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NCT Number: NCT07736339

Photodynamic Therapy for Preventing Recurrent Chromogenic Stains on Deciduous Teeth

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.

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Key information

Conditions

Chromogenic Extrinsic Tooth Stains

Age range

4 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, Cairo Governorate, Egypt

Location contact

Maram Oraby, BDS

CONTACT

+201022040432

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

antimicrobial photodynamic therapy

Procedure

Conventional prophylaxis followed by topical application of methylene blue activated by 660-nm red light for antimicrobial photodynamic therapy.

Conventional Prophylaxis

Procedure

Standard mechanical prophylaxis using rubber-cup polishing and prophylaxis paste.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Maram Gomaa Gebaly Oraby, BDS

CONTACT

[email protected]

+201022040432

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 30, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.