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

NCT01268982 | Completed Phase 2 DMC

• 1 other identifier: 88724
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

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

Conditions

Alveolar Bone Atrophy

Keywords

socket preservation; alveolar ridge augmentation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• histologic evaluation and implant stability measurement

  10 months

Study Arms (1)

preserved socket

EXPERIMENTAL

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

Interventions

socket preservation PROCEDURE

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

Also known as: DFDBA

preserved socket

Eligibility Criteria

• Age: 19 Years - 57 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Non-molar hopeless teeth
• lack of bone volume for ideal implant placement

You may not qualify if:

• Patient's un-wiliness for involvement in the project
• contraindication of surgery due to medically-related problems

Sponsors & Collaborators

• Mashhad University of Medical Sciences: lead

Study Sites (1)

Mashhad University of Medical Sciences

Mashhad, Khorasan Razavi, 91735-984, Iran

Location

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• hamid reza arab, DDS.,Ms.

  Mashhad University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 3, 2011
• First Posted: January 4, 2011
• Study Start: January 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: January 4, 2011

Record last verified: 2010-01

Locations

IR (1)