Effectiveness of Theobromine Toothpaste

NCT05187507 | Completed

• 1 other identifier: UDDS-Pedo-06-2021
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Plaque; Dental Care

Keywords

Dental Primary Prevention; Theobromine toothpaste; Fluoridated toothpaste

Outcome Measures

Primary Outcomes (12)

• 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

Study Arms (4)

Children using fluoridated toothpaste

OTHER

Other: Evaluation of the effectiveness of fluoridated toothpaste.

Children using low- fluoridated toothpaste

OTHER

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

Children using Theobromine toothpaste (2%).

EXPERIMENTAL

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

Children using Theobromine toothpaste(4%)

EXPERIMENTAL

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

Interventions

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).

Children using low- fluoridated toothpaste

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).

Children using fluoridated toothpaste

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).

Children using Theobromine toothpaste (2%).

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).

Children using Theobromine toothpaste(4%)

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Damascus University

Damascus, 30621, Syria

Location

Related Publications (5)

• 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.

  PMID: 33208577 BACKGROUND

• 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.

  PMID: 31720155 BACKGROUND

• 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.

  PMID: 30820200 BACKGROUND

• 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.

  PMID: 34059300 BACKGROUND

• 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.

  PMID: 28458181 BACKGROUND

MeSH Terms

Conditions

Dental Plaque

Interventions

Toothpastes

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dentifrices; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Nour M Zaaweet, DDS

  MSc student in Pedodontics, University of Damascus

  PRINCIPAL INVESTIGATOR

• Ettihad A Abo-Arraj, Phd

  Professor of Pedodontics, Department of Pedodontics, University of Damascus

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2021
• First Posted: January 11, 2022
• Study Start: September 25, 2021
• Primary Completion: November 1, 2021
• Study Completion: December 1, 2021
• Last Updated: January 11, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)