Effectiveness of Theobromine Toothpaste

Study Overview
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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.

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: A group of children using low-fluoridated toothpaste (500ppm) A group of children using fluoridated toothpaste (1450ppm) A group of children using theobromine toothpaste (2%) 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)

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

Conditions
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Dental Care, Dental Plaque

Intervention / Treatment
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* Other: Evaluation of the effectiveness of low- fluoridated toothpaste.
* Other: Evaluation of the effectiveness of fluoridated toothpaste.
* Other: Evaluation of the effectiveness of theobromine toothpaste (2%) toothpaste.
* Other: Evaluation of the effectiveness of theobromine toothpaste(4%) toothpaste.


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Children using fluoridated toothpaste<br> | Other: Evaluation of the effectiveness of fluoridated toothpaste.<br>* 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).<br>|
| Other: Children using low- fluoridated toothpaste<br> | Other: Evaluation of the effectiveness of low- fluoridated toothpaste.<br>* 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).<br>|
| Experimental: Children using Theobromine toothpaste (2%).<br> | Other: Evaluation of the effectiveness of theobromine toothpaste (2%) toothpaste.<br>* 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).<br>|
| Experimental: Children using Theobromine toothpaste(4%)<br> | Other: Evaluation of the effectiveness of theobromine toothpaste(4%) toothpaste.<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dental Primary Prevention, Theobromine toothpaste, Fluoridated toothpaste