Condition category
Oral Health
Date applied
25/04/2018
Date assigned
08/05/2018
Last edited
08/05/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The replacement of the single missing or failing tooth with a dental implant (i.e. a titanium fixture inserted in the bone) is a frequent procedure with a high rate of success. Until now, implant-supported prosthetic restorations have been made with analog (conventional) techniques, but in the last few years the digital revolution has been changing the world of dentistry, and implant-supported crowns can be made using digital technology. Although digital techniques are rapidly spreading in dentistry, there are very few studies that compare the procedures and the results obtained in the replacement of single teeth with digital vs analog (conventional) procedures. The aim of this study is compare the success and complications encountered with digital and analog procedures for the prosthetic restoration of single-tooth implants.

Who can participate?
Patients who have undergone surgical treatment with the insertion of a single Morse taper connection implant in the posterior areas (premolars and molars) of both jaws

What does the study involve?
Participants are randomly allocated to receive an implant-supported crown made with either analog (conventional) or digital technologies. All patients are followed for 1 year after the delivery of the final crown to measure implant-crown success, complications, marginal bone loss around the implant, patient satisfaction, and the time and cost of the treatment.

What are the possible benefits and risks of participating?
The possible benefits of the use of digital techniques for making implant crowns are less patient discomfort, and more time-efficient and less expensive treatment.

Where is the study run from?
Studio Odontoiatrico Mangano (Italy)

When is the study starting and how long is it expected to run for?
September 2014 to September 2017

Who is funding the study?
Studio Odontoiatrico Mangano (Italy)

Who is the main contact?
Dr Francesco Mangano

Trial website

Contact information

Type

Scientific

Primary contact

Dr Francesco Mangano

ORCID ID

Contact details

via Emet 33
Madesimo
23024
Italy

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

0001

Study information

Scientific title

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

Acronym

DAPRSI

Study hypothesis

The study aimed to evaluate if a different exists in the the success and complications encountered in the prosthetic restoration of single-tooth Morse taper connection implants with digital and analog procedures, comparing the two methods; moreover, the study aimed to analyze and compare the patients’ preference, the treatment times, and the costs, relative to the two different methodologies.

Ethics approval

University of Varese - Insubria, 09/10/2013, ref: 826-0034086

Study design

Randomized controlled clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Implant dentistry

Intervention

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 zirconia crown fabricated with digital workflow (test group), or a metal-ceramic crown fabricated with analog workflow (control group). All patients were followed for 1 year after the delivery of the final crown. The primary outcomes were implant-crown success, complications, peri-implant marginal bone loss (PIMBL); the secondary outcomes were patient satisfaction, and time and cost of the treatment.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

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 outcome measures

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

Overall trial start date

01/09/2014

Overall trial end date

30/09/2017

Reason abandoned (if study stopped)

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50 (25 patients per group)

Participant 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.

Recruitment start date

01/09/2014

Recruitment end date

30/09/2016

Locations

Countries of recruitment

Italy

Trial participating centre

Studio Odontoiatrico Mangano
Piazza Trento 4
Gravedona (Como)
22015
Italy

Sponsor information

Organisation

Studio Odontoiatrico Mangano

Sponsor details

Piazza Trento 4
Gravedona ed Uniti
22015
Italy

Sponsor type

Hospital/treatment centre

Website

www.drmangano.com

Funders

Funder type

Hospital/treatment centre

Funder name

Studio Odontoiatrico Mangano

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Additional documents will be available upon reasonable request from Dr Francesco Mangano. The trialists are willing to publish their 1-year follow-up results within the next 6 months.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Francesco Mangano.

Intention to publish date

26/10/2018

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes