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

Not Applicable

Completed

• Conditions: Stem Cell; Periodontal Pocket; Third Molar
• Interventions: Procedure: L-PRF; Procedure: L-PRF + DPSC

• Registration Number: NCT04641533
• Lead Sponsor: Baskent University

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-01-20
• Primary Completion: 2020-04-10
• Study Completion: 2020-08-11
• Study First Submitted: 2020-08-16
• Status Verified: 2020-11
• Study First Submitted QC: 2020-11-17
• Last Update Submitted: 2020-11-17
• Study First Posted: 2020-11-24
• Last Update Posted: 2020-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• Patients aged between 18 and 30 years
• Bilateral impacted LM3 extraction surgeries requirement

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
L-PRF	L-PRF	Mandibular third molars were extracted and L-PRF placed into the socket
L-PRF + DPSC	L-PRF + DPSC	Mandibular third molars were extracted and DPSC with L-PRF placed into the socket.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Relative bone density (rBD)	6 months	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.
Assessment of analgesic usage	7 days	The patients were asked to note the amount of analgesics within the post-operative 7 days.
Radiographic vertical distance	6 months	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).
Post-operative pain as assessed by visual analogue scale (VAS)	7 days	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.

Trial Locations

Locations (1)

Baskent University; 🇹🇷 Ankara, Turkey