Effect of aPDT on Deep Caries in Permanent Tooth

September 16, 2023 updated by: Xiaojing Huang, Fujian Medical University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China
        • Recruiting
        • School and Hospital of Stomatology, Fujian Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Control
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
Local anesthesia was performed. Tooth was isolated using a rubber dam isolation in order to collect the dentin samples.
Procedure: 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.
Procedure: Dentin washed with sodium 0.9% saline
The remaining dentin was dipped in sodium 0.9% saline for 2min.
Procedure: 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).
Experimental: PDT+CH
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
Local anesthesia was performed. Tooth was isolated using a rubber dam isolation in order to collect the dentin samples.
Procedure: 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.
Procedure: 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).
Procedure: Antimicrobial Photodynamic Therapy
The remaining dentin was disinfected with aPDT for 2 min.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fujian Medical University

Investigators

  • Study Chair: Xiaojing Huang, PhD, School and Hospital of Stomatology, Fujian Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

October 8, 2016

First Submitted That Met QC Criteria

October 8, 2016

First Posted (Estimated)

October 11, 2016

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 16, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PDT20160602

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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