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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
Enrollment 983
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Dental Coating Active Dental Coating (CHX)
Hide Arm/Group Description Dental coating with all ingredients except Chlorhexidine topically applied by dental professional supragingivally to the full dentition 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.
Period Title: Overall Study
Started 493 490
Completed 467 460
Not Completed 26 30
Reason Not Completed
Death             2             1
Lost to Follow-up             20             23
Withdrawal by Subject             3             3
Administrative withdrawal             1             1
Other             0             2
Arm/Group Title Placebo Dental Coating Active Dental Coating Total
Hide Arm/Group Description Dental coating with all ingredients except Chlorhexidine topically applied by dental professional supragingivally to the full dentition Dental coating with all ingredients including Chlorhexidine topically applied by dental professional supragingivally to the full dentition Total of all reporting groups
Overall Number of Baseline Participants 493 490 983
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 493 participants 490 participants 983 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, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 493 participants 490 participants 983 participants
42.8  (14.3) 42.9  (14.3) 42.8  (14.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 493 participants 490 participants 983 participants
Female
242
  49.1%
250
  51.0%
492
  50.1%
Male
251
  50.9%
240
  49.0%
491
  49.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 493 participants 490 participants 983 participants
493 490 983
1.Primary Outcome
Title Total Net D12FS Caries Increment (Total of Non-cavitated Lesions (D1), Cavitated Lesions (D2) and Sound Surfaces (S))
Hide Description

Study duration was too short to have progression from D2 (cavitated lesions) to D3 (cavitated lesions that involved dentin). D2 and D3 were treated equivalently for analysis.

This measure is computed as the sum of weighted counts of transitions in tooth surface status (root and coronal surfaces combined) from randomization to the 13-month follow-up visit. Disease progression had a positive weight (e.g., S-to-D1 (sound to non-cavitated lesion) or D1-to-D2 (non-cavitated to cavitated lesion) = 1, S-to-D2 (sound to cavitated lesion)= 2). Reversal had a negative weight (e.g., D1-to-S = −1). No change, transitions to or from missing or unscorable, and impossible transitions had 0 weight. Incident fillings and crowns were treated the same as incident D2 lesions for purposes of scoring. More details of the transition weights may be found at Vollmer WM et al. (2010). Design of the Prevention of Adult Caries Study (PACS): a randomized clinical trial assessing the effect of a

Time Frame (V1) to the 13 month follow-up visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) sample. Multiple imputation with 8 datasets imputed via Markov Chain Monte Carlo sampling was used to handle missing data.
Arm/Group Title Placebo Active
Hide Arm/Group Description:
Participants received a placebo dental coating containing no chlorhexidine diacetate (CHX).
Participants received a dental coating containing chlorhexidine diacetate (CHX) 10% weight per volume.
Overall Number of Participants Analyzed 493 490
Mean (Standard Error)
Unit of Measure: weighted increment units/13 months
2.43  (0.32) 2.68  (0.32)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Active
Comments We hypothesized a lower increment score for the active treatment group but carried out two-tailed hypothesis testing. Sample size was estimated with simulated data with rank normalized scores. We calculated that 832 participants would yield a power of 90% to detect a 20% reduction in caries incidence (from a hypothesized mean increment of 1.5), and adopted a target of 1000 randomized participants to allow for attrition.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.56
Comments No interim analyses were done and no adjustment made for multiple comparisons. Identical analyses were run on each imputed dataset, with results combined with SAS® PROC MIANALZE to obtain final p-values.
Method Regression, Linear
Comments The primary outcome analysis included treatment and site as class variables and age and age-squared as continuous covariates.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.25
Confidence Interval (2-Sided) 95%
-0.60 to 1.11
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.44
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Cumulative Net D12FS Caries Increment
Hide Description This measure was computed similar to the total net D12FS increment, but separately scored and combined transitions from the baseline to 7-month visits and from the 7- to 13-month visits, rather than simply looking at the baseline to 13-month visits.
Time Frame Visit 1, 7-month follow-up, 13-month follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat sample
Arm/Group Title Placebo Dental Coating Active Dental Coating (CHX)
Hide Arm/Group Description:
Dental coating with all ingredients except Chlorhexidine topically applied by dental professional supragingivally to the full dentition
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.
Overall Number of Participants Analyzed 493 490
Mean (Standard Error)
Unit of Measure: caries increment units/13 months
5.53  (0.42) 5.88  (0.43)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Dental Coating, Active Dental Coating (CHX)
Comments hypothesized a reduced caries increment in active arm, though conducted two-tailed hypothesis test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.54
Comments No adjustment for multiple comparisons. Identical analyses were run on each imputed dataset, with results combined with SAS® PROC MIANALYZE to obtain final p-values.
Method Regression, Linear
Comments Model included treatment and site as class variables and age and age-squared as continuous covariates.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.35
Confidence Interval (2-Sided) 95%
-0.77 to 1.46
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.57
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Total Crude D12FS Caries Increment
Hide Description Computed analogous to the total net D12FS caries increment, but ignoring reversals (essentially assigned them zero weight). Computed only using baseline to 13-month visit data.
