Effectiveness of Theobromine Toothpaste

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05187507
• Other study ID #: UDDS-Pedo-06-2021
• Status: Completed
• Phase: N/A
• Start date: September 25, 2021
• Est. completion date: December 1, 2021

Study information

• Verified date: December 2021
• Source: Damascus University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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:

1. A group of children using low-fluoridated toothpaste (500ppm)

2. A group of children using fluoridated toothpaste (1450ppm)

3. A group of children using theobromine toothpaste (2%)

4. 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)

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Dental Care
• Dental Plaque

Intervention

Other:
• 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).
• 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).
• 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).
• 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).

Locations

Country	Name	City	State
Syrian Arab Republic	Damascus University	Damascus

Sponsors (1)

Lead Sponsor	Collaborator
Damascus University

Country where clinical trial is conducted

Syrian Arab Republic, 

References & Publications (5)

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

Outcome

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