Effect of Socket Preservation Procedure on Dimensional Changes of the Ridge, and Its Efficacy.
Primary Purpose
Alveolar Bone Atrophy
Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
socket preservation
Sponsored by
About this trial
This is an interventional prevention trial for Alveolar Bone Atrophy focused on measuring socket preservation, alveolar ridge augmentation
Eligibility Criteria
Inclusion Criteria:
- Non-molar hopeless teeth
- lack of bone volume for ideal implant placement
Exclusion Criteria:
- Patient's un-wiliness for involvement in the project
- contraindication of surgery due to medically-related problems
Sites / Locations
- Mashhad University of Medical Sciences
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
preserved socket
Arm Description
sockets will be filled with DFDBA and covered with absorbable membrane. Primary coverage will be achieved by full thickness mucosal flap advancement over each socket.
Outcomes
Primary Outcome Measures
soft and hard tissue vertical and horizontal changes
soft and hard tissue measurements include horizontal (Bucco-Lingual dimensions at 1mm,3mm and 7mm at the mid portion from the line connecting two adjacent CEJs) and vertical ridge dimensions (vertical distance from the line connecting two adjacent CEJs at 8 points: Mid-Buccal, Mid-Lingual, Mesial, Distal, Disto-Buccal, Disto-Lingual, Mesio-Buccal, Mesio-Lingual around the socket)
Secondary Outcome Measures
histologic evaluation and implant stability measurement
Full Information
NCT ID
NCT01268982
First Posted
January 3, 2011
Last Updated
January 3, 2011
Sponsor
Mashhad University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01268982
Brief Title
Effect of Socket Preservation Procedure on Dimensional Changes of the Ridge, and Its Efficacy.
Official Title
Dimensional Changes of the Alveolar Ridge Contour After Socket Preservation, Stability of Implants Placed, and Histological Evaluation of Newly Formed Bone at These Sites.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mashhad University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In this study, the investigators will evaluate the dimensional changes of alveolar bone in the preserved sites in comparison with extraction only conventional healed sockets, as well.
Dimensional changes of the alveolar ridge contour after socket preservation in comparison to conventional tooth extraction.
Evaluation the stability of implants placed at the preserved sockets.
Histological evaluation of newly formed bone at the socket preserved sites in comparison with extracted only healed sites.
Detailed Description
Nineteen systematically healthy patients (10 female and 9 male; mean age 38 years old; range 19-57) providing 32 hopeless non-molar teeth were selected and divided into 2 treatment groups: In the test group, following tooth extraction, for 16 sockets (9sockets from 5 female and 7 sockets from 5 male patients) soft and hard tissue measurements include horizontal (Bucco-Lingual dimensions at 1mm,3mm and 7mm at the mid portion from the line connecting two adjacent CEJs) and vertical ridge dimensions (vertical distance from the line connecting two adjacent CEJs at 8 points: Mid-Buccal, Mid-Lingual, Mesial, Distal, Disto-Buccal, Disto-Lingual, Mesio-Buccal, Mesio-Lingual around the socket) will be determined using a caliper and a template. All sockets will be filled with DFDBA and covered with absorbable membrane. Primary coverage will be achieved by full thickness mucosal flap advancement over each socket. Then an acid-etch bridge will be applied for the sites, both to avoid the movement of adjacent teeth to the empty space & also for patients esthetics. 6 months following the procedure, the soft and hard tissue in all the sites will be measured again as it was mentioned previously, plus the measurements gained from CBCT radiographs.
Besides, biopsy will be harvested from some of the preserved sites that has enough width with the use of trephine bur no.3 and it was sent for histological evaluation. Subsequently, Implants will be installed in the preserved sites and the implant stability will be measured with the help of Ostell device. The stability will be measured after 4 month following implant insertion with the same device while the implant undergoes the implant exposure procedure.
In control group, 16 sockets (9 sockets from 5 female, and 7 sockets from 4 male patients) served as unfilled extraction only group. Following extraction, soft and hard tissue measurements (horizontal and vertical ridge dimensions) will be determined with the use of caliper and template.
6month after extraction, CBCT will be taken from the site and at the time of implant installation, the soft and hard tissue in all sites will be measured in vertical and horizontal dimensions. Furthermore, biopsy from some of the healed sockets with enough width will be taken with the use of trephine bur no.3 and it will be sent for histological examination.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Bone Atrophy
Keywords
socket preservation, alveolar ridge augmentation
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
preserved socket
Arm Type
Experimental
Arm Description
sockets will be filled with DFDBA and covered with absorbable membrane. Primary coverage will be achieved by full thickness mucosal flap advancement over each socket.
Intervention Type
Procedure
Intervention Name(s)
socket preservation
Other Intervention Name(s)
DFDBA
Intervention Description
sockets will be filled with DFDBA and covered with absorbable membrane. Primary coverage will be achieved by full thickness mucosal flap advancement over each socket
Primary Outcome Measure Information:
Title
soft and hard tissue vertical and horizontal changes
Description
soft and hard tissue measurements include horizontal (Bucco-Lingual dimensions at 1mm,3mm and 7mm at the mid portion from the line connecting two adjacent CEJs) and vertical ridge dimensions (vertical distance from the line connecting two adjacent CEJs at 8 points: Mid-Buccal, Mid-Lingual, Mesial, Distal, Disto-Buccal, Disto-Lingual, Mesio-Buccal, Mesio-Lingual around the socket)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
histologic evaluation and implant stability measurement
Time Frame
10 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
57 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Non-molar hopeless teeth
lack of bone volume for ideal implant placement
Exclusion Criteria:
Patient's un-wiliness for involvement in the project
contraindication of surgery due to medically-related problems
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hamid reza arab, DDS.,Ms.
Organizational Affiliation
Mashhad University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mashhad University of Medical Sciences
City
Mashhad
State/Province
Khorasan Razavi
ZIP/Postal Code
91735-984
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
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Effect of Socket Preservation Procedure on Dimensional Changes of the Ridge, and Its Efficacy.
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