Effectiveness of Theobromine Toothpaste

Not Applicable

Completed

• Conditions: Dental Plaque; Dental Care
• Interventions: Other: Evaluation of the effectiveness of fluoridated toothpaste.; Other: Evaluation of the effectiveness of theobromine toothpaste (2%) toothpaste.; Other: Evaluation of the effectiveness of low- fluoridated toothpaste.; Other: Evaluation of the effectiveness of theobromine toothpaste(4%) toothpaste.

• Registration Number: NCT05187507
• Lead Sponsor: Damascus University

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:

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)

Study Timeline

• Study Start: 2021-09-25
• Primary Completion: 2021-11-01
• Status Verified: 2021-12
• Study Completion: 2021-12-01
• Study First Submitted: 2021-12-24
• Study First Submitted QC: 2021-12-24
• Last Update Submitted: 2021-12-24
• Study First Posted: 2022-01-11
• Last Update Posted: 2022-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Children using fluoridated toothpaste	Evaluation of the effectiveness of fluoridated toothpaste.	-
Children using Theobromine toothpaste (2%).	Evaluation of the effectiveness of theobromine toothpaste (2%) toothpaste.	-
Children using low- fluoridated toothpaste	Evaluation of the effectiveness of low- fluoridated toothpaste.	-
Children using Theobromine toothpaste(4%)	Evaluation of the effectiveness of theobromine toothpaste(4%) toothpaste.	-

Primary Outcome Measures

Name	Time	Method
Clinical evaluation of using low- fluoridaed toothpaste for children	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).
Clinical evaluation of using fluoridated toothpaste for children	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).
Clinical evaluation of using theobromine toothpaste(2%) for children	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).
Clinical evaluation of using theobromine toothpaste(4%) for children	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).

Trial Locations

Locations (1)

Damascus University; 🇸🇾 Damascus, Syrian Arab Republic