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
About this trial
This is an interventional prevention trial for Gingivitis focused on measuring tooth pastes, tooth powders, Stain Index
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)
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
NCT ID
NCT01902095
First Posted
May 9, 2013
Last Updated
July 17, 2013
Sponsor
Sheikh Zayed Federal Postgraduate Medical Institute
Collaborators
Fatima Jinnah Dental College
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
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