Gingival Inflammation and BleedingPhase 2NCT03988374

Clinical Efficacy Evaluation of Three Dentifrices

A Phase 2 study testing Dentifrices in people with Gingival Inflammation and Bleeding and Dental Plaque, run by Church & Dwight Company, Inc. at 1 site in Canada.

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

Clinical study to evaluate and compare the efficacy of two baking soda containing dentifrices, containing 20% and 35% baking soda, to a non-baking soda dentifrice for their ability to reduce gingivitis and plaque following 6-months of use. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Gingival Inflammation and Bleeding, Dental Plaque
What is being tested?: Dentifrices
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 319 participants
Where: 1 siteCanada
Study dates: 22 Feb 2018to 24 Aug 2018
Phase: Phase 2
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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Have provided written informed consent prior to being entered into the study.
Be between 18 and 70 years of age, male or female.
Have at least eighteen (18) natural teeth with scorable facial and lingual surfaces as determined by the Examiner. Teeth that are grossly carious, orthodontically banded, exhibiting general cervical abrasion and/or enamel abrasion, or third molars will not be included in the tooth count.
Have a mean baseline plaque index score ≥ 1.95 as determined by the Soparkar Modification of the Turesky Modification of the Quigley-Hein Plaque Index (Pl).
Have a mean baseline gingival index score of ≥ l.70 and ≤ 3.0 as determined by the Modified Gingival Index (MGI).
Presence of ≥ 10 bleeding sites upon probing.

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Agree not to have a dental prophylaxis or any other elective, non-emergency dental procedures any time during the study.
Agree to abstain from the use of chewing gum, mouth rinses, any toothpaste other than the study toothpaste, tooth whitening products (either professional or at home use) and all other oral hygiene other than the study procedures for the duration of the study.
Agree to refrain from all oral hygiene on the morning of each evaluation visit and to refrain from eating, drinking, and smoking for 4 hrs, prior to each evaluation visit.
Agree to comply with the conditions and schedule of the study.

Who cannot join

Physical limitations or restrictions that might preclude normal tooth brushing.
Evidence of gross oral pathology, including widespread caries or chronic neglect, extensive restoration, preexisting gross plaque or soft or hard tissue tumor of the oral cavity.
Heavy supra- or subgingival calculus that might interfere with evaluations as determined by the Investigator/Examiner.
Evidence of major oral hard or soft tissue lesions or trauma at the baseline visit as determined by the Investigator/Examiner.
Conditions requiring antibiotic treatment prior to dental procedures.
History of uncontrolled diabetes or hepatic or renal disease, or other serious conditions or transmittable diseases, (e.g. cardiovascular disease, AIDS).

Show all 18Show fewer

Subjects with grossly carious, fully crowned, or extensively restored teeth, orthodontic appliances, peri/oral piercings, or removable partial dentures.
Treatment with antibiotics within the 1-month period before the baseline examination, or a condition that is likely to require antibiotic treatment over the course of the trial.
Chronic treatment (2 weeks or more) with any medication known to affect periodontal status (including phenytoin, calcium antagonists, cyclosporine, coumarin, nonsteroidal anti-inflammatory drugs, and aspirin) within 1 month of the baseline examination. All other medications for chronic medical conditions must have been initiated at least 3 months before enrollment.
Have severe periodontal disease or being actively treated for periodontal disease.
Having history of early-onset periodontitis or acute necrotizing ulcerative gingivitis.
Concomitant periodontal therapy other than prophylaxis in the last 6 months.
Professional prophylaxis within 1 month prior to the baseline clinical evaluation.
Subjects who participated in a gingivitis study in the past month.
Daily use of chemotherapeutic antiplaque/antigingivitis products within the past 4 months.
History of significant adverse effects following use of oral hygiene products such as toothpastes and mouthrinses.
Subjects who are allergic to any ingredients in the test or control product, as listed on the IRB Safety Assessment.
Self-reported pregnancy and nursing since hormonal changes can exaggerate gingival response to dental plaque.

Trial locations and contacts

1 site in 1 country.

Canada1 site

All Sum Research Center Ltd.
Mississauga, Ontario, L4W OC2

Other trials in Canada

About this study

Official title: Clinical Efficacy Evaluation of Three Dentifrices Containing 35%, 20%, and 0% Sodium Bicarbonate on the Reduction of Plaque and Gingivitis

Conditions: Gingival Inflammation and Bleeding, Dental Plaque
Being tested: Dentifrices
Medical subject headings: Gingivitis, Hemorrhage, Dental Plaque

What participants receive

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

DentifricesDrug
Dentifrice on plaque, gingivitis, and bleeding.

