Dental Prophylaxis and Implant SurgeryPhase 4NCT02319668

Antimicrobial Agent for Reducing Bacteria in Aerosols and Oral Cavity

A Phase 4 study testing 0.2% w/v Chlorhexidine digluconate and Sodium fluoride toothpaste (Aquafresh Mild & Minty) in people with Dental Prophylaxis and Implant Surgery, run by GlaxoSmithKline at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 64 yearsHealthy volunteers can take part
Conditions the study is for: Dental Prophylaxis and Implant Surgery
What is being tested?: 0.2% w/v Chlorhexidine digluconate and Sodium fluoride toothpaste (Aquafresh Mild & Minty)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 38 participants
Where: 1 siteUnited Kingdom
Study dates: 1 Feb 2015to 29 Feb 2016
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 64 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
Aged between 18-64 years old.
Understands and is willing, able and likely to comply with all study procedures and restrictions
Good general and mental health with, in the opinion of the investigator or medically qualified designee:
No clinically significant and relevant abnormalities in medical history or upon oral examination.
Absence of any condition that could affect the participant's safety or well being or their ability to understand and follow study procedures and requirements.

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Females of childbearing potential who are, in the opinion of the investigator, practicing a reliable method of contraception
Dental Health
Good overall oral health in the opinion of investigator.
A minimum of 20 permanent teeth.
Requiring a single and simple implant (single tooth replacement with no bone augmentation required for implant placement).
Females of childbearing potential who are, in the opinion of the investigator, practising a reliable method of contraception.

Who cannot join

Women who are known to be pregnant or who are intending to become pregnant over the duration of the study
Women who are breast-feeding
Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit
Previous participation in this study
Recent history (within the last 1 year) of alcohol or other substance abuse
Use of antibiotics within 14 days prior to the Baseline visit or Implant surgery visit.
An employee of the sponsor or the study site or members of their immediate family

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

GSK Investigational Site
London, WC1X 8LD

Other trials in United Kingdom

About this study

Official title: A Clinical Study to Evaluate the Efficacy of Pre-procedural and Pre-surgical Rinsing With an Antimicrobial Agent in Reducing Bacteria in Dental Aerosols and in the Oral Cavity

The primary objective of this study will be to evaluate the effect of two week pre-surgical rinsing with an antimicrobial mouthrinse containing 0.2% w/v Chlorhexidine digluconate on the total number of plaque bacteria in the mouth 3 days post implant surgery. The study will be conducted at Eastman Clinical Investigation Centre (ECIC), University College London (UCL) Eastman Dental Institute. Participants will be those who require a single and simple surgical implant to be placed, and will be recruited from new patient referrals within the Eastman Dental Hospital

Conditions: Dental Prophylaxis and Implant Surgery
Being tested: 0.2% w/v Chlorhexidine digluconate, Sodium fluoride toothpaste (Aquafresh Mild & Minty)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

0.2% w/v Chlorhexidine digluconateDrug
Participants will brush their teeth with the reference product (toothpaste) and thoroughly rinse their mouth with water and wait 5 timed minutes before using 10 ml of the 0.2% w/v Chlorhexidine digluconate mouthwash, except when using at site, where no brushing will take place prior to using the mouthrinse.
Sodium fluoride toothpaste (Aquafresh Mild & Minty)Drug
Participants will apply a strip of toothpaste to cover the head of the toothbrush and will brush in their usual manner for two timed minutes twice daily. They will then rinse their mouth thoroughly with water after brushing

Study groups in NCT02319668
Study group	Role	What they receive
Test product	Experimental	Mouthwash containing 0.2% w/v Chlorhexidine digluconate Receives: Drug: 0.2% w/v Chlorhexidine digluconate; Drug: Sodium fluoride toothpaste (Aquafresh Mild & Minty)
Control	Placebo comparator	Sodium fluoride toothpaste (Aquafresh Mild \& Minty) Receives: Drug: Sodium fluoride toothpaste (Aquafresh Mild & Minty)

What is being measured

The primary outcome is the main question the study is designed to answer.

