Dental PlaqueNCT05187507
Effectiveness of Theobromine Toothpaste
A study testing Evaluation of the effectiveness of low- fluoridated toothpaste., Evaluation of the effectiveness of fluoridated toothpaste. and Evaluation of the effectiveness of theobromine toothpaste (2%) toothpaste. in people with Dental Plaque and Dental Care, run by Damascus University at 1 site in Syria.
Trial summary
Since plaque control forms the basis for caries prevention, the type of toothpaste and its constituents becomes more important. Toothpaste containing fluoride are widely popular and fluorides have been historically reported to have effects against dental caries. Read more about this study
- Who is it for?
- Ages 6 to 9 years
- Conditions the study is for
- Dental Plaque, Dental Care
- What is being tested?
- Evaluation of the effectiveness of low- fluoridated toothpaste., Evaluation of the effectiveness of fluoridated toothpaste. and Evaluation of the effectiveness of theobromine toothpaste (2%) toothpaste.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSyria
- Study dates
- 25 Sep 2021to 1 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children of age group 6to 9 years.
- Participant must have least 20 teeth free from dental cries on both buccal and lingual surfaces of the teeth.
- Cooperative children having behavioral rating (positive or definitively positive)according to frankel's behavior rating scale.
- Children who are not on any medication prior or during the study period
Who cannot join
- children with systemic diseases and medically compromising conditions.
- children undergoing orthodontic treatment or with an intraoral prosthesis.
- children who could not brush their teeth or rinse on their own.
- Allergic to any of the toothpaste ingredient used the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness Evaluation of the Theobromine Containing Toothpastes in Controlling Dental Plaque in Children Aged 6-9years(Randomized Controlled Clinical Trial)
Since plaque control forms the basis for caries prevention, the type of toothpaste and its constituents becomes more important.
Toothpaste containing fluoride are widely popular and fluorides have been historically reported to have effects against dental caries. However, the fluoride safe doses are still discussed ,because fluoride has toxicity and causing fluorosis.
The aim of the current research is to find alternative agent that can be used without side effects.
Read the detailed description
Participants will be examined to ensure that they have met the smple entrey criteria,then the participants will be randomly assigned to four groups each one according to a group:
- A group of children using low-fluoridated toothpaste (500ppm)
- A group of children using fluoridated toothpaste (1450ppm)
- A group of children using theobromine toothpaste (2%)
- A group of children using low-fluoridated toothpaste (4%) The researcher will teach the participants how to brush using (tell-show-do)technique.
- The brushing method that will be used is the fones technique.
- Brushing duration must be 2minutes.
- Frequency of brushing must be twice a day
- The amount of toothpaste used is pea size.
Mechanism of examination and follow up:
A thorough scaling and plaque removal was conducted and the children were advised to brush their teeth using their regular toothpaste for a week before starting the research.
Gingival will be evaluated with gingival index (loe and silness)
- Conditions
- Dental Plaque, Dental Care
- Being tested
- Evaluation of the effectiveness of low- fluoridated toothpaste., Evaluation of the effectiveness of fluoridated toothpaste., Evaluation of the effectiveness of theobromine toothpaste (2%) toothpaste., Evaluation of the effectiveness of theobromine toothpaste(4%) toothpaste.
- Keywords
- Dental Primary Prevention, Theobromine toothpaste, Fluoridated toothpaste
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of the effectiveness of low- fluoridated toothpaste.Other
Children will be given low- fluoridated toothpaste, plaque score in groups will be assess pre given toothpaste in baseline,aweek,2week,and after 3weeks by using the TMQHPI for both buccal and lingual surface.
Gingivalitis will be assess pre given toothpaste,aweek,2weeks,and after 3weeks by using gingival index (loe and silness).
Evaluation of the effectiveness of fluoridated toothpaste.Other
Children will be given e fluoridated toothpaste, plaque score in groups will be assess pre given toothpaste in baseline,aweek,2week,and after 3weeks by using the TMQHPI for both buccal and lingual surface.
Gingivalitis will be assess pre given toothpaste,aweek,2weeks,and after 3weeks by using gingival index (loe and silness).
Evaluation of the effectiveness of theobromine toothpaste (2%) toothpaste.Other
Children will be given theobromine toothpaste(2%),plaque score in groups will be assess pre given toothpaste in baseline,aweek,2week,and after 3weeks by using the TMQHPI for both buccal and lingual surface.
Gingivalitis will be assess pre given toothpaste,aweek,2weeks,and after 3weeks by using gingival index (loe and silness).
