Trial Outcomes & Findings for Efficacy of a Commercial Dentifrice Containing Ilex Rotunda Thunb Extract for Dental Plaque and Gingivitis (NCT NCT02313558)
NCT ID: NCT02313558
Last Updated: 2015-06-26
Results Overview
After 6 weeks supra-gingival plaque on the facial and lingual surfaces of each tooth was scored according to the Turesky modification of the Quigley-Hein Plaque Index. Third molars and those teeth with cervical restorations or prosthetic crowns were excluded from the scoring procedure. Plaque was disclosed and scored on each tooth surface according to the following criteria: 0 = No plaque; 1 = Separate flecks of plaque at the cervical margin of the tooth; 2 = A thin, continuous band of plaque (up to 1 mm) at the cervical margin of the tooth; 3 = A band of plaque wider than 1 mm, but covering less than 1/3 of the side of the crown of the tooth; 4 = Plaque covering at least 1/3, but less than 2/3 of the side of the crown of the tooth; 5 = Plaque covering 2/3 or more of the side of the crown of the tooth. Whole-mouth mean scores were obtained by averaging the values obtained over all scoreable surfaces in the mouth.
COMPLETED
NA
100 participants
6 weeks after dentifrice use
2015-06-26
Participant Flow
The recruitment began in March,2013,at West China College of Stomatology Chengdu, Sichuan, China.
In the experimental group, 2 patients withdrew immediately after randomization; the withdrawal was not the result of the dentifrices used.
Participant milestones
| Measure |
Dentifrice Containing Ilex Rotunda Thunb
use the dentifrice containing Ilex Rotunda Thunb to brush teeth twice daily for 12 weeks
|
Control Dentifrice
use the control dentifrice to brush teeth twice daily for 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
44
|
46
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
Reasons for withdrawal
| Measure |
Dentifrice Containing Ilex Rotunda Thunb
use the dentifrice containing Ilex Rotunda Thunb to brush teeth twice daily for 12 weeks
|
Control Dentifrice
use the control dentifrice to brush teeth twice daily for 12 weeks
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
4
|
4
|
Baseline Characteristics
Efficacy of a Commercial Dentifrice Containing Ilex Rotunda Thunb Extract for Dental Plaque and Gingivitis
Baseline characteristics by cohort
| Measure |
Dentifrice Containing Ilex Rotunda Thunb
n=44 Participants
use the dentifrice containing Ilex Rotunda Thunb to brush teeth twice daily for 12 weeks
Dentifrice Containing Ilex Rotunda Thunb: Use the dentifrice to brush teeth twice a day for 12 weeks
|
Control Dentifrice
n=46 Participants
use the control dentifrice to brush teeth twice daily for 12 weeks
Control dentifrice: Use the dentifrice to brush teeth twice a day for 12 weeks
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.16 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
31.26 years
STANDARD_DEVIATION 7.86 • n=7 Participants
|
30.72 years
STANDARD_DEVIATION 7.86 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
44 participants
n=5 Participants
|
46 participants
n=7 Participants
|
90 participants
n=5 Participants
|
|
baseline dental plaque score
|
3.08 units on a scale
STANDARD_DEVIATION 0.59 • n=5 Participants
|
3.05 units on a scale
STANDARD_DEVIATION 0.46 • n=7 Participants
|
3.07 units on a scale
STANDARD_DEVIATION 0.53 • n=5 Participants
|
|
baseline gingivitis score
|
1.32 units on a scale
STANDARD_DEVIATION 0.25 • n=5 Participants
|
1.35 units on a scale
STANDARD_DEVIATION 0.24 • n=7 Participants
|
1.34 units on a scale
STANDARD_DEVIATION 0.24 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeks after dentifrice useAfter 6 weeks supra-gingival plaque on the facial and lingual surfaces of each tooth was scored according to the Turesky modification of the Quigley-Hein Plaque Index. Third molars and those teeth with cervical restorations or prosthetic crowns were excluded from the scoring procedure. Plaque was disclosed and scored on each tooth surface according to the following criteria: 0 = No plaque; 1 = Separate flecks of plaque at the cervical margin of the tooth; 2 = A thin, continuous band of plaque (up to 1 mm) at the cervical margin of the tooth; 3 = A band of plaque wider than 1 mm, but covering less than 1/3 of the side of the crown of the tooth; 4 = Plaque covering at least 1/3, but less than 2/3 of the side of the crown of the tooth; 5 = Plaque covering 2/3 or more of the side of the crown of the tooth. Whole-mouth mean scores were obtained by averaging the values obtained over all scoreable surfaces in the mouth.
