GingivitisPhase 2ToothpowderNCT01902095
Clinical Effects of Tooth Powder on Gingivitis
A Phase 2 study testing Tooth powder in people with Gingivitis and Mouth Diseases, run by Sheikh Zayed Federal Postgraduate Medical Institute.
Trial 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… Read more about this study
- Who is it for?
- Ages 33 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis, Mouth Diseases
- What is being tested?
- Tooth powder
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- No sites listed yet
- Study dates
- Nov 2010to Oct 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 33 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
- 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)
About this study
Official title: Evaluation of the Clinical Effects of Tooth Powder on Plaque Induced Gingivitis
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.
Read more
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.
Read the 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.
- Conditions
- Gingivitis, Mouth Diseases
- Being tested
- Tooth powder, Tooth paste (control)
- Keywords
- tooth pastes, tooth powders, Stain Index
- Medical subject headings
- Gingivitis, Mouth Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tooth powderDevice
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 paste (control)Device
Also called Tooth paste
Active Comparator
| Study group | Role | What they receive |
|---|---|---|
| Tooth powder (test) arm | Experimental | Experimental arm: tooth powder Receives: Device: Tooth powder |
| Tooth Paste (control) | Active comparator | Tooth Paste Receives: Device: Tooth paste (control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: November 2010 - October 2011 (up to 1 year)
Secondary outcomes (2)
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
Measured: November 2010 - October 2011 (up to 1 year)
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
Measured: November 2010 - October 2011 (up to 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2013 (estimated)
- Study startNov 2010
- Primary completionJul 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheikh Zayed Federal Postgraduate Medical Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Fatima Jinnah Dental College
- Responsible party
- Principal investigator, Dr. Muhammad Khalil Khan, Sheikh Zayed Federal Postgraduate Medical Institute
- Investigators
- Ayyaz A Khan, PhD, Study director, University of the Punjab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01902095
- Sponsor's protocol ID
- KhanMK-2012
- Acronym
- Toothpowder
- Status last verified
- May 2013
- First submitted
- 9 May 2013
- Last updated
- 18 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Clinical Effects of Tooth Powder on Plaque Induced Gingivitis
- ClinicalTrials.gov ID
- NCT01902095
- Acronym / sponsor ID
- Toothpowder / KhanMK-2012
- Conditions
- Gingivitis, Mouth Diseases
- Keywords
- tooth pastes, tooth powders, Stain Index
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Sheikh Zayed Federal Postgraduate Medical InstituteUniversity, hospital or other
- Collaborators
- Fatima Jinnah Dental College
- Study start
- Nov 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 18 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tooth powder (test) arm | Experimental | Device: Tooth powderExperimental arm: tooth powder |
| Tooth Paste (control) | Active comparator | Device: Tooth paste (control)Tooth Paste |
Who may qualify
- Ages
- 33 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tooth powderEach 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. | Device | Tooth powder (test) arm |
| Tooth paste (control)Also: Tooth pasteActive Comparator | Device | Tooth Paste (control) |
Primary outcome
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.
2 secondary outcomes
Plaque
Time frame: November 2010 - October 2011 (up to 1 year)
External tooth stains
Time frame: November 2010 - October 2011 (up to 1 year)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayyaz A Khan, PhD study director
University of the Punjab
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tooth powder in people with Gingivitis and Mouth Diseases, run by Sheikh Zayed Federal Postgraduate Medical Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gingivitis (time frame: November 2010 - October 2011 (up to 1 year)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2013.