Prodentis probiotic alongside periodontal cleaning for periodontitis
Probiotics as Adjunctive Therapy in the Management of Periodontitis
This test will see if taking the probiotic Prodentis for up to 12 months after root surface debridement helps adults with stage III–IV periodontitis keep their gums healthier compared with taking it for only three months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Malaya Academic / other |
| Locations | 1 site (Kuala Lumpur, Kuala Lumpur) |
| Trial ID | NCT07531875 on ClinicalTrials.gov |
What this trial studies
Following root surface debridement (RSD), all participants start Prodentis twice daily for three months, after which one group stops and the other continues once daily until month 12; participants are reviewed every three months. Clinical periodontal measures (including pocket depth) and systemic immune-response markers will be recorded at each review to compare the two dosing schedules. Eligible adults must be non-pregnant, have more than 12 teeth, a diagnosis of stage III or IV periodontitis, and at least four residual pockets ≥5 mm after prior therapy. The trial is conducted at Universiti Malaya in Kuala Lumpur with follow-up visits through one year.
Who should consider this trial
Good fit: Adults over 18 (not pregnant) with stage III or IV periodontitis, at least 12 teeth, and at least four residual pockets of ≥5 mm who had periodontal therapy 3–6 months before enrollment.
Not a fit: People with mild periodontitis, fewer than the required residual pockets, who are pregnant, or who have not had recent periodontal therapy are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, long-term Prodentis use could help maintain periodontal stability, reduce deep pockets, and favorably modulate systemic immune markers, potentially reducing the need for repeat interventions.
How similar studies have performed: Previous trials of probiotics as adjuncts to periodontal therapy have shown modest clinical benefits in some cases, but results have been mixed and long-term continuous use is less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Kuala Lumpur, Kuala Lumpur
- Universiti Malaya — Kuala Lumpur, Kuala Lumpur, Malaysia (Recruiting)
Study contacts
- Principal investigator: Cheah — Universiti Malaya
- Study coordinator: Cheah
- Email: chiawei@um.edu.my
- Phone: +60379674806
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.