Effectiveness of Theobromine Toothpaste

Damascus University

Status: Completed

Conditions: Dental Plaque; Dental Care

Treatments: Other: Evaluation of the effectiveness of fluoridated toothpaste.; Other: Evaluation of the effectiveness of low- fluoridated toothpaste.; Other: Evaluation of the effectiveness of theobromine toothpaste(4%) toothpaste.; Other: Evaluation of the effectiveness of theobromine toothpaste (2%) toothpaste.

Study type: Interventional

Funder types: Other

Identifiers

NCT05187507

UDDS-Pedo-06-2021

Details and patient eligibility

About

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.

Full 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)

Enrollment: 80 patients

Sex: All

Ages: 6 to 9 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 4 patient groups

Children using fluoridated toothpaste

Other group

Treatment:

Other: Evaluation of the effectiveness of fluoridated toothpaste.

Children using low- fluoridated toothpaste

Other group

Treatment:

Other: Evaluation of the effectiveness of low- fluoridated toothpaste.

Children using Theobromine toothpaste (2%).

Experimental group

Treatment:

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

Children using Theobromine toothpaste(4%)

Experimental group

Treatment:

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