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

NCT ID: NCT04641533

Last Updated: 2020-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-20

Study Completion Date

2020-08-11

Brief Summary

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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

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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.

Conditions

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Stem Cell Third Molar Periodontal Pocket

Keywords

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dental pulp stem cell third molar Platelet-rich fibrin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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).
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
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).

Study Groups

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L-PRF + DPSC

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

Group Type EXPERIMENTAL

L-PRF + DPSC

Intervention Type PROCEDURE

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

L-PRF

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

Group Type ACTIVE_COMPARATOR

L-PRF

Intervention Type PROCEDURE

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

Interventions

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L-PRF + DPSC

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

Intervention Type PROCEDURE

L-PRF

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

Intervention Type PROCEDURE

Other Intervention Names

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Leukocyte platelet rich fibrin plus dental pulp stem cells Leukocyte platelet rich fibrin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Baskent University

OTHER

Sponsor Role lead

Responsible Party

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Secil Cubuk

Assist Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emine Alaaddinoğlu, Prof,PhD

Role: STUDY_DIRECTOR

Baskent University

Locations

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Baskent University

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 35141806 (View on PubMed)

Other Identifiers

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SecilC

Identifier Type: -

Identifier Source: org_study_id