Clinical Trials Directory

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UnknownNCT02929914

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
Phase
N/A
Study type
Interventional
Enrollment
40 (estimated)
Sponsor
Fujian Medical University · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURELocal anesthesia and rubber dam isolationLocal anesthesia was performed. Tooth was isolated using a rubber dam isolation in order to collect the dentin samples.
PROCEDUREIncomplete caries removal and microbiological samples collectionPartial carious tissue was removed with conventional dentinal curette and collection of dentin with a spoon (1#) was performed.
PROCEDUREDentin washed with sodium 0.9% salineThe remaining dentin was dipped in sodium 0.9% saline for 2min.
PROCEDUREAntimicrobial Photodynamic TherapyThe remaining dentin was disinfected with aPDT for 2 min.
PROCEDUREMicrobiological 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).

Timeline

Start date
2016-06-01
Primary completion
2024-12-01
Completion
2025-12-01
First posted
2016-10-11
Last updated
2023-09-21

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT02929914. Inclusion in this directory is not an endorsement.