NCT02814799

Brief Summary

The research for a haemostasis and for an effective osseous healing are a major stake in oral surgery. The use of glues of fibrin, amplifying the polymerization of the fibrin during the haemostasis is known to reduce the risk of post-operative bruise and accelerate the healing but these glues present the inconvenience to be by-products of the blood, not devoid of infectious risk.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

June 21, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 28, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Last Updated

June 28, 2016

Status Verified

June 1, 2016

Enrollment Period

3.6 years

First QC Date

June 21, 2016

Last Update Submit

June 23, 2016

Conditions

Dental Disease

Outcome Measures

Primary Outcomes (1)

  • thrombin quantification

    Day 1

Study Arms (1)

bone donors

Other: bone removal

Interventions

bone removalOTHER
bone donors

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The inclusive patients will be all the patients requiring dental extractions with bone removal, taken care in the department of odontology of the CHU of Reims and agreeing to participate in the study. Only these patients form the group of observed patients. The duration of participation of the patient in the study is punctual, the time of the osseous taking.

Inclusions criteria Will be included in this study: * The patients requiring dental extractions with bone removal * The patients agreeing to participate in the search Exclusions criteria Will not be included in this study: * Minor patients. * Patients protected by the law.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Chu Reims

France, Reims, 51092, France

RECRUITING

MeSH Terms

Conditions

Stomatognathic Diseases

Central Study Contacts

Sébastien LAURENCE

CONTACT

sebastien.laurence@univ-reims.fr

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2016

First Posted

June 28, 2016

Study Start

May 1, 2013

Primary Completion

December 1, 2016

Last Updated

June 28, 2016

Record last verified: 2016-06

Locations

FR(1)