GingivitisPhase 4NCT01751178

An Efficacy Study of Chlorhexidine Mouthwashes

A Phase 4 study testing Chlorhexidine Digluconate Mouthwash with Alcohol and Chlorhexidine Digluconate Mouthwash without Alcohol in people with Gingivitis, run by GlaxoSmithKline at 3 sites 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

The aim of this study is to compare subject gingival health after 6 weeks of twice daily use of a non-alcohol or alcohol containing mouthrinse and brushing compared to brushing only. Read more about this study

Who is it for?: Ages 18 to 64 yearsHealthy volunteers can take part
Conditions the study is for: Gingivitis
What is being tested?: Chlorhexidine Digluconate Mouthwash with Alcohol and Chlorhexidine Digluconate Mouthwash without Alcohol
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 324 participants
Where: 3 sitesUnited Kingdom
Study dates: Oct 2012to Mar 2013
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

Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or oral/ dental examination.
5. a) Good oral health in the opinion of the investigator (allowing mild to moderate gingivitis to meet entry criteria).
A minimum of 20 permanent gradable teeth at screening. (Gradable teeth are those where restorative materials cover less than 25% of the tooth surface graded).
Mild to moderate gingivitis present at the screening visit in the opinion of the investigator.
Positive response to bleeding on brushing exercise at screening visit. e) A total of 20 bleeding sites or greater at baseline visit.

Who cannot join

Known or suspected intolerance or hypersensitivity to Chlorhexidine or other study materials (or closely related compounds) or any of their stated ingredients.
5. a) Current or relevant history of any serious, severe or unstable physical or psychiatric illness or any other medical condition (e.g. Diabetes Mellitus) that would make the subject unlikely to fully complete the study or any that increases the risk to the subject or undermines the data validity.
Subjects requiring prophylactic antibiotic treatment prior to dental therapy.
Use of concomitant medication that, in the opinion of the investigator, might interfere with the outcome of the study or increases the risk to the subject (eg: phenytoin, calcium antagonists, cyclosporine, warfarin, antibiotics, immuno-suppressants).
Use of antibiotics within two weeks prior to the screening visit or throughout the study.
Use of any systemic medication which would have an effect on gingival conditions within 14 days of gingival examinations (eg: ibuprofen or aspirin therapy) 6. a) Have current active caries b) More than 3 pockets with 5mm or over. c) Excessive calculus present that interferes with the probing examination for Gingival Index.

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Other severe oral/ gingival conditions (e.g. Acute Necrotizing Ulcerative Gingivitis) that may compromise the study or the subjects in the opinion of the investigator or gingivitis examiner.
Medical conditions which may directly influence gingival bleeding. f) Restorations in a poor state of repair. g) Orthodontic appliances anterior cosmetic restorations and veneers. h) Enamel pitting/irregularities. 7. Subjects using chewing tobacco, pan, pan-masala, gutkha or other chewing tobacco products or subjects who have quit using any of those within the past six months prior to screening.
8. b) An employee of any toothpaste manufacturer or their immediate family.

Trial locations and contacts

3 sites in 1 country.

United Kingdom3 sites

4Front, Ellesmere Port
Cheshire, CH65 4BW
Intertek - Manchester Science Park
Manchester, M15 6SE
Intertek 4-Front Research - Widnes
Widnes, Cheshire, WA8 6PG

Other trials in United Kingdom

About this study

Official title: Clinical Study to Evaluate the Efficacy of Chlorhexidine Mouthwashes

The aim of this study is to compare subject gingival health after 6 weeks of twice daily use of a non-alcohol or alcohol containing mouthrinse and brushing compared to brushing only.

Conditions: Gingivitis
Being tested: Chlorhexidine Digluconate Mouthwash with Alcohol, Chlorhexidine Digluconate Mouthwash without Alcohol
Medical subject headings: Gingivitis

What participants receive

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

Chlorhexidine Digluconate Mouthwash with AlcoholDrug
0.2% w/v Chlorhexidine Digluconate, alcohol containing - UK Marketed Mouthwash
Chlorhexidine Digluconate Mouthwash without AlcoholDrug
0.2% w/v Chlorhexidine Digluconate, without alcohol - UK Marketed Mouthwash

Study groups in NCT01751178
Study group	Role	What they receive
Mouthwash with Alcohol	Active comparator	rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash with alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute. Receives: Drug: Chlorhexidine Digluconate Mouthwash with Alcohol
Mouthwash without Alcohol	Active comparator	rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash without alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute. Receives: Drug: Chlorhexidine Digluconate Mouthwash without Alcohol

