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

November 17, 2020 updated by: Secil Cubuk, Baskent University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06540
        • Baskent University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Probing pocket Depth (PPD)
Time Frame: 6 months
Probing pocket Depth (PPD) is the distance between gingival margin and bottom of the periodontal pocket in mm.
6 months
Clinical attachment level (CAL)
Time Frame: 6 months
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
Time Frame: 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).
6 months
Relative bone density (rBD)
Time Frame: 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.
6 months
Post-operative pain as assessed by visual analogue scale (VAS)
Time Frame: 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.
7 days
Assessment of analgesic usage
Time Frame: 7 days
The patients were asked to note the amount of analgesics within the post-operative 7 days.
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baskent University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 20, 2018

Primary Completion (ACTUAL)

April 10, 2020

Study Completion (ACTUAL)

August 11, 2020

Study Registration Dates

First Submitted

August 16, 2020

First Submitted That Met QC Criteria

November 17, 2020

First Posted (ACTUAL)

November 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 24, 2020

Last Update Submitted That Met QC Criteria

November 17, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SecilC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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