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

Sponsor

Baskent University (Other)

Overall Status

Completed

CT.gov ID

NCT04641533

Collaborator

(none)

Enrollment

Location

Arms

30.7

Actual Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stem Cell Third Molar Periodontal Pocket	Procedure: L-PRF + DPSC Procedure: L-PRF	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

13 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention 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).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 (Investigator, Outcomes Assessor)

Masking Description:

The random allocation list was generated by a periodontist (EEA), a clinical staff enrolled patients according to their reference date. The first allocation on the list was assigned to the right mandibular molar for each patient by the oral surgeon (SÇ).

Primary Purpose:

Prevention

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

Actual Study Start Date :

Jan 20, 2018

Actual Primary Completion Date :

Apr 10, 2020

Actual Study Completion Date :

Aug 11, 2020

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: L-PRF + DPSC

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

Procedure: L-PRF + DPSC

After surgical removal of impacted mandibular third molars, extraction sockets were filled with L-PRF membranes + DPSCs.

Other Names:

Leukocyte platelet rich fibrin plus dental pulp stem cells

Active Comparator: L-PRF

Mandibular third molars were extracted and L-PRF placed into the socket

Procedure: L-PRF

After surgical removal of impacted contralateral mandibular third molars, each extraction sockets were only filled with L-PRF membranes.

Other Names:

Leukocyte platelet rich fibrin

Outcome Measures

Primary Outcome Measures

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

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).
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.
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.
Assessment of analgesic usage [7 days]
The patients were asked to note the amount of analgesics within the post-operative 7 days.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 30 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Baskent University	Ankara		Turkey	06540

Sponsors and Collaborators

Baskent University

Investigators

Study Director: Emine Alaaddinoğlu, Prof,PhD, Baskent University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Secil Cubuk, Assist Prof, Baskent University

ClinicalTrials.gov Identifier:

NCT04641533

Other Study ID Numbers:

SecilC

First Posted:

Nov 24, 2020

Last Update Posted:

Nov 24, 2020

Last Verified:

Nov 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Secil Cubuk, Assist Prof, Baskent University

Additional relevant MeSH terms:

Periodontal Pocket

Study Results

No Results Posted as of Nov 24, 2020