Dental DepositsNCT03309748
Phototherapy Remediation of Black Stain
A study testing Dental prophylaxis and Dental prophylaxis + antimicrobial photodynamic therapy in people with Dental Deposits and Tooth Discoloration, run by Cardenal Herrera University.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Deposits, Tooth Discoloration, Dental Prophylaxis
- What is being tested?
- Dental prophylaxis and Dental prophylaxis + antimicrobial photodynamic therapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- 5 May 2014to 30 Apr 2016
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteers with black stained (plaque on) teeth
Who cannot join
- Children
- Pregnant women
- Volunteers having completed antibiotic therapy during 15 days prior to the start of the study
About this study
Official title: Remediation of Adult Black Dental Stains by Phototherapy
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.
Read the detailed 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.
- Conditions
- Dental Deposits, Tooth Discoloration, Dental Prophylaxis
- Being tested
- Dental prophylaxis, Dental prophylaxis + antimicrobial photodynamic therapy
- Keywords
- photodynamic therapy, black-stain, Pigmented bacteria, Tannerella forsythia
- Medical subject headings
- Dental Deposits, 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
American Dental Association, Code on Dental Procedures and Nomenclature (CDT) CDT code D1110
Dental prophylaxis + antimicrobial photodynamic therapyDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Dental Prophylaxis | Active comparator | Standard dental prophylaxis Receives: Procedure: Dental prophylaxis |
| Dental prophylaxis + antimicrobial photodynamic therapy | Active comparator | Dental prophylaxis + aPDT Receives: Procedure: Dental prophylaxis; Device: Dental prophylaxis + antimicrobial photodynamic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Restoration period
Time to restoration of the black stain following each treatment arm
Measured: 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 outcomes (3)
Black stain color
Color of the black stain
Measured: The depth of color of the black stain will be measured at Week 20 following the application of each treatment arm
Black stain area
Area covered by the black stain
Measured: Area covered by the black stain will be carried out at Week 20 following the application of each treatment arm
Microbial composition
Microbial composition of the black plaque
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2017
- Study start5 May 2014
- Primary completion30 Apr 2016
- Study completion30 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental DepositsStudies 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 31 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
- Maria del Mar Jovani Sancho, PhD, Study director, Cardenal Herrera University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03309748
- Sponsor's protocol ID
- UCHCEU INDI-1531
- Status last verified
- Dec 2024
- First submitted
- 2 Oct 2017
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Albelda-Bernardo MA, Jovani-Sancho MDM, Veses V, Sheth CC. Remediation of adult black dental stains by phototherapy. BDJ Open. 2018 Apr 11;4:17035. doi: 10.1038/s41405-018-0001-9. eCollection 2018.
PubMed 29977603
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remediation of Adult Black Dental Stains by Phototherapy
- ClinicalTrials.gov ID
- NCT03309748
- Acronym / sponsor ID
- UCHCEU INDI-1531
- Conditions
- Dental Deposits, Tooth Discoloration, Dental Prophylaxis
- Keywords
- photodynamic therapy, black-stain, Pigmented bacteria, Tannerella forsythia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Cardenal Herrera UniversityUniversity, hospital or other
- Study start
- 5 May 2014 (actual)
- Primary completion
- 30 Apr 2016 (actual)
- Study completion
- 30 Apr 2016 (actual)
- First posted
- 16 Oct 2017 (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.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dental Prophylaxis | Active comparator | Procedure: Dental prophylaxisStandard dental prophylaxis |
| Dental prophylaxis + antimicrobial photodynamic therapy | Active comparator | Procedure: Dental prophylaxis, Device: Dental prophylaxis + antimicrobial photodynamic therapyDental prophylaxis + aPDT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Volunteers with black stained (plaque on) teeth
Key exclusion criteria (3 listed)
- Children
- Pregnant women
- Volunteers having completed antibiotic therapy during 15 days prior to the start of the study
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 prophylaxisAmerican Dental Association, Code on Dental Procedures and Nomenclature (CDT) CDT code D1110 | Procedure or surgery | Dental Prophylaxis, Dental prophylaxis + antimicrobial photodynamic therapy |
| Dental prophylaxis + antimicrobial photodynamic therapyDental 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). | Device | Dental prophylaxis + antimicrobial photodynamic therapy |
Primary outcome
Restoration period
Time frame: 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
Time to restoration of the black stain following each treatment arm
3 secondary outcomes
Black stain color
Time frame: The depth of color of the black stain will be measured at Week 20 following the application of each treatment arm
Black stain area
Time frame: Area covered by the black stain will be carried out at Week 20 following the application of each treatment arm
Microbial composition
Time frame: 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
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 Dec 2024.
- Derived from this study: PubMed 29977603Albelda-Bernardo MA, Jovani-Sancho MDM, Veses V, Sheth CC. Remediation of adult black dental stains by phototherapy. BDJ Open. 2018 Apr 11;4:17035. doi: 10.1038/s41405-018-0001-9. eCollection 2018.
- 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.
Maria del Mar Jovani Sancho, PhD study director
Cardenal Herrera University
Questions about this trial
What is this clinical trial studying?
A study testing Dental prophylaxis and Dental prophylaxis + antimicrobial photodynamic therapy in people with Dental Deposits and Tooth Discoloration, run by Cardenal Herrera University.
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 1 inclusion and 3 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 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Restoration period (time frame: 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). 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 NCT03309748, which also lists 1 linked publication.
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 Dec 2024.