Study groups in NCT03988374
Study group	Role	What they receive
0% Baking Soda Dentifrice	Active comparator	Not described Receives: Drug: Dentifrices
20% Baking Soda Dentifrice	Active comparator	Not described Receives: Drug: Dentifrices
35% Baking Soda Dentifrice	Active comparator	Not described Receives: Drug: Dentifrices

What is being measured

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

Mean Within-Treatment Whole-Mouth Score - Gingival Efficacy
Mean Within-Treatment Whole-Mouth Score as measured by Gingival Index (0=absence of inflammation, 1=mild inflammation: slight change in color, little change in texture of any portion of but not the entire marginal or papillary gingival unit, 2=mild inflammation: slight change in color, little change in texture to entire marginal or papillary gingival unit, 3=moderate inflammation: glazing, redness, edema and/or hypertrophy of the marginal or papillary gingival unit, 4=severe inflammation: marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. The scale ranges from 0-4.
Measured: baseline, six weeks, 3 months and 6 months
Mean Within-Treatment Whole-Mouth Score - Gingival Bleeding Efficacy
Mean Within-Treatment Whole-Mouth Score as measured by Gingival Bleeding Index (0=absence of bleeding after 30 seconds, 1= bleeding observed after 30 seconds, 2= bleeding occurs instantly). The scale ranges from 0-2.
Measured: baseline, six week, three months, and six months
Mean Within-Treatment Whole-Mouth Score - Plaque Efficacy
Mean Within-Treatment Whole-Mouth Score as measured by Plaque Index (0=no visible plaque, 1=separate flecks of plaque at the cervical margin of the tooth, 2=a thin, continuous band of plaque (up to 1mm wide) at the cervical margin, 3= a band of plaque wider than 1 mm but covering less than one-third of the crown, 4=plaque covering at least one-third but less than two-thirds of the crown, 5= plaque covering two-thirds or more of the crown). The scale ranges from 0-5.
Measured: baseline, six weeks, three months, and six months

Timeline

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

22 Feb 201824 Aug 2018

First posted17 Jun 2019
Study start22 Feb 2018
Primary completion24 Aug 2018
Study completion24 Aug 2018

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 Gingival Inflammation and BleedingStudies of the same condition, open and under way.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 319 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03988374
Sponsor's protocol ID: ST-7700
Status last verified: Apr 2021
First submitted: 4 Apr 2019
Last updated: 23 Aug 2021
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: 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

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All Gingival Inflammation and Bleeding trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Efficacy Evaluation of Three Dentifrices Containing 35%, 20%, and 0% Sodium Bicarbonate on the Reduction of Plaque and Gingivitis
ClinicalTrials.gov ID: NCT03988374
Acronym / sponsor ID: ST-7700
Conditions: Gingival Inflammation and Bleeding, Dental Plaque
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 319 participants (actual)
Lead sponsor: Church & Dwight Company, Inc.Industry (pharma, biotech, devices)
Study start: 22 Feb 2018 (actual)
Primary completion: 24 Aug 2018 (actual)
Study completion: 24 Aug 2018 (actual)
First posted: 17 Jun 2019 (actual)
Results: Posted 23 Aug 2021

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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
0% Baking Soda Dentifrice	Active comparator	Drug: Dentifrices
20% Baking Soda Dentifrice	Active comparator	Drug: Dentifrices
35% Baking Soda Dentifrice	Active comparator	Drug: Dentifrices

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Have provided written informed consent prior to being entered into the study.
Be between 18 and 70 years of age, male or female.
Have at least eighteen (18) natural teeth with scorable facial and lingual surfaces as determined by the Examiner. Teeth that are grossly carious, orthodontically banded, exhibiting general cervical abrasion and/or enamel abrasion, or third molars will not be included in the tooth count.
Have a mean baseline plaque index score ≥ 1.95 as determined by the Soparkar Modification of the Turesky Modification of the Quigley-Hein Plaque Index (Pl).
Have a mean baseline gingival index score of ≥ l.70 and ≤ 3.0 as determined by the Modified Gingival Index (MGI).

Key exclusion criteria (18 listed)

Physical limitations or restrictions that might preclude normal tooth brushing.
Evidence of gross oral pathology, including widespread caries or chronic neglect, extensive restoration, preexisting gross plaque or soft or hard tissue tumor of the oral cavity.
Heavy supra- or subgingival calculus that might interfere with evaluations as determined by the Investigator/Examiner.
Evidence of major oral hard or soft tissue lesions or trauma at the baseline visit as determined by the Investigator/Examiner.
Conditions requiring antibiotic treatment prior to dental procedures.

