A Phase 3 interventional study of 10% w/v chlorhexidine acetate coating FDA IND #45466 and Placebo in Caries, Dental, sponsored by Tufts University. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-06-14.
Sponsored by Tufts University · Phase 3, Interventional, and Prevention
Adult tooth decay is an infectious disease that afflicts the majority of Americans aged 55 and older and is the most common chronic disease at midlife with an ever growing economic toll. Despite the fact that specific bacteria cause tooth decay, no FDA-approved anti-microbial treatment for decay is available to the American dental professional. The Prevention of Adult Caries Study (PACS) is a study designed to evaluate the efficacy of a topical, temporary, 10% w/v chlorhexidine dental coating in reducing new decay in adult dental patients at risk for decay.
The Prevention of Adult Caries Study (PACS) is a randomized, double-blind, placebo-controlled Phase III clinical trial conducted under F.D.A. Investigational New Drug license #45,466, with a target enrollment of 1000 at four clinical centers with vastly different populations. The centers participating in this proposed research are: Kaiser Permanente's Dental Plan in Portland, Oregon; Tufts University Dental Clinic in central Boston, Massachusetts; Delta Dental Massachusetts' Dental Clinic in Southborough, Massachusetts; and the dental clinic of the Tuba City Regional Health Care Corporation in Tuba City, Arizona. Kaiser Permanente's Center for Health Research in Portland, Oregon will act as the data-coordinating center, and Tufts University will act as the Administrative Center. This study is designed to evaluate the efficacy of a topical, temporary, 10% w/v chlorhexidine dental coating in reducing caries increment in at-risk adult dental patients. This study will treat participants in months 1(4 weekly applications) and 7(1 application) with final outcome measured at 13 months after randomization. Examiners were trained and certified before data collection started and were recalibrated annually. The primary outcome analysis in the intent -to- treat sample compares active to placebo group on the rank-normalized caries increment score, adjusting for examiner, age and age squared. Multiple imputation (data augmentation using MCMC) will be used to replace missing outcome. Planned secondary analysis examine the secondary caries increment outcomes using the same model, as well as parallel analyses in the per-protocol group. Safety of the coating will be evaluated by comparing development of resistant S. mutans or C. albicans as well as incidence of MedDRA-coded adverse events between the two arms.
1,109 studies on the registry are indexed under Dental Caries; 197 are open to participants now.
This study's enrollment of 983 is above the median of 60 across 916 interventional studies indexed under Dental Caries.
Browse Dental Caries studies →Tufts University is the lead sponsor of 225 studies on the registry; 24 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 7 (70%) have results posted.
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Exclusion Criteria
Dental coating with all ingredients except Chlorhexidine topically applied by dental professional supragingivally to the full dentition
Other: Placebo
10% w/v chlorhexidine acetate coating FDA IND #45466. Dental coating with all ingredients including Chlorhexidine topically applied by dental professional supragingivally to the full dentition
Drug: 10% w/v chlorhexidine acetate coating FDA IND #45466
Dental coating topically applied by dental professional supragingivally to the full dentition
Also known as: CHX
Total Net D12FS Caries Increment (Total of Non-cavitated Lesions (D1), Cavitated Lesions (D2) and Sound Surfaces (S))
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
Cumulative Net D12FS Caries Increment
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
Total Crude D12FS Caries Increment
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
Cumulative Crude D12FS Caries Increment
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
| Milestone | Placebo Dental Coating | Active Dental Coating (CHX) |
|---|---|---|
| Started | 493 | 490 |
| Completed | 467 | 460 |
| Not completed | 26 | 30 |
| Withdrew: Death | 2 | 1 |
| Withdrew: Lost to follow-up | 20 | 23 |
| Withdrew: Withdrawal by subject | 3 | 3 |
| Withdrew: Administrative withdrawal | 1 | 1 |
| Withdrew: Other | 0 | 2 |
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
| weighted increment units/13 months | Placebo | Active |
|---|---|---|
| Total Net D12FS Caries Increment (Total of Non-cavitated Lesions (D1), Cavitated Lesions (D2) and Sound Surfaces (S)) | 2.43 ± 0.32 | 2.68 ± 0.32 |
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.
| caries increment units/13 months | Placebo Dental Coating | Active Dental Coating (CHX) |
|---|---|---|
| Cumulative Net D12FS Caries Increment | 5.53 ± 0.42 | 5.88 ± 0.43 |
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.
| caries increment units/13 months | Placebo Dental Coating | Active Dental Coating (CHX) |
|---|---|---|
| Total Crude D12FS Caries Increment | 6.47 ± 0.27 | 5.96 ± 0.28 |
This is computed analogous to the cumulative net D12FS increment, but ignoring reversals by assigning them weights of zero.
| caries increment units/13 months | Placebo Dental Coating | Active Dental Coating (CHX) |
|---|---|---|
| Cumulative Crude D12FS Caries Increment | 11.39 ± 0.42 | 10.72 ± 0.43 |
Collected over Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 31/493 (6.3%) | 87/493 (17.6%) |
| Active | — | 28/490 (5.7%) | 84/490 (17.1%) |
| Event | Placebo | Active |
|---|---|---|
| Angina pectorisCardiac disorders | 0/493 | 2/490 |
| PneumoniaInfections and infestations | 1/493 | 2/490 |
| Uterine leiomyomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/493 | 2/490 |
| Kidney infectionInfections and infestations | 2/493 | 1/490 |
| Acute myocardial infarctionCardiac disorders | 0/493 | 1/490 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 0/493 | 1/490 |
| Basal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/493 | 1/490 |
| Benign pancreatic neoplasmNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/493 | 1/490 |
| Cervical vertebral fractureInjury, poisoning and procedural complications | 0/493 | 1/490 |
| ConcussionInjury, poisoning and procedural complications | 0/493 | 1/490 |
| Event | Placebo | Active |
|---|---|---|
| NasopharyngitisInfections and infestations | 43/493 | 30/490 |
| Sensitivity of teethGastrointestinal disorders | 32/493 | 26/490 |
| Pharmaceutical product complaintSocial circumstances | 12/493 | 28/490 |
| Age, Categorical(Participants) | Placebo Dental Coating | Active Dental Coating | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 463 | 459 | 922 |
| >=65 years | 30 | 31 | 61 |
| Age, Continuous(years) | Placebo Dental Coating | Active Dental Coating | Total |
|---|---|---|---|
| Mean | 42.8 ± 14.3 | 42.9 ± 14.3 | 42.8 ± 14.3 |
| Sex: Female, Male(Participants) | Placebo Dental Coating | Active Dental Coating | Total |
|---|---|---|---|
| Female | 242 | 250 | 492 |
| Male | 251 | 240 | 491 |
| Region of Enrollment(participants) | Placebo Dental Coating | Active Dental Coating | Total |
|---|---|---|---|
| United States | 493 | 490 | 983 |
Plan to share: No
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