GingivitisNCT05654662
A Clinical Study Investigating the Effects of a Dentifrice Containing 67% Sodium Bicarbonate When Used Twice Daily for 12 Weeks on Gingivitis Treatment and Plaque Removal
A study testing Corsodyl Original Dentifrice and Colgate Cavity Protection Dentifrice in people with Gingivitis and Dental Plaque, run by HALEON at 1 site in United Kingdom.
Trial summary
The main goal of this study is to evaluate and compare the efficacy of an on-market dentifrice containing 67 percent (%) sodium bicarbonate and 0.31% sodium fluoride to a reference regular fluoride dentifrice on treating gingival bleeding and gingival inflammation as well as reducing plaque accumulation in population… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingivitis, Dental Plaque
- What is being tested?
- Corsodyl Original Dentifrice and Colgate Cavity Protection Dentifrice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 197 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Feb 2023to 30 Nov 2023
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant provision of a signed and dated informed consent document indicating that the Participant has been informed of all pertinent aspects of the study before any assessment is performed.
- Participant who is willing and able to comply with scheduled visits, treatment plan, and other study procedures.
- A Participant in good general and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant/relevant abnormalities in medical history or upon oral examination, or condition, that would impact the Participant's safety, wellbeing or the outcome of the study, if they were to participate in the study, or affect the individual's ability to understand and follow study procedures and requirements.
- Participant oral health that meets all the following:
- At Screening (Visit 1):
- Participant with at least 20 natural, permanent teeth.
Show all 12Show fewer
- Participant with at least 40 evaluable surfaces for MGI, BI, and TPI (An evaluable surface is defined as having 2/3rds of the natural tooth surface gradable for the selected clinical indices. The following should not be included in the evaluable surface count- third molars; fully crowned/extensively restored, grossly carious, orthodontically banded/bonded or abutment teeth; surfaces with calculus deposits which, in the opinion of the clinical examiner, would interfere with the baseline assessments of the selected clinical indices).
- A participant with plaque-induced gingivitis, in the opinion of the clinical examiner, as confirmed by a gross visual examination at the Screening Visit.
- At Baseline (Visit 2):
- A participant with ongoing hard tissue eligibility and, in the opinion of the clinical examiner, at least 40 evaluable surfaces.
- A participant with 10% less than (<) bleeding on probing (BOP) < 30%.
- A participant with mean whole mouth TPI score more than or equal to (>=)1.5.
Who cannot join
- A participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or, a sponsor's employee directly involved in the conduct of the study or a member of their immediate family.
- A participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to study entry and/or during study participation.
- A participant with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study.
- A participant who has any other clinical serious or unstable conditions (such as, cardiovascular diseases, diabetes, liver disorders, and kidney disorders) which could have affected study out comes and/or participant safety.
- A participant who is a pregnant female (self-reported) or is intending to become pregnant over the duration of the study.
- A participant who is a breastfeeding female.
Show all 40Show fewer
- A participant who is known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- A participant who is unwilling or unable to comply with the lifestyle considerations.
- Participant who is a current smoker or an ex-smoker who stopped within 6 months of Screening.
- Participant who is using smokeless forms of tobacco (such as, chewing tobacco, gutkha, pan containing tobacco, nicotine-based e-cigarettes).
- A participant who is diagnosed xerostomia or is taking any medication that in the view of the investigator is causing xerostomia.
- A participant who has a medical condition which could have directly influenced gingival bleeding.
- A participant who has a bleeding disorder that could have affected study outcomes and/or participant safety.
- A participant who has a recent history (within the last year) of alcohol or other substance abuse.
- A participant who has a severe oral condition (such as, acute necrotizing ulcerative gingivitis or oral or peri-oral ulceration including herpetic lesions) that could, in the opinion of the investigator, compromise study outcomes or the oral health of the participant/examiner if they participate in the study.
- Presence of a tongue or lip piercing, or any other oral feature that could interfere with the usage of a toothbrush.
- Medication Exclusions At Screening (Visit 1):
- A participant using any antibiotic medication within 14 days prior to screening or at any time during the study.
