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Completed

NCT Number: NCT03750955

Induced Gingivitis & Intra-oral Imaging

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.

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Key information

Conditions

Plaque Induced Gingivitis

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Washington School of Dentistry

Seattle, Washington, 98195, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • • 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
  • 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)

Treatment and study plan

Plaque induced gingivitis

Device

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.

Other names: Cessation of oral hygiene

Oral hygiene maintenance

Device

Non-invasive microimaging (OTC device) of gingival tissue where oral hygiene has been maintained by tooth brushing with fluoride toothpaste and flossing twice daily.

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Change From Baseline Gingivitis at Day 14 as Measured by Non-invasive Microimaging and Plaque Index.

    Time frame: 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

  2. Change From Day 14 Gingivitis at Day 28 as Measured by Non-invasive Microimaging and Plaque Index.

    Time frame: 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

  3. Change From Baseline Angiogenesis Chemokine Concentration at Day 28

    Time frame: Baseline to Day 28

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

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Colgate Palmolive

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 23, 2018
Registry last updated
Mar 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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