NCT02929914

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 11, 2016

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

8.5 years

First QC Date

October 8, 2016

Last Update Submit

September 16, 2023

Conditions

Dental Caries

Keywords

Carious dentinPhotodynamic Therapy

Outcome Measures

Primary Outcomes (1)

  • Quantification of bacteria by colony counting

    Quantification of total bacteria

    2 days after dentin collection

Secondary Outcomes (2)

  • Tooth Pain

    1 day and 6, 12, 24 months

  • Restoration Quality

    1 day and 6, 12, 24 months

Study Arms (2)

Control

EXPERIMENTAL

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 isolationProcedure: Incomplete caries removal and microbiological samples collectionProcedure: Dentin washed with sodium 0.9% salineProcedure: Microbiological samples collection and Indirect pulp treatment

PDT+CH

EXPERIMENTAL

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 isolationProcedure: Incomplete caries removal and microbiological samples collectionProcedure: Antimicrobial Photodynamic TherapyProcedure: Microbiological samples collection and Indirect pulp treatment

Interventions

Local anesthesia and rubber dam isolationPROCEDURE

Local anesthesia was performed. Tooth was isolated using a rubber dam isolation in order to collect the dentin samples.

ControlPDT+CH
Incomplete caries removal and microbiological samples collectionPROCEDURE

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

ControlPDT+CH
Dentin washed with sodium 0.9% salinePROCEDURE

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

Control
Antimicrobial Photodynamic TherapyPROCEDURE

The remaining dentin was disinfected with aPDT for 2 min.

PDT+CH
Microbiological samples collection and Indirect pulp treatmentPROCEDURE

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).

ControlPDT+CH

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Refused to sign the informed consent document
  • Allergic to photosensitizer
  • Unlikely to be able to comply with the study procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School and Hospital of Stomatology, Fujian Medical University

Fuzhou, Fujian, China

RECRUITING

MeSH Terms

Conditions

Dental Caries

Interventions

Anesthesia, LocalSodiumSodium Chloride

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and AnalgesiaMetals, AlkaliElementsInorganic ChemicalsMetals, LightMetalsChloridesHydrochloric AcidChlorine CompoundsSodium Compounds

Study Officials

  • Xiaojing Huang, PhD

    School and Hospital of stomatology, Fujian Medical University

    STUDY CHAIR

Central Study Contacts

Xiuqing Wang, Bachelor

CONTACT

+86136580797791245451840@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DDS, PhD, Professor，Vice Dean，School and Hospital of Stomatology Fujian Medical University

Study Record Dates

First Submitted

October 8, 2016

First Posted

October 11, 2016

Study Start

June 1, 2016

Primary Completion

December 1, 2024

Study Completion

December 1, 2025

Last Updated

September 21, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)