Photodynamic Therapy for Preventing Recurrent Chromogenic Stains on Deciduous Teeth

N/ANot Yet RecruitingNCT07736339

Cairo University36 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Chromogenic Extrinsic Tooth Stains

Interventions

Antimicrobial Photodynamic TherapyPROCEDURE

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

Conventional ProphylaxisPROCEDURE

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

Eligibility

Sex: ALLMin age: 4 YearsMax age: 6 Years

Medical Language ↔ Plain English

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.

Locations (1)

Cairo University

Cairo, Cairo Governorate, Egypt

Outcomes

Primary Outcomes

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.

Time frame: 6 months after treatment

Secondary Outcomes

Complete Stain Removal Assessed by Standardized Clinical Examination

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).

Time frame: Immediately after treatment

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

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

Time frame: Immediately after treatment and at 6 months

Central Contacts

Maram Gomaa Gebaly Oraby, BDS

CONTACT

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

Data from ClinicalTrials.gov

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