Does bisfosfonat preserve the bone volume in transplanted bone in the jaw?
- Conditions
- Jaw abnormalityTherapeutic area: Diseases [C] - Mouth and tooth diseases [C07]
- Registration Number
- EUCTR2014-003817-28-SE
- Lead Sponsor
- Region Östergötland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 20
At least 18 years old
Healthy patients or patients with mild systemic disease (ASA I and II)
Jaw abnormality
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Patient with severe systemic disorder (ASA>III)
Patients medicating with systemic bifosfonates
Pregnant women (positive pregnancy test)
Hypersensitivity agains the substance or any other reagents.
Hypocalcemi
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The volume reduction is 25% less in bone transplant which has received Bondronat compared to bone transplant which has received placebo at 6 month postoperative.;Secondary Objective: 1, Does the bone density of the transplanted bone treated with Bandronate increase between 2 and 26 weeks?<br><br>2, Does the transplanted bone treated with bandonate seem to heal better? ;Primary end point(s): The bone voulme measured with Cone Beam Computed Tomography 2 weeks and 26 weeks postoperative by (CBCT) ;Timepoint(s) of evaluation of this end point: 2 weeks postoperative and 26 weeks postoperative
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1, The bone density measured by Cone Beam Computed Tomography (CBCT) 2 weeks and 26 weeks postoperative<br><br>Healaing of the bone tissue will be observed by Clinical examination at whole study period;Timepoint(s) of evaluation of this end point: 1, 2 and 26 weeks postoperative<br><br>2, 2weeks, 4 weeks, 8 weeks and 26 weeks.