Photodynamic Therapy for Preventing Recurrent Chromogenic Stains on Deciduous Teeth

July 29, 2026 updated by: Maram Gomaa Gebaly Oraby, Cairo University

Antimicrobial Methylene Blue Photodynamic Therapy Versus Conventional Prophylaxis for Preventing Recurrent Chromogenic Stains on Deciduous Teeth: A Pilot Controlled Trial

Chromogenic extrinsic stains are common in children and frequently recur following conventional prophylaxis. Antimicrobial photodynamic therapy (aPDT) using methylene blue activated by red light has demonstrated antimicrobial activity against oral biofilm and may reduce stain recurrence. This pilot controlled clinical trial aims to compare conventional prophylaxis combined with methylene blue-mediated antimicrobial photodynamic therapy with conventional prophylaxis alone for preventing recurrent chromogenic extrinsic stains on deciduous teeth.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Cairo Governorate
      • Cairo, Cairo Governorate, Egypt
        • Cairo University
        • Contact:
          • Maram Oraby, BDS
          • Phone Number: +201022040432

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Children aged 4 to 6 years with chromogenic extrinsic stains affecting deciduous teeth.
  • Medically healthy children (ASA I or II).
  • Children with cooperative behavior suitable for routine dental treatment.
  • Parent or legal guardian willing to provide written informed consent.
  • Ability to attend all scheduled follow-up visits.

Exclusion Criteria:

  • Known allergy or hypersensitivity to methylene blue.
  • Photosensitivity disorders or current use of photosensitizing medications.
  • Extensive untreated dental caries or acute dental infection requiring emergency treatment.
  • Gingival or periodontal conditions that interfere with clinical assessment.
  • Iron-associated extrinsic staining.
  • Children unable to comply with study procedures or follow-up visits.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Antimicrobial Photodynamic Therapy
Participants will receive standardized conventional prophylaxis followed by topical methylene blue (photosensitizer) and irradiation with a 660-nm red-light source according to the study protocol.
Procedure: Antimicrobial Photodynamic Therapy
Conventional prophylaxis followed by topical application of methylene blue activated by 660-nm red light for antimicrobial photodynamic therapy.
Active Comparator: Conventional Prophylaxis
Participants will receive conventional prophylaxis alone according to the standardized clinical protocol.
Procedure: Conventional Prophylaxis
Standard mechanical prophylaxis using rubber-cup polishing and prophylaxis paste.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence of Chromogenic Extrinsic Stains
Time Frame: 6 months after treatment
Recurrence of chromogenic extrinsic stains assessed by standardized clinical visual examination and recorded as the presence or absence of visible chromogenic extrinsic staining at the 6-month follow-up visit.
6 months after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Stain Removal Assessed by Standardized Clinical Examination
Time Frame: Immediately after treatment
Complete stain removal will be assessed immediately after treatment using a standardized clinical examination. The outcome will be recorded for each participant as Complete stain removal (Yes) or Incomplete stain removal (No).
Immediately after treatment
Parent/Guardian Satisfaction Assessed Using a Study-Specific 5-Point Likert Satisfaction Questionnaire
Time Frame: Immediately after treatment and at 6 months

Parent or guardian satisfaction will be assessed using a study-specific 5-point Likert satisfaction questionnaire evaluating satisfaction with the child's dental appearance and perception of stain recurrence.

Scores range from 1 to 5:

  • 1 = Very dissatisfied
  • 2 = Dissatisfied
  • 3 = Neutral
  • 4 = Satisfied
  • 5 = Very satisfied
Immediately after treatment and at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

July 13, 2026

First Submitted That Met QC Criteria

July 29, 2026

First Posted (Actual)

July 30, 2026

Study Record Updates

Last Update Posted (Actual)

July 30, 2026

Last Update Submitted That Met QC Criteria

July 29, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • PED-2025-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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