aPDT for the Remediation of Dental Black Stain

August 16, 2021 updated by: Chirag Sheth, Cardenal Herrera University

Effectiveness of Antimicrobial Photodynamic Therapy for the Elimination of Dental Black Stain: A Randomised Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

One of the most common problems facing the dentist in daily practice is the treatment of the chromatic alterations of the teeth, both of extrinsic origin and of intrinsic origin. The former, caused by the incorporation of chromogenic materials into enamel and dentin, either before or after the tooth eruption, require more complex and usually more aggressive treatments in order to eliminate them. On the other hand, the latter, caused by the deposition of pigments or detritus on the tooth surface, are usually removed more easily, causing little or no damage to the enamel.

However, among the latter, black extrinsic dental stains caused by pigmented bacteria represent a clear exception to the rule. These deposits, which manifest in the form of points or lines of black color located parallel to the gingival margin of the teeth in the cervical third, are firmly attached to the enamel, making them very difficult to remove.

Although the exact etiology of the formation of dental black stain due to pigmented bacteria is not clear, it has been suggested that it arises due to the production of a pigment with characteristics similar to protohemin and protoporphyrin by black-pigmented bacteria. The application of light to inactivate and disinfect intraoral sites is gaining interest in the field of dentistry. Antimicrobial photodynamic therapy is defined as the inactivation of cells, microorganisms or molecules induced by light. The mechanism of action of photodynamic therapy is defined as the process by which a photosensitizer (photoactivable substance) is captured by microorganisms and, after exposure to light at an appropriate wavelength, remains in an excited state. The photosensitizer then transfers energy from light to oxygen molecules to generate singlet oxygen and free radicals that are cytotoxic to the cells.

Published studies suggest that antimicrobial photodynamic therapy can effectively reduce the population of microbial pathogens, also presenting the following advantages: absence of phototoxic effect for human cells, possible clinical, microbiological and immunological benefits, rapid and painless application of light, penetration of light into tissues and plaque and, thereby, elimination of bacteria present in gingival epithelial cells, and finally, selectivity towards pathogenic microorganisms.

The main objective of this research is the application of antimicrobial photodynamic therapy in the control of dental black stain caused by pigmented bacteria.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Valencia
      • Alfara Del Patriarca, Valencia, Spain, 46113
        • Clinica Odontologica Universitaria CEU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • volunteers receiving antibiotic treatment within the month prior to enrolment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Dental prophylaxis
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
Determining the effectiveness of dental prophylaxis alone in eliminating dental black stain.
EXPERIMENTAL: Dental prophylaxis + aPDT

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
Determining the effectiveness of dental prophylaxis alone in eliminating dental black stain.
Device: Antimicrobial photodynamic therapy (aPDT)
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.
Other Names:
  • Dental prophylaxis + aPDT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area and depth of color of black stain - 6 Months
Time Frame: 6 months post final treatment step for each study arm
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and pain
Time Frame: 24 hours post final treatment step for each study arm
Dental sensitivity and/or pain following the final treatment step for each study arm, measured by Wong-Baker faces scale. This is a graphic-numeric scale used to allow the patient to describe the sensitivity or pain they are experiencing. It consists of a row of 6 faces arrayed from left to right displaying a range of expressions denoting increased pain. This is accompanied by a numerical scale 0, 2, 4, 6, 8, 10 where 0 is no pain (smiley face) to 10 being the worst pain imaginable (crying, extremely sad face). Below the numerical description, patients may read the descriptions of pain related to each face, ranging from 0 (No Hurt) to 10 (Hurts Worst). Higher scores (right hand side of the scale; sad crying face) indicate higher discomfort or pain, whilst lower scores (left hand side of the scale, happier face) indicate less discomfort or pain. The scale may be applied rapidly and easily facilitating the follow up of patients in a simple, reproducible manner.
24 hours post final treatment step for each study arm

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area and depth of color of black stain - 3 Months
Time Frame: 3 months post final treatment step for each study arm
Area and depth of color of black stain 3 months post aPDT - Digital intraoral photographs will be analyzed using image analysis software.
3 months post final treatment step for each study arm

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardenal Herrera University

Investigators

  • Principal Investigator: Veronica Veses, Cardenal Herrera University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2018

Primary Completion (ACTUAL)

September 30, 2019

Study Completion (ACTUAL)

January 30, 2020

Study Registration Dates

First Submitted

March 23, 2018

First Submitted That Met QC Criteria

March 23, 2018

First Posted (ACTUAL)

March 30, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 17, 2021

Last Update Submitted That Met QC Criteria

August 16, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VVESES

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

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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