Evaluation of the effectiveness of theobromine toothpaste(4%) toothpaste.Other
Children will be given theobromine toothpaste(4%),plaque score in groups will be assess pre given toothpaste in baseline,aweek,2week,and after 3weeks by using the TMQHPI for both buccal and lingual surface.
Gingivalitis will be assess pre given toothpaste,aweek,2weeks,and after 3weeks by using gingival index (loe and silness).
| Study group | Role | What they receive |
|---|---|---|
| Children using fluoridated toothpaste | Other | Not described Receives: Other: Evaluation of the effectiveness of fluoridated toothpaste. |
| Children using low- fluoridated toothpaste | Other | Not described Receives: Other: Evaluation of the effectiveness of low- fluoridated toothpaste. |
| Children using Theobromine toothpaste (2%). | Experimental | Not described Receives: Other: Evaluation of the effectiveness of theobromine toothpaste (2%) toothpaste. |
| Children using Theobromine toothpaste(4%) | Experimental | Not described Receives: Other: Evaluation of the effectiveness of theobromine toothpaste(4%) toothpaste. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical evaluation of using low- fluoridaed toothpaste for children
Plaque scores will be assess by using the Turesky Modification of the Quigley-Hein Plaque Index(TMQHPI) for both buccal and lingual surfaces. Plaque will detect using plaque disclosing agent.
Gingival scores will be assessed with gingival index(loe and silness).
Measured: 1 week
Clinical evaluation of using low- fluoridaed toothpaste for children
Plaque scores will be assess by using the Turesky Modification of the Quigley-Hein Plaque Index(TMQHPI) for both buccal and lingual surfaces. Plaque will detect using plaque disclosing agent.
Gingival scores will be assessed with gingival index(loe and silness).
Measured: 2 week
Clinical evaluation of using low- fluoridaed toothpaste for children
Plaque scores will be assess by using the Turesky Modification of the Quigley-Hein Plaque Index(TMQHPI) for both buccal and lingual surfaces. Plaque will detect using plaque disclosing agent.
Gingival scores will be assessed with gingival index(loe and silness).
Measured: 3 week
Clinical evaluation of using fluoridated toothpaste for children
Plaque scores will be assess by using the Turesky Modification of the Quigley-Hein Plaque Index(TMQHPI) for both buccal and lingual surfaces. Plaque will detect using plaque disclosing agent.
Gingival scores will be assessed with gingival index(loe and silness).
Measured: 1 week
Clinical evaluation of using fluoridated toothpaste for children
Plaque scores will be assess by using the Turesky Modification of the Quigley-Hein Plaque Index(TMQHPI) for both buccal and lingual surfaces. Plaque will detect using plaque disclosing agent.
Gingival scores will be assessed with gingival index(loe and silness).
Measured: 2 week
Clinical evaluation of using fluoridated toothpaste for children
Plaque scores will be assess by using the Turesky Modification of the Quigley-Hein Plaque Index(TMQHPI) for both buccal and lingual surfaces. Plaque will detect using plaque disclosing agent.
Gingival scores will be assessed with gingival index(loe and silness).
Measured: 3 week
Clinical evaluation of using theobromine toothpaste(2%) for children
Plaque scores will be assess by using the Turesky Modification of the Quigley-Hein Plaque Index(TMQHPI) for both buccal and lingual surfaces. Plaque will detect using plaque disclosing agent.
Gingival scores will be assessed with gingival index(loe and silness).
Measured: 1 week
Clinical evaluation of using theobromine toothpaste(2%) for children
Plaque scores will be assess by using the Turesky Modification of the Quigley-Hein Plaque Index(TMQHPI) for both buccal and lingual surfaces. Plaque will detect using plaque disclosing agent.
Gingival scores will be assessed with gingival index(loe and silness).
Measured: 2 week
Clinical evaluation of using theobromine toothpaste(2%) for children
Plaque scores will be assess by using the Turesky Modification of the Quigley-Hein Plaque Index(TMQHPI) for both buccal and lingual surfaces. Plaque will detect using plaque disclosing agent.
Gingival scores will be assessed with gingival index(loe and silness).
Measured: 3 week
Clinical evaluation of using theobromine toothpaste(4%) for children
Plaque scores will be assess by using the Turesky Modification of the Quigley-Hein Plaque Index(TMQHPI) for both buccal and lingual surfaces. Plaque will detect using plaque disclosing agent.
Gingival scores will be assessed with gingival index(loe and silness).
