Dental PlaqueNCT03483376
aPDT for the Remediation of Dental Black Stain
A study testing Dental prophylaxis and Antimicrobial photodynamic therapy (aPDT) in people with Dental Plaque and Tooth Discoloration, run by Cardenal Herrera University at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Plaque, Tooth Discoloration
- What is being tested?
- Dental prophylaxis and Antimicrobial photodynamic therapy (aPDT)
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2018to 30 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- volunteers with dental black stain in at least two teeth (non-filled, with partner in the opposite arch)
- volunteers older than 12 years
Who cannot join
- volunteers receiving antibiotic treatment within the month prior to enrolment
Trial locations and contacts
1 site in 1 country.
Spain1 site
Clinica Odontologica Universitaria CEU
Alfara del Patriarca, Valencia, 46113
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Dental Plaque, Tooth Discoloration
- Being tested
- Dental prophylaxis, Antimicrobial photodynamic therapy (aPDT)
- Keywords
- black stain, dental plaque, antimicrobial photodynamic therapy, curcumin, tooth discoloration
- Medical subject headings
- Dental Plaque, Tooth Discoloration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental prophylaxisProcedure or surgery
Determining the effectiveness of dental prophylaxis alone in eliminating dental black stain.
Antimicrobial photodynamic therapy (aPDT)Device
Also called Dental prophylaxis + 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Dental prophylaxis; Device: Antimicrobial photodynamic therapy (aPDT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months post final treatment step for each study arm
Secondary outcomes (1)
Sensitivity and pain
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.
Measured: 24 hours post final treatment step for each study arm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2018
- Study start1 Mar 2018
- Primary completion30 Sep 2019
- Study completion30 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Dental PlaqueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardenal Herrera University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chirag Sheth, Cardenal Herrera University
- Investigators
- Veronica Veses, Principal investigator, Cardenal Herrera University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03483376
- Sponsor's protocol ID
- VVESES
- Status last verified
- Aug 2021
- First submitted
- 23 Mar 2018
- Last updated
- 17 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 15793117Araujo 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.
PubMed 22224655Leite 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.
PubMed 25343373Carrera 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.
PubMed 29151775
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Antimicrobial Photodynamic Therapy for the Elimination of Dental Black Stain: A Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT03483376
- Acronym / sponsor ID
- VVESES
- Conditions
- Dental Plaque, Tooth Discoloration
- Keywords
- black stain, dental plaque, antimicrobial photodynamic therapy, curcumin, tooth discoloration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cardenal Herrera UniversityUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 30 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Dental prophylaxis | Active comparator | Procedure: Dental prophylaxisStudy 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. |
| Dental prophylaxis + aPDT | Experimental | Procedure: Dental prophylaxis, Device: Antimicrobial photodynamic therapy (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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- volunteers with dental black stain in at least two teeth (non-filled, with partner in the opposite arch)
- volunteers older than 12 years
Key exclusion criteria (1 listed)
- volunteers receiving antibiotic treatment within the month prior to enrolment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dental prophylaxisDetermining the effectiveness of dental prophylaxis alone in eliminating dental black stain. | Procedure or surgery | Dental prophylaxis, Dental prophylaxis + aPDT |
| Antimicrobial photodynamic therapy (aPDT)Also: Dental prophylaxis + aPDTEstablishing the effectiveness of dental prophylaxis combined with antimicrobial photodynamic therapy using blue light and curcumin as the photosensitizing agent in eliminating dental black stain. | Device | Dental prophylaxis + aPDT |
Primary outcome
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.
1 secondary outcome
Sensitivity and pain
Time frame: 24 hours post final treatment step for each study arm
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2021.
- Background: PubMed 15793117Soukos 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.
- Background: PubMed 22224655Araujo 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.
- Background: PubMed 25343373Leite 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.
- Background: PubMed 29151775Carrera 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Veronica Veses principal investigator
Cardenal Herrera University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dental prophylaxis and Antimicrobial photodynamic therapy (aPDT) in people with Dental Plaque and Tooth Discoloration, run by Cardenal Herrera University at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area and depth of color of black stain - 6 Months (time frame: 6 months post final treatment step for each study arm). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03483376, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2021; AzTrials last refreshed its copy on 8 Nov 2026.