Efficacy of a blood derivative (leukocyte and platelet rich fibrin) in healing after extraction of lower wisdom teeth.

Phase 1

• Conditions: If the addition of L-PRF reduces postoperative pain and inflammation, as well as complications, after extraction of lower third molars; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Dentistry [E06]

• Registration Number: EUCTR2019-000902-31-ES
• Lead Sponsor: OMEQUI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-05
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 36

Inclusion Criteria

Patients> 18 years.
Presence of oral health (periodontally healthy or with treated periodontitis), with a BoP <20% and a PI <20%.
Systemically healthy, without any disease that may contraindicate minor oral surgery, that does not take any medication that may influence coagulation and / or that takes any NSAID or paracetamol daily.
Non-smokers or smokers of <10 cigarettes/day.
No pregnancy or lactation.
The tooth to be extracted will be included or semi-included and will have fully formed roots.
Absence of infectious and cystic pathology in the molar to be extracted.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 36
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients who due to systemic conditions are not possible to draw blood.
Penicillin allergy.
Allergy to ibuprofen and / or paracetamol.
Diseases that limit the use of ibuprofen and / or paracetamol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of L-PRF placement in post-extraction alveoli when reducing postoperative pain after extraction of lower third molars against natural healing using a visual analogue scale (VAS).;Secondary Objective: Evaluate the level of inflammation using the Pasqualini index, the level of healing using the Landry index, the possible complications (osteitis, trismus, ...) and the number of analgesics needed.;Primary end point(s): Intensity of postoperative pain measured by an Analog Visual Scale;Timepoint(s) of evaluation of this end point: At 1, 2, 3, 4, 5, 6 and 7 day

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): Inflammation level according to Pasqualini's Visual scale.<br> Level of healing according to the Landry index.<br> Postoperative complications: trismus and / or osteitis.<br> Number of analgesic pills needed.<br> ;Timepoint(s) of evaluation of this end point: 7 day