A 1-year Clinical Investigation on the the CREOS™ XENOGAIN Bone Graft SUBSTITUTE
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|ClinicalTrials.gov Identifier: NCT03028922|
Recruitment Status : Recruiting
First Posted : January 23, 2017
Last Update Posted : January 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Horizontal Bone Augmentation||Device: creos xenogain||Not Applicable|
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.
Primary endpoint include the bone gain after 8 months healing period, while secondary endpoints includes histological analysis 8 months after performance of the augmentation procedure as well as Implant survival, implant success and marginal bone levels evaluated over a period of 1 year after definitive prosthetic delivery.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||November 2017|
|Estimated Study Completion Date :||July 2019|
Patients in need of bone augmentation prior to implant insertion will undergo GBR procedure using Creos xenogain bone graft substitute
Device: creos xenogain
GBR procedure will be performed using creors xenogain bone graft substitute in patients that need horizontal bone augmentation prior to implant placement. The defect should be located in the pre-molar and molar region of the mandible
- Bone gain 8 months after bone augmentation procedure for implant placement. [ Time Frame: 8 months ]To evaluate bone gain 8 months after bone augmentation procedure for implant placement.
- Implant survival [ Time Frame: 6 months and 1 year after definitive prosthetic delivery ]To demonstrate cumulative survival rate of the implants placed in the augmented bone at 6 months and at 1 year after definitive prosthetic delivery.
- Implant success [ Time Frame: 6 months and 1 year after definitive prosthetic delivery ]To demonstrate cumulative success rate of the implants placed in the augmented bone at 6 months and 1 year after definitive prosthetic delivery.
- Marginal bone levels [ Time Frame: 6 months and 1 year after definitive prosthetic delivery ]To demonstrate the changes in marginal bone levels (ΔMBL) around the implants placed in the augmented bone as measured and evaluated by periapical films, 6 months and 1 year after definitive prosthetic delivery
- Histological analysis prior to implant insertion including percentage of vital bone, residual graft and connective tissue or other non bone components [ Time Frame: 8 months ]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
- Soft tissue outcome 1 year after definitive prosthetic delivery [ Time Frame: 1 year ]Soft tissue outcome is a combination of different parameters that include gingival index, bleeding index, keratinized mucosa and pink esthetic score
- oral health related quality of life assessment [ Time Frame: 1 year ]To demonstrate pre- and postoperatively the oral health related quality of life assessment using the Oral Health Impact Profile questionnaire (OHIP-14).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03028922
|Contact: Yanela Gonzalez, MSCfirstname.lastname@example.org|
|Contact: Isabelle Arrighi, Dr.||+41 792 04 85 email@example.com|
|Praxisklinik der Zahnheilkunde am Luisenhospital||Recruiting|
|Aachen, Germany, 52064|
|Contact: Bastian Wessing, DDS +49 151 5888 7689 firstname.lastname@example.org|
|Universitäts Klinikum Frankfurt||Not yet recruiting|
|Frankfurt, Germany, 60596|
|Contact: Robert Sader, DDS +49 069 6301 3744 email@example.com|
|Contact: Jonas Lorenz, Dr. +496963015879 Jonas.Lorenz@kgu.de|
|Sub-Investigator: Shahram Ghanaati, Dr.|
|Clinica Odontoiatrica - Dipartimento di Neuroscienze, Università di Padova||Recruiting|
|Padua, Italy, 35128|
|Contact: Eriberto Bressan, Prof. DDS +39 0434 648026 firstname.lastname@example.org|
|Sub-Investigator: Luca De Stavola, Dr.|
|Sub-Investigator: Andrea Fincato, Dr.|
|Rimini, Italy, 47923|
|Contact: Mauro Merli, Prof. DDS +39 335 6003652 email@example.com|
|Military Academy of Belgrade, Oral Surgery||Not yet recruiting|
|Belgrade, Serbia, 11 000|
|Contact: Zoran Lazic, Prof. DDS +381 63 372 041 firstname.lastname@example.org|
|University of Belgrade, Periodontology||Not yet recruiting|
|Belgrade, Serbia, 11000|
|Contact: Zoran Aleksic, Prof. DDS +381 63 257 025 email@example.com|