Estimate the Effect of aPDT on Root Canal Disinfection

Fujian Medical University

Status

Enrolling

Conditions

Root Canal Disinfection

Treatments

Procedure: root canal preparation

Procedure: root canal obturation

Procedure: Rubber dam isolation

Drug: 1% iodine tincture

Drug: 2.5%NaClO

Device: aPDT

Study type

Interventional

Funder types

Other

Identifiers

NCT02929927

YTYS83736434

Details and patient eligibility

About

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 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.

Enrollment

40 estimated patients

Sex

All

Ages

12 to 60 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups

Control group

Experimental group

Description:

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.

Treatment:

Procedure: root canal obturation

Procedure: root canal preparation

Drug: 2.5%NaClO

Procedure: Rubber dam isolation

Drug: 1% iodine tincture

Experimental group

Description:

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.

Treatment:

Procedure: root canal obturation

Device: aPDT

Procedure: root canal preparation

Drug: 2.5%NaClO

Procedure: Rubber dam isolation

Drug: 1% iodine tincture