aPDT for the Remediation of Dental Black Stain

NCT03483376 | Completed

• 1 other identifier: VVESES
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

In today's society cosmetic dentistry plays an important role in social relationships and in important aspects of life such as job applications and recruitment processes. Currently, the only available treatment option for patients suffering from black dental pigmentation of bacterial origin is repetitive professional dental cleanings every two or three months, which involve a significant financial outlay, and have been found to be psychologically detrimental due to the lack of a perceived cure. These pigmentations are of unknown etiology, although there has been reported the presence of black-pigment producing bacteria, such as Porphyromonas gingivalis, Tannerella forsythia and Aggregatibacter actinomycetemcomitans in such black plaque. These bacteria are found in a group known as periodontopathogens, bacteria responsible for the appearance of periodontitis, an oral chronic disease with high prevalence. In this context, photodynamic therapy, which uses the application of diode light with a wavelength between 400-500 nm for the elimination of periodontal pathogenic bacteria, has demonstrated effectiveness and absence of adverse effects on the management of patients with periodontitis. The proposed study seeks to evaluate the effect of photodynamic therapy on teeth with extrinsic black pigment, in order achieve an eradication of the stains. The investigators will also proceed to analyze in depth the bacterial composition of these stains before the application of photodynamic therapy, in order to stablish the aetiological agents of this black plaque.

Conditions

Dental Plaque; Tooth Discoloration

Keywords

black stain; dental plaque; antimicrobial photodynamic therapy; curcumin; tooth discoloration

Outcome Measures

Primary Outcomes (1)

• Area and depth of color of black stain - 6 Months

  Area and depth of color of black stain 6 months post aPDT - Digital intraoral photographs will be analyzed using image analysis software.

  6 months post final treatment step for each study arm

Secondary Outcomes (1)

• Sensitivity and pain

  24 hours post final treatment step for each study arm

Other Outcomes (1)

• Area and depth of color of black stain - 3 Months

  3 months post final treatment step for each study arm

Study Arms (2)

Dental prophylaxis

ACTIVE COMPARATOR

Study volunteers with black plaque stained teeth will receive standard dental prophylactic cleaning to remove the stain. The prophylaxis will be carried out using an ultrasonic scaler, prophylaxis brush and abrasive paste.

Procedure: Dental prophylaxis

Dental prophylaxis + aPDT

EXPERIMENTAL

Study volunteers with black plaque stained teeth will receive standard dental prophylactic cleaning, followed by antimicrobial photodynamic therapy (aPDT) to remove the stain. The prophylaxis will be carried out using an ultrasonic scaler, prophylaxis brush and abrasive paste. The aPDT protocol is as follows: * Patient will rinse the oral cavity with 20 ml of an aqueous solution of curcumin (photosensitizer; 1.5 g/L) for 30 seconds. * Blue light from a Bluephase 20i curing lamp will be applied perpendicularly for 1 min per tooth (30 seconds on the vestibular side and 30 seconds on the palatal side). * Remaining photosensitizer will be removed using the prophylaxis brush. The aPDT protocol is repeated following a rest period of 10 days.

Procedure: Dental prophylaxis; Device: Antimicrobial photodynamic therapy (aPDT)

Interventions

Dental prophylaxis PROCEDURE

Determining the effectiveness of dental prophylaxis alone in eliminating dental black stain.

Dental prophylaxis; Dental prophylaxis + aPDT

Antimicrobial photodynamic therapy (aPDT) DEVICE

Establishing the effectiveness of dental prophylaxis combined with antimicrobial photodynamic therapy using blue light and curcumin as the photosensitizing agent in eliminating dental black stain.

Also known as: Dental prophylaxis + aPDT

Dental prophylaxis + aPDT

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• volunteers with dental black stain in at least two teeth (non-filled, with partner in the opposite arch)
• volunteers older than 12 years

You may not qualify if:

• volunteers receiving antibiotic treatment within the month prior to enrolment

Sponsors & Collaborators

• Cardenal Herrera University: lead

Study Sites (1)

Clinica Odontologica Universitaria CEU

Alfara del Patriarca, Valencia, 46113, Spain

Location

Related Publications (4)

• Soukos NS, Som S, Abernethy AD, Ruggiero K, Dunham J, Lee C, Doukas AG, Goodson JM. Phototargeting oral black-pigmented bacteria. Antimicrob Agents Chemother. 2005 Apr;49(4):1391-6. doi: 10.1128/AAC.49.4.1391-1396.2005.

  PMID: 15793117 BACKGROUND

• Araujo NC, Fontana CR, Gerbi ME, Bagnato VS. Overall-mouth disinfection by photodynamic therapy using curcumin. Photomed Laser Surg. 2012 Feb;30(2):96-101. doi: 10.1089/pho.2011.3053. Epub 2012 Jan 6.

  PMID: 22224655 BACKGROUND

• Leite DP, Paolillo FR, Parmesano TN, Fontana CR, Bagnato VS. Effects of photodynamic therapy with blue light and curcumin as mouth rinse for oral disinfection: a randomized controlled trial. Photomed Laser Surg. 2014 Nov;32(11):627-32. doi: 10.1089/pho.2014.3805. Epub 2014 Oct 24.

  PMID: 25343373 BACKGROUND

• Carrera ET, Dias HB, Corbi SCT, Marcantonio RAC, Bernardi ACA, Bagnato VS, Hamblin MR, Rastelli ANS. The application of antimicrobial photodynamic therapy (aPDT) in dentistry: a critical review. Laser Phys. 2016 Dec;26(12):123001. doi: 10.1088/1054-660X/26/12/123001. Epub 2016 Nov 9.

  PMID: 29151775 BACKGROUND

MeSH Terms

Conditions

Dental Plaque; Tooth Discoloration

Interventions

Dental Prophylaxis

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Periodontics; Dentistry; Preventive Dentistry

Study Officials

• Veronica Veses

  Cardenal Herrera University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Epidemiology and Public Health

Model Details: Two parallel arms of the study will be used. One arm will receive dental plaque removal using standard protocol. The other arm will receive the standard plaque removal, followed by antimicrobial photodynamic therapy.

Study Record Dates

• First Submitted: March 23, 2018
• First Posted: March 30, 2018
• Study Start: March 1, 2018
• Primary Completion: September 30, 2019
• Study Completion: January 30, 2020
• Last Updated: August 17, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)