- A participant currently taking an anti-inflammatory medication which, in the opinion of the Investigator, could affect gingival condition.
- A participant currently taking a systemic medication (such as, anti-inflammatory, anticoagulant, immunosuppressants) or traditional/ herbal remedy which, in the opinion of the Investigator, could affect plaque/ gingival condition (such as, ibuprofen, aspirin, warfarin, cyclosporin, phenytoin, calcium channel blockers).
- Medication Exclusions at Baseline (visit 2):
- A participant who has taken (in the previous 14 days), any antibiotics.
- A participant who has taken (in the previous 14 days) a systemic medication (such as, anti-inflammatory, anti-coagulant, immunosuppressants) or traditional/ herbal remedy which, in the opinion of the Investigator, could affect plaque/ gingival condition (such as, ibuprofen, aspirin, warfarin, cyclosporin, phenytoin, calcium channel blockers).
- A participant who has used an antibacterial dentifrice or mouthwash (such as, chlorhexidine) or any oral care product that in the view of the investigator could interfere with plaque formation or measures of gingivitis, in the period between Screening and the Baseline visit.
- Periodontal Exclusions
- A participant who shows signs of periodontitis (one or more sites with probing pocket depths more than [>] 3 mm).
- A participant who is receiving or has received treatment for periodontal disease (including surgery) within 12 months of Screening.
- A participant who has gingivitis, which in the opinion of the investigator, is not expected to respond to treatment with an over the counter (OTC) dentifrice.
- Dental Exclusions
- A participant who has active caries that could, in the opinion of the investigator, compromise study outcomes or the oral health of the participant if they participate in the study.
- A participant who has dentures (partial or full).
- A participant who has an orthodontic appliance (bands, appliances, or fixed/ removable retainers).
- A participant who received orthodontic therapy within 3 months of Screening.
- A participant who has numerous restorations in a poor state of repair.
- A participant who has any dental condition (such as, overcrowding) that could, in the opinion of the investigator, compromise study outcomes or the oral health of the participant if they participate in the study.
- A participant who has had dental prophylaxis within 12 weeks of Screening.
- A participant who has had teeth bleaching within 12 weeks of Screening.
- A participant who has high levels of extrinsic stain or calculus deposits, in the opinion of the investigator, that could have interfered with plaque assessments.
- A participant who has previously been enrolled in this study.
- A participant who, in the opinion of the investigator or medically qualified designee, should not participate in the study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Bristol, Bristol Dental School and Hospital
Bristol, BS1 2LY
About this study
Official title: A Randomized, Controlled, Examiner-Blind Clinical Study Investigating the Effects of a Dentifrice Containing 67% Sodium Bicarbonate When Used Twice Daily for 12 Weeks on Gingivitis Treatment and Plaque Removal
The main goal of this study is to evaluate and compare the efficacy of an on-market dentifrice containing 67 percent (%) sodium bicarbonate and 0.31% sodium fluoride to a reference regular fluoride dentifrice on treating gingival bleeding and gingival inflammation as well as reducing plaque accumulation in population with gingivitis after 12 weeks use.
Read the detailed description
This will be a single center, controlled, single blind (examiner blind), randomized, two treatment arm, parallel study in volunteers with clinically measurable levels of gingivitis (defined as those with 10-30% bleeding sites on probing). Approximately 200 participants (100 per group) will be randomized to ensure 188 evaluable participants (94 per group) complete the study.