Total Number of Detectable Plaque Bacteria Sampled 3 Days Post Implant Surgery
The examiner identified three plaque sampling sites as follows: surgical site, contralateral site to the surgical site and tongue. An individual cotton swab was used at each identified site for up to 20 seconds in order to harvest a plaque sample and immediately be placed into 1mL phosphate buffered saline in a sterile Eppendorf tube. The samples were analysed using quantitative polymerase chain reaction (qPCR) which determined the total number of bacteria in a sample by quantifying the number of 16S ribosomal ribonucleic acid (rRNA) genes in the sample. The number of bacteria in each of the three identified plaque sampling sites (surgical site, contralateral site to the surgical site and tongue) for each participant were summed to calculate the total number of bacteria for each participant.
Measured: At Day 3

Secondary outcomes (3)

Total Number of Detectable Plaque Bacteria Sampled at Implant Surgery (at Pre-rinse, Pre, Mid and Post Implant Surgery) and Post Implant Surgery (at Day 1 and 7)
The examiner identified three plaque sampling sites as follows: surgical site, contralateral site to the surgical site and tongue. An individual cotton swab was used at each identified site for up to 20 seconds in order to harvest a plaque sample and immediately be placed into 1mL phosphate buffered saline in a sterile Eppendorf tube. The samples were analysed using quantitative polymerase chain reaction (qPCR) which determined the total number of bacteria in a sample by quantifying the number of 16S ribosomal ribonucleic acid (rRNA) genes in the sample.
Measured: At Day 0 (pre-rinse, pre, mid and post implant surgery), Day 1 and 7
Area Under the Curve (AUC) for the Total Number of Plaque Bacteria in the Mouth Post Implant Surgery
The examiner identified three plaque sampling sites as follows: surgical site, contralateral site to the surgical site and tongue. An individual cotton swab was used at each identified site for up to 20 seconds in order to harvest a plaque sample and immediately be placed into 1mL phosphate buffered saline in a sterile Eppendorf tube. The samples were analysed using quantitative polymerase chain reaction (qPCR) which determined the total number of bacteria in a sample by quantifying the number of 16S ribosomal ribonucleic acid (rRNA) genes in the sample. The AUC of the total count of detectable plaque bacteria was calculated using trapezoidal rule in the time range from immediately post implant surgery to 7 days post implant surgery
Measured: Up to 7 days post implant surgery
Total Number of Recoverable Viable Bacteria in the Aerosol Generated During Dental Prophylaxis
Thick settle blood agar plates (supplemented with 5% [volume by volume v/v]) defibrinated horse blood) were used to determine the bacterial load of the aerosol. Thirty (30) minutes prior to the participants had their procedure (dental prophylaxis), a total of 5 settle plates with lids removed were placed at set positions around the dental surgery. After 30 minutes, the settle plates lids were replaced. This was repeated during the dental prophylaxis procedure using 5 fresh settle plates. All plates were then sealed with parafilm and transported for incubation in an anaerobic chamber at 37°C for 3 days. The plates were inspected daily to access growth and after 3 days removed and stored at 4°C for subsequent colony enumeration and Colony Forming Unit/mL (CFU/mL) calculation
Measured: At Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 201529 Feb 2016

First posted18 Dec 2014 (estimated)
Study start1 Feb 2015
Primary completion1 Jun 2015
Study completion29 Feb 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Dental Prophylaxis and Implant SurgeryStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02319668
Sponsor's protocol ID: 202200
Other IDs: 2014-003222-40, RH02604, 2014
Status last verified: Jun 2017
First submitted: 15 Dec 2014
Last updated: 19 Jul 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Clinical Study to Evaluate the Efficacy of Pre-procedural and Pre-surgical Rinsing With an Antimicrobial Agent in Reducing Bacteria in Dental Aerosols and in the Oral Cavity
ClinicalTrials.gov ID: NCT02319668
Acronym / sponsor ID: 202200
Conditions: Dental Prophylaxis and Implant Surgery
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 1 Feb 2015 (actual)
Primary completion: 1 Jun 2015 (actual)
Study completion: 29 Feb 2016 (actual)
First posted: 18 Dec 2014 (estimated)
Results: Posted 17 Apr 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Test product	Experimental	Drug: 0.2% w/v Chlorhexidine digluconate, Drug: Sodium fluoride toothpaste (Aquafresh Mild & Minty)Mouthwash containing 0.2% w/v Chlorhexidine digluconate
Control	Placebo comparator	Drug: Sodium fluoride toothpaste (Aquafresh Mild & Minty)Sodium fluoride toothpaste (Aquafresh Mild \& Minty)

