- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05409950
Evaluation of Socket Shield Technique With Immediate Implant Placement in the Esthetic Zone
June 4, 2022 updated by: Egyptian Russian University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ismailia, Egypt
- Suez Canal University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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 |
|---|---|
|
Active Comparator: Study group: implants were inserted using socket shield technique at the esthetic zone
|
Evaluation of socket shield technique with immediate implant placement at the esthetic zone in comparison with the conventional immediate implant placement
|
|
No Intervention: Control group: implants were inserted using conventional immediate technique
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Implant stability
Time Frame: immediate postoperative
|
Using osstell
|
immediate postoperative
|
|
Implant stability
Time Frame: one month post-operative
|
Using osstell
|
one month post-operative
|
|
Implant stability
Time Frame: three month post-operative
|
Using osstell
|
three month post-operative
|
|
Implant stability
Time Frame: six month post-operative
|
Using osstell
|
six month post-operative
|
|
Horizontal gap
Time Frame: immediate postoperative
|
Using cone-beam computed tomography
|
immediate postoperative
|
|
Horizontal gap
Time Frame: six month post-operative
|
Using cone-beam computed tomography
|
six month post-operative
|
|
Vertical bone loss
Time Frame: immediate postoperative
|
Using cone-beam computed tomography
|
immediate postoperative
|
|
Vertical bone loss
Time Frame: six month post-operative
|
Using cone-beam computed tomography
|
six month post-operative
|
|
Bone density
Time Frame: immediate postoperative
|
Using cone-beam computed tomography
|
immediate postoperative
|
|
Bone density
Time Frame: six month post-operative
|
Using cone-beam computed tomography
|
six month post-operative
|
|
peri-implant probing depth
Time Frame: immediate postoperative
|
using periodontal probe
|
immediate postoperative
|
|
peri-implant probing depth
Time Frame: one month post-operative
|
using periodontal probe
|
one month post-operative
|
|
peri-implant probing depth
Time Frame: three month post-operative
|
using periodontal probe
|
three month post-operative
|
|
peri-implant probing depth
Time Frame: six month post-operative
|
using periodontal probe
|
six month post-operative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 16, 2019
Primary Completion (Actual)
January 6, 2021
Study Completion (Actual)
September 7, 2021
Study Registration Dates
First Submitted
May 24, 2022
First Submitted That Met QC Criteria
June 4, 2022
First Posted (Actual)
June 8, 2022
Study Record Updates
Last Update Posted (Actual)
June 8, 2022
Last Update Submitted That Met QC Criteria
June 4, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HR-1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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