Condition category
Oral Health
Date applied
02/03/2009
Date assigned
17/03/2009
Last edited
17/03/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Hamad Al Zoman

ORCID ID

Contact details

Sultan Bin Abdulaziz Humanitarian City
P.O. Box 64399
Riyadh
11536
Saudi Arabia

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

http://www.kacst.edu.sa

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

Publication citations

Additional files

Editorial Notes