Outcome measures
| Measure |
Dentifrice Containing Ilex Rotunda Thunb
n=44 Participants
use the dentifrice containing Ilex Rotunda Thunb to brush teeth twice daily for 12 weeks
|
Control Dentifrice
n=46 Participants
use the control dentifrice to brush teeth twice daily for 12 weeks
|
|---|---|---|
|
Plaque Assessment After 6 Weeks of Dentifrice Use
|
2.98 units on a scale
Standard Deviation 0.56
|
3.04 units on a scale
Standard Deviation 0.47
|
PRIMARY outcome
Timeframe: 6 weeks after dentifrice useAfter 6 weeks gingivitis was scored according to the Löe-Silness Gingival Index. Each tooth was scored on facial and lingual surfaces. Third molars and those teeth with cervical restorations or prosthetic crowns were excluded from the scoring procedure. The gingiva adjacent to each tooth surface was scored as follows: 0 = Absence of inflammation; 1 = Mild inflammation: slight change in color and little change in texture; 2 = Moderate inflammation: moderate glazing, redness, edema, hypertrophy. Tendency to bleed upon probing; 3 = Severe inflammation: marked redness and hypertrophy. Tendency for spontaneous bleeding.
Outcome measures
| Measure |
Dentifrice Containing Ilex Rotunda Thunb
n=44 Participants
use the dentifrice containing Ilex Rotunda Thunb to brush teeth twice daily for 12 weeks
|
Control Dentifrice
n=46 Participants
use the control dentifrice to brush teeth twice daily for 12 weeks
|
|---|---|---|
|
Gingivitis Assessment After 6 Weeks of Dentifrice Use
|
1.22 units on a scale
Standard Deviation 0.23
|
1.30 units on a scale
Standard Deviation 0.21
|
PRIMARY outcome
Timeframe: 12 weeks after dentifrice useAfter 12 weeks supra-gingival plaque on the facial and lingual surfaces of each tooth was scored according to the Turesky modification of the Quigley-Hein Plaque Index. Third molars and those teeth with cervical restorations or prosthetic crowns were excluded from the scoring procedure. Plaque was disclosed and scored on each tooth surface according to the following criteria: 0 = No plaque; 1 = Separate flecks of plaque at the cervical margin of the tooth; 2 = A thin, continuous band of plaque (up to 1 mm) at the cervical margin of the tooth; 3 = A band of plaque wider than 1 mm, but covering less than 1/3 of the side of the crown of the tooth; 4 = Plaque covering at least 1/3, but less than 2/3 of the side of the crown of the tooth; 5 = Plaque covering 2/3 or more of the side of the crown of the tooth. Whole-mouth mean scores were obtained by averaging the values obtained over all scoreable surfaces in the mouth.
Outcome measures
| Measure |
Dentifrice Containing Ilex Rotunda Thunb
n=44 Participants
use the dentifrice containing Ilex Rotunda Thunb to brush teeth twice daily for 12 weeks
|
Control Dentifrice
n=46 Participants
use the control dentifrice to brush teeth twice daily for 12 weeks
|
|---|---|---|
|
Plaque Assessment After 12 Weeks of Dentifrice Use
|
2.53 units on a scale
Standard Deviation 0.5
|
2.93 units on a scale
Standard Deviation 0.44
|
PRIMARY outcome
Timeframe: 12 weeks after dentifrice useAfter 12 weeks gingivitis was scored according to the Löe-Silness Gingival Index. Each tooth was scored on facial and lingual surfaces. Third molars and those teeth with cervical restorations or prosthetic crowns were excluded from the scoring procedure. The gingiva adjacent to each tooth surface was scored as follows: 0 = Absence of inflammation; 1 = Mild inflammation: slight change in color and little change in texture; 2 = Moderate inflammation: moderate glazing, redness, edema, hypertrophy. Tendency to bleed upon probing; 3 = Severe inflammation: marked redness and hypertrophy. Tendency for spontaneous bleeding. Whole-mouth mean scores were obtained by averaging the values obtained over all scoreable surfaces in the mouth.
Outcome measures
| Measure |
Dentifrice Containing Ilex Rotunda Thunb
n=44 Participants
use the dentifrice containing Ilex Rotunda Thunb to brush teeth twice daily for 12 weeks
|
Control Dentifrice
n=46 Participants
use the control dentifrice to brush teeth twice daily for 12 weeks
|
|---|---|---|
|
Gingivitis Assessment After 12 Weeks of Dentifrice Use
|
1.13 units on a scale
Standard Deviation 0.22
|
1.30 units on a scale
Standard Deviation 0.23
|
Adverse Events
Dentifrice Containing Ilex Rotunda Thunb
Control Dentifrice
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Hongchun Liu
Guanghua School of Stomatology, Sun Yat-sen University,
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place