Estimate the Effect of aPDT on Root Canal Disinfection

Study Overview
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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.

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

Conditions
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Root Canal Disinfection

Intervention / Treatment
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* Procedure: Rubber dam isolation
* Device: aPDT
* Drug: 1% iodine tincture
* Drug: 2.5%NaClO
* Procedure: root canal preparation
* Procedure: root canal obturation


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control group<br>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<br>* tooth was isolated using a rubber dam in order to avoid the outside microbe<br>Drug: 1% iodine tincture<br>* use 1% iodine tincture to disinfect the crown of the teeth.in order to avoid the outside microbe<br>Drug: 2.5%NaClO<br>* use 2.5% NaClO as irrigants<br>* Other names: sodium hypochlorite;Procedure: root canal preparation<br>* 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<br>Procedure: root canal obturation<br>* filled the canals with AH-Plus sealer and Gutta-percha by vertical condensation<br>|
| Experimental: Experimental group<br>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<br>* tooth was isolated using a rubber dam in order to avoid the outside microbe<br>Device: aPDT<br>* 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.<br>* Other names: PADPLUS;Drug: 1% iodine tincture<br>* use 1% iodine tincture to disinfect the crown of the teeth.in order to avoid the outside microbe<br>Drug: 2.5%NaClO<br>* use 2.5% NaClO as irrigants<br>* Other names: sodium hypochlorite;Procedure: root canal preparation<br>* 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<br>Procedure: root canal obturation<br>* filled the canals with AH-Plus sealer and Gutta-percha by vertical condensation<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antimicrobial Photodynamic Therapy