Phototherapy Remediation of Black Stain

NCT ID: NCT03309748

Last Updated: 2024-12-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-05
• Study Completion Date: 2016-04-30

Brief 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. 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.

Conditions

Dental Deposits; Tooth Discoloration; Dental Prophylaxis

Keywords

photodynamic therapy; black-stain; Pigmented bacteria; Tannerella forsythia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dental Prophylaxis

Standard dental prophylaxis

Group Type: ACTIVE_COMPARATOR

Dental prophylaxis

Intervention Type: PROCEDURE

American Dental Association, Code on Dental Procedures and Nomenclature (CDT) CDT code D1110

Dental prophylaxis + antimicrobial photodynamic therapy

Dental prophylaxis + aPDT

Group Type: ACTIVE_COMPARATOR

Dental prophylaxis

Intervention Type: PROCEDURE

American Dental Association, Code on Dental Procedures and Nomenclature (CDT) CDT code D1110

Dental prophylaxis + antimicrobial photodynamic therapy

Intervention Type: DEVICE

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).

Interventions

Dental prophylaxis

American Dental Association, Code on Dental Procedures and Nomenclature (CDT) CDT code D1110

Intervention Type: PROCEDURE

Dental prophylaxis + antimicrobial photodynamic therapy

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).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Volunteers with black stained (plaque on) teeth

Exclusion Criteria

• Children
• Pregnant women
• Volunteers having completed antibiotic therapy during 15 days prior to the start of the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cardenal Herrera University

OTHER

Sponsor Role: lead

Responsible Party

Chirag Sheth

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maria del Mar Jovani Sancho, PhD

Role: STUDY_DIRECTOR

Cardenal Herrera University

References

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.

Reference Type: DERIVED

PMID: 29977603 (View on PubMed)

Other Identifiers

UCHCEU INDI-1531

Identifier Type: -

Identifier Source: org_study_id