E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Jaw abnormality |
Käkavvikelse |
|
E.1.1.1 | Medical condition in easily understood language |
Jaw abnormality |
Underbett eller överbett av käken |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Mouth and tooth diseases [C07] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
Volymsminskningen är 25% mindre hos bentransplantat som har fått Bondronat jämfört med bentransplantat som har fått placebo, vid 6-månader postperativt. |
|
E.2.2 | Secondary objectives of the trial |
1, Does the bone density of the transplanted bone treated with Bandronate increase between 2 and 26 weeks?
2, Does the transplanted bone treated with bandonate seem to heal better? |
1. Är förändringen av bentätheten i transplantatet mellan 2 och 26 veckor mer positiv efter behandling med bisfosfonat?
2. Ser transplantatet ut att ha läkt in bättre efter bisfosfonatbehandling?
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
At least 18 years old
Healthy patients or patients with mild systemic disease (ASA I and II)
Jaw abnormality |
Minst 18 år gamla
Friska patienter eller patienter med måttlig systemisk sjukdom (ASA I och II)
Käkavvikelse (under- eller överbett)
|
|
E.4 | Principal 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 |
Patient med svår systemisk sjukdom (ASA >III)
Patient som står på systemisk bisfosfonat
Gravida kvinnor (positivt graviditets-test).
Överkänslighet mot den aktiva substansen eller mot något hjälpämne
Hypokalcemi |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The bone voulme measured with Cone Beam Computed Tomography 2 weeks and 26 weeks postoperative by (CBCT) |
Benvolymen mäts med Cone Beam Computed Tomography (CBCT) 2 veckor och 26 veckor postoperativt. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
2 weeks postoperative and 26 weeks postoperative |
2 veckor postoperativt och 26 veckor postoperativt. |
|
E.5.2 | Secondary end point(s) |
1, The bone density measured by Cone Beam Computed Tomography (CBCT) 2 weeks and 26 weeks postoperative
Healaing of the bone tissue will be observed by Clinical examination at whole study period |
1, Bentätheten mäts med Cone Beam Computed Tomography (CBCT) 2 veckor och 26 veckor postoperativt.
2, Inläkningen bedöms av käkkirurg genom klinisk observation vid under studie perioden |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1, 2 and 26 weeks postoperative
2, 2weeks, 4 weeks, 8 weeks and 26 weeks. |
1, 26 veckor postoperativt och 2 veckor postoperativt.
2, 2 veckor, 4 veckor, 8 veckor och 26 veckor efter operationen. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Interna kontroller (en sida av käken får placebo och en sida får aktiv substans) |
Internal controls (paired analysis) |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
LVLS |
Sista besök sista patienten |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | |