Back to resultsEffect of Dental Pulp Stem Cells and L-PRF After Impacted Third Molar Extraction
Primary Purpose
Stem Cell, Third Molar, Periodontal Pocket
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
L-PRF + DPSC
L-PRF
Sponsored by
About this trial
This is an interventional prevention trial for Stem Cell focused on measuring dental pulp, stem cell, third molar, Platelet-rich fibrin
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
Sites / Locations
- Baskent University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
L-PRF + DPSC
L-PRF
Arm Description
Mandibular third molars were extracted and DPSC with L-PRF placed into the socket.
Mandibular third molars were extracted and L-PRF placed into the socket
Outcomes
Primary Outcome Measures
Probing pocket Depth (PPD)
Probing pocket Depth (PPD) is the distance between gingival margin and bottom of the periodontal pocket in mm.
Clinical attachment level (CAL)
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
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)
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)
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
The patients were asked to note the amount of analgesics within the post-operative 7 days.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04641533
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
January 20, 2018 (Actual)
Primary Completion Date
April 10, 2020 (Actual)
Study Completion Date
August 11, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baskent University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stem Cell, Third Molar, Periodontal Pocket
Keywords
dental pulp, stem cell, third molar, Platelet-rich fibrin
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
InvestigatorOutcomes 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).
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
L-PRF + DPSC
Arm Type
Experimental
Arm Description
Mandibular third molars were extracted and DPSC with L-PRF placed into the socket.
Arm Title
L-PRF
Arm Type
Active Comparator
Arm Description
Mandibular third molars were extracted and L-PRF placed into the socket
Intervention Type
Procedure
Intervention Name(s)
L-PRF + DPSC
Other Intervention Name(s)
Leukocyte platelet rich fibrin plus dental pulp stem cells
Intervention Description
After surgical removal of impacted mandibular third molars, extraction sockets were filled with L-PRF membranes + DPSCs.
Intervention Type
Procedure
Intervention Name(s)
L-PRF
Other Intervention Name(s)
Leukocyte platelet rich fibrin
Intervention Description
After surgical removal of impacted contralateral mandibular third molars, each extraction sockets were only filled with L-PRF membranes.
Primary Outcome Measure Information:
Title
Probing pocket Depth (PPD)
Description
Probing pocket Depth (PPD) is the distance between gingival margin and bottom of the periodontal pocket in mm.
Time Frame
6 months
Title
Clinical attachment level (CAL)
Description
Clinical attachment level (CAL) is the distance between cemento-enamel junction and bottom of the periodontal pocket in mm.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Radiographic vertical distance
Description
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).
Time Frame
6 months
Title
Relative bone density (rBD)
Description
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.
Time Frame
6 months
Title
Post-operative pain as assessed by visual analogue scale (VAS)
Description
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.
Time Frame
7 days
Title
Assessment of analgesic usage
Description
The patients were asked to note the amount of analgesics within the post-operative 7 days.
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emine Alaaddinoğlu, Prof,PhD
Organizational Affiliation
Baskent University
Official's Role
Study Director
Facility Information:
Facility Name
Baskent University
City
Ankara
ZIP/Postal Code
06540
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35141806
Citation
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.
Results Reference
derived
Learn more about this trial
Effect of Dental Pulp Stem Cells and L-PRF After Impacted Third Molar Extraction
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