Does bisfosfonat preserve the bone volume in transplanted bone in the jaw?

Phase 1

• Conditions: Jaw abnormality; Therapeutic 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

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-03-20
• Last Update Posted: 14 December 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

Exclusion Criteria

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.