Estimate the Effect of aPDT on Root Canal Disinfection

NCT ID: NCT02929927

Last Updated: 2022-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Root Canal Disinfection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Rubber dam isolation

Intervention Type PROCEDURE

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

1% iodine tincture

Intervention Type DRUG

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

2.5%NaClO

Intervention Type DRUG

use 2.5% NaClO as irrigants

root canal preparation

Intervention Type 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

root canal obturation

Intervention Type PROCEDURE

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

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.

Group Type EXPERIMENTAL

Rubber dam isolation

Intervention Type PROCEDURE

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

aPDT

Intervention Type 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.

1% iodine tincture

Intervention Type DRUG

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

2.5%NaClO

Intervention Type DRUG

use 2.5% NaClO as irrigants

root canal preparation

Intervention Type 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

root canal obturation

Intervention Type PROCEDURE

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

Interventions

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Rubber dam isolation

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

Intervention Type PROCEDURE

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.

Intervention Type DEVICE

1% iodine tincture

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

Intervention Type DRUG

2.5%NaClO

use 2.5% NaClO as irrigants

Intervention Type DRUG

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

Intervention Type PROCEDURE

root canal obturation

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

Intervention Type PROCEDURE

Other Intervention Names

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PADPLUS sodium hypochlorite

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fujian Medical University

OTHER

Sponsor Role lead

Responsible Party

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Xiaojing Huang

DDS, PhD, Professor,Vice Dean,School and Hospital of Stomatology Fujian Medical University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiaojing Huang, PhD

Role: STUDY_CHAIR

School and Hospital of stomatology,Fujian Medical University

Locations

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School and Hospital of stomatology,Fujian Medical University

Fuzhou, Fujian, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yanhuang Wang, bachelor

Role: CONTACT

+8613635297996

Facility Contacts

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Yanhuang Wang, bachelor

Role: primary

+8613635297996

Other Identifiers

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YTYS83736434

Identifier Type: -

Identifier Source: org_study_id

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