Periodontitis
Conditions
Brief summary
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_SUPPLEMENTProdentis
Non-surgical periodontal therapy
Sponsors
University of Malaya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The subject has given their written consent to participate in the trial. 2. All subjects must be aged \>18 years old, not pregnant, and presented with number of teeth \> 12 3. 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 4. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Periodontal pocket depths | Baseline, 3 months, 6 months and 1 year | UNC-15 probe will be used to measure this outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biomarkers from Serum and Saliva | The collection of saliva and serum will be done at baseline, 3 month and 6 months post RSD, and finally at 12 month. | Serum and saliva will be collected to measure the levels of IL-6 and IL-10 |
Countries
Malaysia
Contacts
CONTACTCheah
PRINCIPAL_INVESTIGATORCheah
Universiti Malaya
Outcome results
None listed