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Digital versus analog procedures for the prosthetic restoration of single implants

Digital versus analog procedures for the prosthetic restoration of single implants: a randomized controlled trial with 1 year of follow-up

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN36259164
Enrollment
50
Registered
2018-05-08
Start date
2014-09-01
Completion date
Unknown
Last updated
2018-09-10

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

Conditions

Implant dentistry Oral Health

Interventions

Over a two-year period (2014-2016), all patients who had received a single Morse taper connection implant in posterior areas of their jaws were randomly assigned either to receive a monolithic zirconi
the secondary outcomes were patient satisfaction, and time and cost of the treatment.

Sponsors

Studio Odontoiatrico Mangano
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Only patients who had undergone surgical treatment with the insertion of a single Morse taper connection implant in the posterior areas (premolars and molars) of both jaws, in the period between September 2014 and September 2016, in a single dental center, were considered for enrollment in the present randomized controlled trial. A further inclusion criterion was the diameter and height of the implant received: the patients had to be installed with a fixture of a minimum diameter of 4.1 mm and a height of at least 8 mm. In order to be enrolled in the study, patients had to have dentition in the opposite jaw and therefore occlusal contacts. Finally, to be enrolled, patients had to read and sign a document of adhesion to the present study, on the nature (and possible therapeutic alternatives) of which they were informed in detail; by signing this document, they committed themselves to come to the dental clinic for the required follow-up appointments.

Exclusion criteria

Exclusion criteria: All patients who received a single implant with a diameter of less than 4.1 mm and a height of less than 8 mm were automatically excluded from this study, as were all patients who had undergone pre-implant regenerative bone therapies or who had been treated with guided bone regeneration and membranes for the presence of peri-implant defects. Additional exclusion criteria included systemic diseases such as uncompensated diabetes, immunocompromised states, head and neck tumors, and osteoporosis treated with amino-bisphosphonates (administered orally and / or parenterally). Active periodontal infections and oral mucosa pathologies also represented exclusion criteria for enrollment in the present study.

Design outcomes

Primary

MeasureTime frame
1. Implant-crown success. An implant-supported restoration was defined as clinically successful if it was still functioning at the end of the study without any complication, either biological or prosthetic, at the last control appointment, 1 year after delivery. On the other hand, if only a single complication involving the implant-supported restoration occurred, the crown was included in the group of failures 2. The biologic and prosthetic complications encountered during the 1-year observation period 3. Peri-implant marginal bone loss, a radiographic measure of peri-implant bone stability, measured on intraoral radiographs comparing the peri-implant bone peaks (mesial and distal) at the time of implant placement (T1) and 1 year after delivery of the definitive crown (T2)

Secondary

MeasureTime frame
1. The degree of satisfaction and the perception of the quality of the treatment received by patients with digital and with analog procedures were investigated by means of a visual analogue score (VAS) questionnaire, based on 10 specific questions, 1 year after delivery of the definitive crown. For each of the selected questions, patients were asked to assign a score of 0 - 10 - 20 - 30 - 40 - 50 - 60 - 70 - 80 - 90 - 100, based on their satisfaction with the treatment received (0 = absolutely dissatisfied with the treatment; 10-20-30-40 = strongly dissatisfied with the treatment; 50 = insufficiently satisfied with the treatment; 60 = sufficiently satisfied with the treatment; 70-80-90 = very satisfied with the treatment; and 100 = fully satisfied with the treatment). 2. The overall treatment time and the active working time (i.e., the effective working time, excluding machine time) required for the prosthetic restoration of 1 single implant with both treatments (digital vs analog procedure) 3. The cost of both procedures (digital vs analog procedure) for the dentist, including all the expenses related to the purchase of materials and the services of the dental laboratory, examined at the end of treatment

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 23, 2026