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Variation in Gingival Inflammatory Responses

Primary Purpose

Gingivitis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Abstinence of oral hygiene on select teeth
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Gingivitis focused on measuring Experimental Gingivitis

Eligibility Criteria

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

Inclusion Criteria: Provide signed and dated informed consent form Willing to comply with all study procedures and be available for the duration of the study Male or female, aged 18-35 years Good general health, ASA I (healthy with no systemic conditions) No clinical signs of gingival inflammation at > 90% of sites observed (whole mouth) (< 10% of sites with GI of < 2 and no sites with a score of 3; < 10% sites with BOP +). Probing depth (PD) ≤ 3.0 mm (Whole Mouth) Attachment loss (AL) = 0 mm (Whole Mouth) Gingival health at Visit 2 (Day 0) for study sites (Test/Control teeth): Average Gingival Index (GI) ≤ 0.1 with no site having a score of 3 and bleeding on probing (BOP)(-) Never smokers The ability to understand and communicate with the examiner. Willing and able to comply with study procedures. Exclusion Criteria: Medical condition which requires premedication prior to dental treatments/visits Subjects unable or unwilling to sign the informed consent form History of periodontal disease History of systemic inflammatory or immune conditions, Diabetes Use of antibiotic or anti-inflammatory drugs within 30 days of enrollment Self-reported pregnancy, planned pregnancy during the planned study commitment, and/or breastfeeding at the time of screening. Concurrent orthodontic treatment Untreated carious lesions and/or inadequate restorations on maxillary posterior 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 maxillary posterior teeth Missing tooth/teeth within the study sites test and control History of allergy to common dentifrice ingredients Immune-compromised individuals (for example: HIV, AIDS, and immune-suppressive drug therapy)

Sites / Locations

  • University of WashingtonRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Healthy Volunteers

Arm Description

Study participants abstain from oral hygiene on a select set of four teeth for a period of 21 days. The use of a custom made acrylic intraoral stent (mouthguard) will be used to protect teeth on designated test sides for each study participant during normal oral hygiene (approximately 4 minutes each day: 2 times for 2 minutes) throughout the induction phase (Day 0-21).

Outcomes

Primary Outcome Measures

Identification of clinical responder types
Identification of clinical responder types through comparative analysis of the levels of clinical parameter for Bleeding on Probing Index (% BOP) at Day 14 of the plaque overgrowth/induction phase measured by calibrated examiners.

Secondary Outcome Measures

Change in relative abundance of bacteria
The rate of change in relative abundance of gram positive Firmicutes bacteria compared to that of gram negative Bacteroidetes bacteria through the plaque overgrowth/induction phase (Day 0-21) assessed through 16S rRNA and Metagenomic Sequencing.

Full Information

First Posted
July 14, 2023
Last Updated
July 27, 2023
Sponsor
University of Washington
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
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1. Study Identification

