Periapical DiseasesNCT06752655
Postoperative Pain in Photodynamic Therapy Using Curcumin As a Photosensitizer
A study testing Curcumin with photodynamic thearpy in people with Periapical Diseases and Postoperative Dental Pain, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
In endodontics, various irrigation solutions are used to achieve antibacterial efficacy within the root canal. The antibacterial effect of curcumin-containing root canal solutions, when combined with photodynamic therapy, has been demonstrated in several studies. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Periapical Diseases, Postoperative Dental Pain, Irrigation Solution
- What is being tested?
- Curcumin with photodynamic thearpy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2025to Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy patients with aged between 18-60.
- Incisor, canine, and premolar teeth that had previously undergone root canal treatment
- Incisor, canine, and premolar teeth with a diagnosis of chronic apical abscess or asymptomatic apical periodontitis
- teeth with only 1 root canal
- the patients had not used any antibiotics for 3 months before treatment
Who cannot join
- the presence of a root fracture
- teeth with any swelling
- ankyloses,
- periodontal pockets deeper than 4 mm.
- teeth which a rubber dam could not be performed
- patients with allergy to ibuprofen or ciprofloxacin were also excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Atatürk University
Erzurum, yakutiye, 25240
meltem çolak, DDS, pHD, +90 442 236 0940, neltem25@gmail.com
About this study
Official title: The Effect of Photodynamic Therapy Using Curcumin As a Photosensitizer on Postoperative Pain After Non-Surgical Root Canal Retreatment: a Randomized Controlled Clinical Trial
In endodontics, various irrigation solutions are used to achieve antibacterial efficacy within the root canal. The antibacterial effect of curcumin-containing root canal solutions, when combined with photodynamic therapy, has been demonstrated in several studies. However, no research has specifically examined their effect on postoperative pain. The aim of this study is to investigate the impact of using a curcumin solution in combination with photodynamic therapy as the final irrigation solution on postoperative pain.
Read the detailed description
Fifty patients were randomly assigned to two groups using a web-based program, according to the selected final irrigation procedure: curcumin-photodynamic therapy or a control group (routine root canal final irrigation with NaOCl and EDTA). The teeth will be isolated with a rubber dam, and access cavities will be created. After root canal preparation, the final irrigation procedure will be performed. Root canal treatments will then be completed, and the patients' postoperative pain levels will be recorded using follow-up forms.
- Conditions
- Periapical Diseases, Postoperative Dental Pain, Irrigation Solution, Photodynamic Therapy (PDT)
- Being tested
- Curcumin with photodynamic thearpy, Control group
- Keywords
- postoperative pain, endodontics, root canal irrigation, curcumin, photodynamic therapy
- Medical subject headings
- Periapical Diseases, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curcumin with photodynamic thearpyOther
root canals will irrigated with final irrigation procedure: curcumin+photodynamic therapy. The teeth will be isolated with a rubber dam, and an access cavity will be created. After root canal preparation, the final irrigation procedure will be performed. Root canal treatments will be completed, and the patients' postoperative pain levels will be recorded using follow-up forms.
Control groupOther
root canals will irrigated with routine root canal final irrigation with NaOCl and EDTA. The teeth will be isolated with a rubber dam, and an access cavity will be created. After root canal preparation, the final irrigation procedure will be performed. Root canal treatments will be completed, and the patients' postoperative pain levels will be recorded using follow-up forms.
| Study group | Role | What they receive |
|---|---|---|
| Curcumin with photodynamic therapy | Experimental | Root canal lengths will be determined using an electronic apex locator with a 15-K file. R25 and R50 Reciproc files will be used at working lengths to complete the canal preparation. During instrumentation, the root canals will be irrigated with 2 mL of 1% NaOCl. Subsequently, the root canals will be dried with paper points, and the final irrigation procedure will be performed using a curcumin solution in combination with photodynamic therapy. The root canals will then be filled with gutta-percha and sealer, and the coronal restoration will be completed. Patients will be provided with a form to assess postoperative pain and asked to score it daily. The completed form will be requested after one week. Receives: Other: Curcumin with photodynamic thearpy |
| control group | Active comparator | Root canal lengths will be determined using an electronic apex locator with a 15-K file. R25 and R50 Reciproc files will be used at working lengths to remove the canal filling. During instrumentation, the root canals will be irrigated with 2 mL of NaOCl (1%). Subsequently, the root canals will be dried with paper points, and the final irrigation procedure will be performed using NaOCl (1%) and EDTA (17%) solutions. The root canals will then be filled with gutta-percha and sealer, and the coronal restoration will be completed. Patients will be provided with a form to assess postoperative pain and asked to score it daily. The completed form will be requested after one week. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain levels
postoperative pain levels will be describe using the visual analog scale (VAS). The VAS was classified using the following scale [15]: no pain (0); mild pain (1-3); moderate pain (4-6), and severe pain (7-10).
Measured: one week
Secondary outcomes (4)
dependent variables-sex
The patients' genders (female or male) will be recorded, and their relationship with postoperative pain will be statistically analyzed.
Measured: one week
dependent variable-age
The patients' ages will be recorded as numbers, and their relationship with postoperative pain will be statistically analyzed.
Measured: one week
dependent variables-teeth number
The patients' tooth numbers will be recorded, and their relationship with postoperative pain will be statistically analyzed.
Measured: one week
dependent variables-smoking habit
The patients' smoking habits will be recorded as either "yes" or "no," and their relationship with postoperative pain will be statistically analyzed.
