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NCT01399775 Clinical Trial

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

Alveolar Ridge Augmentation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01399775
Other study ID # 87703
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received July 21, 2011
Last updated April 7, 2015
Start date May 2010
Est. completion date February 2011

Study information
Verified date April 2015
Source Mashhad University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority Iran: Ministry of Health
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date February 2011
Est. primary completion date December 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients with hopeless single root tooth and willing for dental implants

- Having no systemic disease

Exclusion Criteria:

- Fail to osseointegrate

Study Design

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

Related Conditions & MeSH terms

Intervention

Procedure:
• immediate implantation
Immediately after tooth extraction, a dental implant is inserted
• Delayed implantation
Four months after extraction, a dental implant is inserted and measurements are recorded.

Locations
Country Name City State
Iran, Islamic Republic of Mashhad University of Medical Sciences, Dental school Mashhad Khorasan Razavi

Sponsors (1)
Lead Sponsor Collaborator
Mashhad University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. baseline to 3 months No
Secondary implant stability The primary and secondary stability will be measured using osstell at baseline and 3-month later. baseline to 3 months No
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Enrolling by invitation NCT05892016 - Ridge Preservation Using Different Techniques N/A
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Suspended NCT00299585 - A Clinical Study of the Use of Brushite as Primary Stabilizer in Immediate Dental Implantation Phase 2
Completed NCT06200077 - Patient Outcomes of Staged Ridge-splitting Using Piezo-electric Surgery in Atrophic Posterior Mandible N/A
Completed NCT05005377 - Peri-Implant Soft and Hard Tissue Stability Following Socket Preservation N/A
Not yet recruiting NCT03592381 - Ridge Expansion by Osseodensification Simultaneously With Implant Placement in Narrow Alveolar Ridges N/A