Time Frame V1-13-month follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat sample
Arm/Group Title Placebo Dental Coating Active Dental Coating (CHX)
Hide Arm/Group Description:
Dental coating with all ingredients except Chlorhexidine topically applied by dental professional supragingivally to the full dentition
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.
Overall Number of Participants Analyzed 493 490
Mean (Standard Error)
Unit of Measure: caries increment units/13 months
6.47  (0.27) 5.96  (0.28)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Dental Coating, Active Dental Coating (CHX)
Comments Hypothesized lower increment in active arm, though hypothesis testing was two-sided.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.18
Comments No adjustment for multiple comparisons. Identical analyses were run on each imputed dataset, with results combined with SAS® PROC MIANALYZE to obtain final p-values.
Method Regression, Linear
Comments treatment and site included as class variables and age and age-squared as continuous covariates.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.51
Confidence Interval (2-Sided) 95%
-1.25 to 0.23
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.38
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Cumulative Crude D12FS Caries Increment
Hide Description This is computed analogous to the cumulative net D12FS increment, but ignoring reversals by assigning them weights of zero.
Time Frame Visit 1, 7-month follow-up, 13-month follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat sample
Arm/Group Title Placebo Dental Coating Active Dental Coating (CHX)
Hide Arm/Group Description:
Dental coating with all ingredients except Chlorhexidine topically applied by dental professional supragingivally to the full dentition
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.
Overall Number of Participants Analyzed 493 490
Mean (Standard Error)
Unit of Measure: caries increment units/13 months
11.39  (0.42) 10.72  (0.43)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Dental Coating, Active Dental Coating (CHX)
Comments Hypothesized a lower increment for active treatment arm, although hypothesis testing was two-sided.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.24
Comments No adjustment for multiple comparisons. Identical analyses were run on each imputed dataset, with results combined with SAS® PROC MIANALYZE to obtain final p-values.
Method Regression, Linear
Comments Model included treatment and site as class variables, and age and age-squared as continuous covariates.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.68
Confidence Interval (2-Sided) 95%
-1.80 to 0.45
Parameter Dispersion
Type: Standard Deviation
Value: 0.57
Estimation Comments [Not Specified]
Time Frame Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Adverse Event Reporting Description Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
 
Arm/Group Title Placebo Active
Hide Arm/Group Description Participants received a placebo dental coating containing no chlorhexidine diacetate (CHX). Participants received a dental coating containing chlorhexidine diacetate (CHX) 10% weight per volume.
All-Cause Mortality
Placebo Active
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Active
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   31/493 (6.29%)      28/490 (5.71%)    
Blood and lymphatic system disorders     
Anaemia  1  1/493 (0.20%)  1 0/490 (0.00%)  0
Cardiac disorders     
Acute myocardial infarction  1  0/493 (0.00%)  0 1/490 (0.20%)  1
Angina pectoris  1  0/493 (0.00%)  0 2/490 (0.41%)  2
Cardiovascular disorder  1  1/493 (0.20%)  1 0/490 (0.00%)  0
Coronary artery disease  1  0/493 (0.00%)  0 1/490 (0.20%)  1
Endocrine disorders     
Goitre  1  1/493 (0.20%)  1 0/490 (0.00%)  0
Gastrointestinal disorders     
Diverticulum  1  1/493 (0.20%)  1 0/490 (0.00%)  0
Haematochezia  1  1/493 (0.20%)  1 0/490 (0.00%)  0
Hiatus hernia  1  0/493 (0.00%)  0 1/490 (0.20%)  1
Large intestine perforation  1  0/493 (0.00%)  0 1/490 (0.20%)  1
Pancreatitis  1  0/493 (0.00%)  0 1/490 (0.20%)  1
General disorders     
Non-cardiac chest pain  1  0/493 (0.00%)  0 1/490 (0.20%)  1
Hepatobiliary disorders     
