Condition category
Oral Health
Date applied
19/06/2017
Date assigned
27/06/2017
Last edited
25/08/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Complete mandibular edentulism is the condition where all of the lower teeth are missing. It is a difficult condition for patients because complete removable dental prostheses (dentures) are extremely difficult to wear, move during chewing, lack stability and cause pain/discomfort when eating. A possible solution to stabilize the complete prostheses is to place dental implants in the mandible (lower jaw). Dental implants are titanium fixtures that can be placed in the bone to support the prosthesis and stabilize it, preventing movement and discomfort when eating. In order to obtain better stability of the prosthesis over the implants, the implants can be splinted by means of a bar to support the prosthesis. Conventionally, making a bar to support the prosthesis is a procedure that involves different laboratory steps, with a longer treatment time and higher costs for the patients. As an alternative, and in order to reduce the laboratory steps and time for this treatment, different welding techniques have been proposed for creating the bar inside the mouth of the patients. These techniques can be highly successful. In this study, a new technique for the making a mandibular bar is tested, the ball welding bar. The ball welding bar consists of smooth prosthetic cylinders, interconnected by titanium bars which are adjustable in terms of distance from the ball terminals and inserted into the rotating rings of the cylinders. All the components are welded and self-posing.

Who can participate?
Patients with complete mandibular edentulism and problems related to their complete, removable conventional dentures (i.e. lack of stability, discomfort during eating and aesthetic embarrassment)

What does the study involve?
All participants are treated using the new ball welding bar technique and are followed for a 2-year period in order to assess the survival of the implants and the success of this technique.

What are the possible benefits and risks of participating?
The ball welding bar technique can simplify the creation of mandibular bars, reducing time and costs, with clear benefits for the patients. For the dentists, the main advantages of this method are that it makes it easy to centre the bars over the bone crest, allows for fine regulation, and makes it easy to solder the framework without distortions. Finally, the procedure is very rapid and can be managed by a single operator, both of which allow for reduced rehabilitation costs.

Where is the study run from?
1. Studio Dentistico Guida (Italy)
2. Studio Dentistico Dr. Bacchiocchi (Italy)

When is the study starting and how long is it expected to run for?
January 2010 to December 2015

Who is funding the study?
Studio Dentistico Dr Andrea Guida (Italy)

Who is the main contact?
Prof. Andrea Guida
prof.guida@yahoo.it

Trial website

Contact information

Type

Scientific

Primary contact

Prof Andrea Guida

ORCID ID

http://orcid.org/0000-0002-1462-7205

Contact details

via Sartena 9
Lido di Ostia (RM)
00122
Italy
+39 (0)6 562 3973
prof.guida@yahoo.it

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

0001

Study information

Scientific title

The ball welding bar: a new solution for the immediate loading of screw-retained, mandibular fixed full arch prostheses

Acronym

BWB

Study hypothesis

The purpose of this study was to present a new intraoral welding technique, and in particular a new method for the fabrication of a bar (the ball welding bar) that can be used to support screw-retained, mandibular fixed full arch prostheses.

Ethics approval

Fundacao Universitaria Vida Crista (FUNVIC) Institutional Board, 25/01/2010

Study design

Non-randomised study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Other

Trial type

Treatment

Patient information sheet

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

Condition

Implant prosthodontics

Intervention

In the period between January 2010 and December 2013, all patients with complete mandibular edentulism or irreparably compromised mandibular dentition, who were referred to two different private dental centres patients for restoration of the masticatory function with a fixed mandibular prosthesis supported by dental implants, were treated with the new ball welding bar technique. The patients were then followed for a 2-year period, in order to evaluate the survival of the implants and the success of this technique.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Implant survival, i.e. the clinical condition in which the implants are still in function in the patients' mouth, at the end of the 2-year follow-up period

Secondary outcome measures

Prosthetic success, i.e. the clinical condition in which no adverse events or complications (such as fractures/alterations of the resin superstructure and of the intraorally welded titanium framework) occur at the prosthesis level, assessed at the end of the 2-year follow-up period

Overall trial start date

01/01/2010

Overall trial end date

31/12/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Complete mandibular edentulism, with functional and aesthetic problems related to the presence of a complete, removable conventional denture (i.e. lack of stability of the complete denture, discomfort during function and aesthetic embarrassment)
2. Irreparably compromised mandibular dentition, due to advanced periodontal disease or destructive/massive tooth decay, that made the residual dental elements unrestorable
3. Sufficient bone volume (bone height x width) to allow for the placement of implants of at least 8 mm in length and 3.0 mm in diameter
4. Will to restore the masticatory function with a fixed mandibular prosthesis supported by dental implants
5. Ability to understand and sign an informed consent form for implant treatment.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40-50

Participant exclusion criteria

1. General medical conditions/systemic diseases that represented an absolute contraindication to surgical and implant treatment, such as severely immunocompromised patients or severely uncompensated diabetics, patients receiving radiotherapy to the head and neck area or chemotherapy, patients receiving amino-bisphosphonates intravenously and/or orally
2. Psychiatric disorders
3. Addicted to alcohol or drugs
4. Needed bone augmentation procedures with autogenous bone or other bone substitutes, to allow for proper implant insertion
5. Previously undergone major regenerative bone surgery, preliminary to the placement of dental implants

Recruitment start date

01/01/2010

Recruitment end date

31/12/2013

Locations

Countries of recruitment

Italy

Trial participating centre

Studio Dentistico Guida
via Sartena 9
Lido di Ostia (Roma)
00122
Italy

Trial participating centre

Studio Dentistico Dr. Bacchiocchi
Via Gaetano Donizetti 2
Castelfidardo (AN)
60022
Italy

Sponsor information

Organisation

Studio Dentistico Dr Andrea Guida

Sponsor details

via Sartena 9
Lido di Ostia (RM)
00122
Italy
+39 (0)6 562 3973
ostia@sorridental.it

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Studio Dentistico Dr Andrea Guida

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Andrea Guida (prof.guida@outlook.it).

Intention to publish date

30/07/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28835752

Publication citations

Additional files

Editorial Notes

25/08/2017: Publication reference added.