PMPR and Chlorhexidine on Periodontal Disease and Vascular Function

NCT07311512 | Recruiting

• 2 other identifiers: IRAS Project ID: 351521REC reference: 25/WA/0160
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

• Gum inflammation is called gingivitis. Gum disease, known as periodontal disease, is a long-term inflammation of the gums and bone around teeth, leading to tooth loss. Both gingivitis and periodontal disease are also linked to other health problems, including heart disease. Additionally, salivary proteins play a role in maintaining oral health. For example, a protective layer called the salivary pellicle (SP) forms on teeth after tooth brushing and helps defend against harmful bacteria.
• Nitrate-reducing bacteria (NRB) are also present in saliva and play a role in oral and cardiovascular health by converting nitrate to nitric oxide (NO). This compound supports blood vessel health and overall cardiovascular function. Therefore, NRB's abundance is linked to lower blood pressure and improved cardiovascular health.
• Standard treatments for gum disease include deep cleaning (also called professional mechanical plaque removal, or PMPR), and sometimes chlorhexidine (CHX) mouthwash is used with PMPR to help reduce mouth bacteria. However, while CHX is effective against plaque (a sticky film of bacteria on the tooth surface), it may reduce the activity of "nitrate-reducing" bacteria (NRB), which are important for producing nitric oxide (NO).
• This study investigates the impact of deep cleaning (PMPR) with and without Chlorhexidine mouthwash on salivary and SP proteins, as well as blood vessel function, in people who have gum disease. By examining these links, the investigators aim to gain a deeper understanding of how oral care practices may impact overall health, particularly heart health.

Conditions

Periodontal Disease (PD); Cardio Vascular Disease; Oral-Systemic Link; Vascular Dysfunction; Endothelial Function and Arterial Stiffness

Keywords

Chlorhexidine Mouthwash; Periodontal Disease; Professional Mechanical Plaque Removal (PMPR); Salivary Proteins; Acquired Enamel Pellicle (AEP); Proteomics; Vascular Function; Endothelial Function; Flow-Mediated Dilation (FMD); Pulse Wave Analysis (PWA); Pulse Wave Velocity (PWV); Blood Pressure; Nitric Oxide; Nitrate reducing bacteria (NRB); Inflammation biomarkers; Oral-Systemic Link; Saliva Collection; Blood Sample Collection; Cardiac Output

Outcome Measures

Primary Outcomes (1)

• Proteomics - Salivary Protein Analysis

  Purpose: To identify inflammatory and protective proteins, monitor changes post-PMPR in saliva. * Method ( Protocol from Imperial College, London): * Reduction \& Alkylation: A 10 μL aliquot of saliva will be thawed and mixed with 7 μL of ammonium bicarbonate buffer on ice. For reduction and alkylation, 5 μL each of TCEP and CAA will be added, maintaining a pH of 7-8 to ensure proper modification of disulfide bonds and cysteine residues. * SP4 Protocol: Following reduction and alkylation, the SP4 protocol will be implemented by adding 80 μL of LC/MS-grade acetonitrile to precipitate proteins; the mixture will be centrifuged to separate the supernatant, and the pellet will be washed three times with ethanol for thorough purification. * Digestion: The purified pellet will then be resuspended in stock trypsin by adding 20 μL 25 mM ammonium bicarbonate to lyophilised powdered trypsin (powdered sequencing grade modified trypsin) and incubate overnight at 37°C, and incubated overnight.

  Analysed for WMS samples collected on Day 0, Day 1, Day 14, and Day 90.

Secondary Outcomes (21)

• Salivary Flow-Rate

  Day 0, Day 1, Day 14, and Day 90

• Salivary pH

  Day 0, Day 1, Day 14, and Day 90

• Oral Microbial Composition

  Day 0, Day 1, Day 14, and Day 90

• Acquired Enamel Pellicle (AEP) Protein Composition

  Day 0, Day 1, Day 14, Day 90

• Nitrate Reducing Activity of the Oral Bacteria

  Analysed for the nitrate rinse samples collected on Day 0, Day 1, Day 14, and Day 90.

Study Arms (2)

PMPR + Placebo

PLACEBO COMPARATOR

Arm 2 - Participants in this arm will receive PMPR using ultrasonic scalers at baseline (Visit 1) as part of routine care. At Visit 2 (Day 1), participants will be randomised to receive a placebo mouthwash, identical in taste, color, appearance to the chlorhexidine mouthwash. \- This placebo comparator will allow assessment of the effect of chlorhexidine versus no active antibacterial treatment, while keeping participants and researchers blinded. Participants follow the same regimen (10 ml rinse, 1 min, twice daily for 14 days), with saliva, AEP, blood, and vascular function measurements collected at baseline, Day 1, Day 14, and Day 90.