Measured: 1 week
Clinical evaluation of using theobromine toothpaste(4%) for children
Plaque scores will be assess by using the Turesky Modification of the Quigley-Hein Plaque Index(TMQHPI) for both buccal and lingual surfaces. Plaque will detect using plaque disclosing agent.
Gingival scores will be assessed with gingival index(loe and silness).
Measured: 2 week
Clinical evaluation of using theobromine toothpaste(4%) for children
Plaque scores will be assess by using the Turesky Modification of the Quigley-Hein Plaque Index(TMQHPI) for both buccal and lingual surfaces. Plaque will detect using plaque disclosing agent.
Gingival scores will be assessed with gingival index(loe and silness).
Measured: 3 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start25 Sep 2021
- Primary completion1 Nov 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Dental PlaqueStudies of the same condition, open and under way.
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nour M Zaaweet, DDS, Principal investigator, MSc student in Pedodontics, University of DamascusEttihad A Abo-Arraj, Phd, Study chair, Professor of Pedodontics, Department of Pedodontics, University of Damascus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05187507
- Sponsor's protocol ID
- UDDS-Pedo-06-2021
- Status last verified
- Dec 2021
- First submitted
- 24 Dec 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Farooq I, Samad Khan A, Moheet IA, Alshwaimi E. Preparation of a toothpaste containing theobromine and fluoridated bioactive glass and its effect on surface micro-hardness and roughness of enamel. Dent Mater J. 2021 Mar 31;40(2):393-398. doi: 10.4012/dmj.2020-078. Epub 2020 Nov 19.
PubMed 33208577Premnath P, John J, Manchery N, Subbiah GK, Nagappan N, Subramani P. Effectiveness of Theobromine on Enamel Remineralization: A Comparative In-vitro Study. Cureus. 2019 Sep 17;11(9):e5686. doi: 10.7759/cureus.5686.
PubMed 31720155Lakshmi A, Vishnurekha C, Baghkomeh PN. Effect of theobromine in antimicrobial activity: An in vitro study. Dent Res J (Isfahan). 2019 Mar-Apr;16(2):76-80.
PubMed 30820200Thorn AK, Lin WS, Levon JA, Morton D, Eckert GJ, Lippert F. The effect of theobromine on the in vitro de- and remineralization of enamel carious lesions. J Dent. 2020;103S:100013. doi: 10.1016/j.jjodo.2020.100013. Epub 2020 Feb 17.
PubMed 34059300Lippert F. The effects of fluoride, strontium, theobromine and their combinations on caries lesion rehardening and fluoridation. Arch Oral Biol. 2017 Aug;80:217-221. doi: 10.1016/j.archoralbio.2017.04.022. Epub 2017 Apr 20.
PubMed 28458181
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness Evaluation of the Theobromine Containing Toothpastes in Controlling Dental Plaque in Children Aged 6-9years(Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT05187507
- Acronym / sponsor ID
- UDDS-Pedo-06-2021
- Conditions
- Dental Plaque, Dental Care
- Keywords
- Dental Primary Prevention, Theobromine toothpaste, Fluoridated toothpaste
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 25 Sep 2021 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 11 Jan 2022 (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.
Since plaque control forms the basis for caries prevention, the type of toothpaste and its constituents becomes more important.
Toothpaste containing fluoride are widely popular and fluorides have been historically reported to have effects against dental caries. However, the fluoride safe doses are still discussed ,because fluoride has toxicity and causing fluorosis.
The aim of the current research is to find alternative agent that can be used without side effects.
Detailed description
Participants will be examined to ensure that they have met the smple entrey criteria,then the participants will be randomly assigned to four groups each one according to a group:
- A group of children using low-fluoridated toothpaste (500ppm)
- A group of children using fluoridated toothpaste (1450ppm)
- A group of children using theobromine toothpaste (2%)
- A group of children using low-fluoridated toothpaste (4%) The researcher will teach the participants how to brush using (tell-show-do)technique.
- The brushing method that will be used is the fones technique.
- Brushing duration must be 2minutes.
- Frequency of brushing must be twice a day
- The amount of toothpaste used is pea size.
Mechanism of examination and follow up:
A thorough scaling and plaque removal was conducted and the children were advised to brush their teeth using their regular toothpaste for a week before starting the research.
Gingival will be evaluated with gingival index (loe and silness)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Children using fluoridated toothpaste | Other | Other: Evaluation of the effectiveness of fluoridated toothpaste. |
| Children using low- fluoridated toothpaste | Other | Other: Evaluation of the effectiveness of low- fluoridated toothpaste. |
| Children using Theobromine toothpaste (2%). | Experimental | Other: Evaluation of the effectiveness of theobromine toothpaste (2%) toothpaste. |
| Children using Theobromine toothpaste(4%) | Experimental | Other: Evaluation of the effectiveness of theobromine toothpaste(4%) toothpaste. |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children of age group 6to 9 years.