What is being measured

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

Gingival Severity Index (GSI) Based on the Gingival Index (GI)
Measure of gingival severity averaged across whole mouth site; each site scored 0, 1, 2, 3 based on GI and,
1. GSI = 0 if GI is 0 or 1 (no bleeding)
2. GSI = 1 if GI is 1 or 2 (bleeding)
Measured: Change from baseline to 6 weeks

Secondary outcomes (3)

Gingival Index
The GI was assessed on the facial and lingual surfaces at six sites on each tooth (facial and lingual - distal papillae, margin and mesial papillae). These assessments were performed on all evaluable teeth using moderate pressure sweeping a blunt ended probe, which was engaged in approximately 1 millimetre (mm) into the gingival crevice. The scores could range from 0-3 (0=Absence of inflammation; 1=Mild Inflammation-Slight change in color slight change in texture, no bleeding on probing; 2=Moderate Inflammation -glazing, redness edema and hypertrophy, bleeding on probing; 3= Severe inflammation-marked redness and hypertrophy, tendency for spontaneous bleeding)
Measured: Change from baseline to 6 weeks
Turesky Modification of Quigley & Hein Plaque Index for Overall Plaque Scores
Overall plaque scores were calculated taking the average over all tooth sites for a participant. The scores could range from 0-5 (0=No plaque; 1=Slight flecks of plaque at the cervical margin of the tooth; 2= A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth; 3=A band of plaque wider than 1 mm but covering less than 1/3 of the area to be graded of the crown of the tooth; 4=Plaque covering at least 1/3 but less than 2/3 of the area to be graded of the crown of the tooth; 5=Plaque covering 2/3 or more of the area to be graded of the crown of the tooth)
Measured: Change from baseline to 6 weeks
Turesky Modification of Quigley & Hein Plaque Index for Interproximal Plaque Scores
Interproximal plaque scores were analyzed on the mesiofacial, distofacial, mesiolingual and distolingual surfaces, and calculated taking the average over all tooth sites for a participant. The scores could range from 0-5 (0=No plaque; 1=Slight flecks of plaque at the cervical margin of the tooth; 2= A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth; 3=A band of plaque wider than 1 mm but covering less than 1/3 of the area to be graded of the crown of the tooth; 4=Plaque covering at least 1/3 but less than 2/3 of the area to be graded of the crown of the tooth; 5=Plaque covering 2/3 or more of the area to be graded of the crown of the tooth)
Measured: Change from baseline to 6 weeks

Timeline

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

Oct 2012Mar 2013

First posted17 Dec 2012 (estimated)
Study startOct 2012
Primary completionMar 2013
Study completionMar 2013

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 GingivitisStudies 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 324 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01751178
Sponsor's protocol ID: RH01561
Status last verified: Jun 2014
First submitted: 13 Dec 2012
Last updated: 28 Jul 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitation
Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolerance in People With Gingivitis
Microbiome, Cytokines
Active, not recruitingPhase 3
A Study to Assess the Efficacy of Two Brushing Regimens in the Reduction of Established Dental Plaque and Gingivitis
Plaque, Gingivitis
Not yet recruiting
Effectiveness of Personalized Digital Oral Health Intervention in Patients With Fixed Orthodontic Appliances.
Oral Hygiene in Patients With Fixed Orthodontic Appliances, Dental Plaque
Not yet recruitingPhase 2
Efficacy of Thymus Vulgaris Mouthwash in the Management of Biofilm-Induced Gingivitis
Plaque-Induced Gingivitis
Not yet recruitingPhase 3
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Preterm Birth, Low Birth Weight

All Gingivitis trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Study to Evaluate the Efficacy of Chlorhexidine Mouthwashes
ClinicalTrials.gov ID: NCT01751178
Acronym / sponsor ID: RH01561
Conditions: Gingivitis
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 324 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Oct 2012
Primary completion: Mar 2013 (actual)
Study completion: Mar 2013 (actual)
First posted: 17 Dec 2012 (estimated)
Results: Posted 28 Jul 2014

Clinical summary

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

The aim of this study is to compare subject gingival health after 6 weeks of twice daily use of a non-alcohol or alcohol containing mouthrinse and brushing compared to brushing only.

