Dental CariesNCT02929914
Effect of aPDT on Deep Caries in Permanent Tooth
A study testing Local anesthesia and rubber dam isolation, Incomplete caries removal and microbiological samples collection and Dentin washed with sodium 0.9% saline in people with Dental Caries, run by Fujian Medical University at 1 site in China.
Trial summary
The aim of this study is to assess the clinical effect of aPDT on deep caries in permanent teeth. Half of the deep caries will receive aPDT disinfect in restorative treatment procedure, while the other half will receive sodium 0.9% saline in restorative treatment procedure. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dental Caries
- What is being tested?
- Local anesthesia and rubber dam isolation, Incomplete caries removal and microbiological samples collection and Dentin washed with sodium 0.9% saline
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Jun 2016to Dec 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Good general health, without syndromes or chronic systemic diseases
- Permanent tooth with deep carious lesion (2/3 of dentin) without pain symptomatology and compatible with reversible pulpits
Who cannot join
- Refused to sign the informed consent document
- Allergic to photosensitizer
- Unlikely to be able to comply with the study procedures
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
School and Hospital of Stomatology, Fujian Medical University
Fuzhou, Fujian
Xiuqing Wang, Bachelor, +8613658079779, 1245451840@qq.com
About this study
Official title: Effect of Antimicrobial Photodynamic Therapy on Deep Caries in Permanent Tooth: A Pilot Randomized Controlled Trial
The aim of this study is to assess the clinical effect of aPDT on deep caries in permanent teeth. Half of the deep caries will receive aPDT disinfect in restorative treatment procedure, while the other half will receive sodium 0.9% saline in restorative treatment procedure.
Read the detailed description
The aim of the proposed study is to assess the clinical effect of antimicrobial photodynamic therapy (aPDT) using LED on dentin with deep caries in permanent teeth. Permanent teeth with deep carious lesions on the occlusal surface indicated for restorative treatment will be randomly allocated to two groups: Group 1 -Control after incomplete caries removal, washed with sodium 0.9% saline; Group 2 - PDT + CH after incomplete caries removal, disinfect the residual dentin with PDT(LED + O-Toluidine Blue). Dentin samples will be collected before and after disinfect for microbiological analysis. Then the teeth will be capped with CH and restored using resin with clinical and radiographic follow up at 6, 12 and 24 months.
- Conditions
- Dental Caries
- Being tested
- Local anesthesia and rubber dam isolation, Incomplete caries removal and microbiological samples collection, Dentin washed with sodium 0.9% saline, Antimicrobial Photodynamic Therapy, Microbiological samples collection and Indirect pulp treatment
- Keywords
- Carious dentin, Photodynamic Therapy
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local anesthesia and rubber dam isolationProcedure or surgery
Local anesthesia was performed. Tooth was isolated using a rubber dam isolation in order to collect the dentin samples.
Incomplete caries removal and microbiological samples collectionProcedure or surgery
Partial carious tissue was removed with conventional dentinal curette and collection of dentin with a spoon (1#) was performed.
Dentin washed with sodium 0.9% salineProcedure or surgery
The remaining dentin was dipped in sodium 0.9% saline for 2min.
Antimicrobial Photodynamic TherapyProcedure or surgery
The remaining dentin was disinfected with aPDT for 2 min.
Microbiological samples collection and Indirect pulp treatmentProcedure or surgery
A new dentin collection was performed after this treatment at another site of the cavity. Then teeth were conventionally restored using the following materials: calcium hydroxide lining material and resin (Z350,3M).
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | Local anesthesia, rubber dam isolation, remove caries incompletely, microbiological sample with otoscope curette, dentin washed with sodium 0.9% saline, sampling again. Indirect pulp treatment with calcium hydroxide(CH). Restoration with resin(Z350,3M). Follow up at 6, 12 and 24 months. Receives: Procedure: Local anesthesia and rubber dam isolation; Procedure: Incomplete caries removal and microbiological samples collection; Procedure: Dentin washed with sodium 0.9% saline; Procedure: Microbiological samples collection and Indirect pulp treatment |
| PDT+CH | Experimental | Local anesthesia, rubber dam isolation, remove caries incompletely, microbiological sample with otoscope curette, disinfect the remaining dentin with antimicrobial photodynamic therapy (DENFOTEX PADplus), sampling again. Indirect pulp treatment with calcium hydroxide(CH). Restoration with resin(Z350,3M). Follow up at 6, 12 and 24 months. Receives: Procedure: Local anesthesia and rubber dam isolation; Procedure: Incomplete caries removal and microbiological samples collection; Procedure: Antimicrobial Photodynamic Therapy; Procedure: Microbiological samples collection and Indirect pulp treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of bacteria by colony counting
Quantification of total bacteria
Measured: 2 days after dentin collection
Secondary outcomes (2)
Tooth Pain
Patients reported the presence or absence of tooth pain
Measured: 1 day and 6, 12, 24 months
Restoration Quality
The quality of restoration was evaluated through the absence of radiographic radiolucent area
Measured: 1 day and 6, 12, 24 months
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 startJun 2016
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies 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
- NCT02929914
- Sponsor's protocol ID
- PDT20160602
- Status last verified
- Sep 2023
- First submitted
- 8 Oct 2016
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Antimicrobial Photodynamic Therapy on Deep Caries in Permanent Tooth: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02929914
- Acronym / sponsor ID
- PDT20160602
- Conditions
- Dental Caries
- Keywords
- Carious dentin, Photodynamic Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (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 assess the clinical effect of aPDT on deep caries in permanent teeth. Half of the deep caries will receive aPDT disinfect in restorative treatment procedure, while the other half will receive sodium 0.9% saline in restorative treatment procedure.
