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

Alveolar Bone Atrophy Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01268982
• Other study ID #: 88724
• Status: Completed
• Phase: Phase 2
• First received: January 3, 2011
• Last updated: January 3, 2011
• Start date: January 2010
• Est. completion date: December 2010

Study information

• Verified date: January 2010
• Source: Mashhad University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 57 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Alveolar Bone Atrophy
• Alveolar Bone Loss

Intervention

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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Mashhad University of Medical Sciences	Mashhad	Khorasan Razavi

Sponsors (1)

Lead Sponsor	Collaborator
Mashhad University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	6 months	No
Secondary	histologic evaluation and implant stability measurement		10 months	No