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Photodynamic Remediation of Black Stain

Primary Purpose

Dental Deposits, Tooth Discoloration, Dental Prophylaxis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dental prophylaxis
Dental prophylaxis + antimicrobial photodynamic therapy
Sponsored by
Cardenal Herrera University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Deposits focused on measuring photodynamic therapy, black-stain, Pigmented bacteria, Tannerella forsythia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Volunteers with black stained (plaque on) teeth

Exclusion Criteria:

  • Children
  • Pregnant women
  • Volunteers having completed antibiotic therapy during 15 days prior to the start of the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Dental Prophylaxis

    Dental prophylaxis + antimicrobial photodynamic therapy

    Arm Description

    Standard dental prophylaxis

    Dental prophylaxis + aPDT

    Outcomes

    Primary Outcome Measures

    Restoration period
    Time to restoration of the black stain following each treatment arm

    Secondary Outcome Measures

    Black stain color
    Color of the black stain
    Black stain area
    Area covered by the black stain
    Microbial composition
    Microbial composition of the black plaque

    Full Information

    First Posted
    October 2, 2017
    Last Updated
    October 10, 2017
    Sponsor
    Cardenal Herrera University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03309748
    Brief Title
    Photodynamic Remediation of Black Stain
    Official Title
    Remediation of Adult Black Dental Stains by Photodynamic Therapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    May 5, 2014 (Actual)
    Primary Completion Date
    April 30, 2016 (Actual)
    Study Completion Date
    April 30, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cardenal Herrera University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study investigates the remediation of black-stained tooth surfaces using antimicrobial photodynamic therapy. In this crossover trial, a cohort of patients received standard dental prophylactic cleaning to remove the black stain. Later, following the washout period, (reappearance of the black stain) received photodynamic therapy in addition to the standard cleaning. Stain-free period in each of the arms was the main outcome variable. Additional microbial plaque testing was also carried out.
    Detailed Description
    The standard treatment practice for black dental stain is dental prophylaxis, however this is often harmful to the enamel surface and can result in tooth sensitivity. In this study we aim to explore the application of antimicrobial photodynamic therapy (aPDT) for the treatment of adult black dental stain. aPDT has demonstrated positive results in the treatment of periodontitis. Patients received an oral examination and the extent of black stain was scored (score 1, pigmented spots or incomplete lines parallel to the gingival margin, score 2: solid lines pigmented, readily observable and limited to the cervical third of the tooth surface, score 3: pigmentation extending beyond the cervical third). The patients' oral cavity was photographed in sextants, along with a complete picture of the jaw (lingual plane) and the maxillary arch (palatal plane). For bacterial analysis, 1mg of black plaque was collected by scraping with a plastic scaler from buccal tooth surfaces taking care to avoid unnecessary removal of enamel hydroxyapatite. The first dental prophylaxis was performed to remove the black stain. Patients were reviewed monthly and in each visit, were photographed as previously described, and the level of pigmentation scored according to the mentioned criteria. The monthly visits were continued until the black stain score returned to the initial value. The period between the first and the last appointment was noted. At this point, each volunteer received dental prophylaxis once again, followed by the application of aPDT. Antimicrobial photodynamic therapy was applied to 31 orally healthy volunteers with black stained teeth, using the GLO home whitening device (GLO™ Science LLC, New York, USA) in 2 cycles of 8 minutes. Outcome variables were area, color and time taken to reappearance of black stain following dental prophylaxis with and without antimicrobial photodynamic therapy. Differences in bacterial composition of black stain (specifically Aggregatibacter actinomycetemcomitans, Tannerella forsythia and Porphyromonas gingivalis) were analyzed DNA extracted from plaque samples. Following the application of aPDT, patients were reviewed monthly until the black stain score returned to the initial value.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dental Deposits, Tooth Discoloration, Dental Prophylaxis
    Keywords
    photodynamic therapy, black-stain, Pigmented bacteria, Tannerella forsythia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    31 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Dental Prophylaxis
    Arm Type
    Active Comparator
    Arm Description
    Standard dental prophylaxis
    Arm Title
    Dental prophylaxis + antimicrobial photodynamic therapy
    Arm Type
    Active Comparator
    Arm Description
    Dental prophylaxis + aPDT
    Intervention Type
    Procedure
    Intervention Name(s)
    Dental prophylaxis
    Intervention Description
    American Dental Association, Code on Dental Procedures and Nomenclature (CDT) CDT code D1110
    Intervention Type
    Device
    Intervention Name(s)
    Dental prophylaxis + antimicrobial photodynamic therapy
    Intervention Description
    Dental prophylaxis using American Dental Association, Code on Dental Procedures and Nomenclature (CDT) CDT code D1110 followed by two 8-minute irradiation cycles using GLO Brilliant home use whitening device (GLO ™ Science LLC, New York, USA).
    Primary Outcome Measure Information:
    Title
    Restoration period
    Description
    Time to restoration of the black stain following each treatment arm
    Time Frame
    The period of time required for the restoration of the black stain to pre-cleaning levels will be determined by measurements carried out during Weeks 18-24, post-application of each treatment arm
    Secondary Outcome Measure Information:
    Title
    Black stain color
    Description
    Color of the black stain
    Time Frame
    The depth of color of the black stain will be measured at Week 20 following the application of each treatment arm
    Title
    Black stain area
    Description
    Area covered by the black stain
    Time Frame
    Area covered by the black stain will be carried out at Week 20 following the application of each treatment arm
    Title
    Microbial composition
    Description
    Microbial composition of the black plaque
    Time Frame
    Black plaque sampling will be carried out at Week 0, followed by a second sampling at Week 20, following the application of each treatment arm, in accordance with the reappearance rate of the black stain in each study volunteer

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Volunteers with black stained (plaque on) teeth Exclusion Criteria: Children Pregnant women Volunteers having completed antibiotic therapy during 15 days prior to the start of the study
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Maria del Mar Jovani Sancho, PhD
    Organizational Affiliation
    Cardenal Herrera University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    29977603
    Citation
    Albelda-Bernardo MA, Jovani-Sancho MDM, Veses V, Sheth CC. Remediation of adult black dental stains by phototherapy. BDJ Open. 2018 Apr 11;4:17035. doi: 10.1038/s41405-018-0001-9. eCollection 2018.
    Results Reference
    derived

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    Photodynamic Remediation of Black Stain

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