Photodynamic Therapy for Preventing Recurrent Chromogenic Stains on Deciduous Teeth

NCT07736339 | Not Yet Recruiting

• 1 other identifier: PED-2025-001
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chromogenic Extrinsic Tooth Stains

Outcome Measures

Primary Outcomes (1)

• Recurrence of Chromogenic Extrinsic Stains

  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 Outcomes (2)

• Complete Stain Removal Assessed by Standardized Clinical Examination

  Immediately after treatment

• Parent/Guardian Satisfaction Assessed Using a Study-Specific 5-Point Likert Satisfaction Questionnaire

  Immediately after treatment and at 6 months

Study Arms (2)

Antimicrobial Photodynamic Therapy

EXPERIMENTAL

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

ACTIVE COMPARATOR

Participants will receive conventional prophylaxis alone according to the standardized clinical protocol.

Procedure: Conventional Prophylaxis

Interventions

Antimicrobial Photodynamic Therapy PROCEDURE

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

Antimicrobial Photodynamic Therapy

Conventional Prophylaxis PROCEDURE

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

Conventional Prophylaxis

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Cairo Governorate, Egypt

Location

Central Study Contacts

Maram Gomaa Gebaly Oraby, BDS

CONTACT

+201022040432; maram.gebaly@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The clinical examiner responsible for outcome assessment will be blinded to the participant's treatment allocation throughout the study.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Dentistry Resident

Model Details: Participants will be allocated into two parallel groups. The experimental group will receive conventional prophylaxis followed by antimicrobial photodynamic therapy using topical methylene blue activated by 660-nm red light. The control group will receive conventional prophylaxis alone. Outcomes will be compared between the two groups during the follow-up period.

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 30, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)