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Development of enzyme-based products for oral care

Organizational Data

DRKS-ID:
DRKS00009823
Recruitment Status:
Recruiting complete, study continuing
Date of registration in DRKS:
2016-08-05
Last update in DRKS:
2017-03-18
Registration type:
Retrospective

Acronym/abbreviation of the study

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URL of the study

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Brief summary in lay language

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Brief summary in scientific language

The first part of the study is planned in a splitmouth crossover design. Interdental brushes will be tested and high responder will be determined for the second part of the study. THe second part or main part of the study is planned as a stratified, randomized, double-blind clinical study in a 4 times repeated crossover design. The aim is to test the effect of new enzyme-based toothpastes.The new dentifrices will be compared to a placebo without enzymes and to a control dentifrices (reference dentifrice such as Colgate Total Original). The aim of the study is to investigate the effect of the enzyme-based dentifrices with respect to the degree of inflammation of the gums, the amount of bacteria and plaque development. The study consists of a preparation phase (part one of the study) and a testing phase (part two, main part).The preparation phase consists of two test cycles with the testing of interdental brushes and the testing phase of 4 test cycles. A test cycle consists of Day 0: clinical tests (measuring the amount of bacteria, degree of inflammation and the amount of plaque), professional tooth cleaning, distribution of splint, stopwatch and a manual toothbrush, rinsing with water Day 1 - 3: 2x daily for 2 minutes rinsing with water using the splint (no additional habitual oral hygiene regimes). Day 4: clinical tests, professional tooth cleaning. Day 5 - 13: Wash-out phase (normal habitual oral hygiene). After the four-week preparation phase high-responder will be integrated into the actual study. A high-responder is characterized by reproducible and sufficiently high results in the inflammation parameters and the plaque index. The test cycle in the test phase after preparation phase starts again with Day 0 and clinical tests prior to the tooth cleaning (baseline parameters). Participants rinse twice a day with a test toothpaste. Interdental brushes will not be tested.

Health condition or problem studied

ICD10:
K05 - Gingivitis and periodontal diseases
ICD10:
K02 - Dental caries
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 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. ▪ Paperpoint samples will be taken on teeth 14, 24, 16 and 26. Two samples are used for the determination and quantification in the external laboratory (bacterial load); two other samples will be used to determine the degree of inflammation by means of aMMP-8-measurement (Kraft-Neumarker et al., 2012). Bacterial load will also be measured on the buccal mucosa of both sides. The aMMP-8-determination is determined additionally in the non-stimulated whole saliva of the subject which is collected at the beginning of each examination. ▪ Afterwards BOP is measured (bleeding on probing, Ainamo & Bay, 1975) . ▪ The plaque index is shown intraorally with an indicator solution (MIRA-2-TON, Hager & Werken, Duisburg, Germany) and documented on the basis of plaque index (O'Leary et al. 1972).
Arm 2:
All intervention arms are performed in the same way using different dentifrices. An intervention arm corresponds to a test cycle. This means, there are a total of 6 interventions, 2 interventions in the preparation phase and 4 in the test phase.
Arm 3:
In one intervention arm in the test phase, a placebo is used. This placebo is a toothpaste with the same formula as the enzymbased toothpastes, however containing no enzymes. THe intervention is performed identically to all other intervention arms in the testphase

Endpoints

Primary outcome:
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 .
Secondary outcome:
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) .

Study Design

Purpose:
Prevention
Allocation:
Randomized controlled study
Control:
  • Active control (effective treatment of control group)
  • Placebo
Phase:
N/A
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
Yes
Assignment:
Crossover
Sequence generation:
No Entry
Who is blinded:
  • Data analyst
  • Investigator/therapist
  • Patient/subject

Recruitment

Recruitment Status:
Recruiting complete, study continuing
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Switzerland
Number of study centers:
Monocenter study
Recruitment location(s):
  • University medical center Universität Zürich, Zentrum für Zahnmedizin, Klinik für Präventive Zahnmedizin, Parosontologie und Kariologie Zürich, Schweiz

Recruitment period and number of participants

Planned study start date:
No Entry
Actual study start date:
2016-07-01
Planned study completion date:
No Entry
Actual Study Completion Date:
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Target Sample Size:
20
Final Sample Size:
20

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional 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)

Addresses

Primary Sponsor

Klinik für Präventivzahnmedizin, Parodontologie und Kariologie (PPK)Zentrum für ZahnmedizinUniversität Zürich
Prof. Dr. med. dent Thomas Attin
Plattenstr. 11
8032 Zürich
Switzerland
Telephone:
++41 44 634 3271
Fax:
Fax: ++41 44 634 4308
Contact per E-Mail
URL:
http://www.dent.uzh.ch/ppk
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Universität Zürich, Zentrum für Zahnmedizin, Klinik für Präventive Zahnmedizin, Parosontologie und Kariologie
Dr. med. dent Pune Nina Tawakoli
Plattenstrasse 11
8032 Zürich
Switzerland
Telephone:
0041446343988
Fax:
No Entry
Contact per E-Mail
URL:
http://www.dent.uzh.ch/ppk

Contact for Public Queries

Universität Zürich, Zentrum für Zahnmedizin, Klinik für Präventive Zahnmedizin, Parosontologie und Kariologie
Dr. med. dent Pune Nina Tawakoli
Plattenstrasse 11
8032 Zürich
Switzerland
Telephone:
0041446343988
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Principal Investigator

Universität Zürich, Zentrum für Zahnmedizin, Klinik für Präventive Zahnmedizin, Parosontologie und Kariologie
Dr. med. dent Pune Nina Tawakoli
Plattenstrasse 11
8032 Zürich
Switzerland
Telephone:
0041446343988
Fax:
No Entry
Contact per E-Mail
URL:
http://www.dent.uzh.ch/ppk

Sources of Monetary or Material Support

Commercial (pharmaceutical industry, medical engineering industry, etc.)

Top Caredent AG
Fellenbergstrasse 279
8047 Zürich
Switzerland
Telephone:
+41 433433060
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)

Kommission für Technologie und Innovation (KTI)
Einsteinstrasse 2
3003 Bern
Switzerland
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Kantonale Ethikkommission Zürich
Stampfenbachstrasse 121
8090 Zürich
Germany
Telephone:
(+41)43-2597970
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2016-01-06
Ethics committee number:
2016-00266
Vote of the Ethics Committee:
Approved
Date of the vote:
2016-06-14

Further identification numbers

Other primary registry ID:
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EudraCT Number:
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UTN (Universal Trial Number):
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EUDAMED Number:
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IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
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IPD Sharing Plan:
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Study protocol and other study documents

Study protocols:
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Study abstract:
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Other study documents:
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Background literature:
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Related DRKS studies:
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Publication of study results

Planned publication:
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Publikationen/Studienergebnisse:
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Date of first publication of study results:
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DRKS entry published for the first time with results:
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Basic reporting

Basic Reporting / Results tables:
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Brief summary of results:
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