Effect of aPDT on Deep Caries in Permanent Tooth

Sponsor
Fujian Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT02929914
Collaborator
(none)
40
1
2
102
0.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • 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
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Antimicrobial Photodynamic Therapy on Deep Caries in Permanent Tooth: A Pilot Randomized Controlled Trial
Study Start Date :
Jun 1, 2016
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

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: Antimicrobial Photodynamic Therapy
The remaining dentin was disinfected with aPDT for 2 min.

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).

Outcome Measures

Primary Outcome Measures

  1. Quantification of bacteria by colony counting [2 days after dentin collection]

    Quantification of total bacteria

Secondary Outcome Measures

  1. Tooth Pain [1 day and 6, 12, 24 months]

    Patients reported the presence or absence of tooth pain

  2. Restoration Quality [1 day and 6, 12, 24 months]

    The quality of restoration was evaluated through the absence of radiographic radiolucent area

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 School and Hospital of Stomatology, Fujian Medical University Fuzhou Fujian China

Sponsors and Collaborators

  • Fujian Medical University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Xiaojing Huang, DDS, PhD, Professor,Vice Dean,School and Hospital of Stomatology Fujian Medical University, Fujian Medical University
ClinicalTrials.gov Identifier:
NCT02929914
Other Study ID Numbers:
  • PDT20160602
First Posted:
Oct 11, 2016
Last Update Posted:
Sep 2, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Xiaojing Huang, DDS, PhD, Professor,Vice Dean,School and Hospital of Stomatology Fujian Medical University, Fujian Medical University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 2, 2021