The Clinical and Biological Effects of Leucocyte and Platelet-rich Fibrin (L-PRF) on Post-extraction Sockets Healing
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|ClinicalTrials.gov Identifier: NCT03985033|
Recruitment Status : Recruiting
First Posted : June 13, 2019
Last Update Posted : January 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Tooth Extraction||Other: leucocyte and platelet-rich fibrin (L-PRF)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Split-mouth design allowing to assess two types of treatment in the same patient.|
|Masking:||Double (Care Provider, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||The Clinical and Biological Effects of Leucocyte and Platelet-rich Fibrin (L-PRF) on Post-extraction Sockets Healing: a Randomized Controlled Trial|
|Actual Study Start Date :||October 1, 2019|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||March 31, 2021|
Post-extraction sockets will be filled with autologous leucocyte and platelet-rich fibrin (L-PRF) clot.
Other: leucocyte and platelet-rich fibrin (L-PRF)
The blood collected from each patient will be centrifuged immediately at 2700 rpm for 12 min to separate L-PRF.
No Intervention: Control
Post-extraction sockets will be left to heal spontaneously with natural blood clot.
- Concentrations changes of the molecules and inflammatory mediators [ Time Frame: Baseline, 6 hours, 24 hours, 3 days and 7 days ]Concentrations changes of the molecules and inflammatory mediators in the gingival crevicular fluid (GCF) or wound fluid (WF) from the extraction sockets in L-PRF group and control group at baseline (from GCF), 6 hours, 24 hours, 3 days, 7 days.
- Genes expression profiles [ Time Frame: Baseline and 3 days ]Genes expression profiles of the growth and differentiation factors and inflammatory mediators from the tissue specimen taken from the post-extraction sockets at 3 days.
- Laser Doppler Flowmetry (LDF) measurement [ Time Frame: Before and immediately after the tooth extraction, 6 hours, 24 hours, 3 days and 7 days ]A commercially available Laser Doppler Blood FlowMeter equipped with a standard fiber optic probe will be used for LDF measurements before tooth extraction, immediately postoperatively, 6 hours, 24 hours, 3 days and 7 days.
- Radiographic bone changes (Cone-beam computed tomography) [ Time Frame: Baseline and 4 months ]Cone-beam computed tomography (CBCT) images will be obtained before extraction as the baseline and at the 4 months.
- Wound Healing Index (HI) [ Time Frame: 6 hours, 24 hours, 3 days and 7 days ]Soft tissue healing will be assessed by Wound Healing Index (1 = very poor, 2 = poor, 3 = good, 4 = very good, 5 = excellent).
- Visual analog scale (VAS) [ Time Frame: 6 hours, 24 hours, 3 days and 7 days ]A 10-point VAS with a score of 0 that equals "no pain" and a score of 10 that equals "worst pain imaginable" will be used to evaluate the postoperative pain at 6 hours, 24 hours, 3 days and 7 days. The patients will be asked to fill the pain they feel at the time of questioning. Questionnaires will be collected at the one-week follow-up visit.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03985033
|Contact: Maurizio Tonetti, PhD, DMD||+852 email@example.com|
|Contact: Xuzhu Wang||+852 firstname.lastname@example.org|
|Faculty of Dentistry, The University of Hong Kong||Recruiting|
|Hong Kong, Hong Kong|
|Contact: Maurizio Tonetti, PhD, DMD +852 28590297 email@example.com|
|Contact: Xuzhu Wang +852 66707303 firstname.lastname@example.org|
|Principal Investigator: Maurizio Tonetti, PhD, DMD|