Periodontal Health and Sodium Bicarbonate Toothpaste

NCT07274189 | Recruiting

• 1 other identifier: 5350
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontal Diseases

Keywords

periodontitis; periodontal disease; sodium bicarbonate; toothpaste; microbiome

Outcome Measures

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.

  6 months

Secondary Outcomes (2)

• Oral Microbiome Changes

  6 months

• Blood Pressure Change

  6 months

Study Arms (2)

Sodium bicarbonate toothpaste (67%)

ACTIVE COMPARATOR

Description: Intervention includes receiving Corsodyl Complete Protection Extra Fresh Toothpaste to use which contains sodium bicarbonate.

Procedure: no treatment received; Procedure: Periodontal treatment and OHI

Fluoride toothpaste (1450ppm)

SHAM COMPARATOR

Control group to receive Aquafresh Fresh and Minty Toothpaste

Procedure: no treatment received; Procedure: Periodontal treatment and OHI

Interventions

Periodontal treatment and OHI PROCEDURE

3 months periodontal treatment \& OHI

Also known as: Gum treatment (3 mons)

Fluoride toothpaste (1450ppm); Sodium bicarbonate toothpaste (67%)

no treatment received PROCEDURE

Baseline; 0 months (no periodontal treatment)

Also known as: Gum treatment (baseline)

Fluoride toothpaste (1450ppm); Sodium bicarbonate toothpaste (67%)

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Plymouth: lead
• HALEON: collaborator

Study Sites (1)

Derriford Dental Education Facility

Plymouth, PL4 8AA, United Kingdom

RECRUITING

MeSH Terms

Conditions

Periodontal Diseases; Periodontitis

Interventions

BaseLine dental cement

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Zoe Brookes, BDS, MJDF, PCHE, SFHEA, PhD

  University of Plymouth

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zoe Brookes, BDS, MJDF, PCHE, SFHEA, PhD

CONTACT

01752 586828; zoe.brookes@plymouth.ac.uk

Amazon Doble, BSc, PhD

CONTACT

amazon.doble@plymouth.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Head of School (Teaching & Learning)

Model Details: N/A, care pathway follows national guidelines.

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: December 10, 2025
• Study Start: December 4, 2024
• Primary Completion (Estimated): October 20, 2026
• Study Completion (Estimated): January 30, 2027
• Last Updated: December 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: These will all be made available at the end of the study through publication, as the University of Plymouth own the independent data produced via this collaborative project.
• Access Criteria: Online access unrestricted

Locations

GB (1)