Dental CariesCAMBRA-PBRNNCT01176396
CAMBRA - PBRN Caries Management By Risk Assessment In A Practice-Based Research Network
A study testing Caries prevention active intervention in people with Dental Caries, run by University of California, San Francisco at 1 site in United States.
Trial summary
The goal of this project is to create a Practice Based Research Network with 30 researcher dentists calibrated on the administration of a caries risk assessment and the treatment modalities recommended based on the caries risk assessment results (Caries Management by Risk Assessment - CAMBRA), and to conduct a 2-year… Read more about this study
- Who is it for?
- Ages 12 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Caries prevention active intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 460 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 12 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- These criteria will not be based on race or gender.
- Participants will be new patients and must:
- be at least 12 years old and not older than 65 years
- be able to give informed consent in English
- be unlikely to move from the area during the study period (as determined by residential history and questioning, and be unlikely to move in the next 2.5 years for work, educational, or personal reasons.)
- be willing to participate regardless of group assignment
Show all 9Show fewer
- be willing to comply with all study procedures and protocol
- be dentate with at least sixteen teeth
- will have all treatment needs for caries completed within three months of entry into the study
Who cannot join
- People who want to limit radiation exposure from dental radiographs
- Persons with:
- significant past or current medical problem history especially conditions that may affect oral health or oral flora (i.e., diabetes, HIV, heart conditions that require antibiotic prophylaxis)
- medication use that may affect the oral flora or salivary flow (e.g., antibiotic use in the past three months, drugs associated with dry mouth/xerostomia)
- root caries at enrollment (study will focus on coronal caries)
- periodontal disease that requires surgery, chemotherapeutic agents, or frequent prophys
Show all 12Show fewer
- another household member participating in the study (to prevent sharing F, CHX rinses, etc.)
- drug or alcohol addiction, or other conditions that may decrease the likelihood of adhering to study protocol
- missed screening visit without cancellation or rescheduling
- rescheduled screening visit more than once
- subjects with extreme high caries risk
- sensitive to Chlorhexidine or the ethyl alcohol vehicle in CHX
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF School of Dentistry - Dental Offices in Bay Area
San Francisco, California, 94143
About this study
The goal of this project is to create a Practice Based Research Network with 30 researcher dentists calibrated on the administration of a caries risk assessment and the treatment modalities recommended based on the caries risk assessment results (Caries Management by Risk Assessment - CAMBRA), and to conduct a 2-year CAMBRA study in those dental offices. Participating dentists will be a mix of general practitioners and pediatric dentists selected from private practice, part time university faculty, large group practices, or community clinics. Participating practices will collect baseline data and patient progress and report on patient acceptance and compliance, and the effectiveness of treatment.
The program's duration is anticipated to be approximately four years. Year one will be dedicated to program, protocol and evaluation design, and recruitment, selection and calibration of researcher dentists. Years two and three will be the research and data collection time period, and year four will be dedicated to evaluation.
Read the detailed description
The clinical part of the project will prove that CAMBRA principles can successfully be disseminated into everyday dental practices and that by applying the principles of Caries Management by Risk Assessment to subjects in those practices a major reduction in caries can be seen in the intervention group in comparison to the control group. At the end of the two year clinical part performed in the Practice Based Research Network data will show that the positive results of the first CAMBRA study achieved in the university setting at UCSF can also be accomplished in a dental practice setting to the benefit of patients. If CAMBRA can be successfully disseminated into dental practices dental care costs can significantly be reduced.
The overall study objective is to build a Practice Based Research Network (PBRN) and to conduct in this setting a 2-year randomized, controlled, double blind clinical trial to provide clinical evidence that scientifically based caries risk assessment, in conjunction with aggressive preventive measures and conservative restorations will result in dramatically reduced further caries increment. If successful this study performed in a PBRN will provide substantial evidence for changing the practice of caries management. The planned study is a double blind practice-based clinical study. The California Dental Association Foundation will help to select up to 30 participating dentists. Practitioners will perform a Caries Management by Risk Assessment (CAMBRA) evaluation and will instruct and provide treatment suggestions for the study subjects according to the CAMBRA protocol.
