Clinical trial NCT04641533: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stem Cell
Third Molar
Periodontal Pocket
Keywords: dental pulp
stem cell
third molar
Platelet-rich fibrin
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2020-11-24
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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).
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Probing pocket Depth (PPD)
timeFrame: 6 months
measure: Clinical attachment level (CAL)
timeFrame: 6 months
Secondary outcomes:
measure: Radiographic vertical distance
timeFrame: 6 months
measure: Relative bone density (rBD)
timeFrame: 6 months
measure: Post-operative pain as assessed by visual analogue scale (VAS)
timeFrame: 7 days
measure: Assessment of analgesic usage
timeFrame: 7 days
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Baskent University
Study officials:
affiliation: Baskent University
name: Emine Alaaddinoğlu, Prof,PhD
role: STUDY_DIRECTOR
References:
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.