NCT05187507

Effectiveness of Theobromine Toothpaste

The Effectiveness Evaluation of the Theobromine Containing Toothpastes in Controlling Dental Plaque in Children Aged 6-9years(Randomized Controlled Clinical Trial)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Damascus University · Academic / Other
• Sex: All
• Age: 6 Years – 9 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Dental Plaque
• Dental Care

Interventions

Type	Name	Description
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).
OTHER	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	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	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).

Timeline

• Start date: 2021-09-25
• Primary completion: 2021-11-01
• Completion: 2021-12-01
• First posted: 2022-01-11
• Last updated: 2022-01-11

Locations

1 site across 1 country: Syria