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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amir Moeintaghavi, Mashhad University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01399775
First received: July 21, 2011
Last updated: June 2, 2012
Last verified: June 2012
  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
Procedure: immediate implantation
Procedure: Delayed implantation
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Mashhad University of Medical Sciences:

Primary Outcome Measures:
  • dimensional changes [ Time Frame: baseline to 3 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Genders Eligible for Study:   Both
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
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: 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

No publications provided

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
Study First Received: July 21, 2011
Last Updated: June 2, 2012
Health Authority: Iran: Ministry of Health

Keywords provided by 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
Mouth Diseases
Pathological Conditions, Anatomical
Stomatognathic Diseases
Tooth Diseases

ClinicalTrials.gov processed this record on November 27, 2014