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Healing of Post-ext Sites Using Bovine Bone Mineral: a CBCT and Histologic RCCT

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ClinicalTrials.gov Identifier: NCT01800149
Recruitment Status : Completed
First Posted : February 27, 2013
Last Update Posted : September 2, 2016
Sponsor:
Information provided by (Responsible Party):
Proed

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.


Condition or disease Intervention/treatment Phase
Loss of Teeth Due to Extraction Edentulous Alveolar Ridge Procedure: Ridge Augmentation Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Healing of Post-extraction Sites Using Bovine-bone Mineral: a CBCT and Histologic Randomized Controlled Clinical Study
Study Start Date : February 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Minerals

Arm Intervention/treatment
Active Comparator: BBM+collagen
Ridge Augmentation After tooth extraction, edentulous sockets will be filled with BioOss Collagen and covered with Bio-Gide
Procedure: Ridge Augmentation
After tooth extraction, the sockets will be filled with bovine bone mineral and covered with a porcine collagen membrane

Active Comparator: BBM granules
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
After tooth extraction, the sockets will be filled with bovine bone mineral and covered with a porcine collagen membrane




Primary Outcome Measures :
  1. Clinical horizontal width [ Time Frame: 6 months after tooth extraction ]
    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.


Secondary Outcome Measures :
  1. Radiological horizontal width [ Time Frame: 6 months after tooth extraction ]
    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. Using a diagnostic software, superimposition will be performed in order to measure hard tissue remodelling.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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): NCT01800149


Locations
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Italy
PROED, Institute for Professional Education in Dentistry
Torino, TO, Italy, 10129
Sponsors and Collaborators
Proed
Investigators
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Study Director: Daniele Cardaropoli, DDS Proed

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Responsible Party: Proed
ClinicalTrials.gov Identifier: NCT01800149     History of Changes
Other Study ID Numbers: 01.2013.POST-EXT.PROED
First Posted: February 27, 2013    Key Record Dates
Last Update Posted: September 2, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Proed:
Tooth extraction
Ridge Preservation
Ridge Augmentation
Guided Bone Regeneration

Additional relevant MeSH terms:
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Tooth Loss
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases