PeriodontitisNCT07531875
Probiotics as Adjunctive Therapy in the Management of Periodontitis
A study testing Prodentis in people with Periodontitis, run by University of Malaya at 1 site in Malaysia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontitis
- What is being tested?
- Prodentis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteMalaysia
- Study dates
- 10 Nov 2025to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site, 1 recruiting
- Recruiting
Universiti Malaya
Kuala Lumpur, Kuala Lumpur, 50603
Chia Wei Cheah, BDS, MClinDent, PhD, +60379674806, chiawei@um.edu.my
Cheah
About this study
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
- 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?
Read the 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.
- Conditions
- Periodontitis
- Being tested
- Prodentis
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProdentisDietary supplement
Non-surgical periodontal therapy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Prodentis |
| 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. Receives: Dietary Supplement: Prodentis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periodontal pocket depths
UNC-15 probe will be used to measure this outcome
Measured: Baseline, 3 months, 6 months and 1 year
Secondary outcomes (1)
Biomarkers from Serum and Saliva
Serum and saliva will be collected to measure the levels of IL-6 and IL-10
Measured: The collection of saliva and serum will be done at baseline, 3 month and 6 months post RSD, and finally at 12 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start10 Nov 2025
- Primary completionNov 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr CHEAH CHIA WEI, University of Malaya
- Investigators
- Cheah, Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07531875
- Sponsor's protocol ID
- DF RD2213/0078 (L)
- Status last verified
- Jan 2026
- First submitted
- 9 Apr 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics as Adjunctive Therapy in the Management of Periodontitis
- ClinicalTrials.gov ID
- NCT07531875
- Acronym / sponsor ID
- DF RD2213/0078 (L)
- Conditions
- Periodontitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 10 Nov 2025 (actual)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 15 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OP group | Experimental | Dietary Supplement: ProdentisFollowing 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 | Dietary Supplement: ProdentisFollowing 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProdentisNon-surgical periodontal therapy | Dietary supplement | NP group, OP group |
Primary outcome
Periodontal pocket depths
Time frame: Baseline, 3 months, 6 months and 1 year
UNC-15 probe will be used to measure this outcome
1 secondary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cheah principal investigator
University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prodentis in people with Periodontitis, run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cheah (+60379674806, chiawei@um.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Periodontal pocket depths (time frame: Baseline, 3 months, 6 months and 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.