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Evaluation of Ridge Dimensional Changes After Immediate Implantation and Efficacy of This Procedure

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01399775
First Posted: July 22, 2011
Last Update Posted: April 8, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Amir Moeintaghavi, Mashhad University of Medical Sciences
  Purpose
  1. Evaluation of dimensional changes in alveolar ridge following immediate implantation compared to delayed implantation
  2. evaluation of the effect of gap dimensions between socket walls and dental implant in implant stability

Condition Intervention Phase
Atrophy of Edentulous Alveolar Ridge Alveolar Ridge Augmentation Procedure: immediate implantation Procedure: Delayed implantation Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Implant Stability and Dimensional Changes in Alveolar Ridge Following Immediate Implantation

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

Primary Outcome Measures:
  • dimensional changes [ Time Frame: baseline to 3 months ]
    Horizontal dimensions (bucco-linguall) of alveolar ridge will be measured at 1,3 and 7 mm using caliper and CBCT , and vertical ridge dimensions at 8 points:(mid-buccal,mid-lingual,mesial,distal,disto-buccal-mesio-buccal,disto-lingual,mesio-lingual ) will be determined using a periodontal probe from the line connecting the two adjacent CEJs ,and dimensional changes will be measured after 3 months following implant insertion with the same device during the second stage surgery.


Secondary Outcome Measures:
  • implant stability [ Time Frame: baseline to 3 months ]
    The primary and secondary stability will be measured using osstell at baseline and 3-month later.


Enrollment: 24
Study Start Date: May 2010
Study Completion Date: February 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: immediate implantation
Immediately after tooth extraction, dental implant is inserted.
Procedure: immediate implantation
Immediately after tooth extraction, a dental implant is inserted
Other Name: Implant in fresh socket
Delayed implantation
Four months after extraction, Dental implant is inserted.
Procedure: Delayed implantation
Four months after extraction, a dental implant is inserted and measurements are recorded.

Detailed Description:

24 hopeless single root teeth will be selected. The horizontal and vertical measurements will be assessed in 12socket after immediate implantation and filling the gape with DFDBA.

Horizontal dimensions (bucco-lingual) of alveolar ridge will be measured at 1,3 and 7 mm using caliper and CBCT , and vertical ridge dimensions at 8 points:(mid-buccal,mid-lingual,mesial,distal,disto-buccal-mesio-buccal,disto-lingual,mesio-lingual ) will be determined using a periodontal probe from the line connecting the two adjacent CEJs ,and dimensional changes will be measured after 3 months following implant insertion with the same device during the second stage surgery.

The vertical and horizontal dimensions between the implant and alveolar crest and between the crest and base of the gap will be measured at 8 points:(mid-buccal,mid-lingual,mesial,distal,disto-buccal-mesio-buccal,disto-lingual,mesio-lingual ).

The primary and secondary stability will be measured using Osstell at baseline and 3-month later.

Twelve sockets will heal without grafting materials, soft and hard tissue measurements including horizontal and vertical ridge dimensions will be determined. All the measurement will be assessed using caliper and CBCT at the time of extraction and 3-month later at the time of implant insertion.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with hopeless single root tooth and willing for dental implants
  • Having no systemic disease

Exclusion Criteria:

  • Fail to osseointegrate
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01399775


Locations
Iran, Islamic Republic of
Mashhad University of Medical Sciences, Dental school
Mashhad, Khorasan Razavi, Iran, Islamic Republic of, 91735-984
Sponsors and Collaborators
Mashhad University of Medical Sciences
Investigators
Study Chair: Mehrdad Radvar, DDS., Phd Mashhad University of Medical Sciences
  More Information

Responsible Party: Amir Moeintaghavi, associate professor of periodontics, Mashhad University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01399775     History of Changes
Other Study ID Numbers: 87703
First Submitted: July 21, 2011
First Posted: July 22, 2011
Last Update Posted: April 8, 2015
Last Verified: April 2015

Keywords provided by Amir Moeintaghavi, Mashhad University of Medical Sciences:
Atrophy of Edentulous Alveolar Ridge
Dental Prosthesis, Implant-Supported
Dental Implants, Single-Tooth

Additional relevant MeSH terms:
Atrophy
Mouth, Edentulous
Pathological Conditions, Anatomical
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases


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