Periodontitis, AdultWaist-shapedNCT03851757
Cleansing Efficacy of Waist-shaped Interdental Brushes.
A study testing waist-shaped interdental brush and cylindric interdental brush in people with Periodontitis, Adult, run by Medical University Innsbruck at 1 site in Austria.
Trial summary
The aim of the present randomized and single-blinded cross-over study was to compare the cleansing efficacy of waist-shaped interdental brushes with that of cylindric interdental brushes in interproximal sites. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontitis, Adult
- What is being tested?
- waist-shaped interdental brush and cylindric interdental brush
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteAustria
- Study dates
- 1 Sep 2017to 2 Mar 2018
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Periodontitis stage 3
- Completion of active periodontal treatment
- Maximum probing pocket depths of 5 mm
- No site ≥ 4 mm with bleeding on probing
- Bleeding on probing < 10%
- Open interproximal spaces both, in mandible and maxilla
- Presence of > 23 natural teeth with no need for prosthetic rehabilitation.
Who cannot join
- Oral or systemic diseases other than Periodontitis
- Mucosal / periodontal swelling or Suppuration
- Pregnancy
- Minority
- Need for frequent drug consumption
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cleansing Efficacy of Waist-shaped Interdental Brushes. A Randomized-controlled Crossover Study.
The aim of the present randomized and single-blinded cross-over study was to compare the cleansing efficacy of waist-shaped interdental brushes with that of cylindric interdental brushes in interproximal sites.
Read the detailed description
Brushing efficacy of cylindric and waist-shaped interdental brushes was evaluated in a randomized, controlled, examiner-blinded, two-period crossover study. 20 periodontal maintenance patients of the University Hospital of Dental Prosthetics and Restorative Dentistry were recruited. Each subject was asked to attend three appointments. In the first visit (day one), baseline plaque and bleeding indices were assessed. Each proband was instructed by the same experienced dental hygienist with two sizes of waist-shaped and cylindric interdental brushes, respectively. Primary outcome measure plaque index and secondary outcome measure papillary bleeding index were assessed by two blinded and calibrated examiners at four sites per tooth.The odds ratio and confidence interval for establishing plaque free interdental sites were calculated with logistic regression analysis.
- Conditions
- Periodontitis, Adult
- Being tested
- waist-shaped interdental brush, cylindric interdental brush
- Keywords
- biofilm, interdental brushes, interproximal, oral hygiene, periodontal disease(s)/periodontitis
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
waist-shaped interdental brushDevice
Also called Brand name: Circum Topcaredent
use four times each per interdental space
cylindric interdental brushDevice
Also called Brand name: Topcaredent
use four times each per interdental space
| Study group | Role | What they receive |
|---|---|---|
| waist-shaped interdental brush | Active comparator | waist-shaped interdental brush, use four times per interdental space Receives: Device: waist-shaped interdental brush |
| cylindric interdental brush | Active comparator | cylindric interdental brush, use four times per interdental space Receives: Device: cylindric interdental brush |
What is being measured
The primary outcome is the main question the study is designed to answer.
Turesky modification of the Quigley and Hein Plaque Index
This is a plaque index scored as 0 = no plaque; 1 = slight flecks of plaque at the cervical margin of the tooth; 2 = a thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth; 3 = a band of plaque wider than 1 mm but covering < 1/3 of the crown of the tooth; 4 = plaque covering at least 1/3 but < 2/3 of the crown of the tooth or 5 = plaque covering 2/3 or more of the crown of the tooth. A higher grade is worse (more plaque) than a lower grade. After measuring plaque grades on four sites per tooh, the mode is calculated, which is defined as the plaque grade most often measured in an individual.
Measured: 11 weeks
Secondary outcomes (1)
papillary bleeding index by Saxer and Mühlemann
A periodontal probe is inserted into the gingival sulcus at the line angle on the mesial and distal aspect of the papilla and then moved coronally to the papilla tip (score 0 - no bleeding; score 1 - a single discreet bleeding point; score 2 - several isolated bleeding points or a single line of blood; score 3 - the interdental triangle fills with blood; score 4 - profuse bleeding occurs after probing and flows immediately into the marginal sulcus). A higher bleeding grade is worse (more inflammed tissues) than a lower grade. After measuring papillary bleeeding grades on four sites per tooh, the mode is calculated, which is defined as the papillary bleeding grade most often measured in an individual.
Measured: 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2019
- Study start1 Sep 2017
- Primary completion2 Mar 2018
- Study completion2 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Periodontitis, AdultStudies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomised, controlled, examiner-blinded, two-period crossover study
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ines Kapferer-Seebacher, Professor, Principal investigator, Medical University Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03851757
- Sponsor's protocol ID
- AN5123
- Acronym
- Waist-shaped
- Status last verified
- Jan 2019
- First submitted
- 31 Jan 2019
- Last updated
- 22 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chongcharoen N, Lulic M, Lang NP. Effectiveness of different interdental brushes on cleaning the interproximal surfaces of teeth and implants: a randomized controlled, double-blind cross-over study. Clin Oral Implants Res. 2012 May;23(5):635-40. doi: 10.1111/j.1600-0501.2011.02387.x. Epub 2011 Dec 6.
PubMed 22146002Turesky S, Gilmore ND, Glickman I. Reduced plaque formation by the chloromethyl analogue of victamine C. J Periodontol. 1970 Jan;41(1):41-3. doi: 10.1902/jop.1970.41.41.41. No abstract available.
