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 : June 13, 2019
|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|
|Estimated Study Start Date :||June 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|