- Conditions
- Gingivitis, Dental Plaque
- Being tested
- Corsodyl Original Dentifrice, Colgate Cavity Protection Dentifrice
- Medical subject headings
- Gingivitis, Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corsodyl Original DentifriceDrug
It contains 67% weight/weight (w/w) Sodium Bicarbonate and 0.310% w/w Sodium Fluoride (1400 parts per million [ppm] Fluoride ion [F])
Colgate Cavity Protection DentifriceDrug
It contains 0.76% w/w Sodium Monofluorophosphate (1000 ppm F) and 0.1% w/w Sodium Fluoride (450 ppm F)
| Study group | Role | What they receive |
|---|---|---|
| Corsodyl Original Dentifrice | Experimental | Participants will be instructed to brush their teeth using test product for at least a minute twice a day (morning and evening) for 12 weeks. Participants will dose the toothbrush provided with a ribbon of paste to cover the brush head (a full brush head) on each brushing occasion. Receives: Drug: Corsodyl Original Dentifrice |
| Colgate Cavity Protection Dentifrice | Active comparator | Participants will be instructed to brush their teeth using reference product for at least a minute twice a day (morning and evening) for 12 weeks. Participants will dose the toothbrush provided with a ribbon of paste to cover the brush head (a full brush head) on each brushing occasion. Receives: Drug: Colgate Cavity Protection Dentifrice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adjusted Mean Change From Baseline in Number of Bleeding Sites at Week 12
The number of bleeding sites was calculated using the bleeding index (BI) assessment. The BI was assessed for all evaluable surfaces (having two-thirds of the natural tooth surface gradable for the assessment) of the facial and lingual/palatal gingiva, 6 sites per tooth (mesiobuccal, buccal, and distobuccal; mesiolingual/palatal, lingual/palatal, and distolingual/palatal). Evaluable tooth sites were probed, and gingival bleeding was assessed for approximately 30 seconds after probing. The number of bleeding sites for each participant was calculated as the number of evaluable tooth sites with bleeding observed immediately on probing or within 30 seconds of probing. Change from Baseline was calculated by subtracting the Baseline value from the value at Week 12. Baseline was defined as Day 0. A negative change from Baseline indicated improvement in gingival bleeding.
Measured: Baseline and Week 12
Secondary outcomes (11)
Adjusted Mean Change From Baseline in Number of Bleeding Sites at Week 12 (Test Product Versus [vs.] Reference Product)
The number of bleeding sites was calculated using the BI assessment. The BI was assessed for all evaluable surfaces (having two-thirds of the natural tooth surface gradable for the assessment) of the facial and lingual/palatal gingiva, 6 sites per tooth (mesiobuccal, buccal, and distobuccal; mesiolingual/palatal, lingual/palatal, and distolingual/palatal). Evaluable tooth sites were probed, and gingival bleeding was assessed for approximately 30 seconds after probing. The number of bleeding sites for each participant was calculated as the number of evaluable tooth sites with bleeding observed immediately on probing or within 30 seconds of probing. Change from Baseline was calculated by subtracting the Baseline value from the value at Week 12. Baseline was defined as Day 0. A negative change from Baseline indicated improvement in gingival bleeding.
Measured: Baseline and Week 12
Adjusted Mean Change From Baseline in Number of Bleeding Sites at Week 3 and Week 6
The number of bleeding sites was calculated using the BI assessment. The BI was assessed for all evaluable surfaces (having two-thirds of the natural tooth surface gradable for the assessment) of the facial and lingual/palatal gingiva, 6 sites per tooth (mesiobuccal, buccal, and distobuccal; mesiolingual/palatal, lingual/palatal, and distolingual/palatal). Evaluable tooth sites were probed, and gingival bleeding was assessed for approximately 30 seconds after probing. The number of bleeding sites for each participant was calculated as the number of evaluable tooth sites with bleeding observed immediately on probing or within 30 seconds of probing. Change from Baseline was calculated by subtracting the Baseline value from the value at each indicated timepoint. Baseline was defined as Day 0. A negative change from Baseline indicated improvement in gingival bleeding.
Measured: Baseline, Week 3, and Week 6
Adjusted Mean Change From Baseline in Number of Bleeding Sites at Week 3 and Week 6 (Test Product vs. Reference Product)
The number of bleeding sites was calculated using the BI assessment. The BI was assessed for all evaluable surfaces (having two-thirds of the natural tooth surface gradable for the assessment) of the facial and lingual/palatal gingiva, 6 sites per tooth (mesiobuccal, buccal, and distobuccal; mesiolingual/palatal, lingual/palatal, and distolingual/palatal). Evaluable tooth sites were probed, and gingival bleeding was assessed for approximately 30 seconds after probing. The number of bleeding sites for each participant was calculated as the number of evaluable tooth sites with bleeding observed immediately on probing or within 30 seconds of probing. Change from Baseline was calculated by subtracting the Baseline value from the value at each indicated timepoint. Baseline was defined as Day 0. A negative change from Baseline indicated improvement in gingival bleeding.
