Chromogenic Extrinsic Tooth Stains
Conditions
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.
Interventions
PROCEDUREAntimicrobial Photodynamic Therapy
Conventional prophylaxis followed by topical application of methylene blue activated by 660-nm red light for antimicrobial photodynamic therapy.
PROCEDUREConventional Prophylaxis
Standard mechanical prophylaxis using rubber-cup polishing and prophylaxis paste.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
The clinical examiner responsible for outcome assessment will be blinded to the participant's treatment allocation throughout the study.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
4 Years to 6 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of Chromogenic Extrinsic Stains | 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
| Measure | Time frame | Description |
|---|---|---|
| Complete Stain Removal Assessed by Standardized Clinical Examination | 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). |
| Parent/Guardian Satisfaction Assessed Using a Study-Specific 5-Point Likert Satisfaction Questionnaire | 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 |
Countries
Egypt
Contacts
CONTACTMaram Gomaa Gebaly Oraby, BDS
Outcome results
None listed