Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

aPDT for the Remediation of Dental Black Stain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03483376
Recruitment Status : Recruiting
First Posted : March 30, 2018
Last Update Posted : May 23, 2018
Sponsor:
Information provided by (Responsible Party):
Chirag Sheth, Cardenal Herrera University

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.


Condition or disease Intervention/treatment Phase
Dental Plaque Tooth Discoloration Procedure: Dental prophylaxis Device: Antimicrobial photodynamic therapy (aPDT) Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of Antimicrobial Photodynamic Therapy for the Elimination of Dental Black Stain: A Randomised Clinical Trial
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : January 30, 2020

Resource links provided by the National Library of Medicine


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 Name: Dental prophylaxis + aPDT




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03483376


Contacts
Layout table for location contacts
Contact: Maria del Mar Jovani-Sancho +34 96 136 9000 ext 64348 mar.jovani@uchceu.es
Contact: Chirag C Sheth +34 96 136 9000 ext 64305 chirag.sheth@uchceu.es

Locations
Layout table for location information
Spain
Clinica Odontologica Universitaria CEU Recruiting
Alfara Del Patriarca, Valencia, Spain, 46113
Contact: Maria del Mar Jovani-Sancho    +34 96 136 9000 ext 64348    mar.jovani@uchceu.es   
Contact: Chirag C Sheth    +34 96 136 9000 ext 64305    chirag.sheth@uchceu.es   
Principal Investigator: Veronica Veses         
Sponsors and Collaborators
Cardenal Herrera University
Investigators
Layout table for investigator information
Principal Investigator: Veronica Veses Cardenal Herrera University

Publications:
Layout table for additonal information
Responsible Party: Chirag Sheth, Associate Professor in Epidemiology and Public Health, Cardenal Herrera University
ClinicalTrials.gov Identifier: NCT03483376    
Other Study ID Numbers: VVESES
First Posted: March 30, 2018    Key Record Dates
Last Update Posted: May 23, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Keywords provided by Chirag Sheth, Cardenal Herrera University:
black stain
dental plaque
antimicrobial photodynamic therapy
curcumin
tooth discoloration
Additional relevant MeSH terms:
Layout table for MeSH terms
Dental Plaque
Tooth Discoloration
Dental Deposits
Tooth Diseases
Stomatognathic Diseases
Anti-Bacterial Agents
Curcumin
Anti-Infective Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action