Inadequate oral hygiene * Untreated periodontitis affecting residual teeth

Design outcomes

Primary

MeasureTime frameDescription
bone-to-implant contact3 years2D radiographic assessment of the implant surface in contact with bone expressed in percentage

Secondary

MeasureTime frameDescription
implant survival rate3 years1. the absence of clinically detectable implant mobility 2. a lack of persistent or irreversible signs and symptoms such as pain or any subjective sensation 3. the absence of recurrent peri-implant infection 4. the absence of concrete evidence of continuous periimplant radiolucency

Other

MeasureTime frameDescription
implant success rate3 years1. No pain or tenderness upon function 2. 0 mobility 3. 2 mm radiographic bone loss from initial surgery 4. No exudates history

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026