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

History of Changes

Tracking Information

First Received Date ^ICMJE

July 21, 2011

Last Updated Date

June 2, 2012

Start Date ^ICMJE

May 2010

Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01399775 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Evaluation of Implant Stability and Dimensional Changes in Alveolar Ridge Following Immediate Implantation

Brief Summary

Evaluation of dimensional changes in alveolar ridge following immediate implantation compared to delayed implantation
evaluation of the effect of gap dimensions between socket walls and dental implant in implant stability

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Atrophy of Edentulous Alveolar Ridge

Intervention ^ICMJE

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.

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2011

Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

Fail to osseointegrate

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Iran, Islamic Republic of

Administrative Information

NCT Number ^ICMJE

NCT01399775

Other Study ID Numbers ^ICMJE

87703

Has Data Monitoring Committee

Yes

Responsible Party

Amir Moeintaghavi, Mashhad University of Medical Sciences

Study Sponsor ^ICMJE

Mashhad University of Medical Sciences

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Mehrdad Radvar, DDS., Phd

Mashhad University of Medical Sciences

Information Provided By

Mashhad University of Medical Sciences

Verification Date

June 2012

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

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