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Effect of Socket Preservation Procedure on Dimensional Changes of the Ridge, and Its Efficacy.

This study has been completed.
Sponsor:
Information provided by:
Mashhad University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01268982
First received: January 3, 2011
Last updated: NA
Last verified: January 2010
History: No changes posted

January 3, 2011
January 3, 2011
January 2010
December 2010   (final data collection date for primary outcome measure)
soft and hard tissue vertical and horizontal changes [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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)
Same as current
No Changes Posted
histologic evaluation and implant stability measurement [ Time Frame: 10 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of Socket Preservation Procedure on Dimensional Changes of the Ridge, and Its Efficacy.
Dimensional Changes of the Alveolar Ridge Contour After Socket Preservation, Stability of Implants Placed, and Histological Evaluation of Newly Formed Bone at These Sites.

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.

  1. Dimensional changes of the alveolar ridge contour after socket preservation in comparison to conventional tooth extraction.
  2. Evaluation the stability of implants placed at the preserved sockets.
  3. Histological evaluation of newly formed bone at the socket preserved sites in comparison with extracted only healed sites.

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.
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Alveolar Bone Atrophy
Procedure: socket preservation
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
Other Name: DFDBA
Experimental: preserved socket
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: Procedure: socket preservation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
December 2010
December 2010   (final data collection date for primary outcome measure)

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
Both
19 Years to 57 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT01268982
88724
Yes
Dr. Hamidreza Arab, Mashhad Dental School
Mashhad University of Medical Sciences
Not Provided
Principal Investigator: hamid reza arab, DDS.,Ms. Mashhad University of Medical Sciences
Mashhad University of Medical Sciences
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP