Digital versus analog procedures for the prosthetic restoration of single implants

Completed

• Conditions: Implant dentistry; Oral Health

• Registration Number: ISRCTN36259164
• Lead Sponsor: Studio Odontoiatrico Mangano

Brief Summary

2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30112398

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-09-30
• Study Start: 2018-05-08
• Last Update Posted: 10 September 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>2. The biologic and prosthetic complications encountered during the 1-year observation period<br>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)