Other: Placebo mouthwash

PMPR + CHX

ACTIVE COMPARATOR

* Arm 1 * Participants in this arm will receive PMPR using ultrasonic scalers at baseline (Visit 1), as part of their standard care. At Visit 2 (Day 1), they will be randomised to receive 0.2% chlorhexidine mouthwash (10 ml, 1 min, twice daily for 14 days), with saliva, Acquired Enamel Pellicle (AEP), blood sample collection, and vascular function measurements done at baseline(Day 0), Day 1, Day 14, and Day 90.

Other: Chlorhexidine (0.2%) mouthwash

Interventions

Chlorhexidine (0.2%) mouthwash OTHER

PMPR is a routine standard dental treatment for gingivitis and PD, and will not form part of the research intervention. The research intervention consists of using 0.2% chlorhexidine mouthwash (10 ml, rinsed for 1 minute, twice daily for 14 days).

Also known as: Chlorhexidine Mouthwash

PMPR + CHX

Placebo mouthwash OTHER

PMPR is a routine standard dental treatment for gingivitis and PD, and will not form part of the research intervention. The research intervention consists of a placebo mouthwash (10 ml, 1 min, twice daily for 14 days). The placebo mouthwash (control) is designed to resemble commercially available products but without the active ingredient. Use of this has been ethically approved (IRAS Project ID: 333173), validated and tested in the investigator's previous studies (Data to be published).

PMPR + Placebo

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must have a minimum of 2 natural teeth in each sextant (at least 12 teeth overall).
• Individuals with clinically diagnosed gingivitis and/or early periodontitis (stage 1 and 2)
• Must not have undergone periodontal maintenance therapy (PMPR) within the last 6 months.
• Must not currently be wearing orthodontic appliances, due to their effect on oral microbiota and plaque composition.
• Must not be using removable orthodontic appliances, as they increase plaque accumulation.
• Must not have taken any antibiotic treatments within the last 3 months.
• Must be able to provide written informed consent.
• Individuals with dental erosion or caries will still be included but matched during the baseline visit.

You may not qualify if:

• Individuals under regular medication within one month of the study start date for any medical condition (such as hypertension and/or diabetes)
• Pregnant or breastfeeding individuals.
• Individuals requiring an interpreter or who are non-English speakers.
• Individuals unable to provide written informed consent.
• Individuals participating in another ongoing clinical study (other than observational studies) within 3 months prior to or during this study.
• Individuals who have used mouthwash or tongue scrapers in the last 6 weeks.
• Individuals who consume 20 or more cigarettes per day.
• Individuals who consume more than 5 alcoholic drinks per day.

Sponsors & Collaborators

• Mahdi Mutahar: lead
• Loughborough University: collaborator
• Temple University: collaborator
• Imperial College London: collaborator

Study Sites (1)

University of Portsmouth

Portsmouth, Hampshire, PO1 2QG, United Kingdom

RECRUITING

Related Links

• Dr. Mahdi Mutahar, Senior Lecturer at the University of Portsmouth Dental Academy, supervises Saagarika Sharma's PhD project on the effect of PMPR and chlorhexidine mouthwash on salivary, pellicle proteins and vascular function.
• This University of Portsmouth project investigates how professional mechanical plaque removal and chlorhexidine mouthwash affect salivary proteins, acquired enamel pellicle and vascular function in individuals with periodontal disease.

MeSH Terms

Conditions

Periodontal Diseases

Interventions

Chlorhexidine; Mouthwashes

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Biomedical and Dental Materials; Specialty Uses of Chemicals; Chemical Actions and Uses; Cosmetics; Manufactured Materials; Technology, Industry, and Agriculture

Central Study Contacts

Mahdi Mutahar, PhD

CONTACT

02392845528; mahdi.mutahar@port.ac.uk

Saagarika Sharma

CONTACT

saagarika.sharma@port.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. Mahdi Mutahar

Model Details: * Participants will be identified by School of Dental Health and Care Professions (SDHCP) dental clinicians and research team.Participants will be provided study information ≥24h before appointments. After consent, periodontal screening per BSP 2017 guidelines will be conducted by the calibrated dental clinicians. * Eligible participants will complete medical/dental history, saliva and AEP sampling at SDHCP. Vascular assessments will be performed at the School of Psychology, Sport and Health Sciences (SPSHS) using iontophoresis, flow-mediated dilation, pulse wave velocity, cardiac output , blood pressure, and blood sample collection. * PMPR will be done once at baseline (Visit 1) as standard care by the dental clinicians at SDHCP with research procedures performed before and after the PMPR procedure. * At Visit 2, participants will be randomised to receive either 0.2% chlorhexidine or placebo mouthwash (10 ml, 1 min, twice daily, 14 days), with follow-up at Day 1, Day 14, and Day 90.

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: December 31, 2025
• Study Start: January 23, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: March 25, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)