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Induced Gingivitis & Intra-oral Imaging

Primary Purpose

Plaque Induced Gingivitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Plaque induced gingivitis
Oral hygiene maintenance
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Plaque Induced Gingivitis

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • University of Washington School of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Plaque induced gingivitis

Oral hygiene maintenance

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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
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
Change From Baseline Angiogenesis Chemokine Concentration at Day 28
Assessment of the concentration of the angiogenesis chemokine angiopoietin-1 during experimental gingivitis.

Full Information

First Posted
November 15, 2018
Last Updated
March 8, 2021
Sponsor
University of Washington
Collaborators
Colgate Palmolive
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1. Study Identification

Unique Protocol Identification Number
NCT03750955
Brief Title
Induced Gingivitis & Intra-oral Imaging
Official Title
Induced Gingivitis & Intra-oral Imaging
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
November 5, 2018 (Actual)
Primary Completion Date
June 3, 2019 (Actual)
Study Completion Date
June 3, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
Colgate Palmolive

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Induced Gingivitis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Split-mouth
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Plaque induced gingivitis
Arm Type
Experimental
Arm Description
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.
Arm Title
Oral hygiene maintenance
Arm Type
Active Comparator
Arm Description
Non-invasive microimaging (OTC device) of gingival tissue where oral hygiene (tooth brushing with fluoride toothpaste and flossing twice daily) is maintained.
Intervention Type
Device
Intervention Name(s)
Plaque induced gingivitis
Other Intervention Name(s)
Cessation of oral hygiene
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Oral hygiene maintenance
Intervention Description
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 Outcome Measure Information:
Title
Change From Baseline Gingivitis at Day 14 as Measured by Non-invasive Microimaging and Gingival Index.
Description
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
Time Frame
Baseline to Day 14
Title
Change From Day 14 Gingivitis at Day 28 as Measured by Non-invasive Microimaging and Gingival Index.
Description
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
Time Frame
Day 14 to Day 28
Secondary Outcome Measure Information:
Title
Change From Baseline Gingivitis at Day 14 as Measured by Non-invasive Microimaging and Plaque Index.
Description
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
Time Frame
Baseline to Day 14
Title
Change From Day 14 Gingivitis at Day 28 as Measured by Non-invasive Microimaging and Plaque Index.
Description
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
Time Frame
Day 14 to Day 28
Title
Change From Baseline Angiogenesis Chemokine Concentration at Day 28
Description
Assessment of the concentration of the angiogenesis chemokine angiopoietin-1 during experimental gingivitis.
Time Frame
Baseline to Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard P Darveau, MS, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington School of Dentistry
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

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Induced Gingivitis & Intra-oral Imaging

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