NCT01800149

Brief Summary

Aim of the present investigation will be to evaluate the role of a bovine-bone mineral and a collagen membrane as ridge augmentation procedure following tooth extraction. 20 consecutive adult patients, requiring tooth extraction in the frontal area of the upper and lower arch maxilla (from second premolar to second premolar), will be enrolled into the study. After tooth extraction, sockets will be randomized and divided into two groups: in Group A the socket will be grafted with Bio-Oss Collagen , in Group B the sockets will be grafted with BioOss granules (small granules). The graft will be covered with porcine collagen membrane (BioGide). Then, the flap will be sutured. MEASUREMENTS: The end of the study will be fixed at the 6 months evaluation after tooth extraction. Impression will be taken before tooth extraction and after 6 months in order to create cast models. On the cast models, using reference PVC (polyvinylchloride) guides, the horizontal dimension of the soft tissues will be measured. One measurement per tooth will be recorded, at T0 (before extraction) and T2 (after 6 months). A 3D radiological image, using the CBCT technique, will be obtained at the end of the surgical stage T1 (extraction + bone graft) and after 6 months of healing. Superimposition will be performed in order to measure hard tissue remodelling. After six months (T6), a a biopsy specimen will be also harvested for that augmented extractions sockets on which an implant installation has been previously planned.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

February 25, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 27, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

September 2, 2016

Status Verified

September 1, 2016

Enrollment Period

1.8 years

First QC Date

February 25, 2013

Last Update Submit

September 1, 2016

Conditions

Loss of Teeth Due to ExtractionEdentulous Alveolar Ridge

Keywords

Tooth extractionRidge PreservationRidge AugmentationGuided Bone Regeneration

Outcome Measures

Primary Outcomes (1)

  • Clinical horizontal width

    On the cast models, using reference PVC stants, the horizontal dimension of the soft tissues (measured perpendicular to the tangent of the dental arch at the midpoint of the extraction site as the distance between the most prominent points buccally and orally) will be measured.

    6 months after tooth extraction

Secondary Outcomes (1)

  • Radiological horizontal width

    6 months after tooth extraction

Study Arms (2)

BBM+collagen

ACTIVE COMPARATOR

Ridge Augmentation After tooth extraction, edentulous sockets will be filled with BioOss Collagen and covered with Bio-Gide

Procedure: Ridge Augmentation

BBM granules

ACTIVE COMPARATOR

Ridge Augmentation After tooth extraction, edentulous sockets will be filled with Bio-Oss Granules, 0-25-1 mm, and covered with Bio-Gide

Procedure: Ridge Augmentation

Interventions

Ridge AugmentationPROCEDURE

After tooth extraction, the sockets will be filled with bovine bone mineral and covered with a porcine collagen membrane

BBM granulesBBM+collagen

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy adult patients with one or more teeth to be extracted, from premolar to premolar

You may not qualify if:

  • Heavy smokers (more than 10 cig per day)
  • Current Pregnant patients
  • History of malignancy
  • History of radiotherapy or chemiotherapy in the past 5 years
  • Long term steroidal or antibiotic therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PROED, Institute for Professional Education in Dentistry

Torino, TO, 10129, Italy

Location

MeSH Terms

Interventions

Alveolar Ridge Augmentation

Intervention Hierarchy (Ancestors)

Oral Surgical Procedures, PreprostheticOral Surgical ProceduresSurgical Procedures, OperativeDentistry

Study Officials

  • Daniele Cardaropoli, DDS

    Proed, Torino, Italy

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2013

First Posted

February 27, 2013

Study Start

February 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

September 2, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)