Measured: Baseline, Week 3, and Week 6
Adjusted Mean Change From Baseline in Mean BI at Weeks 3, 6 and 12
The BI was assessed for all evaluable surfaces (having two-thirds of the natural tooth surface gradable for the assessment) of the facial and lingual/palatal gingiva, 6 sites per tooth (mesiobuccal, buccal, and distobuccal; mesiolingual/palatal, lingual/palatal, and distolingual/palatal). Evaluable tooth sites were probed, and gingival bleeding was assessed for approximately 30 seconds after probing and scored on a 3-point scale ranging from 0 to 2, where 0=No bleeding after 30 seconds; 1=Bleeding observed within 30 seconds of probing; 2=Bleeding observed immediately on probing. Mean BI was calculated by taking the average over all tooth sites assessed for a participant. Lower score indicated better outcome. Change from Baseline was calculated by subtracting the Baseline value from the value at each indicated timepoint. Baseline was defined as Day 0. A negative change from Baseline indicated improvement in gingival bleeding.
Measured: Baseline, Weeks 3, 6 and 12
Adjusted Mean Change From Baseline in Mean BI at Weeks 3, 6 and 12 (Test Product vs. Reference Product)
The BI was assessed for all evaluable surfaces (having two-thirds of the natural tooth surface gradable for the assessment) of the facial and lingual/palatal gingiva, 6 sites per tooth (mesiobuccal, buccal, and distobuccal; mesiolingual/palatal, lingual/palatal, and distolingual/palatal). Evaluable tooth sites were probed, and gingival bleeding was assessed for approximately 30 seconds after probing and scored on a 3-point scale ranging from 0 to 2, where 0=No bleeding after 30 seconds; 1=Bleeding observed within 30 seconds of probing; 2=Bleeding observed immediately on probing. Mean BI was calculated by taking the average over all tooth sites assessed for a participant. Lower score indicated better outcome. Change from Baseline was calculated by subtracting the Baseline value from the value at each indicated timepoint. Baseline was defined as Day 0. A negative change from Baseline indicated improvement in gingival bleeding.
Measured: Baseline, Weeks 3, 6 and 12
Adjusted Mean Change From Baseline in Mean Mean Modified Gingival Index (MGI) at Weeks 3, 6 and 12
MGI assessment is a non-invasive evaluation which focuses on visual symptoms of gingivitis (example, redness, texture, edema). MGI was assessed for all evaluable surfaces of facial and lingual/palatal gingiva,4 sites per tooth and scored on a 5-point scale ranging from 0 to 4, where 0=Absence of inflammation;1=Mild inflammation;slight change in color,little change in color;little change in texture of any portion of marginal or papillary gingival unit;2=Mild inflammation; criteria as 1 but involving the entire marginal or papillary gingival unit;3=Moderate inflammation;glazing, redness, edema, and/or hypertrophy of marginal or papillary gingival unit;4= Severe inflammation;marked redness, edema and/or hypertrophy of marginal or papillary gingival unit,spontaneous bleeding, congestion, or ulceration. Lower score indicated better outcome. Change from Baseline=Value at each indicated timepoint minus Baseline [Day 0] value. A negative change from Baseline indicated improvement in symptoms.