The hypothesis to be tested is that caries management based on caries-risk status (low, moderate or high) will significantly reduce the need for caries restorative treatment over two (plus) years compared to usual dental treatment in the practice based setting. The primary outcome measure will be caries increment.
At the end of the two year clinical part performed in the Practice Based Research Network data will show that the positive results of the first CAMBRA study achieved in the university setting at UCSF can also be accomplished in a dental practice setting to the benefit of patients. If CAMBRA can be successfully implemented into dental practices in the future dental care costs can significantly be reduced.
- Conditions
- Dental Caries
- Being tested
- Caries prevention active intervention, control treatment
- Keywords
- Dental Caries, Preventive Dentistry, Dental Prophylaxis, Dental Care
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caries prevention active interventionOther
Subjects will be treated related to their caries risk:
"Low Caries Risk"
The intervention and control treatments for low caries risk are the same:
4 bitewing radiographs dental prophylaxis Oral Hygiene instruction OTC toothpaste with fluoride (1,100 ppm F) 2x daily Periodic oral exam after 12 months Bitewings after 12 months
"Moderate Caries Risk" In addition to the treatment above the intervention group receives OTC fluoride rinse as well as xylitol candies or gums.
"High Caries Risk" The high caries risk level subjects will receive a prescription 5,000 ppm F toothpaste, will rinse 1 day for one week per months with a Chlorhexidine rinse to reduce the bacteria level, and receive a fluoride varnish in the dental office.
control treatmentOther
Subjects will be treated related to their caries risk:
"Low Caries Risk"
The intervention and control treatments for low caries risk are the same:
4 bitewing radiographs dental prophylaxis (if prescribed) Oral Hygiene instruction OTC toothpaste with fluoride (1,100 ppm F) as currently used by patient Periodic oral exam after 12 months Bitewings after 12 months
"Moderate Caries Risk" "Control" group receives regular dental care (placebo rinse and gums without active ingredients allow blinding).
"High Caries Risk" The control treatment group receives regular dental care (regular 1,100 ppm F toothpaste, a placebo rinse without antibacterial ingredients and placebo varnish to allow blinding).
| Study group | Role | What they receive |
|---|---|---|
| Caries prevention active intervention | Active comparator | Patients receive CAMBRA related products like CHX, 5000ppm F-toothpaste etc according to their risk level Receives: Other: Caries prevention active intervention |
| control treatment | Placebo comparator | Patients receive treatment according to standard of care Receives: Other: control treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
caries increment
Measured: 2 years
Secondary outcomes (2)
changes in mutans streptococci (MS), and lactobacilli (LB) in whole saliva
Measured: 2 years
change in caries risk category over time
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2010 (estimated)
- Study startApr 2012
- Primary completionJan 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 460 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- California Dental Association Foundation
- Responsible party
- Sponsor
- Investigators
- Peter Rechmann, DDS, PhD, Principal investigator, University of California, San Francisco, School of DentistryJohn DB Featherstone, MSc, PhD, Principal investigator, University of California, San Francisco, School of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01176396
- Sponsor's protocol ID
- UCSF A113385
- Acronym
- CAMBRA-PBRN
- Status last verified
- Apr 2020
- First submitted
- 4 Aug 2010
- Last updated
- 10 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Kaste LM, Selwitz RH, Oldakowski RJ, Brunelle JA, Winn DM, Brown LJ. Coronal caries in the primary and permanent dentition of children and adolescents 1-17 years of age: United States, 1988-1991. J Dent Res. 1996 Feb;75 Spec No:631-41. doi: 10.1177/002203459607502S03.
PubMed 8594087NCHS. National Center for Heath Statistics, Government Printing Office, Washington D.C. 1974.
NIDR. The prevalence of dental caries in United States children: The National Dental Caries Prevalence Survey: 1979-80. NIH Publication No. 82-2245. National Institutes of Health 1981.
Brunelle JA. Oral Health of United States Children: The National Survey of Dental caries in US School Children:1986-87. National Institute of Dental Research 1989.
