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NCT03750955

Induced Gingivitis & Intra-oral Imaging

Completed NA Results posted Last updated 9 March 2021
What this trial tests

NA trial testing Plaque induced gingivitis in Plaque Induced Gingivitis in 16 participants. Completed in 3 June 2019.

Timeline
5 November 2018
Primary endpoint
3 June 2019
3 June 2019

Quick facts

Lead sponsorUniversity of Washington
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposediagnostic
Enrollment16
Start date5 November 2018
Primary completion3 June 2019
Estimated completion3 June 2019
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Washington

Who can join

Adults 18 to 35, any sex, with Plaque Induced Gingivitis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline Gingivitis at Day 14 as Measured by Non-invasive Microimaging and Gingival Index. Primary · 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

GroupValue95% CI
Plaque Induced Gingivitis0.6± 1.2
Oral Hygiene Maintenance0.15± 0.3
Change From Day 14 Gingivitis at Day 28 as Measured by Non-invasive Microimaging and Gingival Index. Primary · 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

GroupValue95% CI
Plaque Induced Gingivitis0.08± 0.4
Oral Hygiene Maintenance0.08± 0.2
Change From Baseline Gingivitis at Day 14 as Measured by Non-invasive Microimaging and Plaque Index. Secondary · Baseline to Day 14

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

GroupValue95% CI
Plaque Induced Gingivitis0.84± 1.4
Oral Hygiene Maintenance0.17± 0.24
Change From Day 14 Gingivitis at Day 28 as Measured by Non-invasive Microimaging and Plaque Index. Secondary · Day 14 to Day 28

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

GroupValue95% CI
Plaque Induced Gingivitis0.11± 0.18
Oral Hygiene Maintenance0.105± 0.5
Change From Baseline Angiogenesis Chemokine Concentration at Day 28 Secondary · Baseline to Day 28

Assessment of the concentration of the angiogenesis chemokine angiopoietin-1 during experimental gingivitis.

GroupValue95% CI
Plaque Induced Gingivitis137825.56± 339893.64
Oral Hygiene Maintenance164411.80± 408590.49

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Plaque Induced Gingivitis
Serious: 0/13 (0%)
Deaths: 0/13
Oral Hygiene Maintenance
Serious: 0/13 (0%)
Deaths: 0/13
Hygiene Phase
Serious: 0/13 (0%)
Deaths: 0/13
Systemic Adverse Events
Serious: 0/13 (0%)
Deaths: 0/13
Other adverse events (7 terms — click to expand)

ReactionSystemPlaque Induced GingivitisOral Hygiene MaintenanceHygiene PhaseSystemic Adverse Events
rhinorrheaInfections and infestations
menstrual crampsReproductive system and breast disorders
coldInfections and infestations
ulcerated interdental papilla #14/15Injury, poisoning and procedural complications
bruised achilles tendonInjury, poisoning and procedural complications
abraded palatal tissue left posteriorGastrointestinal disorders
tender maxillary left posterior buccal gingivaInjury, poisoning and procedural complications

Data from ClinicalTrials.gov NCT03750955 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Quantitative analysis of gingival vascular morphology using optical coherence tomography angiography in induced gingivitis.
    Le NM, Wang G, Xie Z, Yue CF, et al · · 2025 · cited 1× · PMID 41293691 · DOI 10.1364/boe.570850

Verify or expand the search:

Other recruiting trials for Plaque Induced Gingivitis

Currently open trials in the same condition.

Other University of Washington trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03750955.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing