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

Purpose

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

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

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:

Mouth, Edentulous
Atrophy
Mouth Diseases

Stomatognathic Diseases
Tooth Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 16, 2013

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