Last updated: 11/03/2018 22:20:12
Antimicrobial Agent for Reducing Bacteria in Aerosols and Oral Cavity
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A clinical study to evaluate the efficacy of pre-procedural and pre-surgical rinsing with an antimicrobial agent in reducing bacteria in dental aerosols and in the oral cavity
Trial description: 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
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Single (Investigator)
Allocation:
Randomized
Primary outcomes:
Total number of detectable plaque bacteria sampled 3 days post implant surgery
Timeframe: At Day 3
Secondary outcomes:
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)
Timeframe: At Day 0 (pre-rinse, pre, mid and post implant surgery), Day 1 and 7
Area under the curve (AUC) for the total number of plaque bacteria in the mouth post implant surgery
Timeframe: Up to 7 days post implant surgery
Total Number of recoverable viable bacteria in the aerosol generated during dental prophylaxis
Timeframe: At Baseline
Interventions:
Drug: 0.2% w/v Chlorhexidine digluconate
Drug: Sodium fluoride toothpaste (Aquafresh Mild & Minty)
Enrollment:
38
Observational study model:
Not applicable
Primary completion date:
2016-29-02
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Dental Prophylaxis and Implant Surgery
Product
chlorhexidine, sodium fluoride
Collaborators
Not applicable
Study date(s)
February 2015 to February 2016
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
18 - 64 years
Accepts healthy volunteers
Yes
- 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.
- 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
Inclusion and exclusion 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: a) No clinically significant and relevant abnormalities in medical history or upon oral examination. b) 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 a) Good overall oral health in the opinion of investigator. b) A minimum of 20 permanent teeth. c) 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
Trial location(s)
Study documents
Statistical analysis plan
Available language(s): English
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2016-29-02
Actual study completion date
2016-29-02
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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