PeriodontitisPhase 2NCT02788786
Feasibility and Acceptability of Use of Daily Oral Rinse in Pregnant Women in Rural Nepal
A Phase 2 study testing Chlorhexidine, Cetylpyridinium chloride and Salt and Water in people with Periodontitis and Premature Birth of Newborn, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Nepal.
Trial summary
In Nepal, investigators are conducting a cohort study to estimate the relationship between signs of periodontal disease in pregnant women and preterm delivery. Within that cohort study, investigators plan to conduct an individually randomized trial of the acceptability and effect chlorhexidine, cetylpyridinium… Read more about this study
- Who is it for?
- Ages 15 years and older, women only
- Conditions the study is for
- Periodontitis, Premature Birth of Newborn
- What is being tested?
- Chlorhexidine, Cetylpyridinium chloride and Salt and Water
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteNepal
- Study dates
- 27 Jun 2016to 15 Nov 2016
- Phase
- Phase 2
- 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 15 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pregnant
- <26 weeks gestation at enrollment
- Enrolled in the broader cohort study
Who cannot join
- Already previously enrolled
- Not Pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Acceptability of Daily Oral Rinse in Pregnant Women and Impact on Oral Inflammatory Biomarkers in Rural Nepal
In Nepal, investigators are conducting a cohort study to estimate the relationship between signs of periodontal disease in pregnant women and preterm delivery. Within that cohort study, investigators plan to conduct an individually randomized trial of the acceptability and effect chlorhexidine, cetylpyridinium chloride, and salt water oral rinses on gingival crevicular fluid and plaque during pregnancy. Women for this pilot trial will be chosen from a subset of the area currently engaged in the larger cohort study, to simplify logistics. The pilot trial will have four arms (three oral rinse arms, and one control group).
- Arm 1: Twice daily oral rinse containing chlorhexidine 0.12% w/v (n=25 women with periodontitis
- Arm 2: Twice daily oral rinse with cetylpyridinium chloride (n=50; 25 women with/without periodontitis)
- Arm 3: Twice daily oral rinse with salt and water (n=50: 25 women with/without periodontitis)
- Arm 4: No oral rinse (n=50)
Read more
To select and enroll these 175 participants, data collectors will use the information they collected during an oral health clinical examination conducted at the time of enrollment into the broader cohort study; this information will be used to classify women by signs of periodontitis.
Those selected through this above process will be read an additional consent form; those agreeing to participate will be provided with a supply of their assigned rinse (and instructions on its use and handling/storage), or no rinse. Those in the three rinse groups will be asked to use the provided rinse twice per day after brushing and to save the empty bottles for collection by the health care worker. At the end of this first visit, women will additionally provide a venous blood sample to measure systemic inflammation markers and fluoride.
Women receiving the rinse will be visited by study workers periodically to provide more oral rinse and check on their adherence to the rinse. All 175 women will be visited after 12 weeks to undergo a second oral health clinical examination and provide a second set of gingival crevicular fluid and plaque samples, to allow for evaluation of the effect of each of the oral rinses as compared to the normal physiological changes in gingival inflammation and biofilm composition during the course of pregnancy.
At this final visit, the women in the three rinse arms will also answer a short questionnaire to gather feedback on acceptability and adherence to the oral rinse.
