Black StainsNCT06714695
A Crossover Clinical Study to Evaluate the Effect of Chitosan Mouthwash on Recurrence of Black Stains in Pediatric Patients
A study testing Chitosan in people with Black Stains, run by Al-Azhar University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to learn if Chitosan mouthwash works to affect the recurrence of black stains in pediatric patients. The main questions it aims to answer are: Does Chitosan mouthwash lower the number of times participants need to do a scaling and polishing cleaning sessions more than normal? Does… Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Black Stains
- What is being tested?
- Chitosan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2024to Jul 2025
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 1. Cooperative child to be able to perform and tolerate different oral hygiene procedures 2. Parents providing informed consent 3. Accept 18 weeks follow up period 4. Teeth showing black stains without calculus.
Who cannot join
- 1. Patients with Allergic reactions to food \& drugs containing derivatives from crustacean organisms. 2. Taking any antibiotic drugs within 2- week period before sample collection. 3. Taking any dietary supplements containing iron. 4. Teeth selected should be free of caries 5. Free of any developmental defects
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, 1 recruiting
- Recruiting
Faculty of dental medicine Azhar University
Cairo, Cairo Governorate
Inas M Talaat, +202-24053623, dent.g@azhar.edu.eg
Mohamed H Mostafa
About this study
Official title: Evaluation of the Effective Concentration of Chitosan Mouthwash on the Recurrence of Black Stains in Pediatric Patients. a Crossover Controlled Clinical Trial
The goal of this clinical trial is to learn if Chitosan mouthwash works to affect the recurrence of black stains in pediatric patients. The main questions it aims to answer are:
Does Chitosan mouthwash lower the number of times participants need to do a scaling and polishing cleaning sessions more than normal? Does Chitosan mouthwash will decrease the recurrence of black stains in children and improve esthetics ?
Participants will:
Take chitosan every day for 4 months Visit the clinic once every 6 weeks for checkups and data collection
- Conditions
- Black Stains
- Being tested
- Chitosan
- Keywords
- Black stains, chromogenic, Children, Pediatric, Recurrence
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChitosanDrug
chitosan mouthwash
| Study group | Role | What they receive |
|---|---|---|
| Pediatric patients before and after using chitosan mouthwash | Other | pediatric patients with black stains will be recruited in the study. Scaling and polishing will be done then followed up for 3 months, then scaling and polishing will be repeated after follow up period and the patient will be given chitosan mouthwash to be used for additional 3 months. Receives: Drug: Chitosan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of Black stains
Measured: 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start1 Nov 2024
- Primary completionMar 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Black StainsStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Collaborators
- Misr International University
- Responsible party
- Principal investigator, Rawda wagih Mostafa Hassan, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06714695
- Sponsor's protocol ID
- (P-PE-22-03)
- Status last verified
- Nov 2024
- First submitted
- 28 Nov 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Milleman KR, Creeth JE, Burnett GR, Milleman JL. A randomized clinical trial to evaluate the stain removal efficacy of a sodium phytate dentifrice formulation. J Esthet Restor Dent. 2018 Mar;30(2):E45-E51. doi: 10.1111/jerd.12355. Epub 2018 Feb 7.
PubMed 29411532Qin C, Li H., Xiao Q, Liu Y, Zhu J, Du Y. Water-solubility of chitosan and its antimicrobial activity, Carbohydr Polyr 2006; 63:367-74.
Koch MJ, Bove M, Schroff J, Perlea P, Garcia-Godoy F, Staehle HJ. Black stain and dental caries in schoolchildren in Potenza, Italy. ASDC J Dent Child. 2001 Sep-Dec;68(5-6):353-5, 302.
PubMed 11985199
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effective Concentration of Chitosan Mouthwash on the Recurrence of Black Stains in Pediatric Patients. a Crossover Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06714695
- Acronym / sponsor ID
- (P-PE-22-03)
- Conditions
- Black Stains
- Keywords
- Black stains, chromogenic, Children, Pediatric, Recurrence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Collaborators
- Misr International University
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 4 Dec 2024 (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.
The goal of this clinical trial is to learn if Chitosan mouthwash works to affect the recurrence of black stains in pediatric patients. The main questions it aims to answer are:
Does Chitosan mouthwash lower the number of times participants need to do a scaling and polishing cleaning sessions more than normal? Does Chitosan mouthwash will decrease the recurrence of black stains in children and improve esthetics ?
Participants will:
Take chitosan every day for 4 months Visit the clinic once every 6 weeks for checkups and data collection
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric patients before and after using chitosan mouthwash | Other | Drug: Chitosanpediatric patients with black stains will be recruited in the study. Scaling and polishing will be done then followed up for 3 months, then scaling and polishing will be repeated after follow up period and the patient will be given chitosan mouthwash to be used for additional 3 months. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 1. Cooperative child to be able to perform and tolerate different oral hygiene procedures 2. Parents providing informed consent 3. Accept 18 weeks follow up period 4. Teeth showing black stains without calculus.
Key exclusion criteria (1 listed)
- 1. Patients with Allergic reactions to food \& drugs containing derivatives from crustacean organisms. 2. Taking any antibiotic drugs within 2- week period before sample collection. 3. Taking any dietary supplements containing iron. 4. Teeth selected should be free of caries 5. Free of any developmental defects
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 |
|---|---|---|
| Chitosanchitosan mouthwash | Drug | Pediatric patients before and after using chitosan mouthwash |
Primary outcome
Recurrence of Black stains
Time frame: 36 weeks
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 4 Dec 2024.
- Background: PubMed 29411532Milleman KR, Creeth JE, Burnett GR, Milleman JL. A randomized clinical trial to evaluate the stain removal efficacy of a sodium phytate dentifrice formulation. J Esthet Restor Dent. 2018 Mar;30(2):E45-E51. doi: 10.1111/jerd.12355. Epub 2018 Feb 7.
- BackgroundQin C, Li H., Xiao Q, Liu Y, Zhu J, Du Y. Water-solubility of chitosan and its antimicrobial activity, Carbohydr Polyr 2006; 63:367-74.
- Background: PubMed 11985199Koch MJ, Bove M, Schroff J, Perlea P, Garcia-Godoy F, Staehle HJ. Black stain and dental caries in schoolchildren in Potenza, Italy. ASDC J Dent Child. 2001 Sep-Dec;68(5-6):353-5, 302.
- Individual participant dataSharing planned: Undecided
Related trials for Black Stains
Not yet recruiting
Comparison of Erythritol Air-Polishing and Conventional Polishing Following Ultrasonic Scaling on the Relapse of Chromogenic Tooth Staining in Children
Black Staining
Recruiting
Air Polishers With Erythritol in the Treatment of Dental Black Stain of Bacterial Origin
Black Stain, Black Plaque
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 Chitosan in people with Black Stains, run by Al-Azhar 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 4 Dec 2024. 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 Rawda W Hassan (+201005703873, rawda.el.hariry@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of Black stains (time frame: 36 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06714695, which also lists 3 linked publications.
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 4 Dec 2024.