Effect of aPDT on Deep Caries in Permanent Tooth

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Dental Caries

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


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control<br>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. | Procedure: Local anesthesia and rubber dam isolation<br>* Local anesthesia was performed. Tooth was isolated using a rubber dam isolation in order to collect the dentin samples.<br>Procedure: Incomplete caries removal and microbiological samples collection<br>* Partial carious tissue was removed with conventional dentinal curette and collection of dentin with a spoon (1#) was performed.<br>Procedure: Dentin washed with sodium 0.9% saline<br>* The remaining dentin was dipped in sodium 0.9% saline for 2min.<br>Procedure: Microbiological samples collection and Indirect pulp treatment<br>* 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).<br>|
| Experimental: PDT+CH<br>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. | Procedure: Local anesthesia and rubber dam isolation<br>* Local anesthesia was performed. Tooth was isolated using a rubber dam isolation in order to collect the dentin samples.<br>Procedure: Incomplete caries removal and microbiological samples collection<br>* Partial carious tissue was removed with conventional dentinal curette and collection of dentin with a spoon (1#) was performed.<br>Procedure: Antimicrobial Photodynamic Therapy<br>* The remaining dentin was disinfected with aPDT for 2 min.<br>Procedure: Microbiological samples collection and Indirect pulp treatment<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification of bacteria by colony counting | Quantification of total bacteria | 2 days after dentin collection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tooth Pain | Patients reported the presence or absence of tooth pain | 1 day and 6, 12, 24 months | 
| Restoration Quality | The quality of restoration was evaluated through the absence of radiographic radiolucent area | 1 day and 6, 12, 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Carious dentin, Photodynamic Therapy