Effectiveness of Theobromine Toothpaste

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-25

Study Completion Date

2021-12-01

Brief Summary

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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.

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Detailed Description

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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

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Dental Plaque Dental Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Children using fluoridated toothpaste

Group Type OTHER

Evaluation of the effectiveness of fluoridated toothpaste.

Intervention Type 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).

Children using low- fluoridated toothpaste

Group Type OTHER

Evaluation of the effectiveness of low- fluoridated toothpaste.

Intervention Type 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).

Children using Theobromine toothpaste (2%).

Group Type EXPERIMENTAL

Evaluation of the effectiveness of theobromine toothpaste (2%) toothpaste.

Intervention Type 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).

Children using Theobromine toothpaste(4%)

Group Type EXPERIMENTAL

Evaluation of the effectiveness of theobromine toothpaste(4%) toothpaste.

Intervention Type 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).

Interventions

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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).

Intervention Type 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).

Intervention Type 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).

Intervention Type 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).

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

6 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No