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Prevention of Adult Caries Study (PACS)

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ClinicalTrials.gov Identifier: NCT00357877
Recruitment Status : Completed
First Posted : July 28, 2006
Results First Posted : June 14, 2017
Last Update Posted : June 14, 2017
Sponsor:
Collaborator:
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
Tufts University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Caries, Dental
Interventions: Drug: 10% w/v chlorhexidine acetate coating FDA IND #45466
Other: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Dental Coating Dental coating with all ingredients except Chlorhexidine topically applied by dental professional supragingivally to the full dentition
Active Dental Coating (CHX) Dental coating with all ingredients including Chlorhexidine topically applied by dental professional supragingivally to the full dentition. 10% w/v chlorhexidine acetate coating FDA IND #45466.

Participant Flow:   Overall Study
    Placebo Dental Coating   Active Dental Coating (CHX)
STARTED   493   490 
COMPLETED   467   460 
NOT COMPLETED   26   30 
Death                2                1 
Lost to Follow-up                20                23 
Withdrawal by Subject                3                3 
Administrative withdrawal                1                1 
Other                0                2 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Dental Coating Dental coating with all ingredients except Chlorhexidine topically applied by dental professional supragingivally to the full dentition
Active Dental Coating Dental coating with all ingredients including Chlorhexidine topically applied by dental professional supragingivally to the full dentition
Total Total of all reporting groups

Baseline Measures
   Placebo Dental Coating   Active Dental Coating   Total 
Overall Participants Analyzed 
[Units: Participants]
 493   490   983 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      463  93.9%      459  93.7%      922  93.8% 
>=65 years      30   6.1%      31   6.3%      61   6.2% 
Age 
[Units: Years]
Mean (Standard Deviation)
 42.8  (14.3)   42.9  (14.3)   42.8  (14.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      242  49.1%      250  51.0%      492  50.1% 
Male      251  50.9%      240  49.0%      491  49.9% 
Region of Enrollment 
[Units: Participants]
     
United States   493   490   983 


  Outcome Measures

1.  Primary:   Total Net D12FS Caries Increment (Total of Non-cavitated Lesions (D1), Cavitated Lesions (D2) and Sound Surfaces (S))   [ Time Frame: (V1) to the 13 month follow-up visit ]

2.  Secondary:   Cumulative Net D12FS Caries Increment   [ Time Frame: Visit 1, 7-month follow-up, 13-month follow-up ]

3.  Secondary:   Total Crude D12FS Caries Increment   [ Time Frame: V1-13-month follow-up ]

4.  Secondary:   Cumulative Crude D12FS Caries Increment   [ Time Frame: Visit 1, 7-month follow-up, 13-month follow-up ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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. William Vollmer
Organization: Kaiser Permanente Data Coordinating Center
phone: 503-335-6755
e-mail: william.vollmer@kpchr.org


Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Tufts University
ClinicalTrials.gov Identifier: NCT00357877     History of Changes
Other Study ID Numbers: DE017753-01
U01DE017753 ( U.S. NIH Grant/Contract )
First Submitted: July 26, 2006
First Posted: July 28, 2006
Results First Submitted: October 18, 2016
Results First Posted: June 14, 2017
Last Update Posted: June 14, 2017