Cholecystitis  1  1/493 (0.20%)  1 0/490 (0.00%)  0
Infections and infestations     
Cellulitis  1  1/493 (0.20%)  1 0/490 (0.00%)  0
Cellulitis of male external genital organ  1  1/493 (0.20%)  1 0/490 (0.00%)  0
Cystitis  1  0/493 (0.00%)  0 1/490 (0.20%)  1
Diverticulitis  1  1/493 (0.20%)  1 0/490 (0.00%)  0
Gastroenteritis viral  1  1/493 (0.20%)  1 0/490 (0.00%)  0
Kidney infection  1  2/493 (0.41%)  2 1/490 (0.20%)  1
Osteomyelitis  1  0/493 (0.00%)  0 1/490 (0.20%)  1
Pneumonia  1  1/493 (0.20%)  1 2/490 (0.41%)  2
Postoperative wound infection  1  0/493 (0.00%)  0 1/490 (0.20%)  1
Pyelonephritis  1  1/493 (0.20%)  1 0/490 (0.00%)  0
Sepsis  1  1/493 (0.20%)  1 0/490 (0.00%)  0
Upper respiratory tract infection  1  0/493 (0.00%)  0 1/490 (0.20%)  1
Urinary tract infection  1  1/493 (0.20%)  1 0/490 (0.00%)  0
Abdominal wall abscess  1  0/493 (0.00%)  0 1/490 (0.20%)  1
Injury, poisoning and procedural complications     
Cervical vertebral fracture  1  0/493 (0.00%)  0 1/490 (0.20%)  1
Clavicle fracture  1  1/493 (0.20%)  1 0/490 (0.00%)  0
Concussion  1  0/493 (0.00%)  0 1/490 (0.20%)  1
Facial bones fracture  1  1/493 (0.20%)  1 0/490 (0.00%)  0
Incisional hernia  1  0/493 (0.00%)  0 1/490 (0.20%)  1
Ligament rupture  1  0/493 (0.00%)  0 1/490 (0.20%)  1
Lung injury  1  1/493 (0.20%)  1 0/490 (0.00%)  0
Pelvic fracture  1  1/493 (0.20%)  1 0/490 (0.00%)  0
Rib fracture  1  1/493 (0.20%)  1 1/490 (0.20%)  1
Scapula fracture  1  1/493 (0.20%)  1 0/490 (0.00%)  0
Tibia fracture  1  1/493 (0.20%)  1 0/490 (0.00%)  0
Traumatic liver injury  1  1/493 (0.20%)  1 0/490 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthritis  1  1/493 (0.20%)  1 0/490 (0.00%)  0
Cervical spine stenosis  1  1/493 (0.20%)  1 0/490 (0.00%)  0
Osteoarthritis  1  1/493 (0.20%)  1 1/490 (0.20%)  1
Trismus  1  1/493 (0.20%)  1 0/490 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma  1  0/493 (0.00%)  0 1/490 (0.20%)  1
Benign pancreatic neoplasm  1  0/493 (0.00%)  0 1/490 (0.20%)  1
Gastric cancer  1  1/493 (0.20%)  1 0/490 (0.00%)  0
Head and neck cancer  1  1/493 (0.20%)  1 1/490 (0.20%)  1
Malignant melanoma  1  0/493 (0.00%)  0 1/490 (0.20%)  1
Multiple myeloma  1  1/493 (0.20%)  1 0/490 (0.00%)  0
Prostate cancer  1  0/493 (0.00%)  0 1/490 (0.20%)  1
Thyroid cancer  1  1/493 (0.20%)  1 0/490 (0.00%)  0
Uterine leiomyoma  1  1/493 (0.20%)  1 2/490 (0.41%)  2
Nervous system disorders     
Cerebral ventricle dilation  1  1/493 (0.20%)  1 0/490 (0.00%)  0
Convulsion  1  1/493 (0.20%)  1 0/490 (0.00%)  0
Transient ischaemic attack  1  1/493 (0.20%)  1 0/490 (0.00%)  0
Psychiatric disorders     
Completed suicide  1  1/493 (0.20%)  1 0/490 (0.00%)  0
Mental disorder  1  0/493 (0.00%)  0 1/490 (0.20%)  1
Suicidal ideation  1  0/493 (0.00%)  0 1/490 (0.20%)  1
Renal and urinary disorders     
Nephrolithiasis  1  0/493 (0.00%)  0 1/490 (0.20%)  1
Ureteric stenosis  1  1/493 (0.20%)  1 0/490 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Asthma  1  0/493 (0.00%)  0 1/490 (0.20%)  1
Dyspnoea  1  0/493 (0.00%)  0 1/490 (0.20%)  1
Pleurisy  1  1/493 (0.20%)  1 0/490 (0.00%)  0
Social circumstances     
Exposure to communicable disease  1  1/493 (0.20%)  1 0/490 (0.00%)  0
Surgical and medical procedures     
Gastric bypass  1  0/493 (0.00%)  0 1/490 (0.20%)  1
Hernia repair  1  0/493 (0.00%)  0 1/490 (0.20%)  1
Hip arthroplasty  1  1/493 (0.20%)  1 1/490 (0.20%)  1
Hysterectomy  1  0/493 (0.00%)  0 1/490 (0.20%)  1
Knee arthroplasty  1  1/493 (0.20%)  1 0/490 (0.00%)  0
Rectal fistula repair  1  1/493 (0.20%)  1 0/490 (0.00%)  0
Urinary bladder excision  1  0/493 (0.00%)  0 1/490 (0.20%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Active
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   87/493 (17.65%)      84/490 (17.14%)    
Gastrointestinal disorders     
Sensitivity of teeth  1  32/493 (6.49%)  36 26/490 (5.31%)  29
Infections and infestations     
Nasopharyngitis  1  43/493 (8.72%)  44 30/490 (6.12%)  31
Social circumstances     
Pharmaceutical product complaint  1  12/493 (2.43%)  12 28/490 (5.71%)  28
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.0)
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
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