PubMed 5264376Saxer UP, Turconi B, Elsasser C. Patient motivation with the papillary bleeding index. J Prev Dent. 1977 Jul-Aug;4(4):20-2. No abstract available.
PubMed 351174Schnabl D, Goebel G, Kadletz A, Gaenzer H, Steiner R, Laimer J, Kapferer-Seebacher I. Cleansing efficacy of waist-shaped inter-dental brushes. A randomized-controlled crossover study. J Clin Periodontol. 2020 Jan;47(1):30-35. doi: 10.1111/jcpe.13210. Epub 2019 Nov 3.
PubMed 31609489
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cleansing Efficacy of Waist-shaped Interdental Brushes. A Randomized-controlled Crossover Study.
- ClinicalTrials.gov ID
- NCT03851757
- Acronym / sponsor ID
- Waist-shaped / AN5123
- Conditions
- Periodontitis, Adult
- Keywords
- biofilm, interdental brushes, interproximal, oral hygiene, periodontal disease(s)/periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 2 Mar 2018 (actual)
- Study completion
- 2 Mar 2018 (actual)
- First posted
- 22 Feb 2019 (actual)
- 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.
The aim of the present randomized and single-blinded cross-over study was to compare the cleansing efficacy of waist-shaped interdental brushes with that of cylindric interdental brushes in interproximal sites.
Detailed description
Brushing efficacy of cylindric and waist-shaped interdental brushes was evaluated in a randomized, controlled, examiner-blinded, two-period crossover study. 20 periodontal maintenance patients of the University Hospital of Dental Prosthetics and Restorative Dentistry were recruited. Each subject was asked to attend three appointments. In the first visit (day one), baseline plaque and bleeding indices were assessed. Each proband was instructed by the same experienced dental hygienist with two sizes of waist-shaped and cylindric interdental brushes, respectively. Primary outcome measure plaque index and secondary outcome measure papillary bleeding index were assessed by two blinded and calibrated examiners at four sites per tooth.The odds ratio and confidence interval for establishing plaque free interdental sites were calculated with logistic regression analysis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Randomised, controlled, examiner-blinded, two-period crossover study
| Arm | Type | Receives |
|---|---|---|
| waist-shaped interdental brush | Active comparator | Device: waist-shaped interdental brushwaist-shaped interdental brush, use four times per interdental space |
| cylindric interdental brush | Active comparator | Device: cylindric interdental brushcylindric interdental brush, use four times per interdental space |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Periodontitis stage 3
- Completion of active periodontal treatment
- Maximum probing pocket depths of 5 mm
- No site ≥ 4 mm with bleeding on probing
- Bleeding on probing < 10%
Key exclusion criteria (5 listed)
- Oral or systemic diseases other than Periodontitis
- Mucosal / periodontal swelling or Suppuration
- Pregnancy
- Minority
- Need for frequent drug consumption
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 |
|---|---|---|
| waist-shaped interdental brushAlso: Brand name: Circum Topcaredentuse four times each per interdental space | Device | waist-shaped interdental brush |
| cylindric interdental brushAlso: Brand name: Topcaredentuse four times each per interdental space | Device | cylindric interdental brush |
Primary outcome
Turesky modification of the Quigley and Hein Plaque Index
Time frame: 11 weeks
This is a plaque index scored as 0 = no plaque; 1 = slight flecks of plaque at the cervical margin of the tooth; 2 = a thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth; 3 = a band of plaque wider than 1 mm but covering < 1/3 of the crown of the tooth; 4 = plaque covering at least 1/3 but < 2/3 of the crown of the tooth or 5 = plaque covering 2/3 or more of the crown of the tooth. A higher grade is worse (more plaque) than a lower grade. After measuring plaque grades on four sites per tooh, the mode is calculated, which is defined as the plaque grade most often measured in an individual.
1 secondary outcome
papillary bleeding index by Saxer and Mühlemann
Time frame: 11 weeks
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 22 Feb 2019.
- Background: PubMed 22146002Chongcharoen N, Lulic M, Lang NP. Effectiveness of different interdental brushes on cleaning the interproximal surfaces of teeth and implants: a randomized controlled, double-blind cross-over study. Clin Oral Implants Res. 2012 May;23(5):635-40. doi: 10.1111/j.1600-0501.2011.02387.x. Epub 2011 Dec 6.
- Background: PubMed 5264376Turesky S, Gilmore ND, Glickman I. Reduced plaque formation by the chloromethyl analogue of victamine C. J Periodontol. 1970 Jan;41(1):41-3. doi: 10.1902/jop.1970.41.41.41. No abstract available.
- Background: PubMed 351174Saxer UP, Turconi B, Elsasser C. Patient motivation with the papillary bleeding index. J Prev Dent. 1977 Jul-Aug;4(4):20-2. No abstract available.
- Derived from this study: PubMed 31609489Schnabl D, Goebel G, Kadletz A, Gaenzer H, Steiner R, Laimer J, Kapferer-Seebacher I. Cleansing efficacy of waist-shaped inter-dental brushes. A randomized-controlled crossover study. J Clin Periodontol. 2020 Jan;47(1):30-35. doi: 10.1111/jcpe.13210. Epub 2019 Nov 3.
- Individual participant dataSharing planned: No
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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.
Ines Kapferer-Seebacher, Professor principal investigator
Medical University Innsbruck
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing waist-shaped interdental brush and cylindric interdental brush in people with Periodontitis, Adult, run by Medical University Innsbruck at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. 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 22 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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?
Turesky modification of the Quigley and Hein Plaque Index (time frame: 11 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03851757, which also lists 4 linked publications.
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 22 Feb 2019.