Condition category
Oral Health
Date applied
07/09/2017
Date assigned
13/09/2017
Last edited
13/09/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Perhaps the biggest concern in the field of dental implantology is the increasing incidence of peri-implantitis, which is an aggressive form of dental implant related gum disease. The problem is made worse as there is no predictable way to manage the disease when it occurs. There are many factors that can cause the disease but in the case of full arch fixed bridgework (i.e. replacing all the teeth in one jaw), poor prosthesis design is a large risk factor. Large span fixed bridges are very difficult for even the most dextrous patients (as well as dentists and hygienists) to clean effectively so peri-implantitis will always be a risk. However, the market place demands a fixed solution. A well-meaning dentist may praise the virtues of a removable implant-supported set of teeth, but to some patients this is still just a denture and may seem far removed from the whole point of having the implants in the first place. Obviously, a “fixed” implant prostheses can be designed for easier home maintenance but this can be to the detriment of the aesthetics of the teeth. Perhaps understandably, patients demand the best aesthetics when they have paid a premium for their new implant supported teeth. It is possible to get better aesthetics with a full arch fixed bridge but this may necessitate more radical surgery to ensure the fitting surface of the restoration is hidden below the patient’s lip line. This only serves to compound the hygiene issue and is a very aggressive surgical approach. The system developed uses existing technology whereby the false teeth are fitted to implants via telescopic style abutments. Although designed to be removable, they are usually very tight and often get “locked-in”. A locked-in prosthesis can be removed with a hammer-style device commonly used by dentists but this is not at all comfortable for the patient. The aim of this study is to examine the efficacy of patient utilised removal mechanism for a supported implant bridge which has become "locked in".

Who can participate?
Any patient of any age fitted with a full arch Conus abutment supported bridge which has exhibited "Lock-in".

What does the study involve?
10 patients, fitted with a full arch Atlantis Conus abutment supported bridges, and who have demonstrated "lock-in" are included in this study. Participants are followed up at one, three and six months. They are followed up to see whether their prosthesis is impossible to remove without the method of removal. This is called “Lock-in”. Participants are assessed for efficacy of the method, ease of use of the method and if the bridge can re-lock if it is re-inserted by the participant.

What are the possible benefits and risks of participating?
Participants may benefit from using the fixed bridge as they can removethe bridge for cleaning which reduces the risk of peri-implantitis and “fixed” because it is locked-in. There are no direct risks with participation.

Where is the study run from?
The Raglan Suite (UK)

When is the study starting and how long is it expected to run for?
November 2017-June 2018

Who is funding the study?
1. Investigator initiated and funded (UK)
2. DentsplySirona (UK)

Who is the main contact?
Dr Timothy Doswell

Trial website

Contact information

Type

Scientific

Primary contact

Dr Timothy Doswell

ORCID ID

http://orcid.org/0000-0002-5269-3916

Contact details

The Raglan Suite
16-18 Raglan Street
Harrogate
HG1 1LE
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

IIS ref I-AA-17-007

Study information

Scientific title

Patient satisfaction of "Locked-in" Atlantis Conus Abutment supported bridges and a simple method of removal

Acronym

Study hypothesis

The aim of this study is to examine the efficacy of patient utilised removal mechanism for a Conus Abutment supported implant bridge which has become "locked in".

Ethics approval

Not provided at time of registration

Study design

Observational case series

Primary study design

Observational

Secondary study design

Case series

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available

Condition

Restorative implant dentistry. The use of Conus abutment supported bridges

Intervention

10 patients, fitted with a full arch Atlantis Conus abutment supported bridges, and who have demonstrated "lock-in" are included in this study.

Participants are followed up at one, three and six months. They are followed up to see whether their prosthesis is impossible to remove without the method of removal. This is called “Lock-in”.

The questions in this study include:
1. Efficacy of the method - does the bridge easily dislodge when the method is used?
2. Ease of use of the method
3. Does the bridge then re-lock when the bridge is re-inserted by the patient?

The cases will be either maxillary or mandibular and are evaluated using a scale.

Intervention type

Device

Phase

Drug names

Primary outcome measures

1. Efficacy of the method (does the bridge easily dislodge when the method is used) is meaured using patient questionnaires at one, three and six months
2. Ease of use of the method is measured using a patient questionnaire at one, three and six months
3. How reliably does the prosthesis relic when re-fitted is measured using a patient questionnaire at one, three and six months



Secondary outcome measures

Peri-impant health is measured using a standard BPE probe at one, three and six months.

Overall trial start date

01/10/2017

Overall trial end date

01/06/2018

Reason abandoned

Eligibility

Participant inclusion criteria

Any patient of any age fitted with a full arch Conus abutment supported bridge which has exhibited "Lock-in".

Participant type

Patient

Age group

Mixed

Gender

Both

Target number of participants

10

Participant exclusion criteria

There is no participant exclusion criteria.

Recruitment start date

01/11/2017

Recruitment end date

01/05/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Raglan Suite
16-18 Raglan Street
Harrogate
HG1 1LE
United Kingdom

Sponsor information

Organisation

Tim Doswell

Sponsor details

The Raglan Suite
16 Raglan Street
Harrogate
HG1 1LE
United Kingdom

Sponsor type

Other

Website

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

DentsplySirona

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 is not expected to be made available due to the trial data will form part of the patient record initially so there requires patient confidentiality. However, with patient consent, the dataset could be made available.

Intention to publish date

01/06/2019

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes