Condition category
Oral Health
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
26/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr K Webster

ORCID ID

Contact details

Maxillofacial Surgery
Queen Elizabeth Hospital
Birmingham
B15 2TH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0265154611

Study information

Scientific title

A randomised prospective trial comparing bioabsorbable versus titanium plates in the treatment of mandibular and zygomatic fractures

Acronym

Study hypothesis

Mandibular and zygomatic fractures are conventually fixed by open reduction and internal fixation using titanium plates and screws. Between 18-35% of these plates are subsequently removed due to complications such as loosening.
Bioabsorbable plates are now available as an alternative to metal plates. The potential advantage of using resorbable plates is that the reoperation rate to remove titanium plates that develop complications would be greatly reduced.
The Inion(R) bioabsorbable material comprises the polymers L-polylactic acid, D/L-polylactic acid, trimethylene carbonate and polyglycolic acid. The material degrades by hydrolysis into carbon dioxide and water, in a similar fashion to "dissolving" sutures. The degradation profile provides initial stability to the facial bone and then progressive.
Although bioabsorbable plates have been used in facial fractures there is no prospective data to confirm that they are equivalent to titanium plates. A prospective comparison of the two systems would define whether bioabsorbable plates have a lower complication rate and whether a reduction in reoperation rate can be achieved.

The Null hypothesis to be answered is: there is no difference in the re-operation rate in mandibular and zygomatic fracture repair between titanium and Inion(R) bioabsorbable plates.

Ethics approval

Not provided at time of registration

Study design

Prospective single-blind randomised single-centre study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Oral Health

Intervention

All patients presenting to the maxillofacial trauma service at University Hospital Birmingham with mandibular and maxillary fractures will be randomised to two treatment arms:
1. Conventional treatment with ORIF using titanium miniplates
2. ORIF using bioabsorbable plates

Invasive procedures and investigations: no change in pre-operative workup will be required
Duration of study: outpatient review at 1 week, 6 weeks, six months and 12 months
End points/outcomes: a comparison of complication rates in each group.
Expected complications: infection, loosening of plates and screws, plate fracture, plate exposure (in mouth), malunion, non-union of fracture

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

The rate of removal of resorbable vs non resorbable plates in facial fractures

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/03/2005

Overall trial end date

25/01/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Healthy adult volunteers
2. Traumatic mandibular or zygomatic fractures

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

1. Overt infection
2. Pregnancy
3. Under 16
4. Pathological fractures, prisoner, malignancy

Recruitment start date

01/03/2005

Recruitment end date

25/01/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Queen Elizabeth Hospital
Birmingham
B15 2TH
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

University Hospital Birmingham NHS Trust (UK), NHS R&D Support Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

26/10/2015: no publications found on PubMed.