Clinical trial NCT05187507: Effectiveness of Theobromine Toothpaste
Official title: The Effectiveness Evaluation of the Theobromine Containing Toothpastes in Controlling Dental Plaque in Children Aged 6-9years(Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Plaque
Dental Care
Keywords: Dental Primary Prevention
Theobromine toothpaste
Fluoridated toothpaste
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 80
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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:

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)

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical evaluation of using low- fluoridaed toothpaste for children
timeFrame: 1 week
measure: Clinical evaluation of using low- fluoridaed toothpaste for children
timeFrame: 2 week
measure: Clinical evaluation of using low- fluoridaed toothpaste for children
timeFrame: 3 week
measure: Clinical evaluation of using fluoridated toothpaste for children
timeFrame: 1 week
measure: Clinical evaluation of using fluoridated toothpaste for children
timeFrame: 2 week
measure: Clinical evaluation of using fluoridated toothpaste for children
timeFrame: 3 week
measure: Clinical evaluation of using theobromine toothpaste(2%) for children
timeFrame: 1 week
measure: Clinical evaluation of using theobromine toothpaste(2%) for children
timeFrame: 2 week
measure: Clinical evaluation of using theobromine toothpaste(2%) for children
timeFrame: 3 week
measure: Clinical evaluation of using theobromine toothpaste(4%) for children
timeFrame: 1 week
measure: Clinical evaluation of using theobromine toothpaste(4%) for children
timeFrame: 2 week
measure: Clinical evaluation of using theobromine toothpaste(4%) for children
timeFrame: 3 week
Secondary outcomes:
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Damascus University
Study officials:
affiliation: MSc student in Pedodontics, University of Damascus
name: Nour M Zaaweet, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor of Pedodontics, Department of Pedodontics, University of Damascus
name: Ettihad A Abo-Arraj, Phd
role: STUDY_CHAIR
References:
citation: 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.
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.
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.
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.
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.