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Trial record 13 of 258 for:    colgate

Ecological Effect of Arginine Dentifrice on Oral Microbiota

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ClinicalTrials.gov Identifier: NCT02988349
Recruitment Status : Completed
First Posted : December 9, 2016
Results First Posted : November 12, 2018
Last Update Posted : November 12, 2018
Sponsor:
Information provided by (Responsible Party):
Xin Xu, Sichuan University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Dental Caries
Oral Bacterial Infection
Microbiota
Intervention Other: Colgate® Sensitive Pro-Relief® toothpaste
Enrollment 42
Recruitment Details

The first recruitment took place on Oct. 2013, in the Department of Operative Dentistry and Endodontics, West China Hospital of Stomatology. 15 CF and 15 CA individuals were recruited by the end of Nov. 2013.

The second recruitment took place on May in the same location. 2014. 6 CF and 6 CA individuals were recruited by the end of Jun. 2014.

Pre-assignment Details  
Arm/Group Title Caries-free Subjects Caries-active Subjects
Hide Arm/Group Description

Subjects will use Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks,.

Colgate® Sensitive Pro-Relief® toothpaste: Subjects will be instructed to brush their teeth twice daily for 3 min using Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks.

Subjects will use Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks,.

Colgate® Sensitive Pro-Relief® toothpaste: Subjects will be instructed to brush their teeth twice daily for 3 min using Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks.

Period Title: Overall Study
Started 21 21
Completed 21 21
Not Completed 0 0
Arm/Group Title Caries-free Subjects Caries-active Subjects Total
Hide Arm/Group Description

Subjects will use Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks,.

Colgate® Sensitive Pro-Relief® toothpaste: Subjects will be instructed to brush their teeth twice daily for 3 min using Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks.

Subjects will use Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks,.

Colgate® Sensitive Pro-Relief® toothpaste: Subjects will be instructed to brush their teeth twice daily for 3 min using Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks.

Total of all reporting groups
Overall Number of Baseline Participants 21 21 42
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 21 participants 42 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
21
 100.0%
21
 100.0%
42
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 21 participants 21 participants 42 participants
23
(19 to 31)
23
(19 to 28)
23
(19 to 31)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 21 participants 42 participants
Female
11
  52.4%
17
  81.0%
28
  66.7%
Male
10
  47.6%
4
  19.0%
14
  33.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
China Number Analyzed 21 participants 21 participants 42 participants
21
 100.0%
21
 100.0%
42
 100.0%
1.Primary Outcome
Title The Change of Abundance of Specific Oral Microbes After Intervention as Assessed by 16S rRNA Sequencing
Hide Description Saliva and dental plaque samples will be collected, and the abundance of specific oral microbes such as Streptococcus mutans, Streptococcus sanguinis will be quantified by microbial 16S rRNA sequencing.
Time Frame baseline , 2 week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Caries-free Subjects Caries-active Subjects
Hide Arm/Group Description:

Subjects will use Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks,.

Colgate® Sensitive Pro-Relief® toothpaste: Subjects will be instructed to brush their teeth twice daily for 3 min using Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks.

Subjects will use Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks,.

Colgate® Sensitive Pro-Relief® toothpaste: Subjects will be instructed to brush their teeth twice daily for 3 min using Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks.

Overall Number of Participants Analyzed 21 21
Mean (Standard Deviation)
Unit of Measure: percentage of bacteria
Baseline: sm in supragingival plaque 0.00756  (0.00726) 0.14636  (0.23221)
Baseline: sm in subgingival plaque 0.00629  (0.00835) 0.11956  (0.20686)
Baseline: sm in saliva 0.00608  (0.00575) 0.01314  (0.01272)
Baseline: ss in supragingival plaque 1.007766667  (1.168793223) 0.521506667  (0.511640082)
Baseline: ss in subgingival plaque 2.064646667  (2.595662011) 1.539913333  (1.369851357)
Baseline: ss in saliva 0.812706667  (1.040344461) 0.18324  (0.199811864)
2 week: sm in supragingival plaque 0.003406667  (0.003320384) 0.009526667  (0.011458775)
2 week: sm in subgingival plaque 0.0033  (0.006143173) 0.00284  (0.005101792)
2 week: sm in saliva 0.002493333  (0.004110347) 0.003006667  (0.002304488)
2 week: ss in supragingival plaque 1.655106667  (1.274066247) 3.21486  (3.436273455)
2 week: ss in subgingival plaque 4.588546667  (4.92217214) 3.232233333  (3.336652867)
2 week: ss in saliva 1.3109  (0.885269549) 2.040286667  (3.369773515)
2.Secondary Outcome
Title The Change of Relative Activities of Microbial Enzymes After Intervention as Determined by Laboratory Enzymatic Assays
Hide Description Saliva and dental plaque samples will be collected and microbial enzyme activity will be quantified in the lab. Measures include relative enzyme activity of arginine deiminase, urease and lactase dehydrogenase as determined by standard laboratory enzymatic assay protocols.
Time Frame baseline ,2 week
Hide Outcome Measure Data
Hide Analysis Population Description
Among the 21 participants in each group,we only measured the enzyme activity from randomly choosed 15 participants from each group.
Arm/Group Title Caries-free Subjects Caries-active Subjects
Hide Arm/Group Description:

