Plaque Induced GingivitisNCT03750955
Induced Gingivitis & Intra-oral Imaging
A study testing Plaque induced gingivitis and Oral hygiene maintenance in people with Plaque Induced Gingivitis, run by University of Washington at 1 site in United States.
Trial summary
Using an experimental, non-invasive intra-oral imaging device, this study evaluates the effects on the gingival tissue when oral hygiene is stopped in a section of the mouth for two weeks and gingivitis develops. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Plaque Induced Gingivitis
- What is being tested?
- Plaque induced gingivitis and Oral hygiene maintenance
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2018to 3 Jun 2019
- Phase
- Interventional
- 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 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- In good general health, ASA I
- No clinical signs of gingival inflammation at >90% sites observed
- Probing Depth(PD) ≤ 3.0 mm
- Attachment Loss (AL) = 0 mm
- Gingival health at baseline visit (Day 0): Gingival Index (GI) ≤ 0.5, Bleeding on probing (BOP)(-)
- Fluent in English
Who cannot join
- • Medical condition which requires premedication prior to dental treatments/visits
- Subjects unable or unwilling to undergo informed consent process.
- Subjects currently using anti-gingivitis oral rinses (washout period of 1 week)
- History of periodontal disease
- History of systemic inflammatory or immune conditions
- Use of antibiotic or anti-inflammatory drugs within 30 days of enrollment
Show all 14Show fewer
- Pregnant or breastfeeding at time of screening
- Concurrent orthodontic treatment
- Untreated carious lesions and/or inadequate restorations, implants, crowns on maxillary non-molar teeth
- Participation in any other clinical study or test panel within 1 week prior to enrollment into this study
- Use of tobacco products
- Subjects who must receive dental treatment during the study dates
- Orthodontic bands, appliances, or crowns and bridges, or removable partial dentures affecting the non-molar maxillary teeth
- Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington School of Dentistry
Seattle, Washington, 98195
About this study
Using an experimental, non-invasive intra-oral imaging device, this study evaluates the effects on the gingival tissue when oral hygiene is stopped in a section of the mouth for two weeks and gingivitis develops. The effects on the gingival tissue continues to be evaluated as oral hygiene is resumed and the gingival tissue returns to health.
Read the detailed description
The study will include the following phases - 1) Hygiene phase of 2 weeks; 2) Gingivitis induction phase with stent lasting up to 2 weeks; and 3) Resolution phase of 2 weeks.
The intervention will consist of cessation of oral hygiene versus an active control of oral hygiene with a fluoridated toothpaste. This study is a modification of classical experimental gingivitis model. The study will prospectively enroll subjects and assign a maxillary sextant to the intervention, while the other sextant will serve as control in a split-mouth design of localized experimental gingivitis, utilizing localized stent-induced biofilm overgrowth model (SIBO). The intervention, i.e. oral hygiene cessation will manipulate the participants' oral environment by leading to reversible inflammation of the gingival tissues. The purpose of this study is to evaluate the effects of oral hygiene cessation in the gingival tissues by an innovative non-invasive microimaging technique, i.e. Optical coherence tomography (OCT).
- Conditions
- Plaque Induced Gingivitis
- Being tested
- Plaque induced gingivitis, Oral hygiene maintenance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plaque induced gingivitisDevice
Also called Cessation of oral hygiene
Non-invasive microimaging (OTC device) of gingival tissue where oral hygiene cessation utilizing localized stent-induced biofilm overgrowth model (SIBO), will manipulate the participants' oral environment by leading to reversible inflammation of the gingival tissues.
Oral hygiene maintenanceDevice
Non-invasive microimaging (OTC device) of gingival tissue where oral hygiene has been maintained by tooth brushing with fluoride toothpaste and flossing twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Plaque induced gingivitis | Experimental | Non-invasive microimaging (OTC device) of gingival tissue where plaque induced gingivitis results from a cessation of oral hygiene in a sextant using a stent-induced biofilm overgrowth model. Receives: Device: Plaque induced gingivitis |
| Oral hygiene maintenance | Active comparator | Non-invasive microimaging (OTC device) of gingival tissue where oral hygiene (tooth brushing with fluoride toothpaste and flossing twice daily) is maintained. Receives: Device: Oral hygiene maintenance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline Gingivitis at Day 14 as Measured by Non-invasive Microimaging and Gingival Index.