Study design

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

Arm	Type	Receives
Mouthwash with Alcohol	Active comparator	Drug: Chlorhexidine Digluconate Mouthwash with Alcoholrinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash with alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
Mouthwash without Alcohol	Active comparator	Drug: Chlorhexidine Digluconate Mouthwash without Alcoholrinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash without alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.

Who may qualify

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

Key inclusion criteria (5 listed)

Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or oral/ dental examination.
5. a) Good oral health in the opinion of the investigator (allowing mild to moderate gingivitis to meet entry criteria).

Key exclusion criteria (9 listed)

Known or suspected intolerance or hypersensitivity to Chlorhexidine or other study materials (or closely related compounds) or any of their stated ingredients.
5. a) Current or relevant history of any serious, severe or unstable physical or psychiatric illness or any other medical condition (e.g. Diabetes Mellitus) that would make the subject unlikely to fully complete the study or any that increases the risk to the subject or undermines the data validity.
8. b) An employee of any toothpaste manufacturer or their immediate family.

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
Chlorhexidine Digluconate Mouthwash with Alcohol0.2% w/v Chlorhexidine Digluconate, alcohol containing - UK Marketed Mouthwash	Drug	Mouthwash with Alcohol
Chlorhexidine Digluconate Mouthwash without Alcohol0.2% w/v Chlorhexidine Digluconate, without alcohol - UK Marketed Mouthwash	Drug	Mouthwash without Alcohol

Primary outcome

Gingival Severity Index (GSI) Based on the Gingival Index (GI)
Time frame: Change from baseline to 6 weeks
Measure of gingival severity averaged across whole mouth site; each site scored 0, 1, 2, 3 based on GI and, 1. GSI = 0 if GI is 0 or 1 (no bleeding) 2. GSI = 1 if GI is 1 or 2 (bleeding)

3 secondary outcomes

Gingival Index
Time frame: Change from baseline to 6 weeks
Turesky Modification of Quigley & Hein Plaque Index for Overall Plaque Scores
Time frame: Change from baseline to 6 weeks
Turesky Modification of Quigley & Hein Plaque Index for Interproximal Plaque Scores
Time frame: Change from baseline to 6 weeks

Results and safety

Results posted to the registry on 28 Jul 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Mouthwash With Alcohol	108	105
Mouthwash Without Alcohol	109	109
Reference	107	105

Primary outcome: Gingival Severity Index (GSI) Based on the Gingival Index (GI)

Time frame: Change from baseline to 6 weeks. Mean (Standard Error). Unit: Units on a scale

Measure	Mouthwash With Alcohol n = 105	Mouthwash Without Alcohol n = 109	Reference n = 105
Value	0.152 (0.0085)	0.143 (0.0072)	0.212 (0.0121)

Mouthwash With Alcohol vs Reference: Adjusted Mean Difference: -0.061 (95% CI -0.081 to -0.041), p <0.0001, ANCOVA
Mouthwash Without Alcohol vs Reference: Adjusted Mean Difference: -0.070 (95% CI -0.090 to -0.050), p <0.0001, ANCOVA

Population analysed: This analysis was conducted on the Intent-to-Treat (ITT) population, defined as those subjects who received study treatment and had at least one post-baseline efficacy measurement.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mouthwash With Alcohol	0 of 108 (0%)	67 of 108 (62%)	Not reported
Mouthwash Without Alcohol	1 of 109 (0.9%)	60 of 109 (55%)	Not reported
Reference	0 of 107 (0%)	47 of 107 (43.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Gingivitis

Enrolling by invitation
Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolerance in People With Gingivitis
Microbiome, Cytokines
Active, not recruitingPhase 3
A Study to Assess the Efficacy of Two Brushing Regimens in the Reduction of Established Dental Plaque and Gingivitis
Plaque, Gingivitis
Not yet recruiting
Effectiveness of Personalized Digital Oral Health Intervention in Patients With Fixed Orthodontic Appliances.
Oral Hygiene in Patients With Fixed Orthodontic Appliances, Dental Plaque
Not yet recruitingPhase 2
Efficacy of Thymus Vulgaris Mouthwash in the Management of Biofilm-Induced Gingivitis
Plaque-Induced Gingivitis
Not yet recruitingPhase 3
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Preterm Birth, Low Birth Weight

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

3 sites 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 5 inclusion and 9 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 28 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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. 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 28 Jul 2014). 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?

Gingival Severity Index (GSI) Based on the Gingival Index (GI) (time frame: Change from baseline to 6 weeks). 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 NCT01751178.

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 28 Jul 2014.