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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?
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OP group | Experimental | Following root surface debridement (RSD), subjects in the test group (group OP) will be instructed to take Prodentis® twice/day immediately for 3 months then continue Prodentis® once a day until month 12th. |
|
| NP group | Placebo Comparator | Following root surface debridement (RSD), subjects in the control group (group NP) will be instructed to take Prodentis® twice/day immediately for 3 months then discontinue. The will be reviewed at similar intervals as the test group until month 12th. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prodentis | Dietary Supplement | Non-surgical periodontal therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Periodontal pocket depths | UNC-15 probe will be used to measure this outcome | Baseline, 3 months, 6 months and 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarkers from Serum and Saliva | Serum and saliva will be collected to measure the levels of IL-6 and IL-10 | The collection of saliva and serum will be done at baseline, 3 month and 6 months post RSD, and finally at 12 month. |
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cheah | Contact | +60379674806 | chiawei@um.edu.my |
| Name | Affiliation | Role |
|---|---|---|
| Cheah | University of Malaya | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universiti Malaya | Recruiting | Kuala Lumpur | Kuala Lumpur | 50603 | Malaysia |
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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