The predictive validity of a non-invasive microimaging technique for assessing experimental gingivitis (plaque induced), as compared with gingival index is not reported. The microimaging technique was used to measure changes in the gingival thickness of the inter-dental tooth area. This area measured did not represent the clinical status of the tissue surrounding the tooth.
The gingival index is reported. Loe and Silness Gingival Index (GI); scale: 0 = normal gingiva, 1 = mild inflammation, 2 = moderate inflammation, 3 = severe inflammation
Measured: Baseline to Day 14
Change From Day 14 Gingivitis at Day 28 as Measured by Non-invasive Microimaging and Gingival Index.
The predictive validity of a non-invasive microimaging technique for assessing experimental gingivitis (plaque induced), as compared with gingival index is not reported. The microimaging technique was used to measure changes in the gingival thickness of the inter-dental tooth area. This area measured did not represent the clinical status of the tissue surrounding the tooth.
The gingival index is reported. Loe and Silness Gingival Index (GI); scale: 0 = normal gingiva, 1 = mild inflammation, 2 = moderate inflammation, 3 = severe inflammation
Measured: Day 14 to Day 28
Secondary outcomes (3)
Change From Baseline Gingivitis at Day 14 as Measured by Non-invasive Microimaging and Plaque Index.
The predictive validity of a microimaging technique for assessing experimental gingivitis, as compared with plaque index is not reported. The microimaging technique was used to measure changes in the gingival thickness of the inter-dental tooth area. This area measured did not represent the clinical status of the tissue surrounding the tooth.
The plaque index is reported. Visible Plaque Index; scoring: 0 = no plaque; 1 = visible plaque
Measured: Baseline to Day 14
Change From Day 14 Gingivitis at Day 28 as Measured by Non-invasive Microimaging and Plaque Index.
The predictive validity of a microimaging technique for assessing experimental gingivitis, as compared with plaque index is not reported. The microimaging technique was used to measure changes in the gingival thickness of the inter-dental tooth area. This area measured did not represent the clinical status of the tissue surrounding the tooth.
The plaque index is reported. Visible Plaque Index; scoring: 0 = no plaque; 1 = visible plaque
Measured: Day 14 to Day 28
Change From Baseline Angiogenesis Chemokine Concentration at Day 28
Assessment of the concentration of the angiogenesis chemokine angiopoietin-1 during experimental gingivitis.
Measured: Baseline to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start5 Nov 2018
- Primary completion3 Jun 2019
- Study completion3 Jun 2019
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.
- Other trials for Plaque Induced GingivitisStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Split-mouth
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Colgate Palmolive
- Responsible party
- Principal investigator, Richard Darveau, University of Washington
- Investigators
- Richard P Darveau, MS, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03750955
- Sponsor's protocol ID
- SITE00000993
- Status last verified
- Mar 2021
- First submitted
- 15 Nov 2018
- Last updated
- 9 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induced Gingivitis & Intra-oral Imaging
- ClinicalTrials.gov ID
- NCT03750955
- Acronym / sponsor ID
- SITE00000993
- Conditions
- Plaque Induced Gingivitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Colgate Palmolive
- Study start
- 5 Nov 2018 (actual)
- Primary completion
- 3 Jun 2019 (actual)
- Study completion
- 3 Jun 2019 (actual)
- First posted
- 23 Nov 2018 (actual)
- Results
- Posted 9 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Using an experimental, non-invasive intra-oral imaging device, this study evaluates the effects on the gingival tissue when oral hygiene is stopped in a section of the mouth for two weeks and gingivitis develops. The effects on the gingival tissue continues to be evaluated as oral hygiene is resumed and the gingival tissue returns to health.
Detailed description
The study will include the following phases - 1) Hygiene phase of 2 weeks; 2) Gingivitis induction phase with stent lasting up to 2 weeks; and 3) Resolution phase of 2 weeks.
