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

July 21, 2011
June 2, 2012
May 2010
December 2010   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01399775 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Evaluation of Ridge Dimensional Changes After Immediate Implantation and Efficacy of This Procedure
Evaluation of Implant Stability and Dimensional Changes in Alveolar Ridge Following Immediate Implantation
  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

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.

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Atrophy of Edentulous Alveolar Ridge
  • Procedure: immediate implantation
    Immediately after tooth extraction, a dental implant is inserted
    Other Name: Implant in fresh socket
  • Procedure: Delayed implantation
    Four months after extraction, a dental implant is inserted and measurements are recorded.
  • Experimental: immediate implantation
    Immediately after tooth extraction, dental implant is inserted.
    Intervention: Procedure: immediate implantation
  • Delayed implantation
    Four months after extraction, Dental implant is inserted.
    Intervention: Procedure: Delayed implantation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
February 2011
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Fail to osseointegrate
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT01399775
87703
Yes
Amir Moeintaghavi, Mashhad University of Medical Sciences
Mashhad University of Medical Sciences
Not Provided
Study Chair: Mehrdad Radvar, DDS., Phd Mashhad University of Medical Sciences
Mashhad University of Medical Sciences
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP