Estimate the Effect of aPDT on Root Canal Disinfection

NCT02929927 | Unknown

• 1 other identifier: YTYS83736434
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Root Canal Disinfection

Keywords

Antimicrobial Photodynamic Therapy

Outcome Measures

Primary Outcomes (1)

• Quantification of bacteria by colony counting

  Quantification the total bacteria

  2 days after the sample taken

Secondary Outcomes (2)

• tooth pain

  1 week and 3, 6, 12, 24 months after treatment

• change of the lesion

  3, 6, 12, 24 months after treatment

Study Arms (2)

Control group

EXPERIMENTAL

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 group

EXPERIMENTAL

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

Rubber dam isolation PROCEDURE

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

Control group; Experimental group

aPDT DEVICE

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

Experimental group

1% iodine tincture DRUG

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

Control group; Experimental group

2.5%NaClO DRUG

use 2.5% NaClO as irrigants

Also known as: sodium hypochlorite

Control group; Experimental group

root canal preparation PROCEDURE

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

Control group; Experimental group

root canal obturation PROCEDURE

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

Control group; Experimental group

Eligibility Criteria

• Age: 12 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fujian Medical University: lead

Study Sites (1)

School and Hospital of stomatology,Fujian Medical University

Fuzhou, Fujian, China

RECRUITING

MeSH Terms

Interventions

Sodium Hypochlorite; Root Canal Preparation; Root Canal Obturation

Intervention Hierarchy (Ancestors)

Hypochlorous Acid; Chlorine Compounds; Inorganic Chemicals; Oxides; Oxygen Compounds; Sodium Compounds; Root Canal Therapy; Endodontics; Dentistry; Tooth Preparation

Study Officials

• Xiaojing Huang, PhD

  School and Hospital of stomatology,Fujian Medical University

  STUDY CHAIR

Central Study Contacts

Yanhuang Wang, bachelor

CONTACT

+8613635297996; 279898234@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: March 1, 2016
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: November 17, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)