An interventional study of Dental prophylaxis and Antimicrobial photodynamic therapy (aPDT) in Dental Plaque and Tooth Discoloration, sponsored by Cardenal Herrera University. Completed at 1 site in Spain. Open to participants aged 12 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-17.
Sponsored by Cardenal Herrera University · Not applicable, Interventional, and Treatment
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Among 10 studies in Dental Plaque with a site in Spain — none open to participants now, none under way, none of them phase 3. Dental Plaque · Spain.
Among the 10 studies in Dental Plaque with a site in Spain, this one is the 6th largest by enrollment, is the only one that started in 2018, is one of 3 with no phase, and was the 5th registered.
352 studies on the registry are indexed under Dental Plaque; 60 are open to participants now.
Browse Dental Plaque studies →None of the 10 studies in Dental Plaque with a site in Spain is open now. The open studies under Dental Plaque, anywhere →
Of the 35 Dental Plaque studies recruiting now, 10 (29%) set no upper age limit and 20 (57%) stop at 75 or younger; 14 take children under 18; 22 take healthy volunteers.
This study: 12 Years and older · all sexes · healthy volunteers too.
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10 studies; the count open now beside each. This study's row is marked.
First in 2011; this study’s year is marked. 1 started in 2018.
This study's enrollment of 30 is below the median of 56 across 316 interventional studies indexed under Dental Plaque.
Median enrollment 45 across the 10 interventional studies. Of the 8 that completed or were terminated, 0 (0%) have results posted.
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1 of 10 have an industry lead sponsor. The 7 most frequent:
Cardenal Herrera University is the lead sponsor of 108 studies on the registry; 22 are open to participants now.
Cardenal Herrera University has 1 study filed under Dental Plaque — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 10 studies in Dental Plaque with a site in Spain, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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.
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Exclusion Criteria:
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
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)
Determining the effectiveness of dental prophylaxis alone in eliminating dental black stain.
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
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.
Time frame: 6 months post final treatment step for each study arm
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.
Time frame: 24 hours post final treatment step for each study arm
Area and depth of color of black stain - 3 Months
Area and depth of color of black stain 3 months post aPDT - Digital intraoral photographs will be analyzed using image analysis software.
Time frame: 3 months post final treatment step for each study arm
Plan to share: No
Ran from Mar 2018 to primary completion in Sep 2019, 18 months.
Of 133 non-industry interventional studies with no phase under Dental Plaque, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 16. This study's 18 months is above that.
Counting every sponsor, half of 178 studies reached it within 6 months; a quarter within 2 and three quarters within 14.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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