- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02479958
An in Vitro Evaluation of Antimicrobial Photodynamic Therapy on Deciduous Carious Dentin
June 24, 2015 updated by: Carolina Steiner-Oliveira, University of Sao Paulo
A Randomized in Vitro Evaluation of Antimicrobial Photodynamic Therapy on Deciduous Carious Dentin
Despite of the decline of dental caries, this disease is still common in polarized groups affecting children.
Therefore, the aim of this randomized blind in vivo study was to compare the antimicrobial effect of two antimicrobial therapies in deciduous carious dentin.
Thirty two patients aging from 5 to 7 years old had partial caries removal in deep carious dentin lesion in deciduous molar and were divided in three groups: 1.
Control - chlorhexidine and resin modified glass ionomer cement (RMGIC); 2. LEDTB - antimicrobial photodynamic therapy (APDT) with LED (light emission diode) associated with toluidine blue orto dye solution and RMGIC; 3. LMB - APDT with laser associated with methylene blue dye solution and RMGIC.
The patients were submitted to initial clinical and radiographic examination and demographic features were evaluated by biofilm, gingival, and dmft/dmfs indexes, besides clinical and radiographic follow up at 6 and 12 months after the treatments.
The carious dentin was collected before and after each treatment and the number of Streptococcus mutans, Streptococcus sobrinus, Lactobacillus casei, Fusobacterium nucleatum, Atopobium rimae and total bacteria were established by quantitative PCR.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
58
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 7 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Inclusion criteria consisted of good general health, without syndromes or chronic systemic diseases. They should also have at least one primary molar with deep carious lesion (2/3 of dentin) without pain symptomatology and compatible with reversible pulpits.
Exclusion Criteria:
- Children whose parents refused to sign the informed consent document, who did not cooperate with the clinical exams, whose teeth had the treatment choice changed (pain or evolution to irreversible pulpits), who did not attend to the appointments for the scheduled treatments, or who needed antibiotics treatment for other medical reasons were excluded from the study without prejudice.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Control
|
Tooth was isolated using a rubber dam isolation in order to collect the dentin samples
The tooth was dried with air jet.
Partial carious tissue was removed with conventional dentinal curette and collection of dentin with a micropunch (Ø = 1mm) was performed.
The remaining dentin was washed with chlorhexidine 2%.
After that a a new dentin collection was performed at another site of the cavity, and restoration with resin-modified glass ionomer cement was placed.
|
Experimental: APDT 1
|
Tooth was isolated using a rubber dam isolation in order to collect the dentin samples
The tooth was dried with air jet.
Partial carious tissue was removed with conventional dentine curette and collection of dentin with a micropunch (Ø = 1mm) was performed.
The remaining dentin was washed with 200 µL of O-Toluidine blue dye (0.1 mg/mL) for 60 s.
After this, a red LED light source with wavelength of 630 nm was used at 100 mW power, 9.0 J of energy, for 60 s with energy density of 30.0 J/cm2 .
A new dentin collection was performed after this treatment at another site of the cavity and restoration with resin-modified glass ionomer cement Vitremer was placed.
|
Experimental: APDT 2
|
Tooth was isolated using a rubber dam isolation in order to collect the dentin samples
The tooth was dried with air jet.
Partial carious tissue was removed with conventional dentine curette and initial collection of dentin with a micropunch (Ø = 1mm) was performed.
Treatment of the remaining dentin was performed with 200 µL of methylene blue dye 0.01% for 5 min and after this, a red low level LASER light source with wavelength of 660 nm was used at 100 mW power, 9.0 J of energy, for 90 s with energy density of 320.0 J/cm2 .
A new dentin collection was performed after this treatment at another site of the cavity and restoration with resin-modified glass ionomer cement was placed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quantification of Bacteria by quantitative Polymerase Chain Reaction (PCR)
Time Frame: 15 days after dentin collection
|
Quantification of S. mutans, L. casei, F. nucleatum, A. rimae and total bacteria by PCR (Polymerase Chain Reaction)
|
15 days after dentin collection
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tooth Pain
Time Frame: 6 months
|
Patients reported the presence or absence of tooth pain after 6 months
|
6 months
|
Tooth Pain
Time Frame: 12 months
|
Patients reported the presence or absence of tooth pain after 6 months
|
12 months
|
Restoration Quality
Time Frame: 6 months
|
The quality of restoration was evaluated through the absence of radiographic radiolucent area after 6 months
|
6 months
|
Restoration Quality
Time Frame: 12 months
|
The quality of restoration was evaluated through the absence of radiographic radiolucent area after 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2011
Primary Completion (Actual)
July 1, 2012
Study Completion (Actual)
January 1, 2014
Study Registration Dates
First Submitted
May 25, 2015
First Submitted That Met QC Criteria
June 20, 2015
First Posted (Estimate)
June 24, 2015
Study Record Updates
Last Update Posted (Estimate)
June 25, 2015
Last Update Submitted That Met QC Criteria
June 24, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 150/10
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dental Caries
-
Ain Shams UniversityCompletedPulpitis | Caries | Caries,Dental | Reversible Pulpitis | Caries Class I | Caries; DentinEgypt
-
University of MinnesotaCompletedUsing Motivational Interviewing To Reduce Parental Risk-Related Behaviors For Early Childhood CariesCaries | Caries,DentalUnited States
-
National University of San Marcos, PeruNot yet recruitingPit and Fissure Caries | Caries,Dental | Sealant DentalPeru
-
3MUniversity of MichiganActive, not recruiting
-
Rawda Hesham Abd ElAzizRecruitingCaries,Dental | Caries Class IIEgypt
-
Hue University of Medicine and PharmacyRecruitingOcclusal Caries | Caries,Dental | Caries; InitialVietnam
-
The University of Texas Health Science Center,...National Institute of Dental and Craniofacial Research (NIDCR)RecruitingCaries,DentalUnited States
-
Federal University of PelotasRecruiting
-
Kompetansesenteret Tannhelse Midt (TkMidt)Karolinska Institutet; University of Bergen; Norwegian University of Science... and other collaboratorsActive, not recruiting
-
Marmara UniversityCompleted
Clinical Trials on Rubber dam isolation
-
Federal University of PelotasCompleted
-
University of Sao PauloCompletedDental Caries in ChildrenBrazil
-
King Abdulaziz UniversityNot yet recruitingPain | Airway Obstruction | BehaviorSaudi Arabia
-
Universitat Internacional de CatalunyaCompleted
-
Pakistan Institute of Medical SciencesRecruitingTooth DecayPakistan
-
Zafer Cavit Cehreli, DDS, PhDUnknownDental Caries in Children | Dental Caries on Pit and Fissure Surface | Dental LeakageUnited States
-
Fujian Medical UniversityRecruiting
-
Fujian Medical UniversityRecruiting
-
Istituto Auxologico ItalianoUniversity of Turin, ItalyRecruiting
-
Gazi UniversityRecruiting