- Conditions
- Periodontitis, Premature Birth of Newborn
- Being tested
- Chlorhexidine, Cetylpyridinium chloride, Salt and Water
- Keywords
- chlorhexidine, cetylpyridinium chloride, gingival crevicular fluid
- Medical subject headings
- Periodontitis, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChlorhexidineDrug
Also called chlorhexidine oral rinse
non-alcoholic chlorhexidine gluconate antiseptic mouth rinse
Cetylpyridinium chlorideDrug
non-alcoholic cetylpyridinium chloride antiseptic mouth rinse
Salt and WaterDrug
salt and water mix oral rinse
| Study group | Role | What they receive |
|---|---|---|
| chlorhexidine | Experimental | 0.12% w/v chlorhexidine oral rinse; 15ml, twice-daily, for 12 weeks Receives: Drug: Chlorhexidine |
| cetylpyridinium chloride | Experimental | non-alcoholic cetylpyridinium chloride oral rinse; 15ml, twice-daily, for 12 weeks Receives: Drug: Cetylpyridinium chloride |
| Salt and Water | Active comparator | Salt and water based oral rinse; 15ml, twice-daily, for 12 weeks Receives: Drug: Salt and Water |
| No oral rinse | No intervention | No rinse provided in this group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability
Do women accept the use of their assigned oral rinse?
Measured: 12 weeks
Inflammatory markers in gingival crevicular fluid (IL-1β, IL-6, IL-10, TNF-α, PGE2, and GM-CSF)
Do the oral rinses (or no rinse) have differing impacts on inflammatory markers in gingival crevicular fluid. Specifically, IL-1β, IL-6, IL-10, TNF-α, PGE2, and GM-CSF will be measured (pg/ml) using validated multiplex immunoassays.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2016 (estimated)
- Study start27 Jun 2016
- Primary completion15 Nov 2016
- Study completion15 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Responsible party
- Sponsor
- Investigators
- Luke C Mullany, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02788786
- Sponsor's protocol ID
- OPP1131701
- Status last verified
- Jan 2017
- First submitted
- 24 May 2016
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Erchick DJ, Rai B, Agrawal NK, Khatry SK, Katz J, LeClerq SC, Reynolds MA, Mullany LC. Oral hygiene, prevalence of gingivitis, and associated risk factors among pregnant women in Sarlahi District, Nepal. BMC Oral Health. 2019 Jan 5;19(1):2. doi: 10.1186/s12903-018-0681-5.
PubMed 30611255Lubon AJ, Erchick DJ, Khatry SK, LeClerq SC, Agrawal NK, Reynolds MA, Katz J, Mullany LC. Oral health knowledge, behavior, and care seeking among pregnant and recently-delivered women in rural Nepal: a qualitative study. BMC Oral Health. 2018 Jun 1;18(1):97. doi: 10.1186/s12903-018-0564-9.
PubMed 29859084
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of Daily Oral Rinse in Pregnant Women and Impact on Oral Inflammatory Biomarkers in Rural Nepal
- ClinicalTrials.gov ID
- NCT02788786
- Acronym / sponsor ID
- OPP1131701
- Conditions
- Periodontitis, Premature Birth of Newborn
- Keywords
- chlorhexidine, cetylpyridinium chloride, gingival crevicular fluid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Study start
- 27 Jun 2016 (actual)
- Primary completion
- 15 Nov 2016 (actual)
- Study completion
- 15 Nov 2016 (actual)
- First posted
- 2 Jun 2016 (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.
In Nepal, investigators are conducting a cohort study to estimate the relationship between signs of periodontal disease in pregnant women and preterm delivery. Within that cohort study, investigators plan to conduct an individually randomized trial of the acceptability and effect chlorhexidine, cetylpyridinium chloride, and salt water oral rinses on gingival crevicular fluid and plaque during pregnancy. Women for this pilot trial will be chosen from a subset of the area currently engaged in the larger cohort study, to simplify logistics. The pilot trial will have four arms (three oral rinse arms, and one control group).
- Arm 1: Twice daily oral rinse containing chlorhexidine 0.12% w/v (n=25 women with periodontitis
- Arm 2: Twice daily oral rinse with cetylpyridinium chloride (n=50; 25 women with/without periodontitis)
- Arm 3: Twice daily oral rinse with salt and water (n=50: 25 women with/without periodontitis)
- Arm 4: No oral rinse (n=50)
To select and enroll these 175 participants, data collectors will use the information they collected during an oral health clinical examination conducted at the time of enrollment into the broader cohort study; this information will be used to classify women by signs of periodontitis.