Speechley M, Johnston DW. Some evidence from Ontario, Canada, of a reversal in the dental caries decline. Caries Res. 1996;30(6):423-7. doi: 10.1159/000262354.
PubMed 8946102Beltran-Aguilar ED, Barker LK, Canto MT, Dye BA, Gooch BF, Griffin SO, Hyman J, Jaramillo F, Kingman A, Nowjack-Raymer R, Selwitz RH, Wu T; Centers for Disease Control and Prevention (CDC). Surveillance for dental caries, dental sealants, tooth retention, edentulism, and enamel fluorosis--United States, 1988-1994 and 1999-2002. MMWR Surveill Summ. 2005 Aug 26;54(3):1-43.
PubMed 16121123Bowen WH. Do we need to be concerned about dental caries in the coming millennium? Crit Rev Oral Biol Med. 2002;13(2):126-31. doi: 10.1177/154411130201300203.
PubMed 12097355Ismail AI, Burt BA, Brunelle JA. Prevalence of total tooth loss, dental caries, and periodontal disease in Mexican-American adults: results from the southwestern HHANES. J Dent Res. 1987 Jun;66(6):1183-8. doi: 10.1177/00220345870660061801.
PubMed 3476591Ismail AL, Burt BA, Brunelle JA. Prevalence of dental caries and periodontal disease in Mexican American children aged 5 to 17 years: results from southwestern HHANES, 1982-83. National Health and Nutrition Examination Survey. Am J Public Health. 1987 Aug;77(8):967-70. doi: 10.2105/ajph.77.8.967.
PubMed 3605476Featherstone JDB, Gansky SA, Hoover CI, Rapozo-Hilo ML, Weintraub JA, White JM, et al. Chlorehexidine and fluoride therapy reduces caries risk. J Dent Res 2005;84 [Spec Iss A, abstract 0023].
Hoover CI, Weintraub JA, Gansky SA, White JM, Wilson RS, Featherstone JDB. Effect of a caries management regimen on cariogenic bacterial population. J Dent Res. 2004;83 [Spec Iss A, abstract 0779].
Hoover CI, Weintraub JA, Gansky SA, White JM, Wilson JA, Featherstone JDB. Effect of restorations and Bacterial Challenge Management on Cariogenic Bacteria. J Dent Res. 2005;84 [Spec Iss A, abstract 3254].
Domejean-Orliaguet S, Gansky SA, Featherstone JD. Caries risk assessment in an educational environment. J Dent Educ. 2006 Dec;70(12):1346-54.
PubMed 17170326Young DA, Featherstone JD, Roth JR, Anderson M, Autio-Gold J, Christensen GJ, Fontana M, Kutsch VK, Peters MC, Simonsen RJ, Wolff MS. Caries management by risk assessment: implementation guidelines. J Calif Dent Assoc. 2007 Nov;35(11):799-805.
PubMed 18080486Young DA, Featherstone JD, Roth JR. Curing the silent epidemic: caries management in the 21st century and beyond. J Calif Dent Assoc. 2007 Oct;35(10):681-5.
PubMed 18044376
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAMBRA - PBRN Caries Management By Risk Assessment In A Practice-Based Research Network
- ClinicalTrials.gov ID
- NCT01176396
- Acronym / sponsor ID
- CAMBRA-PBRN / UCSF A113385
- Conditions
- Dental Caries
- Keywords
- Dental Caries, Preventive Dentistry, Dental Prophylaxis, Dental Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 460 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- California Dental Association Foundation
- Study start
- Apr 2012 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 6 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this project is to create a Practice Based Research Network with 30 researcher dentists calibrated on the administration of a caries risk assessment and the treatment modalities recommended based on the caries risk assessment results (Caries Management by Risk Assessment - CAMBRA), and to conduct a 2-year CAMBRA study in those dental offices. Participating dentists will be a mix of general practitioners and pediatric dentists selected from private practice, part time university faculty, large group practices, or community clinics. Participating practices will collect baseline data and patient progress and report on patient acceptance and compliance, and the effectiveness of treatment.
The program's duration is anticipated to be approximately four years. Year one will be dedicated to program, protocol and evaluation design, and recruitment, selection and calibration of researcher dentists. Years two and three will be the research and data collection time period, and year four will be dedicated to evaluation.
