CClinicalTrials.gg
Status unknownNCT02929927Updated Nov 17, 2022

Estimate the Effect of aPDT on Root Canal Disinfection

An interventional study of Rubber dam isolation and aPDT in Root Canal Disinfection, sponsored by Fujian Medical University. Status unknown at 1 site in China. Open to participants aged 12 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-17.

Sponsored by Fujian Medical University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
12 Years to 60 Years
Sex
All
01

Study summary

The aim of this study is to compare the clinical effect of traditional root canal disinfection and aPDT on root canal disinfection. And provide the reference for clinical application and experience.

Read the detailed description

The study of groups:

Group1: Calcium hydroxide-based antibacterial dressing - two session root canal treatment Group2: aPDT - one session root canal treatment Microbiological measurement. Filled with sterile PBS, the root canals were sampled immediately before and after the disinfection procedures.

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Conditions studied

  • Root Canal Disinfection

Keywords

  • Antimicrobial Photodynamic Therapy
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In context

Lead sponsor

Fujian Medical University is the lead sponsor of 144 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

Good general health, without syndromes or chronic systemic diseases; tooth with single root canal; a diagnosis of chronic periapical periodontitis; the lesions of the root tip was less than 6mm; recently (3months)did not take antibiotics.

Exclusion criteria

Exclusion Criteria:

Refused to sign the informed consent document; systemic condition; uncooperative behavior; periodontal-endodontic lesions; allergic to photosensitizer; root apical absorption or destroy; A root canal anatomy of risk factors for the difficulty score ≧ 2

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Control group

    Rubber dam isolation, tooth disinfection,acess to the pulp of the chamber, microbiological sample with two sterile paper points, then mechanical preparation with NITIMTWO to 25#06, and cleaned with 5 ml of 2.5% NaClO between each endodontic file. At the end of the procedure, root canals were ultrasonic irrigated with 2.5% NaClO, 17% EDTA for 1 min followed by irrigation with 0.9% normal saline to remove the smear layer, then take the sample again, drying the canal and fill the canal with a commercial calcium hydroxide-based paste. After 2 weeks, the canals were filled with AH-Plus sealer and Gutta-percha by vertical condensation. The teeth were take crown restoration. Follow up at 3, 6, 12 and 24 months.

    Procedure: Rubber dam isolation · Drug: 1% iodine tincture · Drug: 2.5%NaClO · Procedure: root canal preparation · Procedure: root canal obturation

  • Experimental
    Experimental group

    Rubber dam isolation,tooth disinfection,acess to the pulp of the chamber, microbiological sample with two sterile paper points, then mechanical preparation with NITIMTWO to 25#06, and cleaned with 5 ml of 2.5% NaClO between each endodontic file. At the end of the procedure, root canals were ultrasonic irrigated with 2.5% NaClO for 1 min, then 17%EDTA for 1 min followed by irrigation with 0.9% normal saline to remove the smear layer, drying the canal, aPDT, then take the sample again. then dried the canals and filled the canals with AH-Plus sealer and Gutta-percha by vertical condensation. The teeth were take crown restoration. Follow up at 3, 6, 12 and 24 months.

    Procedure: Rubber dam isolation · Device: aPDT · Drug: 1% iodine tincture · Drug: 2.5%NaClO · Procedure: root canal preparation · Procedure: root canal obturation

Interventions

  • ProcedureRubber dam isolation

    tooth was isolated using a rubber dam in order to avoid the outside microbe

  • DeviceaPDT

    Inject the photosensitizer (PS)to the parallel orifice of the canal,use the small file to stir the PS for 60 s,then irradiation 120 s.

    Also known as: PADPLUS

  • Drug1% iodine tincture

    use 1% iodine tincture to disinfect the crown of the teeth.in order to avoid the outside microbe

  • Drug2.5%NaClO

    use 2.5% NaClO as irrigants

    Also known as: sodium hypochlorite

  • Procedureroot canal preparation

    mechanical preparation with NITIMTWO to 25#06, and cleaned with 5 ml of 2.5% NaClO between each endodontic file. At the end of the procedure, root canals were ultrasonic irrigated with 2.5% NaClO, 17% EDTA for 1 min followed by irrigation with 0.9% normal saline to remove the smear layer

  • Procedureroot canal obturation

    filled the canals with AH-Plus sealer and Gutta-percha by vertical condensation

06

What researchers measure

Primary outcomes

  1. Quantification of bacteria by colony counting

    Quantification the total bacteria

    Time frame: 2 days after the sample taken

Secondary outcomes

  1. tooth pain

    patient subjected sensation and doctor remark the symptoms after clinical examination

    Time frame: 1 week and 3, 6, 12, 24 months after treatment

  2. change of the lesion

    take X ray, measure the lesion and compare to post-treatment

    Time frame: 3, 6, 12, 24 months after treatment

07

Study locations

1 of 1 sites recruiting
  • School and Hospital of stomatology,Fujian Medical University
    Fuzhou, Fujian, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 17, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02929927
Lead sponsor
Fujian Medical University
Responsible party
Xiaojing Huang (DDS, PhD, Professor,Vice Dean,School and Hospital of Stomatology Fujian Medical University, Fujian Medical University) — Principal investigator
First posted
Oct 11, 2016
Start date
Mar 2016
Primary completion
Dec 2023 (estimated)
Completion
Dec 2024 (estimated)
Last update
Nov 17, 2022

Study contacts

Yanhuang Wang, bachelor
Contact
279898234@qq.com
+8613635297996
Xiaojing Huang, PhD
study chair · School and Hospital of stomatology,Fujian Medical University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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