Estimate the Effect of aPDT on Root Canal Disinfection

Overview

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.

Full Title of Study: “Acess the Clinical Effect of Antimicrobial Photodynamic Therapy (aPDT) on Root Canal Disinfection”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: December 2023

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.

Interventions

  • Procedure: Rubber dam isolation
    • tooth was isolated using a rubber dam in order to avoid the outside microbe
  • Device: aPDT
    • 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.
  • Drug: 1% iodine tincture
    • use 1% iodine tincture to disinfect the crown of the teeth.in order to avoid the outside microbe
  • Drug: 2.5%NaClO
    • use 2.5% NaClO as irrigants
  • Procedure: root 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
  • Procedure: root canal obturation
    • filled the canals with AH-Plus sealer and Gutta-percha by vertical condensation

Arms, Groups and Cohorts

  • 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.
  • 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 17TA 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.

Clinical Trial Outcome Measures

Primary Measures

  • Quantification of bacteria by colony counting
    • Time Frame: 2 days after the sample taken
    • Quantification the total bacteria

Secondary Measures

  • tooth pain
    • Time Frame: 1 week and 3, 6, 12, 24 months after treatment
    • patient subjected sensation and doctor remark the symptoms after clinical examination
  • change of the lesion
    • Time Frame: 3, 6, 12, 24 months after treatment
    • take X ray, measure the lesion and compare to post-treatment

Participating in This Clinical Trial

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:

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

Gender Eligibility: All

Minimum Age: 12 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Fujian Medical University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Xiaojing Huang, DDS, PhD, Professor,Vice Dean,School and Hospital of Stomatology Fujian Medical University – Fujian Medical University
  • Overall Official(s)
    • Xiaojing Huang, PhD, Study Chair, School and Hospital of stomatology,Fujian Medical University
  • Overall Contact(s)
    • Yanhuang Wang, bachelor, +8613635297996, 279898234@qq.com

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