Dental Plaque Clinical Trial
Official title:
The Effectiveness Evaluation of the Theobromine Containing Toothpastes in Controlling Dental Plaque in Children Aged 6-9years(Randomized Controlled Clinical Trial)
Verified date | December 2021 |
Source | Damascus University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 80 |
Est. completion date | December 1, 2021 |
Est. primary completion date | November 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 9 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Syrian Arab Republic | Damascus University | Damascus |
Lead Sponsor | Collaborator |
---|---|
Damascus University |
Syrian Arab Republic,
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. — View Citation
Lakshmi 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. — View Citation
Lippert 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. — View Citation
Premnath 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. — View Citation
Thorn 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). |
1 week | |
Primary | 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). |
2 week | |
Primary | 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). |
3 week | |
Primary | 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). |
1 week | |
Primary | 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). |
2 week | |
Primary | 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). |
3 week | |
Primary | 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). |
1 week | |
Primary | 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). |
2 week | |
Primary | 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). |
3 week | |
Primary | 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). |
1 week | |
Primary | 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). |
2 week | |
Primary | 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). |
3 week |
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