Photodynamic Remediation of Black Stain

Remediation of Adult Black Dental Stains by Photodynamic Therapy

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.

Study Overview

• Status: Completed
• Conditions: Dental Deposits; Tooth Discoloration; Dental Prophylaxis
• Intervention / Treatment: Procedure: Dental prophylaxis; Device: Dental prophylaxis + antimicrobial photodynamic therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Dental Prophylaxis; Standard dental prophylaxis	Procedure: Dental prophylaxis; American Dental Association, Code on Dental Procedures and Nomenclature (CDT) CDT code D1110
ACTIVE_COMPARATOR: Dental prophylaxis + antimicrobial photodynamic therapy; Dental prophylaxis + aPDT	Procedure: Dental prophylaxis; American Dental Association, Code on Dental Procedures and Nomenclature (CDT) CDT code D1110; Device: Dental prophylaxis + antimicrobial photodynamic therapy; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Restoration period	Time to restoration of the black stain following each treatment arm	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 Measures

Outcome Measure	Measure Description	Time Frame
Black stain color	Color of the black stain	The depth of color of the black stain will be measured at Week 20 following the application of each treatment arm
Black stain area	Area covered by the black stain	Area covered by the black stain will be carried out at Week 20 following the application of each treatment arm
Microbial composition	Microbial composition of the black plaque	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

Collaborators and Investigators

• Sponsor: Cardenal Herrera University
• Investigators: Study Director: Maria del Mar Jovani Sancho, PhD, Cardenal Herrera University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 5, 2014
• Primary Completion (ACTUAL): April 30, 2016
• Study Completion (ACTUAL): April 30, 2016

Study Registration Dates

• First Submitted: October 2, 2017
• First Submitted That Met QC Criteria: October 10, 2017
• First Posted (ACTUAL): October 16, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 16, 2017
• Last Update Submitted That Met QC Criteria: October 10, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: photodynamic therapy; black-stain; Pigmented bacteria; Tannerella forsythia
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Discoloration; Dental Deposits; Anti-Bacterial Agents; Anti-Infective Agents
• Other Study ID Numbers: UCHCEU INDI-1531

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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