The intervention will consist of cessation of oral hygiene versus an active control of oral hygiene with a fluoridated toothpaste. This study is a modification of classical experimental gingivitis model. The study will prospectively enroll subjects and assign a maxillary sextant to the intervention, while the other sextant will serve as control in a split-mouth design of localized experimental gingivitis, utilizing localized stent-induced biofilm overgrowth model (SIBO). The intervention, i.e. oral hygiene cessation will manipulate the participants' oral environment by leading to reversible inflammation of the gingival tissues. The purpose of this study is to evaluate the effects of oral hygiene cessation in the gingival tissues by an innovative non-invasive microimaging technique, i.e. Optical coherence tomography (OCT).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Split-mouth
| Arm | Type | Receives |
|---|---|---|
| Plaque induced gingivitis | Experimental | Device: Plaque induced gingivitisNon-invasive microimaging (OTC device) of gingival tissue where plaque induced gingivitis results from a cessation of oral hygiene in a sextant using a stent-induced biofilm overgrowth model. |
| Oral hygiene maintenance | Active comparator | Device: Oral hygiene maintenanceNon-invasive microimaging (OTC device) of gingival tissue where oral hygiene (tooth brushing with fluoride toothpaste and flossing twice daily) is maintained. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- In good general health, ASA I
- No clinical signs of gingival inflammation at >90% sites observed
- Probing Depth(PD) ≤ 3.0 mm
- Attachment Loss (AL) = 0 mm
- Gingival health at baseline visit (Day 0): Gingival Index (GI) ≤ 0.5, Bleeding on probing (BOP)(-)
Key exclusion criteria (14 listed)
- • Medical condition which requires premedication prior to dental treatments/visits
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 |
|---|---|---|
| Plaque induced gingivitisAlso: Cessation of oral hygieneNon-invasive microimaging (OTC device) of gingival tissue where oral hygiene cessation utilizing localized stent-induced biofilm overgrowth model (SIBO), will manipulate the participants' oral environment by leading to reversible inflammation of the gingival tissues. | Device | Plaque induced gingivitis |
| Oral hygiene maintenanceNon-invasive microimaging (OTC device) of gingival tissue where oral hygiene has been maintained by tooth brushing with fluoride toothpaste and flossing twice daily. | Device | Oral hygiene maintenance |
Primary outcome
Change From Baseline Gingivitis at Day 14 as Measured by Non-invasive Microimaging and Gingival Index.
Time frame: Baseline to Day 14
The predictive validity of a non-invasive microimaging technique for assessing experimental gingivitis (plaque induced), as compared with gingival index is not reported. The microimaging technique was used to measure changes in the gingival thickness of the inter-dental tooth area. This area measured did not represent the clinical status of the tissue surrounding the tooth. The gingival index is reported. Loe and Silness Gingival Index (GI); scale: 0 = normal gingiva, 1 = mild inflammation, 2 = moderate inflammation, 3 = severe inflammation
Change From Day 14 Gingivitis at Day 28 as Measured by Non-invasive Microimaging and Gingival Index.
Time frame: Day 14 to Day 28
The predictive validity of a non-invasive microimaging technique for assessing experimental gingivitis (plaque induced), as compared with gingival index is not reported. The microimaging technique was used to measure changes in the gingival thickness of the inter-dental tooth area. This area measured did not represent the clinical status of the tissue surrounding the tooth. The gingival index is reported. Loe and Silness Gingival Index (GI); scale: 0 = normal gingiva, 1 = mild inflammation, 2 = moderate inflammation, 3 = severe inflammation
3 secondary outcomes
Change From Baseline Gingivitis at Day 14 as Measured by Non-invasive Microimaging and Plaque Index.
Time frame: Baseline to Day 14
Change From Day 14 Gingivitis at Day 28 as Measured by Non-invasive Microimaging and Plaque Index.
Time frame: Day 14 to Day 28
Change From Baseline Angiogenesis Chemokine Concentration at Day 28
Time frame: Baseline to Day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Richard P Darveau, MS, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plaque induced gingivitis and Oral hygiene maintenance in people with Plaque Induced Gingivitis, run by University of Washington 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 6 inclusion and 14 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 9 Mar 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?
Yes. Results are posted in the registry (first posted 9 Mar 2021). 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?
Change From Baseline Gingivitis at Day 14 as Measured by Non-invasive Microimaging and Gingival Index. (time frame: Baseline to Day 14). 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 9 Mar 2021.