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Estimate the Effect of the Photo-activated Disinfection on the Root Canal Therapy

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ClinicalTrials.gov Identifier: NCT02929927
Recruitment Status : Unknown
Verified October 2016 by Xiaojing Huang, Fujian Medical University.
Recruitment status was:  Recruiting
First Posted : October 11, 2016
Last Update Posted : October 12, 2016
Sponsor:
Information provided by (Responsible Party):
Xiaojing Huang, Fujian Medical University

Brief Summary:
This study tries to collect clinical cases to compare the clinical effect of traditional root canal disinfection, to photodynamic in root canal disinfection .And provide the reference for clinical application and experience.

Condition or disease Intervention/treatment Phase
Root Canal Disinfection Procedure: Rubber dam isolation Device: PDT Drug: tooth disinfection Drug: 1%NaOCl Drug: 2%NaOCl Not Applicable

Detailed Description:

The study of groups:

Group1:2%Sodium hypochlorite ultrasonic irrigation+17%EDTA Group2:2%Sodium hypochlorite ultrasonic irrigation+17%EDTA+PDT Group3:1%Sodium hypochlorite ultrasonic irrigation+17%EDTA+PDT Microbiological measurement. Filled with sterile PBS, the root canals were sampled immediately before and after the disinfection procedures.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acess the Clinical Effect of Photodynamic Therapy(PDT) in the Root Canal Disinfection.
Study Start Date : March 2016
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 2% NaOCl
Rubber dam isolation,tooth disinfection ,acess to the pulp of the chamber ,microbiological sample with two sterile paper points #20,then Mechanical preparation with NITIMTWO to 25#06 ,then use the kerr files hand instrument enlarger the apical to #40,and cleaned with 5 ml of 2.0% NaOCl between each endodontic file. At the end of the procedure, root canals were ultrasonic irrigated with 2% NaOCl ,17% ethylene diamine tetra-acetic acid (EDTA) for 1 min followed by irrigation with 0.9% normal saline to remove the smear layer ,then take the sample again,then drying the canal ,warm vertical condensation +AH-PLUS pasta,ZOE to seal the crown cavity ,one week later ,take crown restoration .Follow up at 1,7days ,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: tooth disinfection
use 1% iodine to disinfect the crown of the teeth.in order to avoid the outside microbe
Other Name: iodine

Drug: 2%NaOCl
use different concentration Naclo as irrigants
Other Name: sodium hypochlorite

Experimental: PDT+2% NaOCl
Rubber dam isolation,tooth disinfection ,acess to the pulp of the chamber ,microbiological sample with two sterile paper points #20,then Mechanical preparation with NITIMTWO to 25#06 ,then use the kerr files hand instrument enlarger the apical to #40,and cleaned with 5 ml of 2.0% NaOCl between each endodontic file. At the end of the procedure, root canals were ultrasonic irrigated with 2% NaOCl ,then17%EDTA for 1 min followed by irrigation with 0.9% normal saline to remove the smear layer ,drying the canal ,PDT,then take the sample again,then drying the canal ,warm vertical condensation +AH-PLUS pasta,ZOE to seal the crown cavity ,one week later ,take crown restoration .Follow up at 1,7days ,3, 6,12 and 24 months.
Procedure: Rubber dam isolation
tooth was isolated using a rubber dam in order to avoid the outside microbe

Device: PDT
Inject the photosensitizer (PS)to the parallel orifice of the canal,use the small file to stir the PS for 60s,then irradiation 120s.
Other Name: PADPLUS

Drug: tooth disinfection
use 1% iodine to disinfect the crown of the teeth.in order to avoid the outside microbe
Other Name: iodine

Drug: 2%NaOCl
use different concentration Naclo as irrigants
Other Name: sodium hypochlorite

Experimental: PDT+1% NaOCl
Rubber dam isolation,tooth disinfection ,acess to the pulp of the chamber ,microbiological sample with two sterile paper points #20,then Mechanical preparation with NITIMTWO to 25#06 ,then use the kerr files hand instrument enlarger the apical to #40,and cleaned with 5 ml of 1.0% NaOCl between each endodontic file, At the end of the procedure, root canals were ultrasonic irrigated with 1.0% NaOClfor 1min, then17%EDTA for 1 min followed by irrigation with 0.9% normal saline to remove the smear layer ,drying the canal,PDT,then take the sample again,then drying the canal ,warm vertical condensation +AH-PLUS pasta,ZOE to seal the crown cavity ,one week later ,take crown restoration .Follow up at 1,7days ,3, 6,12 and 24 months.
Procedure: Rubber dam isolation
tooth was isolated using a rubber dam in order to avoid the outside microbe

Device: PDT
Inject the photosensitizer (PS)to the parallel orifice of the canal,use the small file to stir the PS for 60s,then irradiation 120s.
Other Name: PADPLUS

Drug: tooth disinfection
use 1% iodine to disinfect the crown of the teeth.in order to avoid the outside microbe
Other Name: iodine

Drug: 1%NaOCl
use different concentration Naclo as irrigants
Other Name: sodium hypochlorite




Primary Outcome Measures :
  1. Quantification of bacteria by colony counting [ Time Frame: 2 days after the sample taken ]
    Quantification the total bacteria

  2. tooth pain [ Time Frame: 1day after treatment ]
    make a phone call to patient whether presence or absence of toot pain 1day after treatment

  3. tooth pain [ Time Frame: 1week ]
    patient subjected sensation and doctor remark the symptoms after clinical examination


Secondary Outcome Measures :
  1. tooth pain [ Time Frame: 3months ]
    patient subjected sensation and doctor remark the symptoms after clinical examination

  2. change of the lesion [ Time Frame: 3months ]
    take X ray,measure the lesion and compare to posttreatment

  3. change of the lesion [ Time Frame: 6months ]
    ake X ray,measure the lesion and compare to posttreatment

  4. change of the lesion [ Time Frame: 12months ]
    take X ray,measure the lesion and compare to posttreatment

  5. change of the lesion [ Time Frame: 24months ]
    take X ray,measure the lesion and compare to posttreatment



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Adequate health ,with no systemic conditions;cooperative behavior;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:

Systemic condition,uncooperative behavior; periodontal-endodontic lesions;Allergic to photosensitizer;the root apical absorption or destroy;A root canal anatomy of risk factors for the difficulty score ≧ 2


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02929927


Contacts
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Contact: Li Xu, bachelor +8615659036385 490474482@qq.com

Locations
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China, Fujian
School and Hospital of stomatology,Fujian Medical University Recruiting
Fuzhou, Fujian, China
Contact: Li Xu, bachelor    +8615659036385    490474482@qq.com   
Sponsors and Collaborators
Fujian Medical University
Investigators
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Study Chair: Xiaojing Huang, PhD School and Hospital of stomatology,Fujian Medical University

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Responsible Party: Xiaojing Huang, DDS, PhD, Professor,Vice Dean,School and Hospital of Stomatology Fujian Medical University, Fujian Medical University
ClinicalTrials.gov Identifier: NCT02929927     History of Changes
Other Study ID Numbers: YTYS83736434
First Posted: October 11, 2016    Key Record Dates
Last Update Posted: October 12, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Xiaojing Huang, Fujian Medical University:
PDT
Additional relevant MeSH terms:
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Sodium Hypochlorite
Eusol
Disinfectants
Anti-Infective Agents