- Participant must have least 20 teeth free from dental cries on both buccal and lingual surfaces of the teeth.
- Cooperative children having behavioral rating (positive or definitively positive)according to frankel's behavior rating scale.
- Children who are not on any medication prior or during the study period
Key exclusion criteria (4 listed)
- children with systemic diseases and medically compromising conditions.
- children undergoing orthodontic treatment or with an intraoral prosthesis.
- children who could not brush their teeth or rinse on their own.
- Allergic to any of the toothpaste ingredient used the study.
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 |
|---|---|---|
| Evaluation of the effectiveness of low- fluoridated toothpaste.Children will be given low- fluoridated toothpaste, plaque score in groups will be assess pre given toothpaste in baseline,aweek,2week,and after 3weeks by using the TMQHPI for both buccal and lingual surface. Gingivalitis will be assess pre given toothpaste,aweek,2weeks,and after 3weeks by using gingival index (loe and silness). | Other | Children using low- fluoridated toothpaste |
| Evaluation of the effectiveness of fluoridated toothpaste.Children will be given e fluoridated toothpaste, plaque score in groups will be assess pre given toothpaste in baseline,aweek,2week,and after 3weeks by using the TMQHPI for both buccal and lingual surface. Gingivalitis will be assess pre given toothpaste,aweek,2weeks,and after 3weeks by using gingival index (loe and silness). | Other | Children using fluoridated toothpaste |
| Evaluation of the effectiveness of theobromine toothpaste (2%) toothpaste.Children will be given theobromine toothpaste(2%),plaque score in groups will be assess pre given toothpaste in baseline,aweek,2week,and after 3weeks by using the TMQHPI for both buccal and lingual surface. Gingivalitis will be assess pre given toothpaste,aweek,2weeks,and after 3weeks by using gingival index (loe and silness). | Other | Children using Theobromine toothpaste (2%). |
| Evaluation of the effectiveness of theobromine toothpaste(4%) toothpaste.Children will be given theobromine toothpaste(4%),plaque score in groups will be assess pre given toothpaste in baseline,aweek,2week,and after 3weeks by using the TMQHPI for both buccal and lingual surface. Gingivalitis will be assess pre given toothpaste,aweek,2weeks,and after 3weeks by using gingival index (loe and silness). | Other | Children using Theobromine toothpaste(4%) |
Primary outcome
Clinical evaluation of using low- fluoridaed toothpaste for children
Time frame: 1 week
Plaque scores will be assess by using the Turesky Modification of the Quigley-Hein Plaque Index(TMQHPI) for both buccal and lingual surfaces. Plaque will detect using plaque disclosing agent. Gingival scores will be assessed with gingival index(loe and silness).
Clinical evaluation of using low- fluoridaed toothpaste for children
Time frame: 2 week
Plaque scores will be assess by using the Turesky Modification of the Quigley-Hein Plaque Index(TMQHPI) for both buccal and lingual surfaces. Plaque will detect using plaque disclosing agent. Gingival scores will be assessed with gingival index(loe and silness).
Clinical evaluation of using low- fluoridaed toothpaste for children
Time frame: 3 week
Plaque scores will be assess by using the Turesky Modification of the Quigley-Hein Plaque Index(TMQHPI) for both buccal and lingual surfaces. Plaque will detect using plaque disclosing agent. Gingival scores will be assessed with gingival index(loe and silness).
Clinical evaluation of using fluoridated toothpaste for children
Time frame: 1 week
Plaque scores will be assess by using the Turesky Modification of the Quigley-Hein Plaque Index(TMQHPI) for both buccal and lingual surfaces. Plaque will detect using plaque disclosing agent. Gingival scores will be assessed with gingival index(loe and silness).
Clinical evaluation of using fluoridated toothpaste for children
Time frame: 2 week
Plaque scores will be assess by using the Turesky Modification of the Quigley-Hein Plaque Index(TMQHPI) for both buccal and lingual surfaces. Plaque will detect using plaque disclosing agent. Gingival scores will be assessed with gingival index(loe and silness).
Clinical evaluation of using fluoridated toothpaste for children
Time frame: 3 week
Plaque scores will be assess by using the Turesky Modification of the Quigley-Hein Plaque Index(TMQHPI) for both buccal and lingual surfaces. Plaque will detect using plaque disclosing agent. Gingival scores will be assessed with gingival index(loe and silness).
