Probiotics as Adjunctive Therapy in the Management of Periodontitis
ConditionPeriodontitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Malaya
About this trial
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?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Prodentis
Dietary supplementNon-surgical periodontal therapy
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: OP groupExperimental treatment 1 intervention
Group B: NP groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Periodontal pocket depths
UNC-15 probe will be used to measure this outcome
Time frame
Baseline, 3 months, 6 months and 1 yearSecondary outcomes
1
Biomarkers from Serum and Saliva
Serum and saliva will be collected to measure the levels of IL-6 and IL-10
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov