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

Primary Purpose

Atrophy of Edentulous Alveolar Ridge, Alveolar Ridge Augmentation

Status
Completed
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
immediate implantation
Delayed implantation
Sponsored by
Mashhad University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrophy of Edentulous Alveolar Ridge focused on measuring Atrophy of Edentulous Alveolar Ridge, Dental Prosthesis, Implant-Supported, Dental Implants, Single-Tooth

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Fail to osseointegrate

Sites / Locations

  • Mashhad University of Medical Sciences, Dental school

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

immediate implantation

Delayed implantation

Arm Description

Immediately after tooth extraction, dental implant is inserted.

Four months after extraction, Dental implant is inserted.

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
July 21, 2011
Last Updated
April 7, 2015
Sponsor
Mashhad University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01399775
Brief Title
Evaluation of Ridge Dimensional Changes After Immediate Implantation and Efficacy of This Procedure
Official Title
Evaluation of Implant Stability and Dimensional Changes in Alveolar Ridge Following Immediate Implantation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mashhad University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrophy of Edentulous Alveolar Ridge, Alveolar Ridge Augmentation
Keywords
Atrophy of Edentulous Alveolar Ridge, Dental Prosthesis, Implant-Supported, Dental Implants, Single-Tooth

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
immediate implantation
Arm Type
Experimental
Arm Description
Immediately after tooth extraction, dental implant is inserted.
Arm Title
Delayed implantation
Arm Type
Other
Arm Description
Four months after extraction, Dental implant is inserted.
Intervention Type
Procedure
Intervention Name(s)
immediate implantation
Other Intervention Name(s)
Implant in fresh socket
Intervention Description
Immediately after tooth extraction, a dental implant is inserted
Intervention Type
Procedure
Intervention Name(s)
Delayed implantation
Intervention Description
Four months after extraction, a dental implant is inserted and measurements are recorded.
Primary Outcome Measure Information:
Title
dimensional changes
Description
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.
Time Frame
baseline to 3 months
Secondary Outcome Measure Information:
Title
implant stability
Description
The primary and secondary stability will be measured using osstell at baseline and 3-month later.
Time Frame
baseline to 3 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with hopeless single root tooth and willing for dental implants Having no systemic disease Exclusion Criteria: Fail to osseointegrate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehrdad Radvar, DDS., Phd
Organizational Affiliation
Mashhad University of Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Mashhad University of Medical Sciences, Dental school
City
Mashhad
State/Province
Khorasan Razavi
ZIP/Postal Code
91735-984
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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

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