NCT06379438

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2018

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

March 5, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 8, 2019

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

April 18, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 23, 2024

Completed
Last Updated

April 23, 2024

Status Verified

April 1, 2024

Enrollment Period

12 months

First QC Date

April 18, 2024

Last Update Submit

April 18, 2024

Conditions

Oral UlcerAphthous Recurrent Ulcers

Keywords

photodynamic therapyaphtous ulcerindocyanine green

Outcome Measures

Primary Outcomes (2)

  • Ulcer wound healing with diameter measurement

    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

    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 Outcomes (1)

  • Pain evaluation with Visual Analogue Scale

    One week

Study Arms (2)

Photodynamic Therapy (PDT) Group

EXPERIMENTAL

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)

Control Group

NO INTERVENTION

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.)

Interventions

Photodynamic therapy (indocyanine green+laser)COMBINATION_PRODUCT

Photodynamic therapy with indocyanine green

Photodynamic Therapy (PDT) Group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yuzuncu Yil University

Van, Merkez, 65080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Oral UlcerStomatitis, Aphthous

Interventions

Photochemotherapy

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesStomatitis

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug TherapyPhototherapy

Study Officials

  • Cennet N Eroglu, DDS,PhD

    Yuzuncu Yil University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc Prof Dr

Study Record Dates

First Submitted

April 18, 2024

First Posted

April 23, 2024

Study Start

March 5, 2018

Primary Completion

March 1, 2019

Study Completion

March 8, 2019

Last Updated

April 23, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, ICF, CSR
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.
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.

Locations

TU(1)