- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07700706
Silicate β-TCP vs Extended Sticky Bone for Peri-Implant Jumping Gap in Guided Immediate Implants: RCT (JUMP-ESTHETIC)
Clinical and Digital Outcomes of Silicate-Added β-TCP Putty and Extended Sticky Bone for Peri-Implant Jumping Gap Management Following Fully Guided Immediate Implant Placement in the Maxillary Esthetic Zone: A Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Dakahlia Governorate
-
Al Mansurah, Dakahlia Governorate, Egypt
- Faculty of Dentistry Mansoura University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
1) Patients with non-restorable teeth in maxillary esthetic zone requiring dental extraction.
2) Age range: from18 to 50 years. 3) Adequate inter-arch relation and inter-occlusal space to accommodate the prosthetic restoration.
4) Jumping gap more than 2mm. 5) Patients with good oral hygiene. 6) Patients willing to participate in the study's follow-up intervals.
Exclusion Criteria:
1) Patients with any pathological lesion or aggressive periodontal disease at the planned surgical site impaired the immediate implant placement.
2) Alcohol or drug abuse. 3) Smokers. 4) Patients with systemic diseases that absolutely contraindicate implant placement (bleeding disorders, immunosuppression,…etc.) 5) Pregnancy. 6) Patients with para-functional habits (bruxism and clenching). 7) Lack of motivation or inability to maintain good oral hygiene.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Control group
Fully guided immediate implant placement with an ungrafted peri-implant jumping gap and immediate CAD/CAM provisionalization.
|
The peri-implant jumping gap was managed without grafting.
|
|
Experimental: Study Group 1 (Si-β-TCP Putty Group)
Fully guided immediate implant placement with a peri-implant jumping gap filled using silicate-added β-TCP putty and immediate CAD/CAM provisionalization.
|
The peri-implant jumping gap was managed using silicate-added β-TCP putty.
|
|
Experimental: Study Group 2 (Extended Sticky Bone Group)
Fully guided immediate implant placement with a peri-implant jumping gap filled using extended sticky bone and immediate CAD/CAM provisionalization.
|
The peri-implant jumping gap was managed using extended sticky bone.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Implant Stability
Time Frame: Immediate post-operative, 3 months, and 6 months.
|
Implant stability will be evaluated using Osstell device based on resonance frequency analysis (ISQ values).
|
Immediate post-operative, 3 months, and 6 months.
|
|
Hard Tissue (Peri-implant bone)
Time Frame: - Immediately after implant placement - 6 months after implant placement.
|
Marginal bone loss will be assessed using CBCT measured in mm.
|
- Immediately after implant placement - 6 months after implant placement.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Soft Tissue
Time Frame: Baseline, 1 month, 3 months, and 6 months.
|
Soft tissue contour and peri-implant tissue condition will be assessed using digital intraoral scanning (STL files) using superimposition and modified sulcus bleeding index (mSBI).
|
Baseline, 1 month, 3 months, and 6 months.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
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
Keywords
Other Study ID Numbers
- R.26.06.128
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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