Status unknownNCT03028922Updated Mar 18, 2020

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

An interventional study of creos xenogain in Horizontal Bone Augmentation, sponsored by Nobel Biocare. Status unknown at 6 sites in 3 countries. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-18.

Sponsored by Nobel Biocare · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2020), so the status shown — last known as Active, not recruiting — may be out of date.

Phase: Not applicable
Study type: Interventional
Enrollment: 42
Allocation: Not applicable
Ages: 18 Years to 80 Years
Sex: All

Study 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.

Read the detailed description

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.

Conditions studied

Horizontal Bone Augmentation

Keywords

creos xenogain

In context

Lead sponsor

Nobel Biocare is the lead sponsor of 20 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 42 participants (estimated)

Study arms

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

Interventions

Devicecreos 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

What researchers measure

Primary outcomes

Bone gain 8 months after bone augmentation procedure for implant placement.
To evaluate bone gain 8 months after bone augmentation procedure for implant placement.
Time frame: 8 months

Secondary outcomes

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.
Time frame: 6 months and 1 year after definitive prosthetic delivery
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.
Time frame: 6 months and 1 year after definitive prosthetic delivery
Marginal bone levels
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
Time frame: 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
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
Time frame: 8 months
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
Time frame: 1 year
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).
Time frame: 1 year

Study locations

6 sites

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

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 18, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03028922
Lead sponsor: Nobel Biocare
Responsible party: Sponsor
First posted: Jan 23, 2017
Start date: Oct 2016
Primary completion: Apr 2018
Completion: Jun 2020 (estimated)
Last update: Mar 18, 2020

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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