Effectiveness of Theobromine Toothpaste
Primary Purpose
Dental Plaque, Dental Care
Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
Evaluation of the effectiveness of low- fluoridated toothpaste.
Evaluation of the effectiveness of fluoridated toothpaste.
Evaluation of the effectiveness of theobromine toothpaste (2%) toothpaste.
Evaluation of the effectiveness of theobromine toothpaste(4%) toothpaste.
Sponsored by
About this trial
This is an interventional prevention trial for Dental Plaque focused on measuring Dental Primary Prevention, Theobromine toothpaste, Fluoridated toothpaste
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.
Sites / Locations
- Damascus University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Other
Other
Experimental
Experimental
Arm Label
Children using fluoridated toothpaste
Children using low- fluoridated toothpaste
Children using Theobromine toothpaste (2%).
Children using Theobromine toothpaste(4%)
Arm Description
Outcomes
Primary Outcome Measures
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT05187507
First Posted
December 24, 2021
Last Updated
December 24, 2021
Sponsor
Damascus University
1. Study Identification
Unique Protocol Identification Number
NCT05187507
Brief Title
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
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
September 25, 2021 (Actual)
Primary Completion Date
November 1, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damascus University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Plaque, Dental Care
Keywords
Dental Primary Prevention, Theobromine toothpaste, Fluoridated toothpaste
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Children using fluoridated toothpaste
Arm Type
Other
Arm Title
Children using low- fluoridated toothpaste
Arm Type
Other
Arm Title
Children using Theobromine toothpaste (2%).
Arm Type
Experimental
Arm Title
Children using Theobromine toothpaste(4%)
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Evaluation of the effectiveness of low- fluoridated toothpaste.
Intervention Description
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
Intervention Name(s)
Evaluation of the effectiveness of fluoridated toothpaste.
Intervention Description
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
Intervention Name(s)
Evaluation of the effectiveness of theobromine toothpaste (2%) toothpaste.
Intervention Description
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
Intervention Name(s)
Evaluation of the effectiveness of theobromine toothpaste(4%) toothpaste.
Intervention Description
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).
Primary Outcome Measure Information:
Title
Clinical evaluation of using low- fluoridaed toothpaste for children
Description
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).
Time Frame
1 week
Title
Clinical evaluation of using low- fluoridaed toothpaste for children
Description
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).
Time Frame
2 week
Title
Clinical evaluation of using low- fluoridaed toothpaste for children
Description
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).
Time Frame
3 week
Title
Clinical evaluation of using fluoridated toothpaste for children
Description
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).
Time Frame
1 week
Title
Clinical evaluation of using fluoridated toothpaste for children
Description
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).
Time Frame
2 week
Title
Clinical evaluation of using fluoridated toothpaste for children
Description
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).
Time Frame
3 week
Title
Clinical evaluation of using theobromine toothpaste(2%) for children
Description
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).
Time Frame
1 week
Title
Clinical evaluation of using theobromine toothpaste(2%) for children
Description
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).
Time Frame
2 week
Title
Clinical evaluation of using theobromine toothpaste(2%) for children
Description
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).
Time Frame
3 week
Title
Clinical evaluation of using theobromine toothpaste(4%) for children
Description
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).
Time Frame
1 week
Title
Clinical evaluation of using theobromine toothpaste(4%) for children
Description
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).
Time Frame
2 week
Title
Clinical evaluation of using theobromine toothpaste(4%) for children
Description
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).
Time Frame
3 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nour M Zaaweet, DDS
Organizational Affiliation
MSc student in Pedodontics, University of Damascus
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ettihad A Abo-Arraj, Phd
Organizational Affiliation
Professor of Pedodontics, Department of Pedodontics, University of Damascus
Official's Role
Study Chair
Facility Information:
Facility Name
Damascus University
City
Damascus
ZIP/Postal Code
30621
Country
Syrian Arab Republic
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33208577
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.
Results Reference
background
PubMed Identifier
31720155
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.
Results Reference
background
PubMed Identifier
30820200
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.
Results Reference
background
PubMed Identifier
34059300
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.
Results Reference
background
PubMed Identifier
28458181
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.
Results Reference
background
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Effectiveness of Theobromine Toothpaste
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