Unique Protocol Identification Number
NCT05968742
Brief Title
Variation in Gingival Inflammatory Responses
Official Title
Mechanisms Underlying the Variation in Rate and Levels of Gingival Inflammatory Responses Among the Human Population
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 26, 2023 (Actual)
Primary Completion Date
April 1, 2025 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this NIH National Institute of Dental and Craniofacial Research (NIDCR) funded study is to identify molecular mechanisms underlying observed variations in human responses to natural accumulation and maturation of dental plaque.
Detailed Description
This study will employ the split-mouth Experimental Gingivitis model where healthy study participants are asked to abstain from oral hygiene on a select set of teeth (test teeth) for a period of 21 days. The study consists of 3 phases; Hygiene Phase (Day -14-0), Experimental Induction Phase (Day 0-21), and Resolution Phase (Day 21-35). Abstaining from oral hygiene on the test teeth will result in the natural accumulation and maturation of dental plaque (a bacterial biofilm) on the tooth surface which will in induce a host inflammatory response. By investigating the onset of microbially induced inflammation directly in humans using this highly utilized and well-described experimental gingivitis model, the research community are able to better understand the host-microbial interactions during the initiation, induction of host response, and resolution of mucosal inflammation at the molecular level. The investigators central hypothesis is based on our previous experimental gingivitis studies conducted here at the University of Washington Bamashmous et al. Human Variation in Gingival Inflammation PNAS 2021 and NCT03750955. The investigators hypothesize that specific clinical inflammatory response phenotypes (High, Low and Slow responders) are dependent upon both microbial factors regulating the subgingival plaque growth and maturation rate as well as host factors regulating the human gingival inflammatory mediator levels and type.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis
Keywords
Experimental Gingivitis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Longitudinal prospective clinical study using the experimental gingivitis model. Split Mouth design.
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy Volunteers
Arm Type
Experimental
Arm Description
Study participants abstain from oral hygiene on a select set of four teeth for a period of 21 days. The use of a custom made acrylic intraoral stent (mouthguard) will be used to protect teeth on designated test sides for each study participant during normal oral hygiene (approximately 4 minutes each day: 2 times for 2 minutes) throughout the induction phase (Day 0-21).
Intervention Type
Behavioral
Intervention Name(s)
Abstinence of oral hygiene on select teeth
Other Intervention Name(s)
Split Mouth Experimental Gingivitis
Intervention Description
Study participants abstain from oral hygiene on a select set of four teeth for a period of 21 days
Primary Outcome Measure Information:
Title
Identification of clinical responder types
Description
Identification of clinical responder types through comparative analysis of the levels of clinical parameter for Bleeding on Probing Index (% BOP) at Day 14 of the plaque overgrowth/induction phase measured by calibrated examiners.
Time Frame
Day 0 to Day 21
Secondary Outcome Measure Information:
Title
Change in relative abundance of bacteria
Description
The rate of change in relative abundance of gram positive Firmicutes bacteria compared to that of gram negative Bacteroidetes bacteria through the plaque overgrowth/induction phase (Day 0-21) assessed through 16S rRNA and Metagenomic Sequencing.
Time Frame
Day 0 to Day 21

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: Provide signed and dated informed consent form Willing to comply with all study procedures and be available for the duration of the study Male or female, aged 18-35 years Good general health, ASA I (healthy with no systemic conditions) No clinical signs of gingival inflammation at > 90% of sites observed (whole mouth) (< 10% of sites with GI of < 2 and no sites with a score of 3; < 10% sites with BOP +). Probing depth (PD) ≤ 3.0 mm (Whole Mouth) Attachment loss (AL) = 0 mm (Whole Mouth) Gingival health at Visit 2 (Day 0) for study sites (Test/Control teeth): Average Gingival Index (GI) ≤ 0.1 with no site having a score of 3 and bleeding on probing (BOP)(-) Never smokers The ability to understand and communicate with the examiner. Willing and able to comply with study procedures. Exclusion Criteria: Medical condition which requires premedication prior to dental treatments/visits Subjects unable or unwilling to sign the informed consent form History of periodontal disease History of systemic inflammatory or immune conditions, Diabetes Use of antibiotic or anti-inflammatory drugs within 30 days of enrollment Self-reported pregnancy, planned pregnancy during the planned study commitment, and/or breastfeeding at the time of screening. Concurrent orthodontic treatment Untreated carious lesions and/or inadequate restorations on maxillary posterior 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 maxillary posterior teeth Missing tooth/teeth within the study sites test and control History of allergy to common dentifrice ingredients Immune-compromised individuals (for example: HIV, AIDS, and immune-suppressive drug therapy)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marilynn Rothen, RDH, MS
Phone
206-685-8132
Email
rothen@uw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey S McLean, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey S McLean, PhD
Phone
206-616-1808
Email
jsmclean@uw.edu
First Name & Middle Initial & Last Name & Degree
Marilyn Rothen
Phone
(206) 685-8132
Email
rothen@uw.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34193520
Citation
Bamashmous S, Kotsakis GA, Kerns KA, Leroux BG, Zenobia C, Chen D, Trivedi HM, McLean JS, Darveau RP. Human variation in gingival inflammation. Proc Natl Acad Sci U S A. 2021 Jul 6;118(27):e2012578118. doi: 10.1073/pnas.2012578118.
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Variation in Gingival Inflammatory Responses

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