Dental CariesNCT02885064
Shifts in the Oral Biofilm of Patients With Known Oral Health Risk Factors
An observational study of Dental Caries and Gingivitis, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
This study is observational only and is intended to evaluate changes in the makeup and function of bacteria naturally present in the mouth during treatment with braces to straighten teeth. Read more about this study
- Who is it for?
- Ages 8 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries, Gingivitis
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to 22 Jun 2021
- Phase
- Observational
- 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 8 to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients entering and then undergoing orthodontic treatment
Who may be able to join
- ASA I or II (ASA I is a healthy patient, ASA II is patient with minor systemic disease)
- Patient must be receiving orthodontic treatment at the University of North Carolina School of Dentistry and not yet be in active treatment
Who cannot join
- Patients who have used antibacterial therapy in the past 3 months
- Patients who report current smoking
- ASA III or above (Patients with severe systemic diseases)
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC School of Dentistry
Chapel Hill, North Carolina, 27599
About this study
This study is observational only and is intended to evaluate changes in the makeup and function of bacteria naturally present in the mouth during treatment with braces to straighten teeth.
- Conditions
- Dental Caries, Gingivitis
- Medical subject headings
- Dental Caries, Gingivitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Shannon diversity index from Baseline to Month 6
Measured: Baseline, Month 6
Change from Baseline to Month 6 in Clusters Of Orthologous Groups of proteins
Measured: Baseline, Month 6
Secondary outcomes (2)
Change in gingival index
Measured: Baseline, Month 6
Change in decalcification index
Measured: Baseline, Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2016 (estimated)
- Study startAug 2016
- Primary completion22 Jun 2021
- Study completion22 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Jacox, DMD, PhD, MS, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02885064
- Sponsor's protocol ID
- 16-1624
- Status last verified
- Apr 2021
- First submitted
- 26 Aug 2016
- Last updated
- 14 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shifts in the Oral Biofilm of Patients With Known Oral Health Risk Factors
- ClinicalTrials.gov ID
- NCT02885064
- Acronym / sponsor ID
- 16-1624
- Conditions
- Dental Caries, Gingivitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- 22 Jun 2021 (actual)
- Study completion
- 22 Jun 2021 (actual)
- First posted
- 31 Aug 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.
This study is observational only and is intended to evaluate changes in the makeup and function of bacteria naturally present in the mouth during treatment with braces to straighten teeth.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 8 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients entering and then undergoing orthodontic treatment
Key inclusion criteria (2 listed)
- ASA I or II (ASA I is a healthy patient, ASA II is patient with minor systemic disease)
- Patient must be receiving orthodontic treatment at the University of North Carolina School of Dentistry and not yet be in active treatment
Key exclusion criteria (3 listed)
- Patients who have used antibacterial therapy in the past 3 months
- Patients who report current smoking
- ASA III or above (Patients with severe systemic diseases)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Shannon diversity index from Baseline to Month 6
Time frame: Baseline, Month 6
Change from Baseline to Month 6 in Clusters Of Orthologous Groups of proteins
Time frame: Baseline, Month 6
2 secondary outcomes
Change in gingival index
Time frame: Baseline, Month 6
Change in decalcification index
Time frame: Baseline, Month 6
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 14 Dec 2021.
- Individual participant dataSharing planned: Undecided
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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.
Laura Jacox, DMD, PhD, MS principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Caries and Gingivitis, run by University of North Carolina, Chapel Hill 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 2 inclusion and 3 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 Dec 2021. 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. 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?
Change in Shannon diversity index from Baseline to Month 6 (time frame: Baseline, Month 6). 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?
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 Dec 2021.