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

Phase 1

Completed

• Conditions: Atrophy of Edentulous Alveolar Ridge; Alveolar Ridge Augmentation
• Interventions: Procedure: immediate implantation; Procedure: Delayed implantation

• Registration Number: NCT01399775
• Lead Sponsor: Mashhad University of Medical Sciences

Brief 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

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 Timeline

• Study Start: 2010-05
• Primary Completion: 2010-12
• Study Completion: 2011-02
• Study First Submitted: 2011-07-21
• Study First Submitted QC: 2011-07-21
• Study First Posted: 2011-07-22
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-07
• Last Update Posted: 2015-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

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

Exclusion Criteria

• Fail to osseointegrate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
immediate implantation	immediate implantation	Immediately after tooth extraction, dental implant is inserted.
Delayed implantation	Delayed implantation	Four months after extraction, Dental implant is inserted.

Primary Outcome Measures

Name	Time	Method
dimensional changes	baseline to 3 months	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

Name	Time	Method
implant stability	baseline to 3 months	The primary and secondary stability will be measured using osstell at baseline and 3-month later.

Trial Locations

Locations (1)

Mashhad University of Medical Sciences, Dental school; 🇮🇷 Mashhad, Khorasan Razavi, Iran, Islamic Republic of