search
Back to results

Clinical Effects of Tooth Powder on Gingivitis (Toothpowder)

Primary Purpose

Gingivitis, Mouth Diseases

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Tooth powder
Tooth paste (control)
Sponsored by
Sheikh Zayed Federal Postgraduate Medical Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gingivitis focused on measuring tooth pastes, tooth powders, Stain Index

Eligibility Criteria

33 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers
  1. Inclusion Criteria

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

    1. Females disagree to birth control measure for the duration of the study
    2. Having any acute /chronic systemic illness
    3. Current smokers or tobacco users
    4. Pregnant or lactating Females
    5. Allergy to the ingredients of the products to be tested
    6. Requiring pre-medication prior to dental appointment
    7. Antibiotic use in the last 3 months
    8. Routine use of anticoagulant medication
    9. Routine use of anti-inflammatory medication
    10. Routine use of medications known to have effects on the gingiva e.g., phenytoin etc)
    11. Routine use of medications inhibiting or stimulating salivary flow
    12. Physical handicap that could interfere with daily performance of oral hygiene
    13. Participation in any other study during the study period of this trial
    14. Routine use of any mouthrinse
    15. Routine use of any interdental cleaning device (floss, dental toothpicks)
    16. Having any removable appliance
    17. Having fixed orthodontic appliances (including permanent orthodontic retainers)
    18. Having probing depth ≥4 mm at any site
    19. Having had active periodontal therapy during the last 6 months
    20. Had periodontal prophylaxis or periodontal maintenance therapy in the last 3 months
    21. More than 3 carious lesions requiring immediate care
    22. Gross oral pathology (e.g., tumors, candidiasis, mucocutaneous disease)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Tooth powder (test) arm

    Tooth Paste (control)

    Arm Description

    Experimental arm: tooth powder

    Tooth Paste

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Plaque
    Quigley-Hein (Tuersky) Index was used for plaque deposits. This index is based on the visually check of non-restored surface of all the teeth except third molars; this is done on a scale from score 0 to score 5. An index for the entire mouth is determined by dividing the total score by the number surfaces examined. The criteria for scoring are: 0 = no plaque, 1 = separate flecks of plaque, 2 = continuous band of 1 mm, 3 = >1mm and <1/3 of tooth surface, 4 = >1/3 and <2/3 and 5 = >2/3 of tooth covered with plaque
    External tooth stains
    Lobene index based on the intensity and area of stains covered on the labial surfaces of the anterior teeth was used. Buccal surfaces of teeth are divided into two gingival crescent and body. In this index intensity and area measured on gingival crescent and body separately and also in combination by multiplying intensity and area. An index for the entire mouth is determined by dividing the total score by the number surfaces examined

    Full Information

    First Posted
    May 9, 2013
    Last Updated
    July 17, 2013
    Sponsor
    Sheikh Zayed Federal Postgraduate Medical Institute
    Collaborators
    Fatima Jinnah Dental College
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01902095
    Brief Title
    Clinical Effects of Tooth Powder on Gingivitis
    Acronym
    Toothpowder
    Official Title
    Evaluation of the Clinical Effects of Tooth Powder on Plaque Induced Gingivitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2010 (undefined)
    Primary Completion Date
    July 2011 (Actual)
    Study Completion Date
    October 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sheikh Zayed Federal Postgraduate Medical Institute
    Collaborators
    Fatima Jinnah Dental College

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gingivitis, Mouth Diseases
    Keywords
    tooth pastes, tooth powders, Stain Index

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    154 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Tooth powder (test) arm
    Arm Type
    Experimental
    Arm Description
    Experimental arm: tooth powder
    Arm Title
    Tooth Paste (control)
    Arm Type
    Active Comparator
    Arm Description
    Tooth Paste
    Intervention Type
    Device
    Intervention Name(s)
    Tooth powder
    Intervention Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Tooth paste (control)
    Other Intervention Name(s)
    Tooth paste
    Intervention Description
    Active Comparator
    Primary Outcome Measure Information:
    Title
    Gingivitis
    Description
    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.
    Time Frame
    November 2010 - October 2011 (up to 1 year)
    Secondary Outcome Measure Information:
    Title
    Plaque
    Description
    Quigley-Hein (Tuersky) Index was used for plaque deposits. This index is based on the visually check of non-restored surface of all the teeth except third molars; this is done on a scale from score 0 to score 5. An index for the entire mouth is determined by dividing the total score by the number surfaces examined. The criteria for scoring are: 0 = no plaque, 1 = separate flecks of plaque, 2 = continuous band of 1 mm, 3 = >1mm and <1/3 of tooth surface, 4 = >1/3 and <2/3 and 5 = >2/3 of tooth covered with plaque
    Time Frame
    November 2010 - October 2011 (up to 1 year)
    Title
    External tooth stains
    Description
    Lobene index based on the intensity and area of stains covered on the labial surfaces of the anterior teeth was used. Buccal surfaces of teeth are divided into two gingival crescent and body. In this index intensity and area measured on gingival crescent and body separately and also in combination by multiplying intensity and area. An index for the entire mouth is determined by dividing the total score by the number surfaces examined
    Time Frame
    November 2010 - October 2011 (up to 1 year)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    33 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria 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 Exclusion Criteria 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) Having any removable appliance Having fixed orthodontic appliances (including permanent orthodontic retainers) Having probing depth ≥4 mm at any site Having had active periodontal therapy during the last 6 months Had periodontal prophylaxis or periodontal maintenance therapy in the last 3 months More than 3 carious lesions requiring immediate care Gross oral pathology (e.g., tumors, candidiasis, mucocutaneous disease)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ayyaz A Khan, PhD
    Organizational Affiliation
    University of the Punjab
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Clinical Effects of Tooth Powder on Gingivitis

    We'll reach out to this number within 24 hrs