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Completed

NCT Number: NCT05187507

Effectiveness of Theobromine Toothpaste

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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Key information

Conditions

Dental Plaque Dental Care Dental Deposits Stomatognathic Diseases Tooth Diseases

Age range

6 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Damascus University

Damascus, 30621, Syria

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Evaluation of the effectiveness of low- fluoridated toothpaste.

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).

Evaluation of the effectiveness of fluoridated toothpaste.

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).

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

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).

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

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).

Primary outcomes

  1. Clinical evaluation of using low- fluoridaed toothpaste for children

    Time frame: 1 week

    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. Clinical evaluation of using low- fluoridaed toothpaste for children

    Time frame: 2 week

    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. Clinical evaluation of using low- fluoridaed toothpaste for children

    Time frame: 3 week

    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).

  4. Clinical evaluation of using fluoridated toothpaste for children

    Time frame: 1 week

    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).

  5. Clinical evaluation of using fluoridated toothpaste for children

    Time frame: 2 week

    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).

  6. Clinical evaluation of using fluoridated toothpaste for children

    Time frame: 3 week

    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).

  7. Clinical evaluation of using theobromine toothpaste(2%) for children

    Time frame: 1 week

    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).

  8. Clinical evaluation of using theobromine toothpaste(2%) for children

    Time frame: 2 week

    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).

  9. Clinical evaluation of using theobromine toothpaste(2%) for children

    Time frame: 3 week

    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).

  10. Clinical evaluation of using theobromine toothpaste(4%) for children

    Time frame: 1 week

    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).

  11. Clinical evaluation of using theobromine toothpaste(4%) for children

    Time frame: 2 week

    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).

  12. Clinical evaluation of using theobromine toothpaste(4%) for children

    Time frame: 3 week

    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).

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 11, 2022
Registry last updated
Jan 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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