Keeping gums healthy after periodontal treatment with sodium bicarbonate toothpaste
Maintenance of Periodontal Health With Daily Use of Sodium Bicarbonate Toothpaste
This study will test whether daily use of a sodium bicarbonate fluoride toothpaste helps adults who have had non-surgical periodontal treatment keep their gums healthy over six months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Plymouth Academic / other |
| Locations | 1 site (Plymouth) |
| Trial ID | NCT07274189 on ClinicalTrials.gov |
What this trial studies
About 100 adults attending the University of Plymouth dental education facilities who have completed non-surgical periodontal treatment will be enrolled. Participants will be assigned to use either a sodium bicarbonate fluoride toothpaste or a placebo toothpaste while receiving standardized oral hygiene instruction and periodontal maintenance over six months. Clinical measures (plaque scores, gingival bleeding, periodontal pocket depths), salivary biochemical markers, and the oral microbiome will be recorded at baseline, 3 months, and 6 months. Dental care includes an initial examination, three confirmed hygienist visits, and additional dental appointments as needed.
Who should consider this trial
Good fit: Adults over 18 who have completed non-surgical periodontal therapy, are not diabetic, not pregnant, not using recent antibiotics or antibacterial mouthwash, and can attend in-person visits at the Plymouth site.
Not a fit: People with full dentures, a diabetes diagnosis, recent antibiotic or antimicrobial mouthwash use, recent immunosuppressant or inorganic nitrate use, pregnancy, or BPE scores outside the study's inclusion range are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the toothpaste could help patients keep plaque and gum inflammation lower between appointments, potentially reducing the need for more intensive treatment.
How similar studies have performed: Some small prior studies suggest bicarbonate-containing toothpastes can reduce plaque and improve oral conditions, but strong evidence for sustained periodontal maintenance and microbiome changes is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult participants \>18 years, of any gender will be recruited. Exclusion Criteria: * Full dentures * Diabetics * Cancer diagnosis * Pregnancy * Use of antibiotics (\<3 months prior to participation) * Use of antibacterial mouthwash * Inorganic nitrates taken less than 4 weeks before the study * Immunosuppressants taken less than 4 weeks before the study * BPE's score of less than 3, and or/ BPE score of more than two 4's.
Where this trial is running
Plymouth
- Derriford Dental Education Facility — Plymouth, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Zoe Brookes, BDS, MJDF, PCHE, SFHEA, PhD — University of Plymouth
- Study coordinator: Zoe Brookes, BDS, MJDF, PCHE, SFHEA, PhD
- Email: zoe.brookes@plymouth.ac.uk
- Phone: 01752 586828
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.