Alveolar Bone ResorptionNCT05409950
Evaluation of Socket Shield Technique With Immediate Implant Placement in the Esthetic Zone
A study testing Immediate implant placement using socket shield technique in people with Alveolar Bone Resorption, run by Egyptian Russian University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Resorption
- What is being tested?
- Immediate implant placement using socket shield technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Sep 2019to 7 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Alveolar Bone Resorption
- Being tested
- Immediate implant placement using socket shield technique
- Keywords
- Immediate implants, sockets shield technique, esthetic zone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate implant placement using socket shield techniqueProcedure or surgery
Evaluation of socket shield technique with immediate implant placement at the esthetic zone in comparison with the conventional immediate implant placement
| Study group | Role | What they receive |
|---|---|---|
| Study group: implants were inserted using socket shield technique at the esthetic zone | Active comparator | Not described Receives: Procedure: Immediate implant placement using socket shield technique |
| Control group: implants were inserted using conventional immediate technique | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant stability
Using osstell
Measured: immediate postoperative
Implant stability
Using osstell
Measured: one month post-operative
Implant stability
Using osstell
Measured: three month post-operative
Implant stability
Using osstell
Measured: six month post-operative
Horizontal gap
Using cone-beam computed tomography
Measured: immediate postoperative
Horizontal gap
Using cone-beam computed tomography
Measured: six month post-operative
Vertical bone loss
Using cone-beam computed tomography
Measured: immediate postoperative
Vertical bone loss
Using cone-beam computed tomography
Measured: six month post-operative
Bone density
Using cone-beam computed tomography
Measured: immediate postoperative
Bone density
Using cone-beam computed tomography
Measured: six month post-operative
peri-implant probing depth
using periodontal probe
Measured: immediate postoperative
peri-implant probing depth
using periodontal probe
Measured: one month post-operative
peri-implant probing depth
using periodontal probe
Measured: three month post-operative
peri-implant probing depth
using periodontal probe
Measured: six month post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start16 Sep 2019
- Primary completion6 Jan 2021
- Study completion7 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Bone ResorptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egyptian Russian University
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05409950
- Sponsor's protocol ID
- HR-1
- Status last verified
- Jun 2022
- First submitted
- 24 May 2022
- Last updated
- 8 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Socket Shield Technique With Immediate Implant Placement in the Esthetic Zone
- ClinicalTrials.gov ID
- NCT05409950
- Acronym / sponsor ID
- HR-1
- Conditions
- Alveolar Bone Resorption
- Keywords
- Immediate implants, sockets shield technique, esthetic zone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Egyptian Russian UniversityResearch network
- Study start
- 16 Sep 2019 (actual)
- Primary completion
- 6 Jan 2021 (actual)
- Study completion
- 7 Sep 2021 (actual)
- First posted
- 8 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group: implants were inserted using socket shield technique at the esthetic zone | Active comparator | Procedure: Immediate implant placement using socket shield technique |
| Control group: implants were inserted using conventional immediate technique | No intervention | – |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immediate implant placement using socket shield techniqueEvaluation of socket shield technique with immediate implant placement at the esthetic zone in comparison with the conventional immediate implant placement | Procedure or surgery | Study group: implants were inserted using socket shield technique at the esthetic zone |
Primary outcome
Implant stability
Time frame: immediate postoperative
Using osstell
Implant stability
Time frame: one month post-operative
Using osstell
Implant stability
Time frame: three month post-operative
Using osstell
Implant stability
Time frame: six month post-operative
Using osstell
Horizontal gap
Time frame: immediate postoperative
Using cone-beam computed tomography
Horizontal gap
Time frame: six month post-operative
Using cone-beam computed tomography
Vertical bone loss
Time frame: immediate postoperative
Using cone-beam computed tomography
Vertical bone loss
Time frame: six month post-operative
Using cone-beam computed tomography
Bone density
Time frame: immediate postoperative
Using cone-beam computed tomography
Bone density
Time frame: six month post-operative
Using cone-beam computed tomography
peri-implant probing depth
Time frame: immediate postoperative
using periodontal probe
peri-implant probing depth
Time frame: one month post-operative
using periodontal probe
peri-implant probing depth
Time frame: three month post-operative
using periodontal probe
peri-implant probing depth
Time frame: six month post-operative
using periodontal probe
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2022.
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Alveolar Ridge Augmentation, Bone Substitutes
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Autogenous Mesenchymal Stem Cell Culture-Derived Signalling Molecules as Enhancers of Bone Formation in Bone Grafting
Bone Loss, Osteoclastic, Bone Loss, Alveolar
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Reducing the Time Interval for Implant Placement After Extraction Socket Preservation Using BIOTECK Materials and OITECH Implant System
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate implant placement using socket shield technique in people with Alveolar Bone Resorption, run by Egyptian Russian University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant stability (time frame: immediate postoperative). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2022; AzTrials last refreshed its copy on 2 Nov 2026.