CClinicalTrials.gg
Sign In
Status unknownNCT00240669Updated Apr 27, 2007

RESTIT : Evaluation of Resorbable Osteosynthesis Devices Versus Titanium in Maxillofacial Surgery

An interventional study of Resorbable device PLLA/PGA and Titanium device in Maxillo-Facial Surgery, sponsored by Hospices Civils de Lyon. Status unknown at 1 site in France. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2007-04-27.

Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2007), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
308
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

Primary objective : To evaluate the quality of fractures setting and osteotomy of the facial massif osteosynthesised with resorbable device PLLA/PGA compared with usual Titanium plates.

Secondary objective :

  • To evaluate the resorbable device ergonomy versus Titanium.
  • To evaluate the clinical tolerance of resorbable device versus Titanium.

Hypothesis :

Osteosynthesis with resorbable device demonstrates a non inferiority success probability regarding the success observed in osteosynthesis with Titanium, with a less important probability of re-operation.

Study duration : 14 months for each patient.

Study treatment :

  • Group I : Resorbable device PLLA/PGA.
  • Group II : Titanium device.

Study visits :

  • Screening visit - Baseline with randomization and surgery - Day1 - Day 21 - Day 45(Traumatology)/Day 90 (orthognatic) - Month 6,12 and 14.

Randomization : Stratification by centres, mono or bimaxillar surgery and traumatologic or orthognatic criteria.

02

Conditions studied

  • Maxillo-Facial Surgery

Keywords

  • Maxillo facial surgery,
  • osteosynthesis,
  • resorbable device
03

In context

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 18\<Age\<50.
  • One or more fractures of facial massif requiring a surgical setting with osteosynthesis plates.
  • One or more osteotomy of facial massif requiring a surgical setting with osteosynthesis plates.
  • Orally and written informed patient. Patient willing to participate the study.
  • Signed informed consent.

Exclusion criteria

Exclusion Criteria:

  • Any previous surgery at the same operative site.
  • Patient suffering from chronic affection which could interfere with bone consolidation.
  • Corticotherapy, immunosuppressive or anticonvulsant treatment or long term antibiotherapy.
  • Nursing or pregnant female.
  • Patient with a high risk of non compliance to sudy visits.
  • Unconscious patient.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
308 participants

Interventions

  • DeviceResorbable device PLLA/PGA
  • DeviceTitanium device
06

What researchers measure

Primary outcomes

  1. The quality of fractures setting and osteotomy of the facial massif osteosynthesised with resorbable device PLLA/PGA will be evaluated by the notion of unperfect resuts.

Secondary outcomes

  1. Evaluation of device ergonomy :

  2. The operative time of each surgery will be monitored, to compare operative duration of operations ; the only variable will be the osteosynthesis method.

  3. Clinical tolerance of the devices

  4. pain (Visual Analogic Scale),

  5. local inflammation,

  6. scar disunion,

  7. infection,

  8. subcutaneous or submucous palpation of the plates.

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00240669
Lead sponsor
Hospices Civils de Lyon
First posted
Oct 18, 2005
Start date
Nov 2005
Last update
Apr 27, 2007

Study contacts

Pierre BOULETREAU, MD
Contact
pierre.bouletreau@chu-lyon.fr
33 4 78 86 19 36
Pierre BOULETREAU, MD
principal investigator · Hospices Civile de Lyon
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2007. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Hospices Civils de Lyon

Start the discussion