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NCT Number: NCT07531875

Probiotics as Adjunctive Therapy in the Management of Periodontitis

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?

Recruiting

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Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universiti Malaya

Kuala Lumpur, 50603, Malaysia

Location status: Recruiting

Location contact

Al-Maleki

SUB_INVESTIGATOR

Cheah

PRINCIPAL_INVESTIGATOR

Chia Wei Cheah, BDS, MClinDent, PhD

CONTACT

[email protected]

+60379674806

Lai

SUB_INVESTIGATOR

Teughels

SUB_INVESTIGATOR

Vaithilingam

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

Prodentis

Dietary Supplement

Non-surgical periodontal therapy

Primary outcomes

  1. Periodontal pocket depths

    Time frame: Baseline, 3 months, 6 months and 1 year

    UNC-15 probe will be used to measure this outcome

Secondary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Cheah

CONTACT

[email protected]

+60379674806

Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Apr 15, 2026
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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