Skip to main content
OpenTrials
Completed

NCT Number: NCT04641533

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stem Cell Mouth Diseases Periodontal Diseases Periodontal Pocket Periodontitis Stomatognathic Diseases Third Molar

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baskent University

Ankara, 06540, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

L-PRF + DPSC

Procedure

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

L-PRF

Procedure

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Baskent University

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 24, 2020
Registry last updated
Nov 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.