Measured: Baseline, Weeks 3, 6 and 12
Adjusted Mean Change From Baseline in Mean MGI at Weeks 3, 6 and 12 (Test Product vs. Reference Product)
MGI assessment is a non-invasive evaluation which focuses on visual symptoms of gingivitis (example, redness, texture, edema). MGI was assessed for all evaluable surfaces of facial and lingual/palatal gingiva,4 sites per tooth and scored on a 5-point scale ranging from 0 to 4, where 0=Absence of inflammation;1=Mild inflammation;slight change in color,little change in color;little change in texture of any portion of marginal or papillary gingival unit;2=Mild inflammation; criteria as 1 but involving the entire marginal or papillary gingival unit;3=Moderate inflammation;glazing, redness, edema, and/or hypertrophy of marginal or papillary gingival unit;4= Severe inflammation;marked redness, edema and/or hypertrophy of marginal or papillary gingival unit,spontaneous bleeding, congestion, or ulceration. Lower score indicated better outcome. Change from Baseline=Value at each indicated timepoint minus Baseline [Day 0] value. A negative change from Baseline indicated improvement in symptoms.
Measured: Baseline, Weeks 3, 6 and 12
Adjusted Mean Change From Baseline in Mean Overall TPI (Turesky Plaque Index) at Weeks 3, 6 and 12
TPI was used to assess plaque on the facial and lingual surfaces of each scorable tooth (7-7 in each arch). 3 scores were recorded facially(distal, body, mesial sites), and 3 scores were recorded lingually(distal, body, mesial sites). Plaque was first disclosed using a dye solution and scored on a 6-point scale ranging from 0 to 5, where 0=No plaque; 1=Separate flecks of plaque at the cervical margin; 2=Thin continuous band of plaque (up to 1 millimeter[mm]) at the cervical margin; 3=Band of plaque wider than 1 mm but covering less than (<)1/3 of the tooth surface; 4=Plaque covering greater than or equal to (>=)1/3 but <2/3 of the tooth surface; 5=Plaque covering >=2/3 of the tooth surface. Mean overall TPI score=Average of TPI values over all tooth sites assessed for a participant. Lower score=better outcome. Change from Baseline=Value at each indicated timepoint minus Baseline value. Baseline=Day 0. A negative change from Baseline indicated improvement (less plaque accumulation).
Measured: Baseline, Weeks 3, 6 and 12
Adjusted Mean Change From Baseline in Mean Overall TPI at Weeks 3, 6 and 12 (Test Product vs. Reference Product)
TPI was used to assess plaque on the facial and lingual surfaces of each scorable tooth (7-7 in each arch). 3 scores were recorded facially (distal, body, mesial sites), and 3 scores were recorded lingually (distal, body, mesial sites). Plaque was first disclosed using a dye solution and scored on a 6-point scale ranging from 0 to 5, where 0=No plaque; 1=Separate flecks of plaque at the cervical margin; 2=Thin continuous band of plaque (up to 1 mm) at the cervical margin; 3=Band of plaque wider than 1 mm but covering <1/3 of the tooth surface; 4=Plaque covering >=1/3 but <2/3 of the tooth surface; 5=Plaque covering >=2/3 of the tooth surface. Mean overall TPI score=Average of TPI values over all tooth sites assessed for a participant. Lower score=better outcome. Change from Baseline=Value at each indicated timepoint minus Baseline value. Baseline=Day 0. A negative change from Baseline indicated improvement (less plaque accumulation).
Measured: Baseline, Weeks 3, 6 and 12
Adjusted Mean Change From Baseline in Mean Interproximal TPI at Weeks 3, 6 and 12
TPI was used to assess plaque on the facial and lingual surfaces of each scorable tooth (7-7 in each arch). 3 scores were recorded facially (distal, mesial sites), and 3 scores were recorded lingually (distal, mesial sites). Plaque was first disclosed using a dye solution and scored on a 6-point scale ranging from 0 to 5, where 0=No plaque; 1=Separate flecks of plaque at the cervical margin; 2=Thin continuous band of plaque (up to 1 mm) at the cervical margin; 3=Band of plaque wider than 1 mm but covering <1/3 of the tooth surface; 4=Plaque covering >=1/3 but <2/3 of the tooth surface; 5=Plaque covering >=2/3 of the tooth surface. Mean interproximal TPI score=Average of TPI values over distal and mesial tooth sites assessed for a participant. Lower score indicated better outcome. Change from Baseline=Value at each indicated timepoint minus Baseline value. Baseline=Day 0. A negative change from Baseline indicated improvement (less plaque accumulation).
