NCT04641533

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2020

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

August 16, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 24, 2020

Completed
Last Updated

November 24, 2020

Status Verified

November 1, 2020

Enrollment Period

2.2 years

First QC Date

August 16, 2020

Last Update Submit

November 17, 2020

Conditions

Stem CellThird MolarPeriodontal Pocket

Keywords

dental pulpstem cellthird molarPlatelet-rich fibrin

Outcome Measures

Primary Outcomes (2)

  • Probing pocket Depth (PPD)

    Probing pocket Depth (PPD) is the distance between gingival margin and bottom of the periodontal pocket in mm.

    6 months

  • Clinical attachment level (CAL)

    Clinical attachment level (CAL) is the distance between cemento-enamel junction and bottom of the periodontal pocket in mm.

    6 months

Secondary Outcomes (4)

  • Radiographic vertical distance

    6 months

  • Relative bone density (rBD)

    6 months

  • Post-operative pain as assessed by visual analogue scale (VAS)

    7 days

  • Assessment of analgesic usage

    7 days

Study Arms (2)

L-PRF + DPSC

EXPERIMENTAL

Mandibular third molars were extracted and DPSC with L-PRF placed into the socket.

Procedure: L-PRF + DPSC

L-PRF

ACTIVE COMPARATOR

Mandibular third molars were extracted and L-PRF placed into the socket

Procedure: L-PRF

Interventions

L-PRF + DPSCPROCEDURE

After surgical removal of impacted mandibular third molars, extraction sockets were filled with L-PRF membranes + DPSCs.

Also known as: Leukocyte platelet rich fibrin plus dental pulp stem cells
L-PRF + DPSC
L-PRFPROCEDURE

After surgical removal of impacted contralateral mandibular third molars, each extraction sockets were only filled with L-PRF membranes.

Also known as: Leukocyte platelet rich fibrin
L-PRF

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients aged between 18 and 30 years
  • Bilateral impacted LM3 extraction surgeries requirement

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baskent University

Ankara, 06540, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 35141806DERIVED

MeSH Terms

Conditions

Periodontal Pocket

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Emine Alaaddinoğlu, Prof,PhD

    Baskent University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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).
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist Prof

Study Record Dates

First Submitted

August 16, 2020

First Posted

November 24, 2020

Study Start

January 20, 2018

Primary Completion

April 10, 2020

Study Completion

August 11, 2020

Last Updated

November 24, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)