Probiotics as Adjunctive Therapy in the Management of Periodontitis

April 9, 2026 updated by: Dr CHEAH CHIA WEI, University of Malaya

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?

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Malaysia
    • Kuala Lumpur
      • Kuala Lumpur, Kuala Lumpur, Malaysia, 50603
        • Recruiting
        • Universiti Malaya
        • Contact:
          • Chia Wei Cheah, BDS, MClinDent, PhD
          • Phone Number: +60379674806
          • Email: chiawei@um.edu.my
        • Principal Investigator:
          • Cheah
        • Sub-Investigator:
          • Vaithilingam
        • Sub-Investigator:
          • Al-Maleki
        • Sub-Investigator:
          • Lai
        • Sub-Investigator:
          • Teughels

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OP group
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.
Dietary supplement: Prodentis
Non-surgical periodontal therapy
Placebo Comparator: NP group
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.
Dietary supplement: Prodentis
Non-surgical periodontal therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Periodontal pocket depths
Time Frame: Baseline, 3 months, 6 months and 1 year
UNC-15 probe will be used to measure this outcome
Baseline, 3 months, 6 months and 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Malaya

Investigators

  • Principal Investigator: Cheah, Universiti Malaya

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2025

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

April 9, 2026

First Submitted That Met QC Criteria

April 9, 2026

First Posted (Actual)

April 15, 2026

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DF RD2213/0078 (L)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Periodontitis

Clinical Trials on Prodentis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kyrgyzstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe