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Apical PeriodontitisNCT06553144

Comparative Analysis of Photodynamic Therapy on Periapical Healing

A study testing methylene blue, erythrosine b and curcumin in people with Apical Periodontitis, run by University of Gaziantep at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

As a result of tooth decay, lesions caused by infection occur at the root tip. These teeth can heal with root canal treatment. In this study, additional applications will be made to increase the success of root canal treatment. The materials we will use are harmless. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Apical Periodontitis
What is being tested?
methylene blue, erythrosine b and curcumin
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Feb 2021to 12 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Encompassed lower premolars
  • Upper central and lateral incisors with a single root and canal, along with apical radiolucent lesions

Who cannot join

  • Periodontal pockets exceeding 4 mm,
  • Mobility,
  • Nonrestorability,
  • Immaturity,
  • any indications of fracture or dental anomalies
  • chronic drug users

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Gaziantep Üniversitesi

    Gaziantep, Adana, 01130

Other trials in Turkey (Türkiye)

About this study

Official title: Comparative Analysis of Intra-canal Photodynamic Therapy With Different Photosensitizers on Periapical Healing

As a result of tooth decay, lesions caused by infection occur at the root tip. These teeth can heal with root canal treatment. In this study, additional applications will be made to increase the success of root canal treatment. The materials we will use are harmless. At the end of the procedure, your teeth will be monitored regularly and their healing status will be checked.

Read the detailed description

Root canal therapy seeks to eradicate root canal infections and prevent their recurrence. Given the intricate nature of the root canal system and biofilm formations, achieving complete disinfection with current techniques is challenging. Nevertheless, it has been noted that residual microorganisms within the root canal contribute significantly to either the healing or the development of apical periodontitis. Various methods, such as sonic and ultrasonic activation, laser application, and PDT (Photodynamic Therapy), have been proposed in literature to enhance root canal disinfection.

Several in vivo and in vitro studies have demonstrated a significant reduction in bacterial load following PDT adjunct to root canal therapy. However, long-term in vivo outcomes of PDT as a complement to root canal disinfection remain scarce. From an endodontic perspective, many photosensitizers have not undergone clinical evaluation. This study seeks to assess the impact of PDT using different photosensitizers on in vivo lesion healing.

First of all, teeth that met the inclusion criteria were planned to be randomly divided into 4 groups. However, in this case, gender and tooth numbers would not be distributed equally among the groups. Therefore, a stratified randomization method was employed to ensure balanced distribution of participants across the four study groups based on gender (male, female) and tooth type (anterior, premolar). To ensure an unbiased distribution of teeth across four treatment groups (Curcumin, Methylene Blue, Erythrosine B, and Control) a randomization process was implemented using Excel VBA (Visual Basic for Applications) by a third party not involved in the study intervention.

Vitality tests yielded negative results for all teeth. The treatments were administered consistently by the same operator to ensure uniformity. However, due to irregular attendance at follow-up appointments by six patients and one instance of tooth extraction, the study ultimately involved 70 teeth, as elaborated in. , Study Design Participants were randomized into four groups. Periapical radiographs of the teeth were captured using a dental X-ray unit (Satalect X-Mind, France) set at 250 kV, 4 mA, and 0.12 seconds of irradiation time, employing a parallel technique guided by a cone indicator. For teeth with indistinct lesion sizes on periapical radiographs, three-dimensional images were acquired using cone beam computed tomography (CBCT) (Planmeca, Helsinki, Finland) with settings of 90 kVp, 12 mA, 14 seconds, and a 16x5 imaging field.

Following rubber dam isolation, access cavities were prepared using a diamond bur. The working length was determined using a 15 K-file (Dentsply Maillefer, Ballaigues, Switzerland) coupled with an apex locator (Root ZX, Morita, Japan), ensuring a 0.5 mm short of the \"00\" point. Radiographic confirmation of the working length was obtained.

Canal instrumentation up to a 20 K-file was carried out, followed by further preparation using the R25 Reciproc instrument (VDW, Munich, Germany) operated by a VDW Silver endodontic motor (VDW) at the Reciproc All setting. After three pecking motions, irrigation with 5% Sodium hypochlorite (NaOCl) (Werax, İzmir, Türkiye) was conducted until the full canal length was reached. Mechanical instrumentation is completed with the R40 instrument.

Throughout the procedure, each canal received irrigation with 10 mL of 5% NaOCl at a flow rate of 0.1 ml/sec via a 30-G irrigation needle (Endo-Top Wola, Poland), positioned 1 mm short of the working length. Subsequently, canals were rinsed with distilled water and then irrigated with 5 mL of 17% EDTA (Kemiger, Ankara, Turkey) for 1 minute, allowing an additional 1-minute dwell time. Ultrasonic activation involved using 2 mL of NaOCl in total, administered three times for 20 seconds each, employing a Niti U-File #25 attached to the E2 tip of an ultrasonic device (Woodpecker, China) in endodontic mode, positioned 1 mm short of the working length. After each irrigation step, canals were rinsed with distilled water.

