Effect of aPDT on Deep Caries in Permanent Tooth

Dental Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02929914
• Other study ID #: PDT20160602
• Status: Recruiting
• Phase: N/A
• Start date: June 2016
• Est. completion date: December 2025

Study information

• Verified date: September 2023
• Source: Fujian Medical University
• Contact: Xiuqing Wang, Bachelor
• Phone: +8613658079779
• Email: 1245451840[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries

Intervention

Procedure:
• Local anesthesia and rubber dam isolation
Local anesthesia was performed. Tooth was isolated using a rubber dam isolation in order to collect the dentin samples.
• Incomplete 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.
• Dentin washed with sodium 0.9% saline
The remaining dentin was dipped in sodium 0.9% saline for 2min.
• Antimicrobial Photodynamic Therapy
The remaining dentin was disinfected with aPDT for 2 min.
• Microbiological 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).

Locations

Country	Name	City	State
China	School and Hospital of Stomatology, Fujian Medical University	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantification of bacteria by colony counting	Quantification of total bacteria	2 days after dentin collection
Secondary	Tooth Pain	Patients reported the presence or absence of tooth pain	1 day and 6, 12, 24 months
Secondary	Restoration Quality	The quality of restoration was evaluated through the absence of radiographic radiolucent area	1 day and 6, 12, 24 months