Treatment of Aphtous Ulcers With Photodynamic Therapy

April 18, 2024 updated by: Cennet Neslihan Eroglu, Yuzuncu Yıl University

Treatment of Aphtous Ulcers With Photodynamic Therapy: A Randomised Controlled Clinical Trial

The search for methods that can shorten the treatment process of aphthous ulcers, the etiology of which is not fully understood, continues. The aim of this study was to determine whether photodynamic therapy (PDT) is a clinically effective alternative in the treatment of oral aphthous ulcers.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

After sample size calculation, photodynamic therapy and control groups were formed with 15 patients with aphthous ulcer in each group. Laser therapy with indocyanine green was applied to the photodynamic therapy group on the day they were admitted to the clinic. No treatment was performed in the control group and only follow-up was performed. Lesion diameters, pain intensity and degree of improvement at the end of 1 week were recorded in all patients.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Merkez
      • Van, Merkez, Turkey, 65080
        • Yuzuncu Yil University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • ASA-1 patients without any systemic disease,
  • With a history of canker sores not exceeding 2 days,
  • Not taking any antibiotics or anti-inflammatory drugs.

Exclusion Criteria:

  • Laser therapy contraindicated,
  • Pregnancy,
  • Smoking habbit,
  • Poor oral hygiene,
  • Patients under 18 years of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Photodynamic Therapy (PDT) Group
Patients in the PDT group were treated in a single session on the day of admission to the clinic. Indocyanine green (Perio green, Elexxion AG, Radolfzell, Germany) prepared and applied according to manufacturer's instructions steps (mixing, application, soaking phase, rinsing, activation) in a concentration with 0.1mg/mL was administered via fine-needle syringe as the photosensitizer. Following the completion of topical application of the photosensitizer to the lesion surface, a (GaAlAs) diode laser device (Cheese Diode Laser, Wuhan Gigaa Optronics Technology Co. Ltd, China) in continuous mode (810 nm, 300 mW, 10,000 kHz, 1.26 cm2 spot area), with a 400 μm polymethylmethacrylate optical fiber tip, scanning from the periphery to the center of the lesion with an energy density of approximately 10 J/cm2 for 40 s and applied non-contact at a distance of 1 mm.
Combination product: Photodynamic therapy (indocyanine green+laser)
Photodynamic therapy with indocyanine green
No Intervention: Control Group
The lesions of the patients in the control group were not treated but only followed up. Recommendations were made to reduce their pain (avoidance of hot, spicy and acidic foods, attention to oral hygiene, etc.)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Ulcer wound healing with diameter measurement
Time Frame: One week (preoperatively and on postoperative days 3, 5 and 7 )
Lesion diameters were measured with a elastic ruler and the healing rate of the lesion was monitored.
One week (preoperatively and on postoperative days 3, 5 and 7 )
Level of recovery
Time Frame: Postoperatively 7 th day
A 3-point scale was used. Grade 1 represents "complete recovery", Grade 2 represents "moderate recovery", Grade 3 represents "little recovery".
Postoperatively 7 th day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain evaluation with Visual Analogue Scale
Time Frame: One week
For lesion-related pain follow-up, patients in the PDT group were asked to score the pain they felt on VAS on preoperative, 1st, 3rd, 5th and 7th days. VAS measurements of the patients in the control group were made on days 1, 3, 5 and 7.
One week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yuzuncu Yıl University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Cennet N Eroglu, DDS,PhD, Yuzuncu Yıl University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 5, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 8, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 18, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 23, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 23, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 06/16022018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

After the study published, the study information will be shared with the researchers who request it, taking into account the right to protect personal data.

IPD Sharing Time Frame

IPD and documents will be available for sharing 1 year after publication for a period of 2 years. Access to the IPD and documenta will be open on the IPDShare website with registration. The information will be freely available and can be used for any purpose. There will not be any review process or no Data Use Agreement will be necessary.

IPD Sharing Access Criteria

IPD and documents will be available for sharing 1 year after publication for a period of 2 years. Access to the IPD and documenta will be open on the IPDShare website with registration. The information will be freely available and can be used for any purpose. There will not be any review process or no Data Use Agreement will be necessary.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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