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Trial record 1 of 1 for:    NCT04641533
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Effect of Dental Pulp Stem Cells and L-PRF After Impacted Third Molar Extraction

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ClinicalTrials.gov Identifier: NCT04641533
Recruitment Status : Completed
First Posted : November 24, 2020
Last Update Posted : November 24, 2020
Sponsor:
Information provided by (Responsible Party):
Secil Cubuk, Baskent University

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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).
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 : January 20, 2018
Actual Primary Completion Date : April 10, 2020
Actual Study Completion Date : August 11, 2020
Arms and Interventions
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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 Name: 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 Name: Leukocyte platelet rich fibrin


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.

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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04641533


Locations
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Turkey
Baskent University
Ankara, Turkey, 06540
Sponsors and Collaborators
Baskent University
Investigators
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Study Director: Emine Alaaddinoğlu, Prof,PhD Baskent University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Secil Cubuk, Assist Prof, Baskent University
ClinicalTrials.gov Identifier: NCT04641533    
Other Study ID Numbers: SecilC
First Posted: November 24, 2020    Key Record Dates
Last Update Posted: November 24, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Secil Cubuk, Baskent University:
dental pulp
stem cell
third molar
Platelet-rich fibrin
Additional relevant MeSH terms:
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Periodontal Pocket
Stomatognathic Diseases
Periodontitis
Periodontal Diseases
Mouth Diseases