Root Canal DisinfectionNCT02929927
Estimate the Effect of aPDT on Root Canal Disinfection
A study testing Rubber dam isolation, aPDT and 1% iodine tincture in people with Root Canal Disinfection, run by Fujian Medical University at 1 site in China.
Trial summary
The aim of this study is to compare the clinical effect of traditional root canal disinfection and aPDT on root canal disinfection. And provide the reference for clinical application and experience. Read more about this study
- Who is it for?
- Ages 12 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Root Canal Disinfection
- What is being tested?
- Rubber dam isolation, aPDT and 1% iodine tincture
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Mar 2016to Dec 2024
- 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 12 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Good general health, without syndromes or chronic systemic diseases; tooth with single root canal; a diagnosis of chronic periapical periodontitis; the lesions of the root tip was less than 6mm; recently (3months)did not take antibiotics.
Who cannot join
- Refused to sign the informed consent document; systemic condition; uncooperative behavior; periodontal-endodontic lesions; allergic to photosensitizer; root apical absorption or destroy; A root canal anatomy of risk factors for the difficulty score ≧ 2
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
School and Hospital of stomatology,Fujian Medical University
Fuzhou, Fujian
Yanhuang Wang, bachelor, +8613635297996, 279898234@qq.com
About this study
Official title: Acess the Clinical Effect of Antimicrobial Photodynamic Therapy (aPDT) on Root Canal Disinfection
The aim of this study is to compare the clinical effect of traditional root canal disinfection and aPDT on root canal disinfection. And provide the reference for clinical application and experience.
Read the detailed description
The study of groups:
Group1: Calcium hydroxide-based antibacterial dressing - two session root canal treatment Group2: aPDT - one session root canal treatment Microbiological measurement. Filled with sterile PBS, the root canals were sampled immediately before and after the disinfection procedures.
- Conditions
- Root Canal Disinfection
- Being tested
- Rubber dam isolation, aPDT, 1% iodine tincture, 2.5%NaClO, root canal preparation
- Keywords
- Antimicrobial Photodynamic Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rubber dam isolationProcedure or surgery
tooth was isolated using a rubber dam in order to avoid the outside microbe
aPDTDevice
Also called PADPLUS
Inject the photosensitizer (PS)to the parallel orifice of the canal,use the small file to stir the PS for 60 s,then irradiation 120 s.
1% iodine tinctureDrug
use 1% iodine tincture to disinfect the crown of the teeth.in order to avoid the outside microbe
2.5%NaClODrug
Also called sodium hypochlorite
use 2.5% NaClO as irrigants
root canal preparationProcedure or surgery
mechanical preparation with NITIMTWO to 25#06, and cleaned with 5 ml of 2.5% NaClO between each endodontic file. At the end of the procedure, root canals were ultrasonic irrigated with 2.5% NaClO, 17% EDTA for 1 min followed by irrigation with 0.9% normal saline to remove the smear layer
root canal obturationProcedure or surgery
filled the canals with AH-Plus sealer and Gutta-percha by vertical condensation
| Study group | Role | What they receive |
|---|---|---|
| Control group | Experimental | Rubber dam isolation, tooth disinfection，acess to the pulp of the chamber, microbiological sample with two sterile paper points, then mechanical preparation with NITIMTWO to 25#06, and cleaned with 5 ml of 2.5% NaClO between each endodontic file. At the end of the procedure, root canals were ultrasonic irrigated with 2.5% NaClO, 17% EDTA for 1 min followed by irrigation with 0.9% normal saline to remove the smear layer, then take the sample again, drying the canal and fill the canal with a commercial calcium hydroxide-based paste. After 2 weeks, the canals were filled with AH-Plus sealer and Gutta-percha by vertical condensation. The teeth were take crown restoration. Follow up at 3, 6, 12 and 24 months. Receives: Procedure: Rubber dam isolation; Drug: 1% iodine tincture; Drug: 2.5%NaClO; Procedure: root canal preparation; Procedure: root canal obturation |
| Experimental group | Experimental | Rubber dam isolation，tooth disinfection，acess to the pulp of the chamber, microbiological sample with two sterile paper points, then mechanical preparation with NITIMTWO to 25#06, and cleaned with 5 ml of 2.5% NaClO between each endodontic file. At the end of the procedure, root canals were ultrasonic irrigated with 2.5% NaClO for 1 min, then 17%EDTA for 1 min followed by irrigation with 0.9% normal saline to remove the smear layer, drying the canal, aPDT, then take the sample again. then dried the canals and filled the canals with AH-Plus sealer and Gutta-percha by vertical condensation. The teeth were take crown restoration. Follow up at 3, 6, 12 and 24 months. Receives: Procedure: Rubber dam isolation; Device: aPDT; Drug: 1% iodine tincture; Drug: 2.5%NaClO; Procedure: root canal preparation; Procedure: root canal obturation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of bacteria by colony counting
Quantification the total bacteria
Measured: 2 days after the sample taken
Secondary outcomes (2)
tooth pain
patient subjected sensation and doctor remark the symptoms after clinical examination
Measured: 1 week and 3, 6, 12, 24 months after treatment
change of the lesion
take X ray, measure the lesion and compare to post-treatment
Measured: 3, 6, 12, 24 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Root Canal DisinfectionStudies of the same condition, open and under way.
