Skip to content

Effect of aPDT on Deep Caries in Permanent Tooth

Effect of Antimicrobial Photodynamic Therapy on Deep Caries in Permanent Tooth: A Pilot Randomized Controlled Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02929914
Enrollment
40
Registered
2016-10-11
Start date
2016-06-30
Completion date
2025-12-31
Last updated
2023-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries

Keywords

Carious dentin, Photodynamic Therapy

Brief 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.

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.

Interventions

PROCEDURELocal anesthesia and rubber dam isolation

Local anesthesia was performed. Tooth was isolated using a rubber dam isolation in order to collect the dentin samples.

PROCEDUREIncomplete caries removal and microbiological samples collection

Partial carious tissue was removed with conventional dentinal curette and collection of dentin with a spoon (1#) was performed.

PROCEDUREDentin washed with sodium 0.9% saline

The remaining dentin was dipped in sodium 0.9% saline for 2min.

The remaining dentin was disinfected with aPDT for 2 min.

PROCEDUREMicrobiological samples collection and Indirect pulp treatment

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).

Sponsors

Fujian Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Refused to sign the informed consent document * Allergic to photosensitizer * Unlikely to be able to comply with the study procedures

Design outcomes

Primary

MeasureTime frameDescription
Quantification of bacteria by colony counting2 days after dentin collectionQuantification of total bacteria

Secondary

MeasureTime frameDescription
Tooth Pain1 day and 6, 12, 24 monthsPatients reported the presence or absence of tooth pain
Restoration Quality1 day and 6, 12, 24 monthsThe quality of restoration was evaluated through the absence of radiographic radiolucent area

Countries

China

Contacts

Primary ContactXiuqing Wang, Bachelor
1245451840@qq.com+8613658079779

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026