Horizontal Bone Augmentation Clinical Trial
Official title:
A Prospective, Multi-centre Study Evaluating Creos™ Xenogain Bone Graft Substitute in Horizontal Ridge Augmentation in the Premolar and Molar Region of the Mandible
| Verified date | March 2020 |
| Source | Nobel Biocare |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This clinical investigation is a prospective, multi-centre study to evaluate bone gain after horizontal augmentation using creos xenogain bone graft substitute. Patients included in the study are in need of a GBR procedure prior to implant placement in the premolar and posterior region of the mandible.
| Status | Active, not recruiting |
| Enrollment | 42 |
| Est. completion date | June 2020 |
| Est. primary completion date | April 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - Subjects between 18 and 80 years old. - Patient has signed informed consent to participate in the study. - Patients in need of horizontal ridge augmentation prior to implant placement in the premolar and posterior region of the mandible - Horizontal defect classified as: Horizontal medium defect (Hm) (4-6 mm defect) or Horizontal large defect (Hl) (=7 mm defect) - Patients presented with a combination defect Horizontal/Vertical with a maximum of 2mm loss of vertical dimensions (minimal vertical dimension for patient inclusion is 7.5 mm defined as the distance from the anatomical landmark, alveolar nerve or lingual dehiscence) - The subject must be in good physical and mental condition - The subject is willing and able to comply with all study related procedures (such as exercising oral hygiene and attending all follow-up procedures). - Full-mouth bleeding score (FMBS) lower than 25%. - Full-mouth plaque score (FMPI) lower than 25%. - The subject is suitable for a 2-stage surgical procedure Exclusion Criteria: - Severe bone defect classified as: Vertical medium (Vm) (4-6 mm defect) or Vertical large, (Vl) (=7 mm) - Medium (Cm) and Large (Cl) classified combination defects Prior bone augmentation in the area planned for treatment (i.e ridge preservation) - Health conditions, which do not permit the surgical (including anesthesia) or restorative procedure. - Any disorders directly in the planned implant area such as previous tumors, chronic bone disease. - Any ongoing application of interfering medication (steroid therapy, bisphosphonate, etc). - Alcohol or drug abuse as noted in subject records or in subject history. - Reason to believe that the treatment might have a negative effect on the subject's overall situation (psychiatric problems), as noted in subject records or history. - Heavy smoking (> 10 cigarettes per day). - Uncontrolled diabetes, i.e. a subject with diagnosed diabetes that has a history of neglecting doctor's recommendations regarding treatment, food and alcohol intake or A1c level above 8%. - Poor compliance. - Active periodontal disease involving the residual dentition. - Mucosal diseases in the areas to be treated. - Pregnant or lactating women at the time of bone augmentation procedure. |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Praxisklinik der Zahnheilkunde am Luisenhospital | Aachen | |
| Germany | Universitäts Klinikum Frankfurt | Frankfurt | |
| Italy | Clinica Odontoiatrica - Dipartimento di Neuroscienze, Università di Padova | Padua | |
| Italy | Clinica Merli | Rimini | |
| Serbia | Military Academy of Belgrade, Oral Surgery | Belgrade | |
| Serbia | University of Belgrade, Periodontology | Belgrade |
| Lead Sponsor | Collaborator |
|---|---|
| Nobel Biocare |
Germany, Italy, Serbia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Bone gain 8 months after bone augmentation procedure for implant placement. | To evaluate bone gain 8 months after bone augmentation procedure for implant placement. | 8 months | |
| Secondary | Implant survival | To demonstrate cumulative survival rate of the implants placed in the augmented bone at 6 months and at 1 year after definitive prosthetic delivery. | 6 months and 1 year after definitive prosthetic delivery | |
| Secondary | Implant success | To demonstrate cumulative success rate of the implants placed in the augmented bone at 6 months and 1 year after definitive prosthetic delivery. | 6 months and 1 year after definitive prosthetic delivery | |
| Secondary | Marginal bone levels | To demonstrate the changes in marginal bone levels (?MBL) around the implants placed in the augmented bone as measured and evaluated by periapical films, 6 months and 1 year after definitive prosthetic delivery | 6 months and 1 year after definitive prosthetic delivery | |
| Secondary | Histological analysis prior to implant insertion including percentage of vital bone, residual graft and connective tissue or other non bone components | A bone sample using a trephine bur will be collected after 8 months and prior to implant insertion in order to perform histological analysis. The analysis will include the following parameters: percentage of vital bone and residual graft and connective tissue and if present other non bone components | 8 months | |
| Secondary | Soft tissue outcome 1 year after definitive prosthetic delivery | Soft tissue outcome is a combination of different parameters that include gingival index, bleeding index, keratinized mucosa and pink esthetic score | 1 year | |
| Secondary | oral health related quality of life assessment | To demonstrate pre- and postoperatively the oral health related quality of life assessment using the Oral Health Impact Profile questionnaire (OHIP-14). | 1 year |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT06195761 -
Computer Guided Modified Ridge Splitting Versus Free Hand Technique in Horizontal Deficiency in Posterior Mandible
|
N/A |