Effect of Dental Pulp Stem Cells and L-PRF After Impacted Third Molar Extraction

Study Overview
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Brief Summary
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The purpose of this study is to compare the clinical and radiographic effectiveness of Leukocyte-Platelet Rich Fibrin (L-PRF) and L-PRF combined with dental pulp stem cell (DPSC) application to the extraction socket of mandibular third molars.

Detailed Description
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Patients aged between 18 and 30 years, seeking for bilateral impacted LM3 extraction surgeries and meeting eligibility criteria were included to the study. At baseline right and left impacted third molars (LM3s) were randomly assigned to one of the treatment group (L-PRF and L-PRF + DPSC). Baseline and 6th month clinical and radiographic measurements were compared.

Official Title
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Effect of Dental Pulp Stem Cells and L-PRF Placed Into the Extraction Sockets of Impacted Mandibular Third Molars on the Periodontal Status of Adjacent Second Molars: a Split Mouth Randomised Controlled Clinical Trial

Conditions
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Stem Cell, Third Molar, Periodontal Pocket

Intervention / Treatment
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* Procedure: L-PRF + DPSC
* Procedure: L-PRF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged between 18 and 30 years Bilateral impacted LM3 extraction surgeries requirement Exclusion Criteria: Having clinical signs or symptoms of abscess or cellulitis formation Having a history of radiotherapy Having any systemic diseases interfering with wound healing and/or smokers Patients who had been diagnosed as periodontitis Patients who had LM2s with caries or restorations that have an unidentifiable cementoenamel junction

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Prospective within person randomised split-mouth study. Left and right surgical sites for each participant were randomized using an online generated list to determine test and positive control LM3. (http://www.randomization.com). LM2s and LM3 extraction sockets were divided into two groups: a test group (extraction sockets filled with L-PRF membranes + DPSCs) and a control group (extraction sockets filled with L-PRF membranes).
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: L-PRF + DPSC<br>Mandibular third molars were extracted and DPSC with L-PRF placed into the socket. | Procedure: L-PRF + DPSC<br>* After surgical removal of impacted mandibular third molars, extraction sockets were filled with L-PRF membranes + DPSCs.<br>* Other names: Leukocyte platelet rich fibrin plus dental pulp stem cells;|
| Active Comparator: L-PRF<br>Mandibular third molars were extracted and L-PRF placed into the socket | Procedure: L-PRF<br>* After surgical removal of impacted contralateral mandibular third molars, each extraction sockets were only filled with L-PRF membranes.<br>* Other names: Leukocyte platelet rich fibrin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probing pocket Depth (PPD) | Probing pocket Depth (PPD) is the distance between gingival margin and bottom of the periodontal pocket in mm. | 6 months | 
| Clinical attachment level (CAL) | Clinical attachment level (CAL) is the distance between cemento-enamel junction and bottom of the periodontal pocket in mm. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic vertical distance | The cementoenamel junction (CEJ) and the most coronal point of the alveolar bone were identified (AC) on the mesial and distal of lower second molars on digital panoramic radiographs. The vertical ruler on each digital image was used to calibrate the image and to convert measurements from pixels to millimeters with ImageJ. The vertical distance (VD) between cemento-enamel junction and alveolar crest of the lower second molar was than measured with straight line tool of the software. In order to calculate the real distance; ertical distance was divided to the magnification factor for panoramic image (1.2). | 6 months | 
| Relative bone density (rBD) | For every extraction socket, a region of interest (ROI) is created for the socket region and one for the surrounding bone using the Freehand Selection tool of ImageJ software on panoramic radiographs. Mean grey values were recorded for each group and relative bone density (rBD) was calculated. | 6 months | 
| Post-operative pain as assessed by visual analogue scale (VAS) | Self-reported pain measured in a 100 mm visual analogue scale (VAS) in which (0) denoted no pain and 100 meant severe pain was recorded at the end of the surgery and 7 days after extraction. | 7 days | 
| Assessment of analgesic usage | The patients were asked to note the amount of analgesics within the post-operative 7 days. | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dental pulp, stem cell, third molar, Platelet-rich fibrin