Chromogenic Extrinsic Tooth StainsNCT07736339
Photodynamic Therapy for Preventing Recurrent Chromogenic Stains on Deciduous Teeth
A study testing Antimicrobial Photodynamic Therapy and Conventional Prophylaxis in people with Chromogenic Extrinsic Tooth Stains, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 6 years
- Conditions the study is for
- Chromogenic Extrinsic Tooth Stains
- What is being tested?
- Antimicrobial Photodynamic Therapy and Conventional Prophylaxis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2026to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Cairo University
Cairo, Cairo Governorate
Maram Oraby, BDS, +201022040432
About this study
Official title: Antimicrobial Methylene Blue Photodynamic Therapy Versus Conventional Prophylaxis for Preventing Recurrent Chromogenic Stains on Deciduous Teeth: A Pilot Controlled Trial
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
- Being tested
- Antimicrobial Photodynamic Therapy, Conventional Prophylaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antimicrobial Photodynamic TherapyProcedure or surgery
Conventional prophylaxis followed by topical application of methylene blue activated by 660-nm red light for antimicrobial photodynamic therapy.
Conventional ProphylaxisProcedure or surgery
Standard mechanical prophylaxis using rubber-cup polishing and prophylaxis paste.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Antimicrobial Photodynamic Therapy |
| Conventional Prophylaxis | Active comparator | Participants will receive conventional prophylaxis alone according to the standardized clinical protocol. Receives: Procedure: Conventional Prophylaxis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after treatment
Secondary outcomes (2)
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).
Measured: 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
Measured: Immediately after treatment and at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chromogenic Extrinsic Tooth StainsStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maram Gomaa Gebaly Oraby, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07736339
- Sponsor's protocol ID
- PED-2025-001
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antimicrobial Methylene Blue Photodynamic Therapy Versus Conventional Prophylaxis for Preventing Recurrent Chromogenic Stains on Deciduous Teeth: A Pilot Controlled Trial
- ClinicalTrials.gov ID
- NCT07736339
- Acronym / sponsor ID
- PED-2025-001
- Conditions
- Chromogenic Extrinsic Tooth Stains
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 30 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Antimicrobial Photodynamic Therapy | Experimental | Procedure: Antimicrobial Photodynamic TherapyParticipants 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. |
| Conventional Prophylaxis | Active comparator | Procedure: Conventional ProphylaxisParticipants will receive conventional prophylaxis alone according to the standardized clinical protocol. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antimicrobial Photodynamic TherapyConventional prophylaxis followed by topical application of methylene blue activated by 660-nm red light for antimicrobial photodynamic therapy. | Procedure or surgery | Antimicrobial Photodynamic Therapy |
| Conventional ProphylaxisStandard mechanical prophylaxis using rubber-cup polishing and prophylaxis paste. | Procedure or surgery | Conventional Prophylaxis |
Primary outcome
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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antimicrobial Photodynamic Therapy and Conventional Prophylaxis in people with Chromogenic Extrinsic Tooth Stains, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maram Gomaa Gebaly Oraby, BDS (+201022040432, maram.gebaly@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of Chromogenic Extrinsic Stains (time frame: 6 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.