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

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

Tracking Information

• First Submitted Date: August 16, 2020
• First Posted Date: November 24, 2020
• Last Update Posted Date: November 24, 2020
• Actual Study Start Date: January 20, 2018
• Actual Primary Completion Date: April 10, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 17, 2020)

• 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.
• 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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: November 17, 2020)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effect of Dental Pulp Stem Cells and L-PRF After Impacted Third Molar Extraction
• 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
• 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 Type: Interventional
• Study Phase: Not Applicable

Study Design

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

Condition

• Stem Cell
• Third Molar
• Periodontal Pocket

Intervention

• 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
• 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

Study Arms

• Experimental: L-PRF + DPSC
  Mandibular third molars were extracted and DPSC with L-PRF placed into the socket.
  Intervention: Procedure: L-PRF + DPSC
• Active Comparator: L-PRF
  Mandibular third molars were extracted and L-PRF placed into the socket
  Intervention: Procedure: L-PRF

• Publications *: Cubuk S, Oduncuoglu BF, Alaaddinoglu EE. The effect of dental pulp stem cells and L-PRF when placed into the extraction sockets of impacted mandibular third molars on the periodontal status of adjacent second molars: a split-mouth, randomized, controlled clinical trial. Oral Maxillofac Surg. 2023 Mar;27(1):59-68. doi: 10.1007/s10006-022-01045-2. Epub 2022 Feb 9.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 17, 2020): 13
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: August 11, 2020
• Actual Primary Completion Date: April 10, 2020 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 30 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Turkey

Administrative Information

• NCT Number: NCT04641533
• Other Study ID Numbers: SecilC
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Secil Cubuk, Baskent University
• Original Responsible Party: Same as current
• Current Study Sponsor: Baskent University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Baskent University
• Verification Date: November 2020