Detailed description
The clinical part of the project will prove that CAMBRA principles can successfully be disseminated into everyday dental practices and that by applying the principles of Caries Management by Risk Assessment to subjects in those practices a major reduction in caries can be seen in the intervention group in comparison to the control group. At the end of the two year clinical part performed in the Practice Based Research Network data will show that the positive results of the first CAMBRA study achieved in the university setting at UCSF can also be accomplished in a dental practice setting to the benefit of patients. If CAMBRA can be successfully disseminated into dental practices dental care costs can significantly be reduced.
The overall study objective is to build a Practice Based Research Network (PBRN) and to conduct in this setting a 2-year randomized, controlled, double blind clinical trial to provide clinical evidence that scientifically based caries risk assessment, in conjunction with aggressive preventive measures and conservative restorations will result in dramatically reduced further caries increment. If successful this study performed in a PBRN will provide substantial evidence for changing the practice of caries management. The planned study is a double blind practice-based clinical study. The California Dental Association Foundation will help to select up to 30 participating dentists. Practitioners will perform a Caries Management by Risk Assessment (CAMBRA) evaluation and will instruct and provide treatment suggestions for the study subjects according to the CAMBRA protocol.
The hypothesis to be tested is that caries management based on caries-risk status (low, moderate or high) will significantly reduce the need for caries restorative treatment over two (plus) years compared to usual dental treatment in the practice based setting. The primary outcome measure will be caries increment.
At the end of the two year clinical part performed in the Practice Based Research Network data will show that the positive results of the first CAMBRA study achieved in the university setting at UCSF can also be accomplished in a dental practice setting to the benefit of patients. If CAMBRA can be successfully implemented into dental practices in the future dental care costs can significantly be reduced.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caries prevention active intervention | Active comparator | Other: Caries prevention active interventionPatients receive CAMBRA related products like CHX, 5000ppm F-toothpaste etc according to their risk level |
| control treatment | Placebo comparator | Other: control treatmentPatients receive treatment according to standard of care |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- These criteria will not be based on race or gender.
- Participants will be new patients and must:
- be at least 12 years old and not older than 65 years
- be able to give informed consent in English
- be unlikely to move from the area during the study period (as determined by residential history and questioning, and be unlikely to move in the next 2.5 years for work, educational, or personal reasons.)
Key exclusion criteria (12 listed)
- People who want to limit radiation exposure from dental radiographs
- Persons with:
- significant past or current medical problem history especially conditions that may affect oral health or oral flora (i.e., diabetes, HIV, heart conditions that require antibiotic prophylaxis)
- medication use that may affect the oral flora or salivary flow (e.g., antibiotic use in the past three months, drugs associated with dry mouth/xerostomia)
- root caries at enrollment (study will focus on coronal caries)
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 |
|---|---|---|
| Caries prevention active interventionSubjects will be treated related to their caries risk: "Low Caries Risk" The intervention and control treatments for low caries risk are the same: 4 bitewing radiographs dental prophylaxis Oral Hygiene instruction OTC toothpaste with fluoride (1,100 ppm F) 2x daily Periodic oral exam after 12 months Bitewings after 12 months "Moderate Caries Risk" In addition to the treatment above the intervention group receives OTC fluoride rinse as well as xylitol candies or gums. "High Caries Risk" The high caries risk level subjects will receive a prescription 5,000 ppm F toothpaste, will rinse 1 day for one week per months with a Chlorhexidine rinse to reduce the bacteria level, and receive a fluoride varnish in the dental office. | Other | Caries prevention active intervention |
| control treatmentSubjects will be treated related to their caries risk: "Low Caries Risk" The intervention and control treatments for low caries risk are the same: 4 bitewing radiographs dental prophylaxis (if prescribed) Oral Hygiene instruction OTC toothpaste with fluoride (1,100 ppm F) as currently used by patient Periodic oral exam after 12 months Bitewings after 12 months "Moderate Caries Risk" "Control" group receives regular dental care (placebo rinse and gums without active ingredients allow blinding). "High Caries Risk" The control treatment group receives regular dental care (regular 1,100 ppm F toothpaste, a placebo rinse without antibacterial ingredients and placebo varnish to allow blinding). | Other | control treatment |
Primary outcome
caries increment
Time frame: 2 years
2 secondary outcomes
changes in mutans streptococci (MS), and lactobacilli (LB) in whole saliva
Time frame: 2 years
change in caries risk category over time
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2020.
