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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00009823 |
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Date of registration:
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05/08/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Development of enzyme-based products for oral care
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Scientific title:
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Development of enzyme-based products for oral care |
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Date of first enrolment:
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01/07/2016 |
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Target sample size:
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20 |
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Recruitment status: |
Complete |
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URL:
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http://drks.de/search/en/trial/DRKS00009823 |
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Study type:
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interventional |
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Study design:
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Allocation: Randomized controlled study; Masking: Blinded (masking used); Control: active//placebo; Assignment: crossover; Study design purpose: prevention
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Phase:
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N/A
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Countries of recruitment
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Switzerland
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Contacts
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Name:
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Pune Nina
Tawakoli |
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Address:
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Plattenstrasse 11
8032
Zürich
Switzerland |
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Telephone:
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0041446343988 |
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Email:
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punenina.tawakoli@zzm.uzh.ch |
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Affiliation:
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Universität Zürich, Zentrum für Zahnmedizin, Klinik für Präventive Zahnmedizin, Parosontologie und Kariologie |
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Name:
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Pune Nina
Tawakoli |
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Address:
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Plattenstrasse 11
8032
Zürich
Switzerland |
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Telephone:
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0041446343988 |
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Email:
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punenina.tawakoli@zzm.uzh.ch |
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Affiliation:
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Universität Zürich, Zentrum für Zahnmedizin, Klinik für Präventive Zahnmedizin, Parosontologie und Kariologie |
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Key inclusion & exclusion criteria
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Inclusion criteria: -10 female + 10 male subjects (stratified study), in the age of at least 18 years
- either full dentition or partial missing (at least 3 adjacent posterior teeth with no more than 2 approximate and/or 2 buccal restorations on both maxilla sides without buccal dental veneer)
- caries-free denture
- Gingiva free of inflammation
- interdental brushes should be applicable
- signed information sheet
- subjects should be able to perform the study plan
Exclusion criteria: - artificial dentition
- pregnant and lactating women
- patients participating in any other clinical trial within the last 3 months prior to enrollment
- lack of compliance (adherence)
- patients taking antibiotics during study
- alcoholic-, drug- or medicaments abuse
- patients with known sensibilities against ingredients of the used dentifrices
- strong smoker (more than 10 cigarettes per day)
Age minimum:
18 Years
Age maximum:
None
Gender:
All
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Health Condition(s) or Problem(s) studied
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Gingivitis and periodontal diseases
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K05
K02
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Dental caries
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Intervention(s)
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Group 1: A test cycle begins with an examination on day 0, a four -day rinsing phase, and an examination on day 4 with a subsequent 9-day wash-out phase. In the rinsing phase the participant should waive additional oral hygiene and only rinse twice a day (in the morning and evening) with the test-toothpaste applied (the rinsing will be performed by using a maxillary splint) . In the preparatory phase, the rinsing will only performed with water instead of toothpaste. Each subject receives a splint, a manual toothbrush, a stopwatch and the test toothpastes.
In the test phase, rinsing will be performed 8 times:
- Toothpaste application 1 and 2 (day 0)
- Toothpaste application 3 and 4 (Day 1)
- Toothpaste application 5 and 6 (day 2)
- Toothpaste application 7 and 8 (day 3)
- Only clinical examination (Day 4)
For every rinsing procedure, subjects will put 1 cm (about 1 g) of blinded test toothpastes on the toothbrush. In total, about 8 g of each test toothpaste will be used for rinsing. The rinsing procedure contains a brushing with the toothbrush and the applied toothpaste on the surface of the maxillary inserted splint for 30 seconds. Then, rinsing with the resulting slurry will be performed for 90 s. The duration of the whole rinsing will be 2 minutes. The time period is monitored automatically by a timer (stopwatch) by the subjects.
Measurements of the various parameters on day 0 and day 4 of the preparation and test phase are based on a 4-day plaque model modified by Addy et al. (1983)
The evaluation of the amount of plaque formed will be measured at baseline and after four days, in which the respective dentifrices in each test cycle are used to rinse.
? An intraoral baseline examination will take place after information about the study and consent of the subjects.
? P
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Primary Outcome(s)
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After the preparation phase , the testing phase can be started with the test toothpastes (only high responder) . Here, baseline and post-treatment measurements will be compared of the amount of bacteria, degree of inflammation, and the amount of plaque in dependence of the respective test toothpastes. Baseline measurements are taken on day 0, post-treatment measurements in each cycle (4 in total) on day 4. In each case, a clinical examination is carried out .
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Secondary Outcome(s)
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The cleaning effect of the differently shaped interdental brushes will be examined in the preparation phase . In addition, so-called high responders are included in the study . Clinical examinations (measurements) will be performed on day 0 and day 4 (bacteria load, degree of inflammation of the gums , probing depth) .
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Source(s) of Monetary Support
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Kommission für Technologie und Innovation (KTI)
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Top Caredent AG
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Ethics review
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Status: Approved
Approval date: 14/06/2016
Contact:
info.kek@kek.zh.ch
Kantonale Ethikkommission Zürich
(+41)43-2597970
info.kek@kek.zh.ch
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