Trial Outcomes & Findings for Clinical Efficacy Evaluation of Three Dentifrices (NCT NCT03988374)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

319 participants

Primary outcome timeframe

baseline, six weeks, 3 months and 6 months

Results posted on

2021-08-23

Participant Flow

Participant milestones

Participant milestones
Measure	0% Baking Soda Dentifrice Dentifrice, not containing baking soda, evaluated for ability to reduce gingivitis and plaque following 6-months of use.	20% Baking Soda Dentifrice Dentifrice, containing 20% baking soda, evaluated for ability to reduce gingivitis and plaque following 6-months of use.	35% Baking Soda Dentifrice Dentifrice, containing 35% baking soda, evaluated for ability to reduce gingivitis and plaque following 6-months of use.
Overall Study STARTED	104	107	108
Overall Study COMPLETED	103	105	107
Overall Study NOT COMPLETED	1	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	0% Baking Soda Dentifrice n=103 Participants Dentifrices: Dentifrice on plaque, gingivitis, and bleeding.	20% Baking Soda Dentifrice n=105 Participants Dentifrices: Dentifrice on plaque, gingivitis, and bleeding.	35% Baking Soda Dentifrice n=107 Participants Dentifrices: Dentifrice on plaque, gingivitis, and bleeding.	Total n=315 Participants Total of all reporting groups
Age, Continuous	44.07 Age n=103 Participants	47.50 Age n=105 Participants	47.32 Age n=107 Participants	46.3 Age n=315 Participants
Sex: Female, Male Female	75 Participants n=103 Participants	74 Participants n=105 Participants	80 Participants n=107 Participants	229 Participants n=315 Participants
Sex: Female, Male Male	28 Participants n=103 Participants	31 Participants n=105 Participants	27 Participants n=107 Participants	86 Participants n=315 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Canada	103 participants n=103 Participants	105 participants n=105 Participants	107 participants n=107 Participants	315 participants n=315 Participants
Gingvial Efficacy	2.081 units on a scale n=103 Participants	2.094 units on a scale n=105 Participants	2.092 units on a scale n=107 Participants	2.089 units on a scale n=315 Participants
Gingival Bleeding Efficacy	0.165 units on a scale n=103 Participants	0.178 units on a scale n=105 Participants	0.189 units on a scale n=107 Participants	0.177 units on a scale n=315 Participants
Plaque Efficacy	2.409 units on a scale n=103 Participants	2.411 units on a scale n=105 Participants	2.356 units on a scale n=107 Participants	2.4 units on a scale n=315 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	0% Baking Soda Dentifrice n=103 Participants Dentifrices: Dentifrice on plaque, gingivitis, and bleeding.	20% Baking Soda Dentifrice n=105 Participants Dentifrices: Dentifrice on plaque, gingivitis, and bleeding.	35% Baking Soda Dentifrice n=107 Participants Dentifrices: Dentifrice on plaque, gingivitis, and bleeding.
Mean Within-Treatment Whole-Mouth Score - Gingival Efficacy Baseline	2.081 units on a scale Standard Deviation 0.096	2.094 units on a scale Standard Deviation 0.117	2.092 units on a scale Standard Deviation 0.106
Mean Within-Treatment Whole-Mouth Score - Gingival Efficacy 6 weeks	1.996 units on a scale Standard Deviation 0.138	1.919 units on a scale Standard Deviation 0.171	1.882 units on a scale Standard Deviation 0.174
Mean Within-Treatment Whole-Mouth Score - Gingival Efficacy 3 months	1.980 units on a scale Standard Deviation 0.155	1.841 units on a scale Standard Deviation 0.198	1.766 units on a scale Standard Deviation 0.229
Mean Within-Treatment Whole-Mouth Score - Gingival Efficacy 6 months	1.946 units on a scale Standard Deviation 0.149	1.763 units on a scale Standard Deviation 0.209	1.653 units on a scale Standard Deviation 0.256

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	0% Baking Soda Dentifrice n=103 Participants Dentifrices: Dentifrice on plaque, gingivitis, and bleeding.	20% Baking Soda Dentifrice n=105 Participants Dentifrices: Dentifrice on plaque, gingivitis, and bleeding.	35% Baking Soda Dentifrice n=107 Participants Dentifrices: Dentifrice on plaque, gingivitis, and bleeding.
Mean Within-Treatment Whole-Mouth Score - Gingival Bleeding Efficacy Baseline	0.165 units on a scale Standard Deviation 0.085	0.178 units on a scale Standard Deviation 0.129	0.189 units on a scale Standard Deviation 0.114
Mean Within-Treatment Whole-Mouth Score - Gingival Bleeding Efficacy 6 weeks	0.149 units on a scale Standard Deviation 0.091	0.135 units on a scale Standard Deviation 0.122	0.122 units on a scale Standard Deviation 0.081
Mean Within-Treatment Whole-Mouth Score - Gingival Bleeding Efficacy 3 months	0.141 units on a scale Standard Deviation 0.088	0.116 units on a scale Standard Deviation 0.117	0.094 units on a scale Standard Deviation 0.067
Mean Within-Treatment Whole-Mouth Score - Gingival Bleeding Efficacy 6 months	0.129 units on a scale Standard Deviation 0.082	0.096 units on a scale Standard Deviation 0.104	0.069 units on a scale Standard Deviation 0.053

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	0% Baking Soda Dentifrice n=103 Participants Dentifrices: Dentifrice on plaque, gingivitis, and bleeding.	20% Baking Soda Dentifrice n=105 Participants Dentifrices: Dentifrice on plaque, gingivitis, and bleeding.	35% Baking Soda Dentifrice n=107 Participants Dentifrices: Dentifrice on plaque, gingivitis, and bleeding.
Mean Within-Treatment Whole-Mouth Score - Plaque Efficacy 3 months 3 months	2.251 units on a scale Standard Deviation 0.202	2.066 units on a scale Standard Deviation 0.260	1.907 units on a scale Standard Deviation 0.265
Mean Within-Treatment Whole-Mouth Score - Plaque Efficacy Baseline	2.409 units on a scale Standard Deviation 0.220	2.411 units on a scale Standard Deviation 0.244	2.356 units on a scale Standard Deviation 0.240
Mean Within-Treatment Whole-Mouth Score - Plaque Efficacy 6 weeks	2.280 units on a scale Standard Deviation 0.211	2.134 units on a scale Standard Deviation 0.259	2.026 units on a scale Standard Deviation 0.227
Mean Within-Treatment Whole-Mouth Score - Plaque Efficacy 6 months	2.196 units on a scale Standard Deviation 0.191	1.925 units on a scale Standard Deviation 0.239	1.793 units on a scale Standard Deviation 0.287

Adverse Events

0% Baking Soda Dentifrice

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

20% Baking Soda Dentifrice

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

35% Baking Soda Dentifrice

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	0% Baking Soda Dentifrice n=103 participants at risk Dentifrices: Dentifrice on plaque, gingivitis, and bleeding.	20% Baking Soda Dentifrice n=105 participants at risk Dentifrices: Dentifrice on plaque, gingivitis, and bleeding.	35% Baking Soda Dentifrice n=107 participants at risk Dentifrices: Dentifrice on plaque, gingivitis, and bleeding.
General disorders Primary discomforts	0.00% 0/103 • 6 months	2.9% 3/105 • Number of events 3 • 6 months	1.9% 2/107 • Number of events 2 • 6 months

Additional Information

Dr. Annahita Ghassemi, PhD

Church & Dwight Co., Inc

Phone: 6098061200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Master service agreement and confidentiality agreement in place
Publication restrictions are in place

Restriction type: OTHER