- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07373600
Clinical and Radiographic Evaluation of Delayed Dental Implant Placement After Socket Preservation Using Injectable Bone Graft
Clinical and Radiographic Evaluation of Delayed Implant Placement Following Socket Preservation With Injectable Alloplastic Bone Graft. A Randomized Controlled Study.
This clinical study aims to evaluate the clinical and radiographic outcomes of delayed dental implant placement following socket preservation using an injectable alloplastic bone graft material.
The study will include patients who require tooth extraction and are candidates for implant placement.
After tooth extraction, the socket will be preserved using the bone graft material, and dental implants will be placed after a healing period.
Clinical and radiographic assessments will be performed to evaluate bone quality, bone height, and implant stability.
The goal of this study is to determine the effectiveness of injectable alloplastic bone grafts in maintaining the alveolar ridge and improving the success of delayed implant placement.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
- Patient aged between 40 and 60 years
- General good health.
- Volunteer subjects have to voluntarily sign an informed consent.
- Patient Indicated for single implant placement in lower posterior area.
Inclusion criteria for patients in group I
· Patient with a previously extracted lower posterior tooth and the socket was preserved with injectable bone graft .
Exclusion criteria:
- Patient with systemic disease affection bone metabolism .
- Patients with contraindication to surgical treatment.
- Patients with uncontrolled medical conditions.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Group
Extraction sites left to heal naturally without any bone grafting material before delayed implant placement.
Dental implants will be placed after the natural healing period, and clinical and radiographic evaluations will be performed to assess ridge dimensions and implant outcomes
|
|
|
Experimental: Study Group
Extraction sockets will be preserved using an injectable alloplastic bone graft material immediately after tooth extraction.
After a healing period, delayed implant placement will be performed.
Clinical and radiographic measurements will be used to evaluate ridge preservation and implant success.
|
Following tooth extraction, socket preservation will be performed using an injectable alloplastic bone graft material composed of biocompatible synthetic components.
The material will be placed into the extraction socket to maintain ridge dimensions and promote bone regeneration.
After a healing period of several months, delayed implant placement will be performed, and clinical and radiographic evaluations will assess ridge preservation and implant success
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Implant stability at the time of delayed implant placement
Time Frame: At the time of delayed implant placement (approximately 4 to 6 months after tooth extraction)
|
Implant stability will be assessed at the time of delayed implant placement using resonance frequency analysis (RFA) to obtain implant stability quotient (ISQ) values.
The ISQ readings will be used to evaluate the effect of socket preservation with injectable alloplastic bone graft on implant stability in comparison to sites without grafting.
|
At the time of delayed implant placement (approximately 4 to 6 months after tooth extraction)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1004/2025
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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