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study startJan 2025 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periapical DiseasesStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- 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
- Model description
- Randomized Clinical Trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meltem Sümbüllü, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06752655
- Sponsor's protocol ID
- 404380
- Status last verified
- Dec 2024
- First submitted
- 18 Dec 2024
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Photodynamic Therapy Using Curcumin As a Photosensitizer on Postoperative Pain After Non-Surgical Root Canal Retreatment: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06752655
- Acronym / sponsor ID
- 404380
- Conditions
- Periapical Diseases, Postoperative Dental Pain, Irrigation Solution, Photodynamic Therapy (PDT)
- Keywords
- postoperative pain, endodontics, root canal irrigation, curcumin, photodynamic therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 31 Dec 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.
In endodontics, various irrigation solutions are used to achieve antibacterial efficacy within the root canal. The antibacterial effect of curcumin-containing root canal solutions, when combined with photodynamic therapy, has been demonstrated in several studies. However, no research has specifically examined their effect on postoperative pain. The aim of this study is to investigate the impact of using a curcumin solution in combination with photodynamic therapy as the final irrigation solution on postoperative pain.
Detailed description
Fifty patients were randomly assigned to two groups using a web-based program, according to the selected final irrigation procedure: curcumin-photodynamic therapy or a control group (routine root canal final irrigation with NaOCl and EDTA). The teeth will be isolated with a rubber dam, and access cavities will be created. After root canal preparation, the final irrigation procedure will be performed. Root canal treatments will then be completed, and the patients' postoperative pain levels will be recorded using follow-up forms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Curcumin with photodynamic therapy | Experimental | Other: Curcumin with photodynamic thearpyRoot canal lengths will be determined using an electronic apex locator with a 15-K file. R25 and R50 Reciproc files will be used at working lengths to complete the canal preparation. During instrumentation, the root canals will be irrigated with 2 mL of 1% NaOCl. Subsequently, the root canals will be dried with paper points, and the final irrigation procedure will be performed using a curcumin solution in combination with photodynamic therapy. The root canals will then be filled with gutta-percha and sealer, and the coronal restoration will be completed. Patients will be provided with a form to assess postoperative pain and asked to score it daily. The completed form will be requested after one week. |
| control group | Active comparator | Other: Control groupRoot canal lengths will be determined using an electronic apex locator with a 15-K file. R25 and R50 Reciproc files will be used at working lengths to remove the canal filling. During instrumentation, the root canals will be irrigated with 2 mL of NaOCl (1%). Subsequently, the root canals will be dried with paper points, and the final irrigation procedure will be performed using NaOCl (1%) and EDTA (17%) solutions. The root canals will then be filled with gutta-percha and sealer, and the coronal restoration will be completed. Patients will be provided with a form to assess postoperative pain and asked to score it daily. The completed form will be requested after one week. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- healthy patients with aged between 18-60.
- Incisor, canine, and premolar teeth that had previously undergone root canal treatment
- Incisor, canine, and premolar teeth with a diagnosis of chronic apical abscess or asymptomatic apical periodontitis
- teeth with only 1 root canal
- the patients had not used any antibiotics for 3 months before treatment
Key exclusion criteria (6 listed)
- the presence of a root fracture
- teeth with any swelling
- ankyloses,
- periodontal pockets deeper than 4 mm.
- teeth which a rubber dam could not be performed
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 |
|---|---|---|
| Curcumin with photodynamic thearpyroot canals will irrigated with final irrigation procedure: curcumin+photodynamic therapy. The teeth will be isolated with a rubber dam, and an access cavity will be created. After root canal preparation, the final irrigation procedure will be performed. Root canal treatments will be completed, and the patients' postoperative pain levels will be recorded using follow-up forms. | Other | Curcumin with photodynamic therapy |
| Control grouproot canals will irrigated with routine root canal final irrigation with NaOCl and EDTA. The teeth will be isolated with a rubber dam, and an access cavity will be created. After root canal preparation, the final irrigation procedure will be performed. Root canal treatments will be completed, and the patients' postoperative pain levels will be recorded using follow-up forms. | Other | control group |
Primary outcome
postoperative pain levels
Time frame: one week
postoperative pain levels will be describe using the visual analog scale (VAS). The VAS was classified using the following scale [15]: no pain (0); mild pain (1-3); moderate pain (4-6), and severe pain (7-10).
4 secondary outcomes
dependent variables-sex
Time frame: one week
dependent variable-age
Time frame: one week
dependent variables-teeth number
Time frame: one week
dependent variables-smoking habit
Time frame: one week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Periapical Diseases
Enrolling by invitationPhase 4
Nanozymes in Endodontics
Apical Periodontitis, Endodontic Disease
Active, not recruiting
Effect of Apical Patency on Periapical Lesion Healing
Periapical Lesion, Apical Periodontitis
Not yet recruiting
Clinical and Radiographic Success of Calcium Hydroxide-Iodoform Paste Versus Modified Triple Antibiotic Paste for Necrotic Primary Molars in Children
Dental Pulp Necrosis, Periapical Diseases
Recruiting
Effect of Photobiomodulation on Pain and Healing of the Vertical Releasing Incision After Endodontic Microsurgery
Apical Periodontitis, Endodontically Treated Teeth
Not yet recruitingObservational study
Comparative Analysis of Diagnostic Accuracy and Case Difficulty Assessment of Three Large Language Models
Pulp and Periapical Tissue Disease
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Curcumin with photodynamic thearpy in people with Periapical Diseases and Postoperative Dental Pain, run by Ataturk University 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 5 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: opening soon, as of the sponsor's last update on 31 Dec 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meltem Sumbullu, DDS (+90 442 231 1111, meltem_endo@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain levels (time frame: one week). 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 31 Dec 2024; AzTrials last refreshed its copy on 7 Nov 2026.