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
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
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
NCT ID
NCT03309748
First Posted
October 2, 2017
Last Updated
October 10, 2017
Sponsor
Cardenal Herrera University
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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