Evaluation of Socket Shield Technique With Immediate Implant Placement in the Esthetic Zone
Primary Purpose
Alveolar Bone Resorption
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Immediate implant placement using socket shield technique
Sponsored by
About this trial
This is an interventional treatment trial for Alveolar Bone Resorption focused on measuring Immediate implants, sockets shield technique, esthetic zone
Eligibility Criteria
Inclusion Criteria:
- Endodontic or non-endodontic treated un-restorable remaining root/ tooth related to maxillary anterior teeth.
- Healthy adult patients > 20 years old (ASAI, II) .
- Adequate oral hygiene.
- Intact periodontal tissues.
Exclusion Criteria:
- Periapical or periodontal active infection involving the teeth/root to be extracted (as excluded by radiographic examination).
- Medically compromised patients (ASA III, IV, V).
- Patients receiving chemotherapy or radiotherapy.
- Heavy smokers,alcohol or drug abuse.
- Patients with parafunctional habits such as bruxism, clenching, excessive gum chewing, lip or fingernail biting.
Sites / Locations
- Suez canal university
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Study group: implants were inserted using socket shield technique at the esthetic zone
Control group: implants were inserted using conventional immediate technique
Arm Description
Outcomes
Primary Outcome Measures
Implant stability
Using osstell
Implant stability
Using osstell
Implant stability
Using osstell
Implant stability
Using osstell
Horizontal gap
Using cone-beam computed tomography
Horizontal gap
Using cone-beam computed tomography
Vertical bone loss
Using cone-beam computed tomography
Vertical bone loss
Using cone-beam computed tomography
Bone density
Using cone-beam computed tomography
Bone density
Using cone-beam computed tomography
peri-implant probing depth
using periodontal probe
peri-implant probing depth
using periodontal probe
peri-implant probing depth
using periodontal probe
peri-implant probing depth
using periodontal probe
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05409950
Brief Title
Evaluation of Socket Shield Technique With Immediate Implant Placement in the Esthetic Zone
Official Title
Evaluation of Socket Shield Technique With Immediate Implant Placement in the Esthetic Zone
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
September 16, 2019 (Actual)
Primary Completion Date
January 6, 2021 (Actual)
Study Completion Date
September 7, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Egyptian Russian University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The study was conducted on 20 immediate implant placement sites in the anterior maxillary region. In the study group, 10 implants were inserted using socket shield technique, while in control group, 10 implants were inserted using conventional immediate placement technique. All patients received immediate and 6 months post-operative CBCT to assess horizontal bone loss, vertical bone loss, and measurement of bone density. Implant stability quotients (ISQs) was measured immediately, 1st, 3rd and 6 months post-operatively.
Detailed Description
Unrestorable tooth extraction with immediate implant placement is considered one of the best treatment options in restoring the esthetics and function. Extraction socket resorption is considered a challenging procedure when it involves the esthetics zone. The preservation of the entire attachment apparatus for complete preservation of the alveolar ridge makes socket shield technique a promising procedure that helps to maintain anatomy, esthetics and function. Socket shield technique, eliminate the negative consequences of bone resorption of the buccal plate of bone; leading to maintaining hard and soft tissue contours and provides a perfect pleasing esthetic result with good function. It is a highly promising technique in terms of maintaining pink and white esthetics through preservation of the interdental papilla during preparation of the interdental socket shield. It is considered a minimally invasive surgical procedure and offers the advantages of immediate implant placement.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Bone Resorption
Keywords
Immediate implants, sockets shield technique, esthetic zone
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study group: implants were inserted using socket shield technique at the esthetic zone
Arm Type
Active Comparator
Arm Title
Control group: implants were inserted using conventional immediate technique
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Immediate implant placement using socket shield technique
Intervention Description
Evaluation of socket shield technique with immediate implant placement at the esthetic zone in comparison with the conventional immediate implant placement
Primary Outcome Measure Information:
Title
Implant stability
Description
Using osstell
Time Frame
immediate postoperative
Title
Implant stability
Description
Using osstell
Time Frame
one month post-operative
Title
Implant stability
Description
Using osstell
Time Frame
three month post-operative
Title
Implant stability
Description
Using osstell
Time Frame
six month post-operative
Title
Horizontal gap
Description
Using cone-beam computed tomography
Time Frame
immediate postoperative
Title
Horizontal gap
Description
Using cone-beam computed tomography
Time Frame
six month post-operative
Title
Vertical bone loss
Description
Using cone-beam computed tomography
Time Frame
immediate postoperative
Title
Vertical bone loss
Description
Using cone-beam computed tomography
Time Frame
six month post-operative
Title
Bone density
Description
Using cone-beam computed tomography
Time Frame
immediate postoperative
Title
Bone density
Description
Using cone-beam computed tomography
Time Frame
six month post-operative
Title
peri-implant probing depth
Description
using periodontal probe
Time Frame
immediate postoperative
Title
peri-implant probing depth
Description
using periodontal probe
Time Frame
one month post-operative
Title
peri-implant probing depth
Description
using periodontal probe
Time Frame
three month post-operative
Title
peri-implant probing depth
Description
using periodontal probe
Time Frame
six month post-operative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Endodontic or non-endodontic treated un-restorable remaining root/ tooth related to maxillary anterior teeth.
Healthy adult patients > 20 years old (ASAI, II) .
Adequate oral hygiene.
Intact periodontal tissues.
Exclusion Criteria:
Periapical or periodontal active infection involving the teeth/root to be extracted (as excluded by radiographic examination).
Medically compromised patients (ASA III, IV, V).
Patients receiving chemotherapy or radiotherapy.
Heavy smokers,alcohol or drug abuse.
Patients with parafunctional habits such as bruxism, clenching, excessive gum chewing, lip or fingernail biting.
Facility Information:
Facility Name
Suez canal university
City
Ismailia
Country
Egypt
12. IPD Sharing Statement
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Evaluation of Socket Shield Technique With Immediate Implant Placement in the Esthetic Zone
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