Following this stage, participants were allocated into four groups for the final irrigation protocol. The randomization process determined which protocol would be performed for each tooth and was performed by a blinded assistant.

Group 1: A curcumin solution was prepared by dissolving curcumin (Sigma-Aldrich, Steinheim, Germany) in 0.5% dimethyl sulfoxide (DMSO) (Aromel Medikal, Konya, Türkiye) to achieve a final concentration of 5.0 mg/mL. The photosensitizer was delivered into the canal using an irrigation needle until the pulp chamber was filled. After a 3-minute wait, ultrasonic activation was performed for 20 seconds. The solution was then refreshed, and the activation process was repeated two more times for a total of 60 seconds. The last refreshed photosensitizer was irradiated with a 200mW diode laser (SiroLaser Blue, Dentsply, Germany) at a wavelength of 450 nm, employing spiral movements with an EasyTip 200 µm Endo fiber optic tip for 20 seconds. This process was repeated two more times. Finally, the photosensitizer was rinsed with distilled water.

Group 2: Erythrosine B (Sigma Aldrich, St. Louis, MO, USA) was diluted with phosphate-buffered saline solution to achieve a final concentration of 0.3 mg/mL. Ultrasonic activation was performed similarly to Group 1, but laser application utilized a wavelength of 660 nm and a power of 100 mW.

Group 3: Methylene blue (Sigma-Aldrich, Germany) at a concentration of 0.1 mg/mL was introduced into the canal as in the previous groups and activated by both ultrasonic and laser methods. The parameters for this group were also set to a wavelength of 660 nm and a power of 100 mW.

Group 4: Canals were irrigated with 10 mL of 5% NaOCl at a flow rate of 0.1 mL/sec.

All canals were subsequently rinsed with distilled water. The final irrigation involved the use of 2 mL of 1% EDTA for 1 minute. A 40/04 master gutta-percha cone was placed and confirmed radiographically. Canals were dried using sterile paper points. The obturation of canals with the 40/04 gutta-percha cones was carried out using Endoplus (President/München/ Germany) and the lateral condensation technique. Following the removal of excess gutta-percha, access cavities were cleaned with alcohol and restored incrementally with resin-modified glass ionomer cement (Riva Light Cure HV, Australia) and composite resin (G-Premio Bond, Tokyo, Japan).

Participants were scheduled for follow-up appointments at 6, 12, and 24 hours, as well as at 1 week, during which they were asked to report any pain experienced. Pain levels were assessed using the Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (most severe pain), and recorded accordingly. Subsequent follow-up appointments were scheduled at 1, 3, 6, and 9 months, and a final 1-year follow-up, during which radiographs were taken to monitor the healing of the lesions.

Being tested
control, methylene blue, erythrosine b, curcumin
Medical subject headings
Periapical Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • controlProcedure or surgery

    Canals were irrigated with only10 mL of 5% NaOCl

  • methylene blueProcedure or surgery

    0.1 mg/mL methylene blue solition delivered into the canal and irradiated with a 100mW diode laser at a wavelength of 660 nm

  • erythrosine bProcedure or surgery

    0.3 mg/mL eryrhtosine b solition delivered into the canal and irradiated with a 100mW diode laser at a wavelength of 660 nm

  • curcuminProcedure or surgery

    5.0 mg/mL curcumin solition delivered into the canal and irradiated with a 200mW diode laser at a wavelength of 450 nm

Study groups in NCT06553144
Study groupRoleWhat they receive
CurcuminExperimentalpatient with single root and canal, along with apical radiolucent lesions
Receives: Procedure: curcumin
Erythrosine BExperimentalpatient with single root and canal, along with apical radiolucent lesions
Receives: Procedure: erythrosine b
ControlActive comparatorpatient with single root and canal, along with apical radiolucent lesions
Receives: Procedure: control
Methylene BlueExperimentalpatient with single root and canal, along with apical radiolucent lesions
Receives: Procedure: methylene blue

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. healing of periapical lesions by radiography

    The area of lesions in periapical radiographs, captured using the parallel technique, was calculated in mm² utilizing Image J 1.28 software (Figure 7) (National Institute of Health, USA).

    Measured: long-term follow-up evaluation in 12 months

  2. post-op pain

    Participants were scheduled for follow-up appointments at 6, 12, and 24 hours, as well as at 1 week, during which they were asked to report any pain experienced. Pain levels were assessed using the Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (most severe pain), and recorded accordingly.

    Measured: Participants were scheduled for follow-up appointments at 6, 12, and 24 hours, as well as at 1 week,

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2024
  2. Study start1 Feb 2021
  3. Primary completion1 Nov 2021
  4. Study completion12 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06553144
Sponsor's protocol ID
Gaziantep Ünivesitesi 2019/259
Status last verified
Aug 2024
First submitted
10 Aug 2024
Last updated
16 Aug 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing methylene blue, erythrosine b and curcumin in people with Apical Periodontitis, run by University of Gaziantep at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

healing of periapical lesions by radiography (time frame: long-term follow-up evaluation in 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2024; AzTrials last refreshed its copy on 7 Nov 2026.

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