- More trials run by Fujian Medical 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaojing Huang, Fujian Medical University
- Investigators
- Xiaojing Huang, PhD, Study chair, School and Hospital of stomatology,Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02929927
- Sponsor's protocol ID
- YTYS83736434
- Status last verified
- Nov 2022
- First submitted
- 8 Oct 2016
- Last updated
- 17 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acess the Clinical Effect of Antimicrobial Photodynamic Therapy (aPDT) on Root Canal Disinfection
- ClinicalTrials.gov ID
- NCT02929927
- Acronym / sponsor ID
- YTYS83736434
- Conditions
- Root Canal Disinfection
- Keywords
- Antimicrobial Photodynamic Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 11 Oct 2016 (estimated)
- 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.
The aim of this study is to compare the clinical effect of traditional root canal disinfection and aPDT on root canal disinfection. And provide the reference for clinical application and experience.
Detailed description
The study of groups:
Group1: Calcium hydroxide-based antibacterial dressing - two session root canal treatment Group2: aPDT - one session root canal treatment Microbiological measurement. Filled with sterile PBS, the root canals were sampled immediately before and after the disinfection procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Experimental | Procedure: Rubber dam isolation, Drug: 1% iodine tincture, Drug: 2.5%NaClO, Procedure: root canal preparation, Procedure: root canal obturationRubber dam isolation, tooth disinfection，acess to the pulp of the chamber, microbiological sample with two sterile paper points, then mechanical preparation with NITIMTWO to 25#06, and cleaned with 5 ml of 2.5% NaClO between each endodontic file. At the end of the procedure, root canals were ultrasonic irrigated with 2.5% NaClO, 17% EDTA for 1 min followed by irrigation with 0.9% normal saline to remove the smear layer, then take the sample again, drying the canal and fill the canal with a commercial calcium hydroxide-based paste. After 2 weeks, the canals were filled with AH-Plus sealer and Gutta-percha by vertical condensation. The teeth were take crown restoration. Follow up at 3, 6, 12 and 24 months. |
| Experimental group | Experimental | Procedure: Rubber dam isolation, Device: aPDT, Drug: 1% iodine tincture, Drug: 2.5%NaClO, Procedure: root canal preparation, Procedure: root canal obturationRubber dam isolation，tooth disinfection，acess to the pulp of the chamber, microbiological sample with two sterile paper points, then mechanical preparation with NITIMTWO to 25#06, and cleaned with 5 ml of 2.5% NaClO between each endodontic file. At the end of the procedure, root canals were ultrasonic irrigated with 2.5% NaClO for 1 min, then 17%EDTA for 1 min followed by irrigation with 0.9% normal saline to remove the smear layer, drying the canal, aPDT, then take the sample again. then dried the canals and filled the canals with AH-Plus sealer and Gutta-percha by vertical condensation. The teeth were take crown restoration. Follow up at 3, 6, 12 and 24 months. |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Good general health, without syndromes or chronic systemic diseases; tooth with single root canal; a diagnosis of chronic periapical periodontitis; the lesions of the root tip was less than 6mm; recently (3months)did not take antibiotics.
Key exclusion criteria (1 listed)
- Refused to sign the informed consent document; systemic condition; uncooperative behavior; periodontal-endodontic lesions; allergic to photosensitizer; root apical absorption or destroy; A root canal anatomy of risk factors for the difficulty score ≧ 2
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 |
|---|---|---|
| Rubber dam isolationtooth was isolated using a rubber dam in order to avoid the outside microbe | Procedure or surgery | Control group, Experimental group |
| aPDTAlso: PADPLUSInject the photosensitizer (PS)to the parallel orifice of the canal,use the small file to stir the PS for 60 s,then irradiation 120 s. | Device | Experimental group |
| 1% iodine tinctureuse 1% iodine tincture to disinfect the crown of the teeth.in order to avoid the outside microbe | Drug | Control group, Experimental group |
| 2.5%NaClOAlso: sodium hypochloriteuse 2.5% NaClO as irrigants | Drug | Control group, Experimental group |
| root canal preparationmechanical preparation with NITIMTWO to 25#06, and cleaned with 5 ml of 2.5% NaClO between each endodontic file. At the end of the procedure, root canals were ultrasonic irrigated with 2.5% NaClO, 17% EDTA for 1 min followed by irrigation with 0.9% normal saline to remove the smear layer | Procedure or surgery | Control group, Experimental group |
| root canal obturationfilled the canals with AH-Plus sealer and Gutta-percha by vertical condensation | Procedure or surgery | Control group, Experimental group |
Primary outcome
Quantification of bacteria by colony counting
Time frame: 2 days after the sample taken
Quantification the total bacteria
2 secondary outcomes
tooth pain
Time frame: 1 week and 3, 6, 12, 24 months after treatment
change of the lesion
Time frame: 3, 6, 12, 24 months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2022.
- Individual participant dataSharing planned: No
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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.
Xiaojing Huang, PhD study chair
School and Hospital of stomatology,Fujian Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rubber dam isolation, aPDT and 1% iodine tincture in people with Root Canal Disinfection, run by Fujian Medical University at 1 site in China.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 17 Nov 2022. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanhuang Wang, bachelor (+8613635297996, 279898234@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification of bacteria by colony counting (time frame: 2 days after the sample taken). 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 17 Nov 2022.