Estimate the Effect of aPDT on Root Canal Disinfection

Acess the Clinical Effect of Antimicrobial Photodynamic Therapy (aPDT) on Root Canal Disinfection

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.

Study Overview

• Status: Recruiting
• Conditions: Root Canal Disinfection
• Intervention / Treatment: Procedure: Rubber dam isolation; Drug: 1% iodine tincture; Drug: 2.5%NaClO; Procedure: root canal preparation; Procedure: root canal obturation; Device: aPDT

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yanhuang Wang, bachelor; Phone Number: +8613635297996; Email: 279898234@qq.com

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China
      • Recruiting
      • School and Hospital of stomatology,Fujian Medical University
      • Contact: Yanhuang Wang, bachelor; Phone Number: +8613635297996; Email: 279898234@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; tooth was isolated using a rubber dam in order to avoid the outside microbe; 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; Other Names: sodium hypochlorite; 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
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; tooth was isolated using a rubber dam in order to avoid the outside microbe; 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; Other Names: sodium hypochlorite; 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; 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.; Other Names: PADPLUS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantification of bacteria by colony counting	Quantification the total bacteria	2 days after the sample taken

Secondary Outcome Measures

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: October 8, 2016
• First Submitted That Met QC Criteria: October 8, 2016
• First Posted (Estimate): October 11, 2016

Study Record Updates

• Last Update Posted (Actual): November 17, 2022
• Last Update Submitted That Met QC Criteria: November 14, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Antimicrobial Photodynamic Therapy
• Additional Relevant MeSH Terms: Anti-Infective Agents; Disinfectants; Sodium Hypochlorite; Eusol
• Other Study ID Numbers: YTYS83736434

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No