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
  Purpose

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.

Condition Intervention Phase
Alveolar Bone Atrophy
Procedure: socket preservation
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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.

Further study details as provided by Mashhad University of Medical Sciences:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • histologic evaluation and implant stability measurement [ Time Frame: 10 months ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: January 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

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.

  Eligibility

Ages Eligible for Study:   19 Years to 57 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01268982

Locations
Iran, Islamic Republic of
Mashhad University of Medical Sciences
Mashhad, Khorasan Razavi, Iran, Islamic Republic of, 91735-984
Sponsors and Collaborators
Mashhad University of Medical Sciences
Investigators
Principal Investigator: hamid reza arab, DDS.,Ms. Mashhad University of Medical Sciences
  More Information

No publications provided

Responsible Party: Dr. Hamidreza Arab, Mashhad Dental School
ClinicalTrials.gov Identifier: NCT01268982     History of Changes
Other Study ID Numbers: 88724
Study First Received: January 3, 2011
Last Updated: January 3, 2011
Health Authority: Iran: Ethics Committee

Keywords provided by Mashhad University of Medical Sciences:
socket preservation
alveolar ridge augmentation

Additional relevant MeSH terms:
Alveolar Bone Loss
Bone Resorption
Bone Diseases
Musculoskeletal Diseases
Periodontal Atrophy
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on October 01, 2014