Clinical Effects of Tooth Powder on Gingivitis

NCT01902095 | Completed Phase 2

• 1 other identifier: KhanMK-2012
• Study Type: interventional
• Target: 154
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gingivitis; Mouth Diseases

Keywords

tooth pastes; tooth powders; Stain Index

Outcome Measures

Primary Outcomes (1)

• Gingivitis

  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.

  November 2010 - October 2011 (up to 1 year)

Secondary Outcomes (2)

• Plaque

  November 2010 - October 2011 (up to 1 year)

• External tooth stains

  November 2010 - October 2011 (up to 1 year)

Study Arms (2)

Tooth powder (test) arm

EXPERIMENTAL

Experimental arm: tooth powder

Device: Tooth powder

Tooth Paste (control)

ACTIVE COMPARATOR

Tooth Paste

Device: Tooth paste (control)

Interventions

Tooth powder DEVICE

Each participant was handed over a sealed pack containing a teeth cleaning kit that included tooth powder (test) or toothpaste (control) and a new soft toothbrush along with written and verbal instructions of usage. They were advised to brush their teeth twice a day with the given dentifrices and tooth brush for two weeks.

Tooth powder (test) arm

Tooth paste (control) DEVICE

Active Comparator

Also known as: Tooth paste

Tooth Paste (control)

Eligibility Criteria

• Age: 33 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female
• Age ≥ 18-to-65 years (18th birthday completed)
• In good general health
• Available for the duration of the study
• Able and willing to follow study protocol
• Able and willing to sign approved informed consent
• At least 20 natural teeth suitable for evaluation
• Full mouth Gingival Index (GI) score ≥ 1.04

You may not qualify if:

• Females disagree to birth control measure for the duration of the study
• Having any acute /chronic systemic illness
• Current smokers or tobacco users
• Pregnant or lactating Females
• Allergy to the ingredients of the products to be tested
• Requiring pre-medication prior to dental appointment
• Antibiotic use in the last 3 months
• Routine use of anticoagulant medication
• Routine use of anti-inflammatory medication
• Routine use of medications known to have effects on the gingiva e.g., phenytoin etc)
• Routine use of medications inhibiting or stimulating salivary flow
• Physical handicap that could interfere with daily performance of oral hygiene
• Participation in any other study during the study period of this trial
• Routine use of any mouthrinse
• Routine use of any interdental cleaning device (floss, dental toothpicks)

Sponsors & Collaborators

• Sheikh Zayed Federal Postgraduate Medical Institute: lead
• Fatima Jinnah Dental College: collaborator

MeSH Terms

Conditions

Gingivitis; Mouth Diseases

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Stomatognathic Diseases

Study Officials

• Ayyaz A Khan, PhD

  University of the Punjab

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 9, 2013
• First Posted: July 18, 2013
• Study Start: November 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: October 1, 2011
• Last Updated: July 18, 2013

Record last verified: 2013-05