Measured: Baseline, Weeks 3, 6 and 12
Adjusted Mean Change From Baseline in Mean Interproximal TPI at Weeks 3, 6 and 12 (Test Product vs. Reference Product)
TPI was used to assess plaque on the facial and lingual surfaces of each scorable tooth (7-7 in each arch). 3 scores were recorded facially (distal, mesial sites), and 3 scores were recorded lingually (distal, mesial sites). Plaque was first disclosed using a dye solution and scored on a 6-point scale ranging from 0 to 5, where 0=No plaque; 1=Separate flecks of plaque at the cervical margin; 2=Thin continuous band of plaque (up to 1 mm) at the cervical margin; 3=Band of plaque wider than 1 mm but covering <1/3 of the tooth surface; 4=Plaque covering >=1/3 but <2/3 of the tooth surface; 5=Plaque covering >=2/3 of the tooth surface. Mean interproximal TPI score=Average of TPI values over distal and mesial tooth sites assessed for a participant. Lower score indicated better outcome. Change from Baseline=Value at each indicated timepoint minus Baseline value. Baseline=Day 0. A negative change from Baseline indicated improvement (less plaque accumulation).
Measured: Baseline, Weeks 3, 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start20 Feb 2023
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
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 HALEONThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- HALEON
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05654662
- Sponsor's protocol ID
- 300029
- Status last verified
- Nov 2024
- First submitted
- 8 Dec 2022
- Last updated
- 13 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trial-register@haleon.com
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Examiner-Blind Clinical Study Investigating the Effects of a Dentifrice Containing 67% Sodium Bicarbonate When Used Twice Daily for 12 Weeks on Gingivitis Treatment and Plaque Removal
- ClinicalTrials.gov ID
- NCT05654662
- Acronym / sponsor ID
- 300029
- Conditions
- Gingivitis, Dental Plaque
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- HALEONIndustry (pharma, biotech, devices)
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 16 Dec 2022 (actual)
- Results
- Posted 13 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main goal of this study is to evaluate and compare the efficacy of an on-market dentifrice containing 67 percent (%) sodium bicarbonate and 0.31% sodium fluoride to a reference regular fluoride dentifrice on treating gingival bleeding and gingival inflammation as well as reducing plaque accumulation in population with gingivitis after 12 weeks use.
Detailed description
This will be a single center, controlled, single blind (examiner blind), randomized, two treatment arm, parallel study in volunteers with clinically measurable levels of gingivitis (defined as those with 10-30% bleeding sites on probing). Approximately 200 participants (100 per group) will be randomized to ensure 188 evaluable participants (94 per group) complete the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Corsodyl Original Dentifrice | Experimental | Drug: Corsodyl Original DentifriceParticipants will be instructed to brush their teeth using test product for at least a minute twice a day (morning and evening) for 12 weeks. Participants will dose the toothbrush provided with a ribbon of paste to cover the brush head (a full brush head) on each brushing occasion. |
| Colgate Cavity Protection Dentifrice | Active comparator | Drug: Colgate Cavity Protection DentifriceParticipants will be instructed to brush their teeth using reference product for at least a minute twice a day (morning and evening) for 12 weeks. Participants will dose the toothbrush provided with a ribbon of paste to cover the brush head (a full brush head) on each brushing occasion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Participant provision of a signed and dated informed consent document indicating that the Participant has been informed of all pertinent aspects of the study before any assessment is performed.
- Participant who is willing and able to comply with scheduled visits, treatment plan, and other study procedures.
- A Participant in good general and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant/relevant abnormalities in medical history or upon oral examination, or condition, that would impact the Participant's safety, wellbeing or the outcome of the study, if they were to participate in the study, or affect the individual's ability to understand and follow study procedures and requirements.
- Participant oral health that meets all the following:
- Participant with at least 20 natural, permanent teeth.
Key exclusion criteria (40 listed)
- A participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or, a sponsor's employee directly involved in the conduct of the study or a member of their immediate family.
- A participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to study entry and/or during study participation.
- A participant with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study.
