An interventional study of Dental prophylaxis and Dental prophylaxis + antimicrobial photodynamic therapy in Dental Deposits, Tooth Discoloration and Dental Prophylaxis, sponsored by Cardenal Herrera University. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-17.
Sponsored by Cardenal Herrera University · Not applicable, Interventional, and Treatment
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.
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.
105 studies on the registry are indexed under Tooth Discoloration; 19 are open to participants now.
This study's enrollment of 31 is below the median of 48 across 97 interventional studies indexed under Tooth Discoloration.
Browse Tooth Discoloration studies →Cardenal Herrera University is the lead sponsor of 107 studies on the registry; 22 are open to participants now.
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Exclusion Criteria:
Standard dental prophylaxis
Procedure: Dental prophylaxis
Dental prophylaxis + aPDT
Procedure: Dental prophylaxis · Device: Dental prophylaxis + antimicrobial photodynamic therapy
American Dental Association, Code on Dental Procedures and Nomenclature (CDT) CDT code D1110
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).
Restoration period
Time to restoration of the black stain following each treatment arm
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
Black stain color
Color of the black stain
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
Area covered by the black stain
Time frame: 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
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
No study locations are listed for this record.
Plan to share: No
Ran from May 2014 to primary completion in Apr 2016, 23 months.
Of 44 non-industry interventional studies with no phase under Tooth Discoloration, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 21. This study's 23 months is above that.
Counting every sponsor, half of 52 studies reached it within 8 months; a quarter within 2 and three quarters within 18.
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This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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