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Clinical Trials/NCT01902095
NCT01902095
Completed
Phase 2

Evaluation of the Clinical Effects of Tooth Powder on Plaque Induced Gingivitis

Sheikh Zayed Federal Postgraduate Medical Institute0 sites154 target enrollmentNovember 2010

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Gingivitis
Sponsor
Sheikh Zayed Federal Postgraduate Medical Institute
Enrollment
154
Primary Endpoint
Gingivitis
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

Dental plaque, known as dental biofilm, is implicated as the primary etiological agent responsible for oral inflammatory diseases. Matured form of dental plaque plays a major role in the pathogenicity of gingivitis; if not managed in early stages it results in a cascade of events leading to the destruction of periodontal tissues.

Effective plaque control techniques have been suggested that maintain dental biofilm at levels compatible with oral health and is the cornerstone for all preventive strategies to control oral diseases particularly gingivitis. To clean teeth and ensure effective plaque control, different mechanical means have been in use since centuries. However because of an inadequacy in plaque removal, different antimicrobial and antiplaque agents have been introduced in oral-care products.

The use of dentifrices has been recommended over the years as the ultimate way of preventing the incidence of oral diseases. Dentifrices have the anti-plaque and the anti-gingivitis capabilities due to their composition. Toothpastes and to a lesser extent toothpowders are common oral-care products used to eliminate plaque and other deposits from tooth surfaces. Existent literature has focused more on toothpaste and mouth rinse and derelicts toothpowder despite its difference owing to the absence of humectants. With the intention to advance the knowledge on this issue as well as close the research gap, this study was conducted to evaluate the efficacy of toothpowder in alleviating gingivitis, controlling dental plaque, and inhibiting extrinsic stains.

A single-blind, parallel arm randomized controlled trial (RCT) evaluated the efficacy of toothpowder against toothpaste through oral hygiene parameters of plaque and stain deposits on teeth and gingival inflammation. Plaque Index, Lobene Stain Index and Gingival Index were used as measures of oral hygiene.

The current RCT revealed that toothpowder and toothpaste were equally effective in both treatment and control groups from clinical perspective however toothpowder showed a statistically significant effectiveness as compared to toothpaste. Toothpowder, composed of calcium carbonate and essential oils, has demonstrated to be statistically more effective than toothpaste in controlling extrinsic dental staining, dental plaque and gingival inflammation.

Detailed Description

A single-blind randomized controlled trial was conducted during November 2010 and October 2011. After screening and consent, eligible subjects received mechanical periodontal therapy. Subjects were then randomized to Test group and Control group at a 1:1 ratio. The test group was provided tooth powder and a control group received toothpaste. Healthy subjects with plaque induced gingivitis and who fulfilled the inclusion criteria were recruited from the Department of Periodontology, Fatima Jinnah Dental College Hospital, Karachi, Pakistan.77 subjects with gingivitis were randomized to test group and 77 subjects to the control group. Therefore, to complete the randomized controlled trial, a total of 154 subjects were recruited and randomized. Outcome measure gingivitis was measured through plaque index, gingival index and Lobene stain index.

Registry
clinicaltrials.gov
Start Date
November 2010
End Date
October 2011
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Muhammad Khalil Khan

Associate Professor

Sheikh Zayed Federal Postgraduate Medical Institute

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Gingivitis

Time Frame: November 2010 - October 2011 (up to 1 year)

Gingival Index (Löe and Silness, 1963) modified by Talbott et al. (1977) was used for the assessment of the gingival condition and record qualitative changes in the gingiva. Its scores (0 to 3) recorded the marginal and interproximal tissues separately. The criteria are: 0= normal gingiva, 1= mild inflammation - slight change in color and slight edema but no bleeding on probing, 2= moderate inflammation - redness, edema and glazing, bleeding on probing and 3= severe inflammation - marked redness and edema, ulceration with a tendency to spontaneous bleeding.

Secondary Outcomes

  • Plaque(November 2010 - October 2011 (up to 1 year))
  • External tooth stains(November 2010 - October 2011 (up to 1 year))

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