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?
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.
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, email@example.com
The influence of the outcome of conservative periodontal therapy after intake of Nutrident Paro Pro during therapy - a placebo-controlled double-blind study
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.
Approved (06/11/2019) Ethics committee of the Medical University of Vienna (Borschkegasse 8b/6
1090 Wien, Österreich; +43(0)1 404 00-21470; firstname.lastname@example.org), ref: 1324/2019
Randomized controlled double-blinded clinical trial
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
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.
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
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
1. Aged ≥18 years
2. Periodontitis stage III or IV
Target number of participants
Participant exclusion criteria
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Medical University of Vienna
University Clinic of Dentistry Sensengasse 2a
Medizinische Universität Wien
Medical University of Vienna, MediUni Wien
Funding Body Type
Funding Body Subtype
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
Participant level data
Basic results (scientific)
- ISRCTN38663186_PROTOCOL_v5.0_German_16Oct2019.pdf Uploaded 05/09/2020
- ISRCTN38663186_PROTOCOL_v5.0_English_16Oct2019.pdf Uploaded 05/09/2020