Maintenance of Periodontal Health With Daily Use of Sodium Bicarbonate Toothpaste
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Plymouth
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Maintenance of periodontal health
Study Overview
Brief Summary
The goal of this clinical trial is to determine whether sodium bicarbonate fluoride toothpaste can help maintain periodontal health in adults who have undergone non-surgical periodontal treatment. The main question it aims to answer is:
Does daily use of toothpaste affect the following outcomes: clinical oral health (plaque scores, gingival bleeding scores and periodontal pocket depths), salivary biochemical markers and the oral microbiome.
Outcomes measures will be recorded at 0,3, and 6 months, during which time participants will receive either the treatment or placebo toothpaste and undergo oral hygiene instruction and PMPR over 6 months.
Detailed Description
Study Design, Setting and Participants
The investigators will conduct an ongoing longitudinal study evaluating structured hygiene treatment, with required dental treatment over six months, with outcome measures recorded at three time points: baseline (0 months), 3 months, and 6 months.
The study will recruit adult male and female individuals (n=100, aged >18 years) from patients attending Peninsula Dental School (PDS) Dental Education Facilities in Plymouth.
These patients will not currently be being seen by students and therefore will be recruited to take part in a 6-month study, where their oral hygiene, periodontal treatment and dental treatment will be carried out by our research team.
Before completing recruitment and booking in for any dental appointments, the following exclusion criteria will applied to the patients: previous diagnosis of diabetes (Type I or II), current antibiotics use, complete denture users, immunosuppressants use, antimicrobial mouthwash use within 3 months.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Maintenance of periodontal health
Time Frame: 6 months
Determine whether sodium bicarbonate fluoride toothpaste as part of daily oral hygiene, can provide benefits for maintenance of clinical periodontal health post non-surgical periodontal treatment.
Maintenance of periodontal health
Time Frame: 6 months
Determine whether sodium bicarbonate fluoride toothpaste as part of daily oral hygiene, can provide benefits for maintenance of clinical periodontal health post non-surgical periodontal treatment.
Secondary Outcomes
- Oral Microbiome Changes(6 months)
- Blood Pressure Change(6 months)
Investigators
Zoe Brookes
Associate Head of School (Teaching & Learning)
University of Plymouth