Caries, DentalPhase 3NCT00357877
Prevention of Adult Caries Study (PACS)
A Phase 3 study testing 10% w/v chlorhexidine acetate coating FDA IND #45466 in people with Caries, Dental, run by Tufts University at 4 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Caries, Dental
- What is being tested?
- 10% w/v chlorhexidine acetate coating FDA IND #45466
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 983 participants
- Where
- 4 sitesUnited States
- Study dates
- Jul 2006to Jun 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age and older
- at least 20 intact natural teeth, excluding third molars
- 2 or more lesions, of which at least one must be a cavitated D2 or D3
- willing and able to provide informed consent
Who cannot join
- pregnant or planning to become pregnant or planning to become pregnant during the study (breastfeeding is permitted)
- use of fixed orthodontic appliances
- allergic to any of the ingredients of the study medication
- long-term antibiotic therapy
- a history of, or currently active, radiation therapy for cancers of the head or neck
- Sjögren's syndrome
Show all 11Show fewer
- advanced periodontitis
- consumption of the equivalent of more than five servings of acidic or sugared drinks per day
- having 10 or more lesions requiring restorative care at the time of the screening visit
- remineralization therapy within one month of randomization
- investigator discretion
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Tufts University School of Dental Medicine
Boston, Massachusetts, 02111
Dental Services of Massachusetts
Boston, Massachusetts, 02129
Center for Health Research
Portland, Oregon, 97227
Tuba City Regional Health Care
Tuba City, Arizona, 86045-0600
About this study
Official title: Prevention of Adult Caries Study
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.
Read the detailed description
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.
- Conditions
- Caries, Dental
- Being tested
- 10% w/v chlorhexidine acetate coating FDA IND #45466, Placebo
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10% w/v chlorhexidine acetate coating FDA IND #45466Drug
Also called CHX
Dental coating topically applied by dental professional supragingivally to the full dentition
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Placebo Dental Coating | Placebo comparator | Dental coating with all ingredients except Chlorhexidine topically applied by dental professional supragingivally to the full dentition Receives: Other: Placebo |
| Active Dental Coating | Active comparator | 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 Receives: Drug: 10% w/v chlorhexidine acetate coating FDA IND #45466 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: (V1) to the 13 month follow-up visit
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Visit 1, 7-month follow-up, 13-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2006 (estimated)
- Study startJul 2006
- Primary completionAug 2009
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Caries, DentalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 983 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Sponsor
- Investigators
- Athena Papas, PhD DMD, Principal investigator, Tufts University of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00357877
- Sponsor's protocol ID
- DE017753-01
- Other IDs
- U01DE017753
- Status last verified
- May 2017
- First submitted
- 26 Jul 2006
- Last updated
- 14 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Papas AS, Vollmer WM, Gullion CM, Bader J, Laws R, Fellows J, Hollis JF, Maupome G, Singh ML, Snyder J, Blanchard P; PACS Collaborative Group. Efficacy of chlorhexidine varnish for the prevention of adult caries: a randomized trial. J Dent Res. 2012 Feb;91(2):150-5. doi: 10.1177/0022034511424154. Epub 2011 Dec 7.
PubMed 22156917Singh M, Papas A, Vollmer W, Bader J, Laws R, Maupome G, Snyder J, Blanchard P. Predictors of coronal caries progression in adults: results from the Prevention of Adult Caries Study. Community Dent Oral Epidemiol. 2013 Dec;41(6):558-64. doi: 10.1111/cdoe.12059. Epub 2013 Jul 9.
PubMed 23834229Banting DW, Amaechi BT, Bader JD, Blanchard P, Gilbert GH, Gullion CM, Holland JC, Makhija SK, Papas A, Ritter AV, Singh ML, Vollmer WM. Examiner training and reliability in two randomized clinical trials of adult dental caries. J Public Health Dent. 2011 Fall;71(4):335-44. doi: 10.1111/j.1752-7325.2011.00278.x. Epub 2011 Aug 17.
