Condition category
Oral Health
Date applied
19/06/2017
Date assigned
21/06/2017
Last edited
31/08/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Dental implants are used to support false teeth. This is done to replace a root of a tooth by using a screw that connects the tooth into the jawbone. Dental implants can usually last a long time, however depending on the technique that the dentist uses could impact how long they can survive. Dental implants with a locking connection (such as Morse taper connection implants) can be placed in the mouth using two different grafting techniques. The aim of this study is to investigate the long-term survival and complication rates of dental implants placed using the Morse taper connection technique, in order to evaluate the predictability of this treatment procedure.

Who can participate?
Patients who underwent tooth implants from January 2003 to August 2006

What does the study involve?
Participants who underwent dental implants have their medical records reviewed in order to see what the ten year survival and complications rates are. Researchers gather data the implant survival, functioning, complications, infections and other clinically important events over ten years in order to evaluate the predictability of the treatment.

What are the possible benefits and risks of participating?
There are no benefits or risks with participating

Where is the study run from?
1. Dental Surgery Mangano (Studio Odontoiatrico Mangano)
2. Dental Surgery Frezzato (Studio Dentistico Frezzato)

When is the study starting and how long is it expected to run for?
October 2013 to May 2017

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

Who is the main contact?
Dr Francesco Mangano
francescomangano1@mclink.net

Trial website

Contact information

Type

Scientific

Primary contact

Dr Francesco Mangano

ORCID ID

Contact details

Studio Odontoiatrico Mangano
Piazza Trento 4
Gravedona
22015
Italy
+39 (0)3332 795204
francescoguidomangano@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

0001

Study information

Scientific title

Morse Taper Connection Implants placed in Grafted Sinuses of 65 patients: a retrospective clinical study with 10 years of follow-up

Acronym

MTCIsGS

Study hypothesis

The aim of this study is to investigate the 10-year survival and complication rates of Morse taper connection implants (MTCIs) placed in grafted sinuses.

Ethics approval

Ethics Committee of the Hospital of Varese (Comitato Etico Ospedale di Circolo e Fondazione Macchi), 03/10/2013, ref: 826

Study design

Retrospective observational clinical study

Primary study design

Observational

Secondary study design

Cohort study

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

This is a retrospective chart review study. The focus of the data collected is about the ten year implant survival and complication rates of a particular implant-abutment connection, the Morse taper.

These records included all information about each enrolled patient (patient-related information: systemic health, age at surgery, gender, smoking habit, oral hygiene), each implant-supported restoration placed (implant-related information: position – premolar or molar – length and diameter; restoration-related information: type of prosthesis – SC or FPD - date of deliveries). The customized records included all information about any implant failure and/or biological/prosthetic complication occurred during the 10-year follow-up.

The data collected from the medical record includes clinical functioning (implant survival and implant-supported restorations) and biologic and prosthetic complications.

Implants were classified as “surviving” when still clinically in function at the final 10-year follow-up. Conversely, all implants that were lost and/or had to be removed (for implant mobility due to absence and/or loss of osseointegration in absence of infection, for recurrent/persistent peri-implantitis and for implant body fracture) during the entire period of the study, were considered as “failed”. Implant-supported restorations were classified as “surviving” when still clinically in function at the final 10-year follow-up. Conversely, all implant-supported restorations that had to be removed (for implant failure) during the entire period of the study, were considered as “failed”.

Among the biologic complications, loss of the graft, sinus infection, peri-implant mucositis and peri-implantitis were considered. Among the prosthetic complications, all mechanical complications (i.e., complications affecting the pre-fabricated implant components at the implant-abutment interface such as abutment loosening and abutment fracture) and all technical complications (i.e., complications affecting the superstructures made by the dental technician, such as loss of retention, ceramic chipping/fracture, fracture of the metallic framework of restoration) were considered.

Intervention type

Other

Phase

Drug names

Primary outcome measures

The 10-year implant survival (still clinically functioning) are measured clinically at the 10-year follow-up

Secondary outcome measures

Biologic and prosthetic complications affecting the fixed implant-supported restorations are measured clinically during the ten year follow up

Overall trial start date

03/10/2013

Overall trial end date

30/05/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients that been treated with maxillary sinus augmentation (with the lateral window or the transalveolar osteotomy technique)
2. Restored with fixed prosthetic restorations (SCs and FPDs) supported by MTCIs
3. Received treatment in the period from January 2003 to August 2006 in two private dental clinics (located in Gravedona, Como, Italy; and in Padua, Italy, respectively)
4. Aged 18 and older

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

65

Participant exclusion criteria

1. Systemic diseases or ongoing treatments/conditions that may contra-indicate intervention (uncontrolled diabetes, immunocompromised states, chemo/radiotherapy of the head/neck region, treatment with amino-bisphosphonates, psychiatric disorders and abuse of drugs/alcohol)
2. Oral diseases (non-treated periodontal disease, active/ chronic/ persistent sinus infections)

Recruitment start date

01/01/2015

Recruitment end date

30/08/2016

Locations

Countries of recruitment

Italy

Trial participating centre

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

Trial participating centre

Studio Dentistico Frezzato
Studio Dentistico Frezzato via Cavour 10, 45100 Rovigo
Rovigo
45100
Italy

Sponsor information

Organisation

Dental Surgery Mangano (Studio Odontoiatrico Mangano)

Sponsor details

Piazza Trento 4
Gravedona
22015
Italy
+39 (0)344 85524
info@drmangano.com

Sponsor type

Hospital/treatment centre

Website

www.drmangano.com

Funders

Funder type

Hospital/treatment centre

Funder name

Dental Surgery Mangano (Studio Odontoiatrico Mangano)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

This retrospective study has been submitted for publication.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Principal Investigator Francesco Mangano at francescomangano1@mclink.net

Intention to publish date

30/08/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28848604

Publication citations

Additional files

Editorial Notes

31/08/2017: Publication reference added.