Those selected through this above process will be read an additional consent form; those agreeing to participate will be provided with a supply of their assigned rinse (and instructions on its use and handling/storage), or no rinse. Those in the three rinse groups will be asked to use the provided rinse twice per day after brushing and to save the empty bottles for collection by the health care worker. At the end of this first visit, women will additionally provide a venous blood sample to measure systemic inflammation markers and fluoride.
Women receiving the rinse will be visited by study workers periodically to provide more oral rinse and check on their adherence to the rinse. All 175 women will be visited after 12 weeks to undergo a second oral health clinical examination and provide a second set of gingival crevicular fluid and plaque samples, to allow for evaluation of the effect of each of the oral rinses as compared to the normal physiological changes in gingival inflammation and biofilm composition during the course of pregnancy.
At this final visit, the women in the three rinse arms will also answer a short questionnaire to gather feedback on acceptability and adherence to the oral rinse.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| chlorhexidine | Experimental | Drug: Chlorhexidine0.12% w/v chlorhexidine oral rinse; 15ml, twice-daily, for 12 weeks |
| cetylpyridinium chloride | Experimental | Drug: Cetylpyridinium chloridenon-alcoholic cetylpyridinium chloride oral rinse; 15ml, twice-daily, for 12 weeks |
| Salt and Water | Active comparator | Drug: Salt and WaterSalt and water based oral rinse; 15ml, twice-daily, for 12 weeks |
| No oral rinse | No intervention | –No rinse provided in this group |
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Pregnant
- <26 weeks gestation at enrollment
- Enrolled in the broader cohort study
Key exclusion criteria (2 listed)
- Already previously enrolled
- Not Pregnant
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 |
|---|---|---|
| ChlorhexidineAlso: chlorhexidine oral rinsenon-alcoholic chlorhexidine gluconate antiseptic mouth rinse | Drug | chlorhexidine |
| Cetylpyridinium chloridenon-alcoholic cetylpyridinium chloride antiseptic mouth rinse | Drug | cetylpyridinium chloride |
| Salt and Watersalt and water mix oral rinse | Drug | Salt and Water |
Primary outcome
Acceptability
Time frame: 12 weeks
Do women accept the use of their assigned oral rinse?
Inflammatory markers in gingival crevicular fluid (IL-1β, IL-6, IL-10, TNF-α, PGE2, and GM-CSF)
Time frame: 12 weeks
Do the oral rinses (or no rinse) have differing impacts on inflammatory markers in gingival crevicular fluid. Specifically, IL-1β, IL-6, IL-10, TNF-α, PGE2, and GM-CSF will be measured (pg/ml) using validated multiplex immunoassays.
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 23 Feb 2017.
- Derived from this study: PubMed 30611255Erchick DJ, Rai B, Agrawal NK, Khatry SK, Katz J, LeClerq SC, Reynolds MA, Mullany LC. Oral hygiene, prevalence of gingivitis, and associated risk factors among pregnant women in Sarlahi District, Nepal. BMC Oral Health. 2019 Jan 5;19(1):2. doi: 10.1186/s12903-018-0681-5.
- Derived from this study: PubMed 29859084Lubon AJ, Erchick DJ, Khatry SK, LeClerq SC, Agrawal NK, Reynolds MA, Katz J, Mullany LC. Oral health knowledge, behavior, and care seeking among pregnant and recently-delivered women in rural Nepal: a qualitative study. BMC Oral Health. 2018 Jun 1;18(1):97. doi: 10.1186/s12903-018-0564-9.
- 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.
Luke C Mullany, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chlorhexidine, Cetylpyridinium chloride and Salt and Water in people with Periodontitis and Premature Birth of Newborn, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Nepal.
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 3 inclusion and 2 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 23 Feb 2017. 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 Nepal. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Acceptability (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 NCT02788786, which also lists 2 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 23 Feb 2017.