- A participant who has any other clinical serious or unstable conditions (such as, cardiovascular diseases, diabetes, liver disorders, and kidney disorders) which could have affected study out comes and/or participant safety.
- A participant who is a pregnant female (self-reported) or is intending to become pregnant over the duration of the 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 |
|---|---|---|
| Corsodyl Original DentifriceIt contains 67% weight/weight (w/w) Sodium Bicarbonate and 0.310% w/w Sodium Fluoride (1400 parts per million [ppm] Fluoride ion [F]) | Drug | Corsodyl Original Dentifrice |
| Colgate Cavity Protection DentifriceIt contains 0.76% w/w Sodium Monofluorophosphate (1000 ppm F) and 0.1% w/w Sodium Fluoride (450 ppm F) | Drug | Colgate Cavity Protection Dentifrice |
Primary outcome
Adjusted Mean Change From Baseline in Number of Bleeding Sites at Week 12
Time frame: Baseline and Week 12
The number of bleeding sites was calculated using the bleeding index (BI) assessment. The BI was assessed for all evaluable surfaces (having two-thirds of the natural tooth surface gradable for the assessment) of the facial and lingual/palatal gingiva, 6 sites per tooth (mesiobuccal, buccal, and distobuccal; mesiolingual/palatal, lingual/palatal, and distolingual/palatal). Evaluable tooth sites were probed, and gingival bleeding was assessed for approximately 30 seconds after probing. The number of bleeding sites for each participant was calculated as the number of evaluable tooth sites with bleeding observed immediately on probing or within 30 seconds of probing. Change from Baseline was calculated by subtracting the Baseline value from the value at Week 12. Baseline was defined as Day 0. A negative change from Baseline indicated improvement in gingival bleeding.
11 secondary outcomes
Adjusted Mean Change From Baseline in Number of Bleeding Sites at Week 12 (Test Product Versus [vs.] Reference Product)
Time frame: Baseline and Week 12
Adjusted Mean Change From Baseline in Number of Bleeding Sites at Week 3 and Week 6
Time frame: Baseline, Week 3, and Week 6
Adjusted Mean Change From Baseline in Number of Bleeding Sites at Week 3 and Week 6 (Test Product vs. Reference Product)
Time frame: Baseline, Week 3, and Week 6
Adjusted Mean Change From Baseline in Mean BI at Weeks 3, 6 and 12
Time frame: Baseline, Weeks 3, 6 and 12
Adjusted Mean Change From Baseline in Mean BI at Weeks 3, 6 and 12 (Test Product vs. Reference Product)
Time frame: Baseline, Weeks 3, 6 and 12
Adjusted Mean Change From Baseline in Mean Mean Modified Gingival Index (MGI) at Weeks 3, 6 and 12
Time frame: Baseline, Weeks 3, 6 and 12
Adjusted Mean Change From Baseline in Mean MGI at Weeks 3, 6 and 12 (Test Product vs. Reference Product)
Time frame: Baseline, Weeks 3, 6 and 12
Adjusted Mean Change From Baseline in Mean Overall TPI (Turesky Plaque Index) at Weeks 3, 6 and 12
Time frame: Baseline, Weeks 3, 6 and 12
Adjusted Mean Change From Baseline in Mean Overall TPI at Weeks 3, 6 and 12 (Test Product vs. Reference Product)
Time frame: Baseline, Weeks 3, 6 and 12
Adjusted Mean Change From Baseline in Mean Interproximal TPI at Weeks 3, 6 and 12
Time frame: Baseline, Weeks 3, 6 and 12
Adjusted Mean Change From Baseline in Mean Interproximal TPI at Weeks 3, 6 and 12 (Test Product vs. Reference Product)
Time frame: Baseline, Weeks 3, 6 and 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trial-register@haleon.com
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Corsodyl Original Dentifrice and Colgate Cavity Protection Dentifrice in people with Gingivitis and Dental Plaque, run by HALEON at 1 site in United Kingdom.
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 40 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 13 Jan 2025. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jan 2025). 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?
Adjusted Mean Change From Baseline in Number of Bleeding Sites at Week 12 (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jan 2025.