Probiotics as Adjunctive Therapy in the Management of Periodontitis

NCT07531875 | Recruiting

• 1 other identifier: DF RD2213/0078 (L)
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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?

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (1)

• Periodontal pocket depths

  UNC-15 probe will be used to measure this outcome

  Baseline, 3 months, 6 months and 1 year

Secondary Outcomes (1)

• 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.

Study Arms (2)

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.

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.

Dietary Supplement: Prodentis

Interventions

Prodentis DIETARY_SUPPLEMENT

Non-surgical periodontal therapy

NP group; OP group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

Universiti Malaya

Kuala Lumpur, Kuala Lumpur, 50603, Malaysia

RECRUITING

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Cheah

  Universiti Malaya

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cheah

CONTACT

+60379674806; chiawei@um.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 15, 2026
• Study Start: November 10, 2025
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)