Phase 4
N=38
Antimicrobial Agent for Reducing Bacteria in Aerosols and Oral Cavity
Dental Prophylaxis and Implant Surgery
Bottom Line
View on ClinicalTrials.gov: NCT02319668 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Total Number of Detectable Plaque Bacteria Sampled 3 Days Post Implant Surgery — 7.63; 7.43 log(10) colony forming equivalents (CFE) — p=0.2965
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- 0.2% w/v Chlorhexidine digluconate (Drug); Sodium fluoride toothpaste (Aquafresh Mild & Minty) (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Number of Detectable Plaque Bacteria Sampled 3 Days Post Implant Surgery |
7.63; 7.43 | 0.2965 |
| SECONDARY Total Number of Detectable Plaque Bacteria Sampled at Implant Surgery (at Pre-rinse, Pre, Mid and Post Implant Surgery) and Post Implant Surgery (at Day 1 and 7) |
7.55; 7.74; 7.65; 8.01; 7.58; 7.84 | — |
| SECONDARY Area Under the Curve (AUC) for the Total Number of Plaque Bacteria in the Mouth Post Implant Surgery |
8.57; 8.37 | — |
| SECONDARY Total Number of Recoverable Viable Bacteria in the Aerosol Generated During Dental Prophylaxis |
0.94; 0.91; 1.31; 1.33 | — |
Summary
The primary objective of this study will be to evaluate the effect of two week pre-surgical rinsing with an antimicrobial mouthrinse containing 0.2% w/v Chlorhexidine digluconate on the total number of plaque bacteria in the mouth 3 days post implant surgery. The study will be conducted at Eastman Clinical Investigation Centre (ECIC), University College London (UCL) Eastman Dental Institute. Participants will be those who require a single and simple surgical implant to be placed, and will be recruited from new patient referrals within the Eastman Dental Hospital
Eligibility Criteria
Inclusion Criteria
- Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
- Aged between 18-64 years old.
- Understands and is willing, able and likely to comply with all study procedures and restrictions
- Good general and mental health with, in the opinion of the investigator or medically qualified designee:
- No clinically significant and relevant abnormalities in medical history or upon oral examination.
- Absence of any condition that could affect the participant's safety or well being or their ability to understand and follow study procedures and requirements.
- Females of childbearing potential who are, in the opinion of the investigator, practicing a reliable method of contraception
- Dental Health
- Good overall oral health in the opinion of investigator.
- A minimum of 20 permanent teeth.
- Requiring a single and simple implant (single tooth replacement with no bone augmentation required for implant placement).
- Females of childbearing potential who are, in the opinion of the investigator, practising a reliable method of contraception.
Exclusion Criteria
- Women who are known to be pregnant or who are intending to become pregnant over the duration of the study
- Women who are breast-feeding
- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
- Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit
- Previous participation in this study
- Recent history (within the last 1 year) of alcohol or other substance abuse
- Use of antibiotics within 14 days prior to the Baseline visit or Implant surgery visit.
- An employee of the sponsor or the study site or members of their immediate family
Data sourced from ClinicalTrials.gov (NCT02319668). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.