PubMed 22320292Vollmer WM, Papas AS, Bader JD, Maupome G, Gullion CM, Hollis JF, Snyder JJ, Fellows JL, Laws RL, White BA; PACS Collaborative Research Group. Design of the Prevention of Adult Caries Study (PACS): a randomized clinical trial assessing the effect of a chlorhexidine dental coating for the prevention of adult caries. BMC Oral Health. 2010 Oct 5;10:23. doi: 10.1186/1472-6831-10-23.
PubMed 20923557
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Adult Caries Study
- ClinicalTrials.gov ID
- NCT00357877
- Acronym / sponsor ID
- DE017753-01
- Conditions
- Caries, Dental
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 983 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- Jul 2006
- Primary completion
- Aug 2009 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 28 Jul 2006 (estimated)
- Results
- Posted 14 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Dental Coating | Placebo comparator | Other: PlaceboDental coating with all ingredients except Chlorhexidine topically applied by dental professional supragingivally to the full dentition |
| Active Dental Coating | Active comparator | Drug: 10% w/v chlorhexidine acetate coating FDA IND #4546610% 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age and older
- at least 20 intact natural teeth, excluding third molars
- 2 or more lesions, of which at least one must be a cavitated D2 or D3
- willing and able to provide informed consent
Key exclusion criteria (11 listed)
- pregnant or planning to become pregnant or planning to become pregnant during the study (breastfeeding is permitted)
- use of fixed orthodontic appliances
- allergic to any of the ingredients of the study medication
- long-term antibiotic therapy
- a history of, or currently active, radiation therapy for cancers of the head or neck
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 10% w/v chlorhexidine acetate coating FDA IND #45466Also: CHXDental coating topically applied by dental professional supragingivally to the full dentition | Drug | Active Dental Coating |
| Placebo | Other | Placebo Dental Coating |
Primary outcome
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
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
3 secondary outcomes
Cumulative Net D12FS Caries Increment
Time frame: Visit 1, 7-month follow-up, 13-month follow-up
Total Crude D12FS Caries Increment
Time frame: V1-13-month follow-up
Cumulative Crude D12FS Caries Increment
Time frame: Visit 1, 7-month follow-up, 13-month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22156917Papas AS, Vollmer WM, Gullion CM, Bader J, Laws R, Fellows J, Hollis JF, Maupome G, Singh ML, Snyder J, Blanchard P; PACS Collaborative Group. Efficacy of chlorhexidine varnish for the prevention of adult caries: a randomized trial. J Dent Res. 2012 Feb;91(2):150-5. doi: 10.1177/0022034511424154. Epub 2011 Dec 7.
- Derived from this study: PubMed 23834229Singh M, Papas A, Vollmer W, Bader J, Laws R, Maupome G, Snyder J, Blanchard P. Predictors of coronal caries progression in adults: results from the Prevention of Adult Caries Study. Community Dent Oral Epidemiol. 2013 Dec;41(6):558-64. doi: 10.1111/cdoe.12059. Epub 2013 Jul 9.
- Derived from this study: PubMed 22320292Banting DW, Amaechi BT, Bader JD, Blanchard P, Gilbert GH, Gullion CM, Holland JC, Makhija SK, Papas A, Ritter AV, Singh ML, Vollmer WM. Examiner training and reliability in two randomized clinical trials of adult dental caries. J Public Health Dent. 2011 Fall;71(4):335-44. doi: 10.1111/j.1752-7325.2011.00278.x. Epub 2011 Aug 17.
- Derived from this study: PubMed 20923557Vollmer WM, Papas AS, Bader JD, Maupome G, Gullion CM, Hollis JF, Snyder JJ, Fellows JL, Laws RL, White BA; PACS Collaborative Research Group. Design of the Prevention of Adult Caries Study (PACS): a randomized clinical trial assessing the effect of a chlorhexidine dental coating for the prevention of adult caries. BMC Oral Health. 2010 Oct 5;10:23. doi: 10.1186/1472-6831-10-23.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Athena Papas, PhD DMD principal investigator
Tufts University of Dental Medicine
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 10% w/v chlorhexidine acetate coating FDA IND #45466 in people with Caries, Dental, run by Tufts University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00357877, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2017; AzTrials last refreshed its copy on 7 Nov 2026.