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Effect of aPDT on Deep Caries in Permanent Tooth

Primary Purpose

Dental Caries

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Local anesthesia and rubber dam isolation
Incomplete caries removal and microbiological samples collection
Dentin washed with sodium 0.9% saline
Antimicrobial Photodynamic Therapy
Microbiological samples collection and Indirect pulp treatment
Sponsored by
Fujian Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries focused on measuring Carious dentin, Photodynamic Therapy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • School and Hospital of Stomatology, Fujian Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Control

PDT+CH

Arm 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.

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.

Outcomes

Primary Outcome Measures

Quantification of bacteria by colony counting
Quantification of total bacteria

Secondary Outcome Measures

Tooth Pain
Patients reported the presence or absence of tooth pain
Restoration Quality
The quality of restoration was evaluated through the absence of radiographic radiolucent area

Full Information

First Posted
October 8, 2016
Last Updated
September 16, 2023
Sponsor
Fujian Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02929914
Brief Title
Effect of aPDT on Deep Caries in Permanent Tooth
Official Title
Effect of Antimicrobial Photodynamic Therapy on Deep Caries in Permanent Tooth: A Pilot Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 2016 (undefined)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fujian Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
Carious dentin, Photodynamic Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Experimental
Arm 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.
Arm Title
PDT+CH
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Local anesthesia and rubber dam isolation
Intervention Description
Local anesthesia was performed. Tooth was isolated using a rubber dam isolation in order to collect the dentin samples.
Intervention Type
Procedure
Intervention Name(s)
Incomplete caries removal and microbiological samples collection
Intervention Description
Partial carious tissue was removed with conventional dentinal curette and collection of dentin with a spoon (1#) was performed.
Intervention Type
Procedure
Intervention Name(s)
Dentin washed with sodium 0.9% saline
Intervention Description
The remaining dentin was dipped in sodium 0.9% saline for 2min.
Intervention Type
Procedure
Intervention Name(s)
Antimicrobial Photodynamic Therapy
Intervention Description
The remaining dentin was disinfected with aPDT for 2 min.
Intervention Type
Procedure
Intervention Name(s)
Microbiological samples collection and Indirect pulp treatment
Intervention Description
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).
Primary Outcome Measure Information:
Title
Quantification of bacteria by colony counting
Description
Quantification of total bacteria
Time Frame
2 days after dentin collection
Secondary Outcome Measure Information:
Title
Tooth Pain
Description
Patients reported the presence or absence of tooth pain
Time Frame
1 day and 6, 12, 24 months
Title
Restoration Quality
Description
The quality of restoration was evaluated through the absence of radiographic radiolucent area
Time Frame
1 day and 6, 12, 24 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiuqing Wang, Bachelor
Phone
+8613658079779
Email
1245451840@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaojing Huang, PhD
Organizational Affiliation
School and Hospital of stomatology, Fujian Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
School and Hospital of Stomatology, Fujian Medical University
City
Fuzhou
State/Province
Fujian
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiuqing Wang, Bachelor
Phone
+8613658079779
Email
1245451840@qq.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of aPDT on Deep Caries in Permanent Tooth

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