Subjects will use Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks,.

Colgate® Sensitive Pro-Relief® toothpaste: Subjects will be instructed to brush their teeth twice daily for 3 min using Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks.

Subjects will use Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks,.

Colgate® Sensitive Pro-Relief® toothpaste: Subjects will be instructed to brush their teeth twice daily for 3 min using Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks.

Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: enzyme activity (μmol/min/g)
baseline: ADS activity in supragingival plaque 0.8945  (0.13310) 0.3653  (0.06108)
baseline: ADS activity in subgingival plaque 0.63150  (0.08604) 0.29110  (0.04347)
baseline: ADS activity in saliva plaque 0.75870  (0.09211) 0.23470  (0.03328)
baseline: urease activity in supragingival plaque 0.6795  (0.11518) 0.3207  (0.06317)
baseline: urease activity in subgingival plaque 0.71840  (0.08770) 0.34630  (0.04611)
baseline: urease activity in saliva 0.72900  (0.66210) 0.17920  (0.03047)
baseline: LDH activity in supragingival plaque 8.859050  (0.6648584) 20.965090  (1.549900)
baseline: LDH activity in subgingival plaque 7.267220  (0.2555969) 17.576110  (0.887500)
baseline: LDH activity in saliva 7.508787  (0.8707994) 16.053870  (2.361490)
2 week: ADS activity in supragingival plaque 1.0771  (0.23754) 0.8418  (0.13711)
2 week: ADS activity in subgingival plaque 0.74650  (0.10275) 0.73600  (0.07218)
2 week: ADS activity in saliva 0.77410  (0.11136) 0.34850  (0.04391)
2 week: urease activity in supragingival plaque 0.5871  (0.07970) 0.6508  (0.10083)
2 week: urease activity in subgingival plaque 0.73330  (0.06165) 0.69680  (0.08427)
2 week: urease activity in saliva 0.73240  (0.05464) 0.25260  (0.04560)
2 week: LDH activity in supragingival plaque 11.347060  (0.9240766) 14.096910  (0.3565668)
2 week: LDH activity in subgingival plaque 8.664124  (0.8184378) 11.649030  (1.135210)
2 week: LDH activity in saliva 9.496731  (0.1797688) 15.268450  (0.3687766)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Caries-free Subjects Caries-active Subjects
Hide Arm/Group Description

Subjects will use Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks,.

Colgate® Sensitive Pro-Relief® toothpaste: Subjects will be instructed to brush their teeth twice daily for 3 min using Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks.

Subjects will use Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks,.

Colgate® Sensitive Pro-Relief® toothpaste: Subjects will be instructed to brush their teeth twice daily for 3 min using Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks.

All-Cause Mortality
Caries-free Subjects Caries-active Subjects
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/21 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Caries-free Subjects Caries-active Subjects
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/21 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Caries-free Subjects Caries-active Subjects
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/21 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Xin Xu
Organization: Sichuan University
Phone: 86-28-85503494
Responsible Party: Xin Xu, Sichuan University
ClinicalTrials.gov Identifier: NCT02988349     History of Changes
Other Study ID Numbers: WCHSIRB-D-2013-067-R2
First Submitted: November 24, 2016
First Posted: December 9, 2016
Results First Submitted: April 24, 2017
Results First Posted: November 12, 2018
Last Update Posted: November 12, 2018