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

Periodontal Pocket Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04641533
• Other study ID #: SecilC
• Status: Completed
• Phase: N/A
• Start date: January 20, 2018
• Est. completion date: August 11, 2020

Study information

• Verified date: November 2020
• Source: Baskent University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: August 11, 2020
• Est. primary completion date: April 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Periodontal Pocket
• Stem Cell
• Third Molar

Intervention

Procedure:
• L-PRF + DPSC
After surgical removal of impacted mandibular third molars, extraction sockets were filled with L-PRF membranes + DPSCs.
• L-PRF
After surgical removal of impacted contralateral mandibular third molars, each extraction sockets were only filled with L-PRF membranes.

Locations

Country	Name	City	State
Turkey	Baskent University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Baskent University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Probing pocket Depth (PPD)	Probing pocket Depth (PPD) is the distance between gingival margin and bottom of the periodontal pocket in mm.	6 months
Primary	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	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
Secondary	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
Secondary	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
Secondary	Assessment of analgesic usage	The patients were asked to note the amount of analgesics within the post-operative 7 days.	7 days