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).
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
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.
- Conditions
- Apical Periodontitis
- 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 group | Role | What they receive |
|---|---|---|
| Curcumin | Experimental | patient with single root and canal, along with apical radiolucent lesions Receives: Procedure: curcumin |
| Erythrosine B | Experimental | patient with single root and canal, along with apical radiolucent lesions Receives: Procedure: erythrosine b |
| Control | Active comparator | patient with single root and canal, along with apical radiolucent lesions Receives: Procedure: control |
| Methylene Blue | Experimental | patient 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.
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
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.
- First posted14 Aug 2024
- Study start1 Feb 2021
- Primary completion1 Nov 2021
- Study completion12 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apical PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Gaziantep
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reyhan Ece Ari, University of Gaziantep
- Investigators
- REYHAN ECE ARI, Study director, University of Gaziantep
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of Intra-canal Photodynamic Therapy With Different Photosensitizers on Periapical Healing
- ClinicalTrials.gov ID
- NCT06553144
- Acronym / sponsor ID
- Gaziantep Ünivesitesi 2019/259
- Conditions
- Apical Periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of GaziantepUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 12 Dec 2021 (actual)
- First posted
- 14 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Curcumin | Experimental | Procedure: curcuminpatient with single root and canal, along with apical radiolucent lesions |
| Erythrosine B | Experimental | Procedure: erythrosine bpatient with single root and canal, along with apical radiolucent lesions |
| Control | Active comparator | Procedure: controlpatient with single root and canal, along with apical radiolucent lesions |
| Methylene Blue | Experimental | Procedure: methylene bluepatient with single root and canal, along with apical radiolucent lesions |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Encompassed lower premolars
- Upper central and lateral incisors with a single root and canal, along with apical radiolucent lesions
Key exclusion criteria (6 listed)
- Periodontal pockets exceeding 4 mm,
- Mobility,
- Nonrestorability,
- Immaturity,
- any indications of fracture or dental anomalies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| controlCanals were irrigated with only10 mL of 5% NaOCl | Procedure or surgery | Control |
| methylene blue0.1 mg/mL methylene blue solition delivered into the canal and irradiated with a 100mW diode laser at a wavelength of 660 nm | Procedure or surgery | Methylene Blue |
| erythrosine b0.3 mg/mL eryrhtosine b solition delivered into the canal and irradiated with a 100mW diode laser at a wavelength of 660 nm | Procedure or surgery | Erythrosine B |
| curcumin5.0 mg/mL curcumin solition delivered into the canal and irradiated with a 200mW diode laser at a wavelength of 450 nm | Procedure or surgery | Curcumin |
Primary outcome
healing of periapical lesions by radiography
Time frame: long-term follow-up evaluation in 12 months
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).
post-op pain
Time frame: Participants were scheduled for follow-up appointments at 6, 12, and 24 hours, as well as at 1 week,
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
REYHAN ECE ARI study director
University of Gaziantep
1 site in 1 country: see every site and its status.
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.