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
DentifricesDentifrice on plaque, gingivitis, and bleeding.	Drug	0% Baking Soda Dentifrice, 20% Baking Soda Dentifrice, 35% Baking Soda Dentifrice

Primary outcome

Mean Within-Treatment Whole-Mouth Score - Gingival Efficacy
Time frame: baseline, six weeks, 3 months and 6 months
Mean Within-Treatment Whole-Mouth Score as measured by Gingival Index (0=absence of inflammation, 1=mild inflammation: slight change in color, little change in texture of any portion of but not the entire marginal or papillary gingival unit, 2=mild inflammation: slight change in color, little change in texture to entire marginal or papillary gingival unit, 3=moderate inflammation: glazing, redness, edema and/or hypertrophy of the marginal or papillary gingival unit, 4=severe inflammation: marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. The scale ranges from 0-4.
Mean Within-Treatment Whole-Mouth Score - Gingival Bleeding Efficacy
Time frame: baseline, six week, three months, and six months
Mean Within-Treatment Whole-Mouth Score as measured by Gingival Bleeding Index (0=absence of bleeding after 30 seconds, 1= bleeding observed after 30 seconds, 2= bleeding occurs instantly). The scale ranges from 0-2.
Mean Within-Treatment Whole-Mouth Score - Plaque Efficacy
Time frame: baseline, six weeks, three months, and six months
Mean Within-Treatment Whole-Mouth Score as measured by Plaque Index (0=no visible plaque, 1=separate flecks of plaque at the cervical margin of the tooth, 2=a thin, continuous band of plaque (up to 1mm wide) at the cervical margin, 3= a band of plaque wider than 1 mm but covering less than one-third of the crown, 4=plaque covering at least one-third but less than two-thirds of the crown, 5= plaque covering two-thirds or more of the crown). The scale ranges from 0-5.

Results and safety

Results posted to the registry on 23 Aug 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
0% Baking Soda Dentifrice	104	103
20% Baking Soda Dentifrice	107	105
35% Baking Soda Dentifrice	108	107

Primary outcome: Mean Within-Treatment Whole-Mouth Score - Gingival Efficacy

Time frame: baseline, six weeks, 3 months and 6 months. Mean (Standard Deviation). Unit: units on a scale

Measure	0% Baking Soda Dentifrice n = 103	20% Baking Soda Dentifrice n = 105	35% Baking Soda Dentifrice n = 107
Baseline	2.081 (0.096)	2.094 (0.117)	2.092 (0.106)
6 weeks	1.996 (0.138)	1.919 (0.171)	1.882 (0.174)
3 months	1.980 (0.155)	1.841 (0.198)	1.766 (0.229)
6 months	1.946 (0.149)	1.763 (0.209)	1.653 (0.256)

Primary outcome: Mean Within-Treatment Whole-Mouth Score - Gingival Bleeding Efficacy

Time frame: baseline, six week, three months, and six months. Mean (Standard Deviation). Unit: units on a scale

Measure	0% Baking Soda Dentifrice n = 103	20% Baking Soda Dentifrice n = 105	35% Baking Soda Dentifrice n = 107
Baseline	0.165 (0.085)	0.178 (0.129)	0.189 (0.114)
6 weeks	0.149 (0.091)	0.135 (0.122)	0.122 (0.081)
3 months	0.141 (0.088)	0.116 (0.117)	0.094 (0.067)
6 months	0.129 (0.082)	0.096 (0.104)	0.069 (0.053)

Primary outcome: Mean Within-Treatment Whole-Mouth Score - Plaque Efficacy

Time frame: baseline, six weeks, three months, and six months. Mean (Standard Deviation). Unit: units on a scale

Measure	0% Baking Soda Dentifrice n = 103	20% Baking Soda Dentifrice n = 105	35% Baking Soda Dentifrice n = 107
Baseline	2.409 (0.220)	2.411 (0.244)	2.356 (0.240)
6 weeks	2.280 (0.211)	2.134 (0.259)	2.026 (0.227)
3 months 3 months	2.251 (0.202)	2.066 (0.260)	1.907 (0.265)
6 months	2.196 (0.191)	1.925 (0.239)	1.793 (0.287)

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
0% Baking Soda Dentifrice	0 of 103 (0%)	4 of 103 (3.9%)	0 of 103
20% Baking Soda Dentifrice	0 of 105 (0%)	17 of 105 (16.2%)	0 of 105
35% Baking Soda Dentifrice	0 of 107 (0%)	2 of 107 (1.9%)	0 of 107

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Gingival Inflammation and Bleeding

RecruitingObservational study
Prevalence and Associated Factors of High BMI and Periodontitis in Thai Adults Aged Under 60 Years
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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 Phase 2 study testing Dentifrices in people with Gingival Inflammation and Bleeding and Dental Plaque, run by Church & Dwight Company, Inc. at 1 site in Canada.

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 10 inclusion and 18 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 23 Aug 2021. 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 Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 23 Aug 2021). 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?

Mean Within-Treatment Whole-Mouth Score - Gingival Efficacy (time frame: baseline, six weeks, 3 months and 6 months). The study lists 3 primary outcomes in all. 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 NCT03988374.

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 23 Aug 2021.