BridgeMD
Compares treatment options for Periodontitis (Stage 3)
Official title A Clinical Trial Comparing 2x/Day for 30-minutes Use of the Emanate Perio PODS Post-SRP to a Control Group Post-SRP.
ClinicalTrials.gov ID: NCT06914596
What this study is testing
- What it's testing
- The goal of this clinical trial is to compare safety and to see if individuals with generalized stage III periodontitis that are given a periodontal hydrogel dressing on a wound healing after plaque and tartar have been removed from teeth have greater healing than individuals who are given no treatment after.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 75
You may be able to join if
- people must meet all the following criteria to be entered into the study:
- people will have read, understood, and signed an institutional review board (IRB) approved Informed Consent Form (ICF).
- people 30 to 75 years of age.
- Generalized Stage III periodontitis with at least 8 teeth having interproximal clinical attachment level of ≥3 mm and a probing pocket depth of ≥5 mm...
- people have a minimum of 24 natural teeth with a minimum of 2 natural teeth per quadrant excluding third molars.
You likely can't join if
- people who meet the above inclusion criteria will be eligible for the study, unless they present with any of the following:
- Periodontal surgery, implant placement or SRP within 12 months prior to screening or a cleaning/prophylaxis three months prior to screening.
- Presence of fixed or removable (e.g. Invisalign) orthodontic appliances.
- Subject with an underlying medical condition which requires antibiotic prophylaxis prior to dental treatment.
- people with vesiculobullous processes or other similar chronic oral lesions / conditions resulting in gingival irritation, discomfort/pain, or...
- people with soft or hard tissue tumor(s) of oral cavity.
See the full eligibility criteria
- people must meet all the following criteria to be entered into the study:
- people will have read, understood, and signed an institutional review board (IRB) approved Informed Consent Form (ICF).
- people 30 to 75 years of age.
- Generalized Stage III periodontitis with at least 8 teeth having interproximal clinical attachment level of ≥3 mm and a probing pocket depth of ≥5 mm and ≤7mm, distributed between the mandible and the maxilla, with at...
- people have a minimum of 24 natural teeth with a minimum of 2 natural teeth per quadrant excluding third molars.
- All supragingival accretions can be removed from below the height of contour of the tooth crown to allow for a comprehensive periodontal evaluation and accurate intraoral digital scan of both arches at screening.
- people agree to refrain from use of oral rinses or dentifrice with known antibacterial properties (e.g., Peridex®, Listerine®, Colgate Total®, Crest Pro-Health®, etc.).
- people agree to refrain from use of electric flossers or irrigation devices for the duration of the study.
- people can provide self-care (oral hygiene) without disabilities requiring assistance with daily oral hygiene measures.
- people are able and willing to follow study procedures and instructions.
- people who meet the above inclusion criteria will be eligible for the study, unless they present with any of the following:
- Periodontal surgery, implant placement or SRP within 12 months prior to screening or a cleaning/prophylaxis three months prior to screening.
- Presence of fixed or removable (e.g. Invisalign) orthodontic appliances.
- Subject with an underlying medical condition which requires antibiotic prophylaxis prior to dental treatment.
- people with vesiculobullous processes or other similar chronic oral lesions / conditions resulting in gingival irritation, discomfort/pain, or erosions.
- people with soft or hard tissue tumor(s) of oral cavity.
- Use of any smoked substances such as tobacco / cannabis including cigarettes, vape, cigars, or use of smokeless tobacco 30 days prior to screening and throughout the study.
- Uncontrolled medical conditions (e.g., diabetes mellitus, hypertension, cancer).
- people who are lactating or pregnant or planning to become pregnant through their projected study duration.
- people taking medications known to affect gingival conditions. (e.g., hyperplasia).
- Regular, prolonged use of oral antimicrobial rinses 30 days prior to screening or continued anticipated use through their projected study duration.
- Use of systemic antibiotics 30 days prior to screening or anticipated during the trial period.
- people taking corticosteroids on a regular basis one week prior to baseline examination and throughout the duration of the study, including oral inhalers.
- people taking non-steroidal anti-inflammatory (NSAIDS) or other pain medication on a daily basis for more than 3 consecutive days beginning one week prior to the baseline examination and throughout the duration of the...
- people taking anticoagulant medications such as warfarin or Plavix or Eliquis.
- people participating in other clinical studies involving therapeutic intervention (either medical or dental) within 30 days of Screening.
- people that are known to be hypersensitive to chlorhexidine gluconate, glycerin, polyvinyl alcohol or ethylene vinyl acetate.
- people, who in the opinion of the investigator, for any reason other than those listed above, will not be able to complete the study per protocol.
The study team makes the final eligibility decision.
Where it's taking place
- Fullerton, California, United States
- New London, Connecticut, United States
- Boston, Massachusetts, United States
- La Vista, Nebraska, United States
- Houston, Texas, United States
- Spring, Texas, United States
- Richmond, Virginia, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 30 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fullerton, California, United States; New London, Connecticut, United States; Boston, Massachusetts, United States; La Vista, Nebraska, United States; Houston, Texas, United States; Spring, Texas, United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.