Photodynamic Remediation of Black Stain

Tooth Discoloration Clinical Trial

Official title:

Remediation of Adult Black Dental Stains by Photodynamic Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03309748
• Other study ID #: UCHCEU INDI-1531
• Status: Completed
• Phase: N/A
• First received: October 2, 2017
• Last updated: October 10, 2017
• Start date: May 5, 2014
• Est. completion date: April 30, 2016

Study information

• Verified date: October 2017
• Source: Cardenal Herrera University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: April 30, 2016
• Est. primary completion date: April 30, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dental Deposits
• Dental Prophylaxis
• Tooth Discoloration

Intervention

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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cardenal Herrera University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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