Probiotics as Adjunctive Therapy in the Management of Periodontitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Prodentis.
- Who it may be relevant to
- Registry conditions: Periodontitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Malaysia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The goal of this clinical trials is to learn about the effect of taking Prodentis on a long term basis following periodontal therapy. The main question it aims to answer is 1\. what is the effect of long-term consumption of Prodentis on regulating periodontal health and systemic immune-response, when compare to only taking it for 3 months post RSD?
Detailed description
Following root surface debridement (RSD), subjects in the control group (group NP) will be instructed to take Prodentis® twice/day immediately for 3 months only then continue 3 monthly review until month 12th.
For subjects in the test group (group OP), following RSD, they will be instructed to take Prodentis® twice/day immediately for 3 months then continue Prodentis® once a day until month 12th. They will be reviewed 3 monthly.
Interventions
- Dietary supplement Prodentis
Non-surgical periodontal therapy
Primary outcome measures
- Periodontal pocket depths [Time frame: Baseline, 3 months, 6 months and 1 year]
Secondary outcome measures (1)
- Biomarkers from Serum and Saliva [Time frame: The collection of saliva and serum will be done at baseline, 3 month and 6 months post RSD, and finally at 12 month.]
Eligibility criteria
- The subject has given their written consent to participate in the trial.
- All subjects must be aged >18 years old, not pregnant, and presented with number of teeth > 12
- Diagnosis for periodontitis Stage III and IV, will be according to 2017 the American Academy of Periodontology (AAP) and European Federation of Periodontology (EFP) classification
- Has had 1 round of periodontal therapy within 3-6 months' time from recruitment date, and currently presented with at least 4 residual pockets with pocket depth 5mm and above.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Malaysia · 1 center
- Universiti Malaya — Kuala Lumpur
Identifiers
NCT: NCT07531875 · DF RD2213/0078 (L)