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

Primary Purpose

Loss of Teeth Due to Extraction, Edentulous Alveolar Ridge

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Ridge Augmentation
Sponsored by
Proed, Torino, Italy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Loss of Teeth Due to Extraction focused on measuring Tooth extraction, Ridge Preservation, Ridge Augmentation, Guided Bone Regeneration

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • PROED, Institute for Professional Education in Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

BBM+collagen

BBM granules

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Radiological horizontal width
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.

Full Information

First Posted
February 25, 2013
Last Updated
September 1, 2016
Sponsor
Proed, Torino, Italy
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1. Study Identification

Unique Protocol Identification Number
NCT01800149
Brief Title
Healing of Post-ext Sites Using Bovine Bone Mineral: a CBCT and Histologic RCCT
Official Title
Healing of Post-extraction Sites Using Bovine-bone Mineral: a CBCT and Histologic Randomized Controlled Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Proed, Torino, Italy

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Both animal and human studies have clearly demonstrated that the healing of post extraction sites usually results in pronounced alveolar ridge resorption, that mostly stabilized after 4 to 6 months. The marked tri-dimensional alterations of the ridge volume may jeopardize patients' aesthetics and create anatomical difficulties for further implant placement. Aim of the present investigation will be to evaluate the role of a bovine-bone mineral and a collagen membrane as ridge augmentation procedure (intended as "increase of the ridge volume beyond the skeletal envelope existing at the time of extraction") following tooth extraction. Furthermore, the authors aim to evaluate as the collagen membrane acts when used for "open-healing". 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 local anesthesia, a buccal full thickness flap will be elevated, and then the hopeless teeth will be gently extracted. All granulation tissue will be removed from the alveolus, that will be rinsed with saline. At this time the post-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) using the Bio-Oss Pen device. The graft will be covered with porcine collagen membrane (BioGide). Then, the flap will be sutured. The sutures (single sutures) will involve only the interdental gingival tissue, and no attempt will be done to reach a complete soft tissue closure of the sockets: in the alveolus area BioGide will be mostly left exposed, intended as "open healing" for second intention wound healing. The patient swill assume antibiotics per 6 days (Amoxicillin + Clavulanate 1gr), and will rinse with Digluconate Chlorhexidine 0.20% per 14 days. At day 14 the sutures will be removed. If, at this moment, the gingiva over the graft will not be completely closed, the patient will use Digluconate Chlorhexidine 0.20% until the secondary closure will be completed. MEASUREMENTS: The end of the study will be fixed at the 6 months evaluation after tooth extraction (corresponding to the planned time for implant installation). Impression will be taken before tooth extraction and after 6 months in order to create cast models. On the cast models, using reference PVC guides, 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. 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. Using a diagnostic software, 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, with the purpose of an histologic and histomorphometric evaluation (measurement of new bone formation and measurement of remaining BioOss granules). The biopsy will be taken exactly in the area where dental implants will be placed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Loss of Teeth Due to Extraction, Edentulous Alveolar Ridge
Keywords
Tooth extraction, Ridge Preservation, Ridge Augmentation, Guided Bone Regeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BBM+collagen
Arm Type
Active Comparator
Arm Description
Ridge Augmentation After tooth extraction, edentulous sockets will be filled with BioOss Collagen and covered with Bio-Gide
Arm Title
BBM granules
Arm Type
Active Comparator
Arm Description
Ridge Augmentation After tooth extraction, edentulous sockets will be filled with Bio-Oss Granules, 0-25-1 mm, and covered with Bio-Gide
Intervention Type
Procedure
Intervention Name(s)
Ridge Augmentation
Intervention Description
After tooth extraction, the sockets will be filled with bovine bone mineral and covered with a porcine collagen membrane
Primary Outcome Measure Information:
Title
Clinical horizontal width
Description
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.
Time Frame
6 months after tooth extraction
Secondary Outcome Measure Information:
Title
Radiological horizontal width
Description
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.
Time Frame
6 months after tooth extraction

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniele Cardaropoli, DDS
Organizational Affiliation
Proed, Torino, Italy
Official's Role
Study Director
Facility Information:
Facility Name
PROED, Institute for Professional Education in Dentistry
City
Torino
State/Province
TO
ZIP/Postal Code
10129
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

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

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