NCT03309748

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2014

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 5, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2016

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 2, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 16, 2017

Completed
Last Updated

December 17, 2024

Status Verified

December 1, 2024

Enrollment Period

2 years

First QC Date

October 2, 2017

Last Update Submit

December 12, 2024

Conditions

Dental DepositsTooth DiscolorationDental Prophylaxis

Keywords

photodynamic therapyblack-stainPigmented bacteriaTannerella forsythia

Outcome Measures

Primary Outcomes (1)

  • Restoration period

    Time to restoration of the black stain following each treatment arm

    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

    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 will be carried out at Week 20 following the application of each treatment arm

  • Microbial composition

    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

Study Arms (2)

Dental Prophylaxis

ACTIVE COMPARATOR

Standard dental prophylaxis

Procedure: Dental prophylaxis

Dental prophylaxis + antimicrobial photodynamic therapy

ACTIVE COMPARATOR

Dental prophylaxis + aPDT

Procedure: Dental prophylaxisDevice: Dental prophylaxis + antimicrobial photodynamic therapy

Interventions

Dental prophylaxisPROCEDURE

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

Dental ProphylaxisDental prophylaxis + antimicrobial photodynamic therapy
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).

Dental prophylaxis + antimicrobial photodynamic therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Volunteers with black stained (plaque on) teeth

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 29977603DERIVED

MeSH Terms

Conditions

Dental DepositsTooth Discoloration

Interventions

Dental Prophylaxis

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

PeriodonticsDentistryPreventive Dentistry

Study Officials

  • Maria del Mar Jovani Sancho, PhD

    Cardenal Herrera University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 2, 2017

First Posted

October 16, 2017

Study Start

May 5, 2014

Primary Completion

April 30, 2016

Study Completion

April 30, 2016

Last Updated

December 17, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share