Evaluation the Accuracy of Immediate Implant Placement Using SocketFit Static Surgical Guide Versus Conventional Static Surgical Guide in Anterior Esthetic Zone (SocketFit)
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Aliaa s. Kishk, Batchelor
- Phone Number: +201015101949
- Email: Aliaa8271staff@dent.tanta.edu.eg
Study Contact Backup
- Name: rehab f ghouraba, PHD
- Phone Number: +201211512429
- Email: rehab_ghouraba@dent.tanta.edu.eg
Study Locations
-
-
Gharbia Governorate
-
Tanta, Gharbia Governorate, Egypt, 31773
- Recruiting
- Periodontology Clinic at Faculty of Dentistry Tanta University
-
Contact:
- rehab f ghouraba, PHD
- Phone Number: +201211512429
- Email: rehab_ghouraba@dent.tanta.edu.eg
-
Contact:
- Aliaa S Kishk, Batchelor
- Phone Number: +201015101949
- Email: Aliaa8271staff@dent.tanta.edu.eg
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients in good health with absence of any relevant medical condition that contraindicates dental implant placement e.g. blood coagulation disorder.
- Optimal compliance is evidenced by no missed treatment appointments and a positive attitude toward oral hygiene.
- Extraction socket type I according to Ellian et al criteria with adequate native/apical bone to achieve primary implant stability and intact buccal plate of bone.
- Thick mucosal phenotype.
- Probing depth ≤ 3 mm at mid-buccal aspect of failing tooth.
- Age ranged from 18- 35 years old of both genders.
Exclusion Criteria:
- Patients subjected to irradiation in the head and neck area.
- Bisphosphonate therapy.
- Females who are pregnant or trying to conceive, and nursing mothers.
- Smokers and uncontrolled diabetic patients.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: SocketFit Static Surgical Guide
Participants will undergo immediate implant placement in the anterior esthetic zone using the SocketFit static surgical guide.
The guide incorporates a socket-engaging extension designed to enhance guide stability and drilling accuracy following atraumatic tooth extraction.
Implant placement will be performed according to the planned digital workflow.
|
Participants will undergo immediate implant placement in the anterior esthetic zone using the SocketFit static surgical guide.
The guide incorporates a socket-engaging extension designed to enhance guide stability and drilling accuracy following atraumatic tooth extraction.
Implant placement will be performed according to the planned digital workflow.
|
|
Active Comparator: Conventional Static Surgical Guide
Participants allocated to the control group will undergo immediate implant placement in the anterior esthetic zone using a conventional tooth-supported static surgical guide designed through the standard digital workflow.
Following atraumatic tooth extraction, the guide will be seated on the remaining teeth to direct sequential osteotomy preparation and implant placement according to the preoperative virtual implant plan.
All other surgical procedures, implant system, drilling protocol, and postoperative management will be identical to those used in the experimental group.
|
Participants allocated to the control group will undergo immediate implant placement in the anterior esthetic zone using a conventional tooth-supported static surgical guide designed through the standard digital workflow.
Following atraumatic tooth extraction, the guide will be seated on the remaining teeth to direct sequential osteotomy preparation and implant placement according to the preoperative virtual implant plan.
All other surgical procedures, implant system, drilling protocol, and postoperative management will be identical to those used in the experimental group.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Coronal deviation
Time Frame: Immediately after implant placement following digital superimposition of the planned and actual implant positions.
|
The linear distance (mm) between the planned and actual implant positions at the coronal platform, measured by digital superimposition of the preoperative implant plan and postoperative Cone Beam Computed Tomography (CBCT) data.
|
Immediately after implant placement following digital superimposition of the planned and actual implant positions.
|
|
apical deviation
Time Frame: Immediately after implant placement following digital superimposition of the planned and actual implant positions.
|
The linear distance (mm) between the planned and actual implant positions at the implant apex, measured using digital superimposition of the preoperative implant plan and postoperative Cone Beam Computed Tomography (CBCT) data.
|
Immediately after implant placement following digital superimposition of the planned and actual implant positions.
|
|
depth(vertical) deviation
Time Frame: Immediately after implant placement following digital superimposition of the planned and actual implant positions.
|
The vertical difference (mm) between the planned and actual implant positions along the implant long axis, measured using digital superimposition of the preoperative implant plan and postoperative Cone Beam Computed Tomography (CBCT) data.
|
Immediately after implant placement following digital superimposition of the planned and actual implant positions.
|
|
angular deviation
Time Frame: Immediately after implant placement following digital superimposition of the planned and actual implant positions.
|
The angular difference (degrees) between the long axes of the planned and actual implant positions, measured using digital superimposition of the preoperative implant plan and postoperative Cone Beam Computed Tomography (CBCT) data.
|
Immediately after implant placement following digital superimposition of the planned and actual implant positions.
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Aliaa s. Kishk, Batchelor, Tanta University
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- 3626
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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