A Prospective, Multi-centre Study Evaluating Creos™ Xenogain Bone Graft Substitute in Horizontal Ridge Augmentation in the Premolar and Molar Region of the Mandible
Sponsor study identifier
interventional
42
3 countries
6
Study Start
October 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2018
Actual (reported)Study Completion
June 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2016
Date type not reportedThis date has not been verified as actual or estimated.
January 10, 2017
Actual (reported)January 23, 2017
Actual (reported)April 2018
Actual (reported)June 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Implant survival
6 months and 1 year after definitive prosthetic delivery
Implant success
6 months and 1 year after definitive prosthetic delivery
Marginal bone levels
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
8 months
Soft tissue outcome 1 year after definitive prosthetic delivery
1 year
Patients in need of bone augmentation prior to implant insertion will undergo GBR procedure using Creos xenogain bone graft substitute
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Praxisklinik der Zahnheilkunde am Luisenhospital
Aachen, 52064, Germany
Universitäts Klinikum Frankfurt
Frankfurt, 60596, Germany
Clinica Odontoiatrica - Dipartimento di Neuroscienze, Università di Padova
Padua, 35128, Italy
Clinica Merli
Rimini, 47923, Italy
Military Academy of Belgrade, Oral Surgery
Belgrade, 11 000, Serbia
University of Belgrade, Periodontology
Belgrade, 11000, Serbia
Lorenz J, Ghanaati S, Aleksic Z, Milinkovic I, Lazic Z, Magic M, Wessing B, Grotenclos RS, Merli M, Mariotti G, Bressan E, De Stavola L, Sader R. Horizontal Guided Bone Regeneration of the Posterior Mandible to Allow Implant Placement: 1-Year Prospective Study Results. Clin Oral Implants Res. 2025 Jan;36(1):100-116. doi: 10.1111/clr.14363. Epub 2024 Oct 1.
First Submitted
January 10, 2017
First Posted
January 23, 2017
Study Start
October 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2018
Actual (reported)Contact the study team to confirm eligibility.
Study Completion
June 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 18, 2020
Record last verified: 2020-03
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Source: ClinicalTrials.gov.
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