Dental implant surgery for patients on oral anticoagulants
| ISRCTN | ISRCTN36419844 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN36419844 |
| Secondary identifying numbers | 006 |
- Submission date
- 02/03/2009
- Registration date
- 17/03/2009
- Last edited
- 17/03/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Hamad Al Zoman
Scientific
Scientific
Sultan Bin Abdulaziz Humanitarian City
P.O. Box 64399
Riyadh
11536
Saudi Arabia
Study information
| Study design | Observational cohort case study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Flapless dental implant surgery for patients on oral anticoagulants: a novel bridging paradigm between clinical technique and therapeutic guidelines (WarLess Procedure) |
| Study objectives | To evaluate the combination of minimally invasive flapless dental implant surgery without interrupting the regular dose of the anticoagulant medications. |
| Ethics approval(s) | Research and Ethics Committee, Sultan Bin Abdulaziz Humanitarian City gave approval on the 23rd March 2007 (ref: 006) |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Amoxicillin, chlorhexidine, lidocaine, epinephrine, ibuprofen |
| Primary outcome measure | 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 study start date | 06/04/2007 |
| Completion date | 29/09/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 2 |
| Key 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 |
| Key exclusion criteria | 1. International normalised ratio (INR) greater than 4.1 2. No missing tooth/teeth |
| Date of first enrolment | 06/04/2007 |
| Date of final enrolment | 29/09/2008 |
Locations
Countries of recruitment
- Saudi Arabia
Study participating centre
Sultan Bin Abdulaziz Humanitarian City
Riyadh
11536
Saudi Arabia
11536
Saudi Arabia
Sponsor information
King Abdulaziz City for Science and Technology (Saudi Arabia)
Government
Government
General Directorate of Research Grants Programmes
P.O Box 6086
Riyadh
11442
Saudi Arabia
| Website | http://www.kacst.edu.sa |
|---|---|
"ROR" |
https://ror.org/05tdz6m39 |
Funders
Funder type
Research organisation
King Abdulaziz City for Science and Technology (Saudi Arabia) - General Directorate of Research Grants Programmes
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
