Condition category
Oral Health
Date applied
10/08/2020
Date assigned
19/08/2020
Last edited
05/09/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Periodontitis also called gum disease, is a serious gum infection that damages the soft tissue and, without treatment, can destroy the bone that supports the teeth. A healthy periodontium is the basis for oral health and for any further dental treatment. If there is an inflammation of the entire periodontium, it is called periodontitis. The inflammation continues from the gums into the depths and finally dissolves the bone around the roots. Periodontoal pockets form, i.e. the gums are no longer firmly attached to the root but a gap of several millimeters is formed between the gums and the gum tissue. In order to stop the inflammation and the decomposition of the tissue, these periodontal pockets are mechanically cleaned out under local anesthetic. In addition to mechanical cleaning, various measures are discussed to further improve the treatment results. Here, the intake of food supplements, which have a positive effect on wound healing and have an anti-inflammatory effect, could be beneficial. Such a dietary supplement is already commercially available (Nutrident Paro Pro ®) and would be compared with a placebo preparation in this study. A placebo preparation looks visually the same as the dietary supplement, but contains no active ingredients, only cellulose in this case.

Who can participate?
Adults over 18 years, with periodontitis stage III or IV.

What does the study involve?
The
participants will be provided with the Nutrident Paro Pro® dietary supplement (Biogena) or an ineffective placebo (cellulose = non-resorbable and indigestible dietary fibre) (Biogena) for the duration of the study. The participants have to take the preparation twice daily for a period of two
months. The data collected before and after taking the dietary supplement or placebo, both 8-12 weeks after the end of the last cleansing session and at the time of the 1-year "Recall with Status" session, will be analysed. The allocation of who receives a dietary supplement and who receives the placebo is randomized. Neither you nor the practitioner knows which product (dietary supplement or placebo) you are taking at home (this is not visible or traceable on the packaging, but is indicated by a code).

What are the possible benefits and risks of participating?
Benefits: The micronutrients contained in Nutrident Paro Pro® could lead to an improvement in periodontal disease. In addition, an existing lack of micronutrients can be compensated. Taking the placebo preparation does not affect your health.
Risks: None

Where is the study run from?
Medical University of Vienna (Austria)

When is the study starting and how long is it expected to run for?
October 2019 to January 2021 (updated 03/09/2020, previously: October 2020)

Who is funding the study?
Medical University of Vienna (Austria)

Who is the main contact?
Prof. Hady Haririan, hady.haririan@med.sfu.ac.at

Trial website

Contact information

Type

Scientific

Primary contact

Prof Hady Haririan

ORCID ID

https://orcid.org/0000-0003-0783-609X

Contact details

Freudplatz 3/2
Vienna
1020
Austria
+43 6504239423
hady.haririan@med.sfu.ac.at

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

1324/2019

Study information

Scientific title

The influence of the outcome of conservative periodontal therapy after intake of Nutrident Paro Pro during therapy - a placebo-controlled double-blind study

Acronym

Study hypothesis

The concomitant use of Nutrident Paro Pro leads to significant clinical improvements during nonsurgical periodontal therapy compared to a placebo. The periodontal parameters "Bleeding on Probing" and "Probing Pocket Depths" improve significantly.

Ethics approval

Approved (06/11/2019) Ethics committee of the Medical University of Vienna (Borschkegasse 8b/6
1090 Wien, Österreich; +43(0)1 404 00-21470; ethik-kom@meduniwien.ac.at), ref: 1324/2019

Study design

Randomized controlled double-blinded clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Periodontitis

Intervention

Patient recruitment: Patients with a periodontal screening index (CPITN >= 3) are referred to the Division of Conservative Dentistry and Periodontology, University Clinic of Dentistry, Medical University of Vienna. After the diagnosis of periodontitis stage III or IV, patients can give written consent to participate in the present study. Subsequently, they will be treated according to the Viennese Periodontal Concept. This comprises a full-mouth probing index (start of intake of verum or placebo), a supra- and subgingival cleaning of all affected tooth and root surfaces with ultrasonic devices and manual instruments under local anaesthesia. Patients take parallel to this non surgical periodontal treatment in a randomized way either a placebo or verum (Nutrident Paro Pro(R), Biogena) for 8-12 weeks. After the completion of non surgical periodontal therapy and intake of the preparations after 8-12 weeks, a reassessment will take place (probing pocket depth, bleeding on probing). This will mark the end of the study. The lower bleeding on probing and probing pocket depths, the better is the outcome of periodontal therapy.

Randomization: The randomization will be performed by an independent dentist of the Division of Conservative Dentistry and Periodontology who is not involved in the study. The software Rand function, Excel 2016 for Mac, Microsoft, Redmond, VA, USA, will be used. The code to discriminate the verum from the placebo will be written on the bottom of the box by the company (Biogena) and only the above mentioned dentist will be informed about decoding.

Intervention type

Supplement

Phase

Drug names

Primary outcome measure

Probing pocket depth measured using a periodontal probe (PCP-12, Hu-Friedy) is inserted into the gingival sulcus at 6 sites per tooth at baseline and end of study (8 - 12 weeks)

Secondary outcome measures

Bleeding on probing measured using a periodontal probe (PCP-12, Hu-Friedy) is inserted into the gingival sulcus at 6 sites per tooth at baseline and end of study (8 - 12 weeks)

Overall trial start date

01/10/2019

Overall trial end date

10/01/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged ≥18 years
2. Periodontitis stage III or IV

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

42 participants

Participant exclusion criteria

Pregnancy

Recruitment start date

07/01/2020

Recruitment end date

07/01/2021

Locations

Countries of recruitment

Austria

Trial participating centre

Medical University of Vienna
University Clinic of Dentistry Sensengasse 2a
Vienna
1090
Austria

Sponsor information

Organisation

Medical University of Vienna

Sponsor details

Spitalgasse 23
Vienna
1090
Austria
+43 1400704720
parodontologie-unizahnklinik@meduniwien.ac.at

Sponsor type

University/education

Website

http://www.meduniwien.ac.at

Funders

Funder type

University/education

Funder name

Medizinische Universität Wien

Alternative name(s)

Medical University of Vienna, MediUni Wien

Funding Body Type

government organisation

Funding Body Subtype

Local government

Location

Austria

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication.

Intention to publish date

01/04/2021

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Editorial Notes

05/09/2020: Uploaded protocol version 5.0, 16 October 2019, in English and German (not peer reviewed).03/09/2020: The following changes were made to the trial record: 1. The recruitment end date was changed from 01/09/2020 to 07/01/2021. 2. The overall end date was changed from 01/10/2020 to 10/01/2021. 3. The intention to publish date was changed from 01/12/2020 to 01/04/2021. 4. The plain English summary was updated to reflect these changes. 17/08/2020: Trial’s existence confirmed by Ethics committee of the Medical University of Vienna.