Clinical evaluation of using theobromine toothpaste(2%) for children
Time frame: 1 week
Plaque scores will be assess by using the Turesky Modification of the Quigley-Hein Plaque Index(TMQHPI) for both buccal and lingual surfaces. Plaque will detect using plaque disclosing agent. Gingival scores will be assessed with gingival index(loe and silness).
Clinical evaluation of using theobromine toothpaste(2%) for children
Time frame: 2 week
Plaque scores will be assess by using the Turesky Modification of the Quigley-Hein Plaque Index(TMQHPI) for both buccal and lingual surfaces. Plaque will detect using plaque disclosing agent. Gingival scores will be assessed with gingival index(loe and silness).
Clinical evaluation of using theobromine toothpaste(2%) for children
Time frame: 3 week
Plaque scores will be assess by using the Turesky Modification of the Quigley-Hein Plaque Index(TMQHPI) for both buccal and lingual surfaces. Plaque will detect using plaque disclosing agent. Gingival scores will be assessed with gingival index(loe and silness).
Clinical evaluation of using theobromine toothpaste(4%) for children
Time frame: 1 week
Plaque scores will be assess by using the Turesky Modification of the Quigley-Hein Plaque Index(TMQHPI) for both buccal and lingual surfaces. Plaque will detect using plaque disclosing agent. Gingival scores will be assessed with gingival index(loe and silness).
Clinical evaluation of using theobromine toothpaste(4%) for children
Time frame: 2 week
Plaque scores will be assess by using the Turesky Modification of the Quigley-Hein Plaque Index(TMQHPI) for both buccal and lingual surfaces. Plaque will detect using plaque disclosing agent. Gingival scores will be assessed with gingival index(loe and silness).
Clinical evaluation of using theobromine toothpaste(4%) for children
Time frame: 3 week
Plaque scores will be assess by using the Turesky Modification of the Quigley-Hein Plaque Index(TMQHPI) for both buccal and lingual surfaces. Plaque will detect using plaque disclosing agent. Gingival scores will be assessed with gingival index(loe and silness).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Background: PubMed 33208577Farooq I, Samad Khan A, Moheet IA, Alshwaimi E. Preparation of a toothpaste containing theobromine and fluoridated bioactive glass and its effect on surface micro-hardness and roughness of enamel. Dent Mater J. 2021 Mar 31;40(2):393-398. doi: 10.4012/dmj.2020-078. Epub 2020 Nov 19.
- Background: PubMed 31720155Premnath P, John J, Manchery N, Subbiah GK, Nagappan N, Subramani P. Effectiveness of Theobromine on Enamel Remineralization: A Comparative In-vitro Study. Cureus. 2019 Sep 17;11(9):e5686. doi: 10.7759/cureus.5686.
- Background: PubMed 30820200Lakshmi A, Vishnurekha C, Baghkomeh PN. Effect of theobromine in antimicrobial activity: An in vitro study. Dent Res J (Isfahan). 2019 Mar-Apr;16(2):76-80.
- Background: PubMed 34059300Thorn AK, Lin WS, Levon JA, Morton D, Eckert GJ, Lippert F. The effect of theobromine on the in vitro de- and remineralization of enamel carious lesions. J Dent. 2020;103S:100013. doi: 10.1016/j.jjodo.2020.100013. Epub 2020 Feb 17.
- Background: PubMed 28458181Lippert F. The effects of fluoride, strontium, theobromine and their combinations on caries lesion rehardening and fluoridation. Arch Oral Biol. 2017 Aug;80:217-221. doi: 10.1016/j.archoralbio.2017.04.022. Epub 2017 Apr 20.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Nour M Zaaweet, DDS principal investigator
MSc student in Pedodontics, University of Damascus
Ettihad A Abo-Arraj, Phd study chair
Professor of Pedodontics, Department of Pedodontics, University of Damascus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evaluation of the effectiveness of low- fluoridated toothpaste., Evaluation of the effectiveness of fluoridated toothpaste. and Evaluation of the effectiveness of theobromine toothpaste (2%) toothpaste. in people with Dental Plaque and Dental Care, run by Damascus University at 1 site in Syria.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 11 Jan 2022. 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 Syria. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical evaluation of using low- fluoridaed toothpaste for children (time frame: 1 week). The study lists 12 primary outcomes in all. 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 NCT05187507, which also lists 5 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 11 Jan 2022.