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (12 listed)

Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
Aged between 18-64 years old.
Understands and is willing, able and likely to comply with all study procedures and restrictions
Good general and mental health with, in the opinion of the investigator or medically qualified designee:
Females of childbearing potential who are, in the opinion of the investigator, practicing a reliable method of contraception

Key exclusion criteria (8 listed)

Women who are known to be pregnant or who are intending to become pregnant over the duration of the study
Women who are breast-feeding
Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit
Previous participation in this study

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
0.2% w/v Chlorhexidine digluconateParticipants will brush their teeth with the reference product (toothpaste) and thoroughly rinse their mouth with water and wait 5 timed minutes before using 10 ml of the 0.2% w/v Chlorhexidine digluconate mouthwash, except when using at site, where no brushing will take place prior to using the mouthrinse.	Drug	Test product
Sodium fluoride toothpaste (Aquafresh Mild & Minty)Participants will apply a strip of toothpaste to cover the head of the toothbrush and will brush in their usual manner for two timed minutes twice daily. They will then rinse their mouth thoroughly with water after brushing	Drug	Control, Test product

Primary outcome

Total Number of Detectable Plaque Bacteria Sampled 3 Days Post Implant Surgery
Time frame: At Day 3
The examiner identified three plaque sampling sites as follows: surgical site, contralateral site to the surgical site and tongue. An individual cotton swab was used at each identified site for up to 20 seconds in order to harvest a plaque sample and immediately be placed into 1mL phosphate buffered saline in a sterile Eppendorf tube. The samples were analysed using quantitative polymerase chain reaction (qPCR) which determined the total number of bacteria in a sample by quantifying the number of 16S ribosomal ribonucleic acid (rRNA) genes in the sample. The number of bacteria in each of the three identified plaque sampling sites (surgical site, contralateral site to the surgical site and tongue) for each participant were summed to calculate the total number of bacteria for each participant.

3 secondary outcomes

Total Number of Detectable Plaque Bacteria Sampled at Implant Surgery (at Pre-rinse, Pre, Mid and Post Implant Surgery) and Post Implant Surgery (at Day 1 and 7)
Time frame: At Day 0 (pre-rinse, pre, mid and post implant surgery), Day 1 and 7
Area Under the Curve (AUC) for the Total Number of Plaque Bacteria in the Mouth Post Implant Surgery
Time frame: Up to 7 days post implant surgery
Total Number of Recoverable Viable Bacteria in the Aerosol Generated During Dental Prophylaxis
Time frame: At Baseline

Results and safety

Results posted to the registry on 17 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Test and Reference Product	19	19
Reference Product	19	17

Primary outcome: Total Number of Detectable Plaque Bacteria Sampled 3 Days Post Implant Surgery

Time frame: At Day 3. Mean (Standard Deviation). Unit: log(10) colony forming equivalents (CFE)

Measure	Test and Reference Product n = 19	Reference Product n = 19
Value	7.63 (0.501)	7.43 (0.598)

Test and Reference Product vs Reference Product: Least square (LS) Mean difference: 0.20 (95% CI -0.18 to 0.58), p = 0.2965, ANCOVA

Population analysed: Intent to treat (ITT) population (N=38): defined as all the participants who were randomised, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test and Reference Product	0 of 19 (0%)	17 of 19 (89.5%)	Not reported
Reference Product	0 of 19 (0%)	18 of 19 (94.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Number of Detectable Plaque Bacteria Sampled 3 Days Post Implant Surgery (time frame: At Day 3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02319668.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2017; AzTrials last refreshed its copy on 8 Nov 2026.