Efficacy of a Plaque Disclosing Toothpaste on Home Oral Hygiene Procedures

NCT03287011 | Unknown DMC

• 1 other identifier: SUKD
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Plaque accumulation on tooth and gingival surfaces is a causative factor for oral diseases such as demineralization, dental caries, gingivitis, and periodontitis. Tooth brushing and flossing have been the cornerstone of oral hygiene and health. However, the high incidence and prevalence of gum problems in both the developed and developing world show these mechanical routines are not enough. Furthermore, many patients find it difficult to comply with this daily regime of brushing and flossing. Consistent with problems associated with maintaining oral health, periodontal disease is one of the most common chronic infections in adults. According to Philstrom, et al. up to 90% of the world's population has or will suffer from periodontal disease.Thus, the maintenance of an adequate level of plaque control by the individual through his or her daily oral hygiene is vital to prevent and control periodontal disease. Studies demonstrate that poor oral hygiene is widespread with about 60% of plaque found on the surfaces of the teeth after brushing. This may be due to the lack of manipulative skills, lack of motivation and compliance.Hence, increasing education and improving brushing technique by improving oral hygiene products is one way to enhance plaque removal in everyday brushing. The ability to see plaque while brushing will enhance patient's awareness and encourage them to be more thorough when performing oral hygiene.

Conditions

Chronic Gingivitis, Plaque Induced

Keywords

dental plaque; tooth pastes; oral hygiene

Outcome Measures

Primary Outcomes (2)

• Plaque removal efficacy of a disclosing toothpaste

  Silness and Loe plaque index

  from Baseline to 1 year

• Assessment of prevalence and severity of gingivitis in individuals who use the disclosing toothpaste

  Loe and Silness gingival index

  from Baseline to 1 year

Secondary Outcomes (3)

• digital image analysis

  from Baseline to 1 year

• adverse effects

  baseline to 1 year

• patient perceived outcomes

  baseline to 1 year

Study Arms (2)

Control tooth paste

ACTIVE COMPARATOR

controlled fluoridated toothpaste will be provided for brushing to both the groups initially

Other: Colgate toothpaste

Shoplaque tooth paste

EXPERIMENTAL

Fluoridated toothpaste with organic plaque disclosing dye will be given to the test group second visit

Other: Shoplaq toothpaste

Interventions

Shoplaq toothpaste OTHER

ACTIVE INGREDIENT Sodium Monofluorophosphate 1000 PPM INGREDIENTS Precipitated Calcium Carbonate, Sorbitol, Glycerin, Precipitated Silica, Sodium Carboxy Methyl Cellulose, Sodium Benzoate, DM Water, Colour CI-45410, Holy Basil Oil, Neem Oil, Citrus Oil, Thymol Oi, Clove Oil, Piper Betel Leaf Oil, Tea Tree Oil, Eucalyptus Oil, Peppermint Oil, Spearmint Oil. Dye containing tooth paste for disclosing plaque and efficient brushing for better oral health.

Shoplaque tooth paste

Colgate toothpaste OTHER

fluoridated

Control tooth paste

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Students of SEGi must be aged 18 to 25 years with chronic generalized gingivitis 2)
• With no known systemic illness.
• Minimum of 12 anterior teeth present (canine to canine) in both upper and lower arches

You may not qualify if:

• Participants who are pregnant or nursing.
• A dental student or faculty or dental staff member.
• Who have been on antibiotics within two weeks prior to examination.
• Having dry mouth syndrome or significant food allergies.
• Have undergone any dental procedures or oral prophylaxis within 30 days prior to testing

Sponsors & Collaborators

• Segi University: lead

Study Sites (1)

Avita Rath

Petaling Jaya, Selangor, 47810, Malaysia

RECRUITING

MeSH Terms

Conditions

Dental Plaque

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Toothpaste tubes will be masked so the care provider would not know which tube he/she allocating to the participants as well the outcome assessor would be masked from both groups ( test and control) so data is assessed unbiased.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: interventional preventive trial

Study Record Dates

• First Submitted: September 11, 2017
• First Posted: September 19, 2017
• Study Start: September 11, 2017
• Primary Completion: March 30, 2018
• Study Completion: April 30, 2018
• Last Updated: September 19, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: July 2018
• Access Criteria: through journal publication

Locations

MY (1)