- Background: PubMed 8594087Kaste LM, Selwitz RH, Oldakowski RJ, Brunelle JA, Winn DM, Brown LJ. Coronal caries in the primary and permanent dentition of children and adolescents 1-17 years of age: United States, 1988-1991. J Dent Res. 1996 Feb;75 Spec No:631-41. doi: 10.1177/002203459607502S03.
- BackgroundNCHS. National Center for Heath Statistics, Government Printing Office, Washington D.C. 1974.
- BackgroundNIDR. The prevalence of dental caries in United States children: The National Dental Caries Prevalence Survey: 1979-80. NIH Publication No. 82-2245. National Institutes of Health 1981.
- BackgroundBrunelle JA. Oral Health of United States Children: The National Survey of Dental caries in US School Children:1986-87. National Institute of Dental Research 1989.
- Background: PubMed 8946102Speechley M, Johnston DW. Some evidence from Ontario, Canada, of a reversal in the dental caries decline. Caries Res. 1996;30(6):423-7. doi: 10.1159/000262354.
- Background: PubMed 16121123Beltran-Aguilar ED, Barker LK, Canto MT, Dye BA, Gooch BF, Griffin SO, Hyman J, Jaramillo F, Kingman A, Nowjack-Raymer R, Selwitz RH, Wu T; Centers for Disease Control and Prevention (CDC). Surveillance for dental caries, dental sealants, tooth retention, edentulism, and enamel fluorosis--United States, 1988-1994 and 1999-2002. MMWR Surveill Summ. 2005 Aug 26;54(3):1-43.
- Background: PubMed 12097355Bowen WH. Do we need to be concerned about dental caries in the coming millennium? Crit Rev Oral Biol Med. 2002;13(2):126-31. doi: 10.1177/154411130201300203.
- Background: PubMed 3476591Ismail AI, Burt BA, Brunelle JA. Prevalence of total tooth loss, dental caries, and periodontal disease in Mexican-American adults: results from the southwestern HHANES. J Dent Res. 1987 Jun;66(6):1183-8. doi: 10.1177/00220345870660061801.
- Background: PubMed 3605476Ismail AL, Burt BA, Brunelle JA. Prevalence of dental caries and periodontal disease in Mexican American children aged 5 to 17 years: results from southwestern HHANES, 1982-83. National Health and Nutrition Examination Survey. Am J Public Health. 1987 Aug;77(8):967-70. doi: 10.2105/ajph.77.8.967.
- BackgroundFeatherstone JDB, Gansky SA, Hoover CI, Rapozo-Hilo ML, Weintraub JA, White JM, et al. Chlorehexidine and fluoride therapy reduces caries risk. J Dent Res 2005;84 [Spec Iss A, abstract 0023].
- BackgroundHoover CI, Weintraub JA, Gansky SA, White JM, Wilson RS, Featherstone JDB. Effect of a caries management regimen on cariogenic bacterial population. J Dent Res. 2004;83 [Spec Iss A, abstract 0779].
- BackgroundHoover CI, Weintraub JA, Gansky SA, White JM, Wilson JA, Featherstone JDB. Effect of restorations and Bacterial Challenge Management on Cariogenic Bacteria. J Dent Res. 2005;84 [Spec Iss A, abstract 3254].
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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.
Peter Rechmann, DDS, PhD principal investigator
University of California, San Francisco, School of Dentistry
John DB Featherstone, MSc, PhD principal investigator
University of California, San Francisco, School of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caries prevention active intervention in people with Dental Caries, run by University of California, San Francisco at 1 site 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 9 inclusion and 12 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 10 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
caries increment (time frame: 2 years). 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 NCT01176396, which also lists 24 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 10 Apr 2020.