Effect of aPDT on Deep Caries in Permanent Tooth

NCT ID: NCT02929914

Last Updated: 2023-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2025-12-31

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.

Conditions

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Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Local anesthesia and rubber dam isolation

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

The remaining dentin was dipped in sodium 0.9% saline for 2min.

Microbiological samples collection and Indirect pulp treatment

Intervention Type PROCEDURE

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).

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.

Group Type EXPERIMENTAL

Local anesthesia and rubber dam isolation

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

Partial carious tissue was removed with conventional dentinal curette and collection of dentin with a spoon (1#) was performed.

Antimicrobial Photodynamic Therapy

Intervention Type PROCEDURE

The remaining dentin was disinfected with aPDT for 2 min.

Microbiological samples collection and Indirect pulp treatment

Intervention Type PROCEDURE

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).

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Dentin washed with sodium 0.9% saline

The remaining dentin was dipped in sodium 0.9% saline for 2min.

Intervention Type PROCEDURE

Antimicrobial Photodynamic Therapy

The remaining dentin was disinfected with aPDT for 2 min.

Intervention Type 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).

Intervention Type PROCEDURE

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fujian Medical University

OTHER

Sponsor Role lead

Responsible Party

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Xiaojing Huang

DDS, PhD, Professor,Vice Dean,School and Hospital of Stomatology Fujian Medical University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiaojing Huang, PhD

Role: STUDY_CHAIR

School and Hospital of stomatology, Fujian Medical University

Locations

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School and Hospital of Stomatology, Fujian Medical University

Fuzhou, Fujian, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiuqing Wang, Bachelor

Role: CONTACT

+8613658079779

Facility Contacts

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Xiuqing Wang, Bachelor

Role: primary

+8613658079779

Other Identifiers

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PDT20160602

Identifier Type: -

Identifier Source: org_study_id

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