Effect of aPDT on Deep Caries in Permanent Tooth

Not Applicable

Recruiting

• Conditions: Dental Caries
• Interventions: 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

• Registration Number: NCT02929914
• Lead Sponsor: Fujian Medical University

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.

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-10-08
• Study First Submitted QC: 2016-10-08
• Study First Posted: 2016-10-11
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-16
• Last Update Posted: 2023-09-21
• Primary Completion: 2024-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Local anesthesia and rubber dam isolation	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.
Control	Dentin washed with sodium 0.9% saline	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.
Control	Microbiological samples collection and Indirect pulp treatment	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.
PDT+CH	Local anesthesia and rubber dam isolation	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.
Control	Incomplete caries removal and microbiological samples collection	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.
PDT+CH	Incomplete caries removal and microbiological samples collection	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.
PDT+CH	Antimicrobial Photodynamic Therapy	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.
PDT+CH	Microbiological samples collection and Indirect pulp treatment	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.

Primary Outcome Measures

Name	Time	Method
Quantification of bacteria by colony counting	2 days after dentin collection	Quantification of total bacteria

Secondary Outcome Measures

Name	Time	Method
Tooth Pain	1 day and 6, 12, 24 months	Patients reported the presence or absence of tooth pain
Restoration Quality	1 day and 6, 12, 24 months	The quality of restoration was evaluated through the absence of radiographic radiolucent area

Trial Locations

Locations (1)

School and Hospital of Stomatology, Fujian Medical University; 🇨🇳 Fuzhou, Fujian, China