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Not yet recruiting NCT07736339

Photodynamic Therapy for Preventing Recurrent Chromogenic Stains on Deciduous Teeth

No phase Interventional Chromogenic Extrinsic Tooth Stains

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Antimicrobial Photodynamic Therapy, Conventional Prophylaxis.
Who it may be relevant to
Registry conditions: Chromogenic Extrinsic Tooth Stains. Basic parameters: 4 years — 6 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Procedure Antimicrobial Photodynamic Therapy
    Conventional prophylaxis followed by topical application of methylene blue activated by 660-nm red light for antimicrobial photodynamic therapy.
  • Procedure Conventional Prophylaxis
    Standard mechanical prophylaxis using rubber-cup polishing and prophylaxis paste.

Primary outcome measures

  • Recurrence of Chromogenic Extrinsic Stains [Time frame: 6 months after treatment]
Secondary outcome measures (2)
  • Complete Stain Removal Assessed by Standardized Clinical Examination [Time frame: 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Egypt · 1 center
  • Cairo University — Cairo

Identifiers

NCT: NCT07736339 · PED-2025-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