Possible benefits from nutritional supplements during periodontitis (gum disease) treatment
| ISRCTN | ISRCTN38663186 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN38663186 |
| Secondary identifying numbers | 1324/2019 |
- Submission date
- 10/08/2020
- Registration date
- 19/08/2020
- Last edited
- 28/02/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
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 December 2021
Who is funding the study?
Medical University of Vienna (Austria)
Who is the main contact?
Prof. Hady Haririan, hady.haririan@med.sfu.ac.at
Contact information
Scientific
Freudplatz 3/2
Vienna
1020
Austria
 ORCID ID |
0000-0003-0783-609X |
|---|---|
| Phone | +43 6504239423 |
| hady.haririan@med.sfu.ac.at |
Study information
| Study design | Randomized controlled double-blinded clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| 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 |
| 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(s) | 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 |
| 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 |
| 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 study start date | 01/10/2019 |
| Overall study end date | 01/12/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 42 participants |
| Participant inclusion criteria | 1. Aged ≥18 years 2. Periodontitis stage III or IV |
| Participant exclusion criteria | Pregnancy |
| Recruitment start date | 07/01/2020 |
| Recruitment end date | 30/09/2021 |
Locations
Countries of recruitment
- Austria
Study participating centre
Sensengasse 2a
Vienna
1090
Austria
Sponsor information
University/education
Spitalgasse 23
Vienna
1090
Austria
| Phone | +43 1400704720 |
|---|---|
| parodontologie-unizahnklinik@meduniwien.ac.at | |
| Website | http://www.meduniwien.ac.at |
"ROR" |
https://ror.org/05n3x4p02 |
Funders
Funder type
University/education
Government organisation / Local government
- Alternative name(s)
- Medical University of Vienna, MediUni Wien
- Location
- Austria
Results and Publications
| Intention to publish date | 01/10/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version v5.0 | 16/10/2019 | 05/09/2020 | No | No |
| Protocol file | version v5.0 | 16/10/2019 | 05/09/2020 | No | No |
Additional files
- ISRCTN38663186_PROTOCOL_v5.0_German_16Oct2019.pdf
- Uploaded 05/09/2020
- ISRCTN38663186_PROTOCOL_v5.0_English_16Oct2019.pdf
- Uploaded 05/09/2020
Editorial Notes
28/02/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 07/01/2021 to 30/09/2021.
2. The overall end date was changed from 10/01/2021 to 01/12/2021.
3. The intention to publish date was changed from 01/04/2021 to 01/10/2022.
4. The plain English summary was updated to reflect these changes.
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.
