Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
006
Study information
Scientific title
Flapless dental implant surgery for patients on oral anticoagulants: a novel bridging paradigm between clinical technique and therapeutic guidelines (WarLess Procedure)
Acronym
Study hypothesis
To evaluate the combination of minimally invasive flapless dental implant surgery without interrupting the regular dose of the anticoagulant medications.
Ethics approval
Research and Ethics Committee, Sultan Bin Abdulaziz Humanitarian City gave approval on the 23rd March 2007 (ref: 006)
Study design
Observational cohort case study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Haematology/dental implants
Intervention
Males and females with a history of rheumatic heart disease were included for the case study. Four tablets of amoxicillin 500 mg (2 grams) were given to both patients one hour pre-operatively as a prophylactic antibiotic. Patients were instructed to rinse their mouth for 30 seconds with mouth rinse (chlorhexidine) prior to the dental surgery. Infiltration of one carpule of local anaesthesia (2% lidocaine with 1:100,000 epinephrine) was administered around the edentulous area and then the flapless dental implant procedure was peformed. Radiographic images were taken pre- and post-implant insertion. Patients were given post-operative instructions and the antibiotic was prescribed (amoxicillin 500 mg, three times/day) for the next ten days with analgesics (ibuprofen 400 mg) to be taken only in need.
Intervention type
Drug
Phase
Not Applicable
Drug names
Amoxicillin, chlorhexidine, lidocaine, epinephrine, ibuprofen
Primary outcome measures
1. Bone healing
2. No bleeding
Measured at baseline, 1-week, 4-week and 6-month follow-up visit.
Secondary outcome measures
No secondary outcome measures
Overall trial start date
06/04/2007
Overall trial end date
29/09/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. History of rheumatic heart disease
2. Long term anticoagulant maintenance therapy with warfarin
3. Missing tooth/teeth
4. Both sexes, aged from 40 to 60 years
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
2
Participant exclusion criteria
1. International normalised ratio (INR) greater than 4.1
2. No missing tooth/teeth
Recruitment start date
06/04/2007
Recruitment end date
29/09/2008
Locations
Countries of recruitment
Saudi Arabia
Trial participating centre
Sultan Bin Abdulaziz Humanitarian City
Riyadh
11536
Saudi Arabia
Sponsor information
Organisation
King Abdulaziz City for Science and Technology (Saudi Arabia)
Sponsor details
General Directorate of Research Grants Programmes
P.O Box 6086
Riyadh
11442
Saudi Arabia
Sponsor type
Government
Website
Funders
Funder type
Research organisation
Funder name
King Abdulaziz City for Science and Technology (Saudi Arabia) - General Directorate of Research Grants Programmes
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary