Effect of aPDT on Deep Caries in Permanent Tooth

Fujian Medical University

Status: Enrolling

Conditions: Dental Caries

Treatments: Procedure: Dentin washed with sodium 0.9% saline; Procedure: Antimicrobial Photodynamic Therapy; Procedure: Microbiological samples collection and Indirect pulp treatment; Procedure: Incomplete caries removal and microbiological samples collection; Procedure: Local anesthesia and rubber dam isolation

Study type: Interventional

Funder types: Other

Identifiers

NCT02929914

PDT20160602

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Control

Experimental group

Description:

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.

Treatment:

Procedure: Microbiological samples collection and Indirect pulp treatment

Procedure: Incomplete caries removal and microbiological samples collection

Procedure: Local anesthesia and rubber dam isolation

Procedure: Dentin washed with sodium 0.9% saline

PDT+CH

Experimental group

Description:

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.

Treatment:

Procedure: Antimicrobial Photodynamic Therapy

Procedure: Microbiological samples collection and Indirect pulp treatment

Procedure: Incomplete caries removal and microbiological samples collection

Procedure: Local anesthesia and rubber dam isolation