Health TrialsbyHealthPanel

Periodontal Health and Sodium Bicarbonate Toothpaste

ConditionPeriodontal Diseases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Plymouth

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult participants >18 years, of any gender will be recruited.

Disqualifiers

Full dentures

Diabetics

Cancer diagnosis

Pregnancy

Trial design

Design model

Parallel

Treatments tested in this trial

  • no treatment received

    Procedure/Surgery

    Baseline; 0 months (no periodontal treatment)

  • Periodontal treatment and OHI

    Procedure/Surgery

    3 months periodontal treatment \& OHI

  • Periodontal treatment and OHI

    Procedure/Surgery

    6 months periodontal treatment \& OHI

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Sodium bicarbonate toothpaste (67%)Active comparator 2 interventions
Group B: Fluoride toothpaste (1450ppm)Sham comparator 2 interventions

Trial outcomes

Primary outcomes

1

Maintenance of periodontal health

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.

Time frame
6 months

Secondary outcomes

1

Oral Microbiome Changes

Does the oral microbiome and biochemical composition of saliva differ in individuals using the intervention versus the control toothpaste for 6 months.

Time frame
6 months
2

Blood Pressure Change

Does blood pressure change at all in individuals using the intervention versus the control toothpaste for 6 months.

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Plymouth

Lead sponsor

HALEON

Collaborator

Source ClinicalTrials.gov
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