Effect of Toothpaste on the Reduction of Plaque and Inflammation

NCT02552589 | Completed DMC

• 1 other identifier: PAR012015
• Study Type: interventional
• Target: 241
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this double blind study is to prove whether a fluoride containing toothpaste is able to reduce dental plaque and gingival inflammation in patients who have gingivitis when applied twice daily during brushing at home over a period of 12 weeks.

Conditions

Gingivitis; Dental Plaque

Keywords

clinical trial, phase III; plaque index; gingivitis index; fluoride; toothpaste

Outcome Measures

Primary Outcomes (1)

• Plaque index (Silness and Loe 1964)

  Difference of plaque index, compared between test group and control group.

  Change in plaque index from baseline at 12 weeks

Secondary Outcomes (9)

• Plaque index (Silness and Loe 1964)

  Change in plaque index from baseline at 3 weeks

• Plaque index (Silness and Loe 1964)

  Change in plaque index from week 3 at 12 weeks

• Gingival Index (Loe 1967)

  Change in gingival index from baseline at 3 weeks

• Gingival Index (Loe 1967)

  Change in gingival index from baseline at 12 weeks

• Gingival Index (Loe 1967)

  Change in gingival index from 3 weeks at week 12

Study Arms (2)

Test group

EXPERIMENTAL

Amine fluoride toothpaste

Other: Amine fluoride

Control group

PLACEBO COMPARATOR

Placebo Sodium monofluorophosphate toothpaste

Other: Placebo

Interventions

Amine fluoride OTHER

toothpaste

Test group

Placebo OTHER

toothpaste

Also known as: Sodium monofluorophosphate

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female adults (aged 18 to 65 years),
• Non-smokers or former smokers for at least 1 year or occasional smokers with a maximum of 5 cigarettes per week,
• Individuals who have at least 20 own teeth excluding the wisdom teeth,
• Subjects must have read, understood and signed the informed consent form
• Willingness to abstain from use of interdental brushing devices that contain antibacterial agents, like amine fluoride, chlorhexidine, silver ions etc. during the full course of the study

You may not qualify if:

• Individuals who have severe systemic diseases (tumors, infectious diseases) and diseases that require regular systemic medication intake that may affect the gingival condition (e. g. phenytoin, nifedipine, cyclosporine, antibiotics, steroids, antiphlogistics)
• Individuals who have moderate and severe chronic or aggressive periodontitis (PSI \> 2 in more than 2 sextants or PSI \> 3),
• Individuals who require antibiotic treatments for dental appointments (endocarditis prophylaxis), Individuals treated with antibiotics less than 8 weeks prior to the baseline examination and/or during the duration of the trial,
• Individuals who have participated in another clinical study less than 4 weeks prior to the baseline examination,
• Individuals who have mucosal diseases,
• Individuals who have severe oro-pharyngeal infections,
• Individuals who have significant dental disorders (e.g.: caries, suspected pulp pathology, abscess, pulpitis),
• History of gingival surgery in the previous three month,
• Ongoing dental treatment or any other medical treatment of the oral cavity,
• Individuals who are pregnant or breast feeding,
• Individuals with a history of chronic drug abuse or another illness which does not allow the person to assess the nature and/or possible consequences of the study,
• Smokers with more than 5 cigarettes per week,
• Individuals with known hypersensitivity or allergy to the test products and its ingredients,
• Individuals who were treated with antibacterial mouthrinses (e. g. chlorhexidine) 4 weeks or less before recruitment,
• Individuals unwilling to abstain from additional oral hygiene measures during the treatment phase with exception of their habitual mechanical cleaning procedures,

Sponsors & Collaborators

• Technische Universität Dresden: lead
• Colgate Palmolive: collaborator

Study Sites (1)

Technische Universität Dresden

Dresden, 01307, Germany

Location

MeSH Terms

Conditions

Gingivitis; Dental Plaque

Interventions

fluorophosphate

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Dental Deposits; Tooth Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr., M.Sc., Assistant Professor

Study Record Dates

• First Submitted: September 3, 2015
• First Posted: September 17, 2015
• Study Start: September 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: February 8, 2016

Record last verified: 2016-02

Locations

DE (1)