A 1-year Clinical Investigation on the the CREOS™ XENOGAIN Bone Graft SUBSTITUTE

NCT03028922 | Unknown

• 1 other identifier: T-189
• Study Type: interventional
• Target: 42
• Locations: 3 countries
• Sites: 6

Brief Summary

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.

Conditions

Horizontal Bone Augmentation

Keywords

creos xenogain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Study Arms (1)

creos xenogain

OTHER

Patients in need of bone augmentation prior to implant insertion will undergo GBR procedure using Creos xenogain bone graft substitute

Device: creos xenogain

Interventions

creos xenogain DEVICE

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

creos xenogain

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nobel Biocare: lead

Study Sites (6)

Praxisklinik der Zahnheilkunde am Luisenhospital

Aachen, 52064, Germany

Location

Universitäts Klinikum Frankfurt

Frankfurt, 60596, Germany

Location

Clinica Odontoiatrica - Dipartimento di Neuroscienze, Università di Padova

Padua, 35128, Italy

Location

Clinica Merli

Rimini, 47923, Italy

Location

Military Academy of Belgrade, Oral Surgery

Belgrade, 11 000, Serbia

Location

University of Belgrade, Periodontology

Belgrade, 11000, Serbia

Location

Related Publications (1)

• 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.

  PMID: 39351703 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2017
• First Posted: January 23, 2017
• Study Start: October 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: June 1, 2020
• Last Updated: March 18, 2020

Record last verified: 2020-03

Locations

DE (2); IT (2); SE (2)