Detailed description
The aim of the proposed study is to assess the clinical effect of antimicrobial photodynamic therapy (aPDT) using LED on dentin with deep caries in permanent teeth. Permanent teeth with deep carious lesions on the occlusal surface indicated for restorative treatment will be randomly allocated to two groups: Group 1 -Control after incomplete caries removal, washed with sodium 0.9% saline; Group 2 - PDT + CH after incomplete caries removal, disinfect the residual dentin with PDT(LED + O-Toluidine Blue). Dentin samples will be collected before and after disinfect for microbiological analysis. Then the teeth will be capped with CH and restored using resin with clinical and radiographic follow up at 6, 12 and 24 months.
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 | Experimental | Procedure: Local anesthesia and rubber dam isolation, Procedure: Incomplete caries removal and microbiological samples collection, Procedure: Dentin washed with sodium 0.9% saline, Procedure: Microbiological samples collection and Indirect pulp treatmentLocal anesthesia, rubber dam isolation, remove caries incompletely, microbiological sample with otoscope curette, dentin washed with sodium 0.9% saline, sampling again. Indirect pulp treatment with calcium hydroxide(CH). Restoration with resin(Z350,3M). Follow up at 6, 12 and 24 months. |
| PDT+CH | Experimental | Procedure: Local anesthesia and rubber dam isolation, Procedure: Incomplete caries removal and microbiological samples collection, Procedure: Antimicrobial Photodynamic Therapy, Procedure: Microbiological samples collection and Indirect pulp treatmentLocal anesthesia, rubber dam isolation, remove caries incompletely, microbiological sample with otoscope curette, disinfect the remaining dentin with antimicrobial photodynamic therapy (DENFOTEX PADplus), sampling again. Indirect pulp treatment with calcium hydroxide(CH). Restoration with resin(Z350,3M). Follow up at 6, 12 and 24 months. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Good general health, without syndromes or chronic systemic diseases
- Permanent tooth with deep carious lesion (2/3 of dentin) without pain symptomatology and compatible with reversible pulpits
Key exclusion criteria (3 listed)
- Refused to sign the informed consent document
- Allergic to photosensitizer
- Unlikely to be able to comply with the study procedures
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 |
|---|---|---|
| Local anesthesia and rubber dam isolationLocal anesthesia was performed. Tooth was isolated using a rubber dam isolation in order to collect the dentin samples. | Procedure or surgery | Control, PDT+CH |
| Incomplete caries removal and microbiological samples collectionPartial carious tissue was removed with conventional dentinal curette and collection of dentin with a spoon (1#) was performed. | Procedure or surgery | Control, PDT+CH |
| Dentin washed with sodium 0.9% salineThe remaining dentin was dipped in sodium 0.9% saline for 2min. | Procedure or surgery | Control |
| Antimicrobial Photodynamic TherapyThe remaining dentin was disinfected with aPDT for 2 min. | Procedure or surgery | PDT+CH |
| Microbiological samples collection and Indirect pulp treatmentA new dentin collection was performed after this treatment at another site of the cavity. Then teeth were conventionally restored using the following materials: calcium hydroxide lining material and resin (Z350,3M). | Procedure or surgery | Control, PDT+CH |
Primary outcome
Quantification of bacteria by colony counting
Time frame: 2 days after dentin collection
Quantification of total bacteria
2 secondary outcomes
Tooth Pain
Time frame: 1 day and 6, 12, 24 months
Restoration Quality
Time frame: 1 day and 6, 12, 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- 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 Local anesthesia and rubber dam isolation, Incomplete caries removal and microbiological samples collection and Dentin washed with sodium 0.9% saline in people with Dental Caries, 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 2 inclusion and 3 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 21 Sep 2023. 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 Xiuqing Wang, Bachelor (+8613658079779, 1245451840@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 dentin collection). 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 21 Sep 2023.