Dental Prophylaxis and Implant Surgery Clinical Trial
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
| Verified date | January 2017 |
| Source | GlaxoSmithKline |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 38 |
| Est. completion date | February 2016 |
| Est. primary completion date | June 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 64 Years |
| Eligibility |
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: 1. No clinically significant and relevant abnormalities in medical history or upon oral examination. 2. 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 1. Good overall oral health in the opinion of investigator. 2. A minimum of 20 permanent teeth. 3. 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 |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | GSK Investigational Site | London |
| Lead Sponsor | Collaborator |
|---|---|
| GlaxoSmithKline |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Change in richness of plaque bacteria in the mouth in the area of the implant surgery (pre, mid, post) and post implant surgery | The richness of bacteria will be determined using Next generation sequencing technique which will be performed on an Illumina (MiSeq) platform using the 16S rRNA gene as target | Baseline to 1 day, 3 days and 7 days | |
| Primary | Total number of detectable plaque bacteria sampled post implant surgery | The examiner will identify three plaque sampling sites as, surgical site, contralateral site to the surgical site and tongue. An individual cotton swab will be used at each identified site for up to 20 seconds in order to harvest a plaque sample and will immediately be placed into 1mL phosphate buffered saline in a sterile Eppendorf tube. The samples will be analysed using two methods; qPCR and Next Generation Sequencing, that will determine the total number of bacteria in a sample by quantifying the number of 16S rRNA genes in the sample. Both techniques use the 16S rRNA gene as a target and either simply enumerate this via real time PCR or sequence c100,000 16S rRNA genes in each participant sample. | Baseline to 3 days | |
| Secondary | Total number of detectable plaque bacteria sampled at day 1 and day 7 | The examiner will identify three plaque sampling sites as, surgical site, contralateral site to the surgical site and tongue. An individual cotton swab will be used at each identified site for up to 20 seconds in order to harvest a plaque sample and will immediately be placed into 1mL phosphate buffered saline in a sterile Eppendorf tube. The samples will be analysed using two methods; qPCR and Next Generation Sequencing, that will determine the total number of bacteria in a sample by quantifying the number of 16S rRNA genes in the sample. | Baseline to 1 day and 7 days | |
| Secondary | Total number of detectable plaque bacteria sampled recoverable viable bacteria in an aerosol generated during a typical dental procedure (dental prophylaxis) | Thick (approx 10 millimetre (mm)) settle blood agar (supplemented with 5% (v/v) defibrinated horse blood) plates will be used to determine the bacterial load of the aerosol. Thirty minutes prior to the participants having their procedure (prophylaxis), a total of 5 settle plates with lids removed will be placed at set positions around the dental surgery. After 30 minutes, the settle plates will have their lids replaced. This will be repeated during the prophylaxis procedure using 5 fresh settle plates. All plates will then be sealed with parafilm and transported for incubation in an anaerobic chamber at 37°C for 3 days. The plates will be inspected daily to access growth and after 3 days removed and stored at 4°C for subsequent colony enumeration and Colony Forming Unit/mL (CFU/mL) calculation. | Baseline | |
| Secondary | Area under the curve (AUC) for the total number of plaque bacteria in the mouth post implant surgery | The examiner will identify three plaque sampling sites as, surgical site, contralateral site to the surgical site and tongue. An individual cotton swab will be used at each identified site for up to 20 seconds in order to harvest a plaque sample and will immediately be placed into 1mL phosphate buffered saline in a sterile Eppendorf tube. The samples will be analysed using two methods; qPCR and Next Generation Sequencing, that will determine the total number of bacteria in a sample by quantifying the number of 16S rRNA genes in the sample. | Baseline to 1 day, 3 days and 7 days |