Bone LossImplantsNCT05658419
Immediate Implant vs.Socket Shield Technique in Esthetic Zone
A study testing socket sheild in people with Bone Loss, run by Alexandria University at 1 site in Egypt.
Trial summary
immediate implant placement versus socket shield approach Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Loss
- What is being tested?
- socket sheild
- 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
- 14 Jan 2021to 5 Aug 2022
- 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients of 20-45 years of both sexes. Good oral hygiene Demonstrating non-restorable maxillary anterior single rooted teeth in the esthetic zone with as far diagnosable.
- Fairly intact buccal periodontal tissues. Patients' acceptance to sign the informed consent. Labial bone plates less than 1.5 mm in thickness or cases with labial root curvatures.
- Intact root with no mobility in the tooth and no sub-gingival caries.
Who cannot join
- Patients with systemic diseases that would interfere with the normal healing such as uncontrolled diabetes mellitus.
- History of radiation therapy to the head and neck. No history of bruxism/ para-functional habits. (119) Teeth with periodontal disease, vertical root fracture, horizontal fracture at or below the bone level, and teeth with local pathologic incidents that affect the labial part of the root as external or internal root resorption were also excluded.
- Maxillary 1st and 2nd premolars. Pregnant and lactating females.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Immediate Loaded Implants Placed Using the Socket Shield Technique in the Esthetic Zone
immediate implant placement versus socket shield approach
Read the detailed description
This study was a randomized controlled clinical trial; patients were randomly allocated to two groups: the study group: ten dental implants were placed in the maxillary esthetic zone, implants were placed using the socket shield technique with immediate loading; and the control group: ten implants were placed immediately with immediate loading. Preoperative and 6 months postoperative CBCT were performed for both groups to assess the dimensional changes in the labial bone plates. Implant stability quotients (ISQs), pink esthetic scores and attachment loss were measured at the time of implant placement and 6 months postoperatively.
- Conditions
- Bone Loss
- Being tested
- socket sheild
- Keywords
- socket shield
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
socket sheildProcedure or surgery
Also called partial extraction therapies
the socket shield technique, in which a partial root fragment was retained around an immediately placed implant with the aim of avoiding tissue alterations after tooth extraction. Histologic evaluation in a beagle dog showed no resorption of the root fragment and new cementum formed on the implant surface.
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | immediate implant placement Receives: Procedure: socket sheild |
| study group | Active comparator | socket shield immediate implant placement Receives: Procedure: socket sheild |
What is being measured
The primary outcome is the main question the study is designed to answer.
radiographic bone level
vertical and horizontal bone loss
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2022
- Study start14 Jan 2021
- Primary completion1 Dec 2021
- Study completion5 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone LossStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study group (socket shield) vs. Control group (immediate implants)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05658419
- Sponsor's protocol ID
- 1103701#
- Acronym
- Implants
- Status last verified
- Dec 2022
- First submitted
- 12 Dec 2022
- Last updated
- 20 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Immediate Loaded Implants Placed Using the Socket Shield Technique in the Esthetic Zone
- ClinicalTrials.gov ID
- NCT05658419
- Acronym / sponsor ID
- Implants / 1103701#
- Conditions
- Bone Loss
- Keywords
- socket shield
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 14 Jan 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 5 Aug 2022 (actual)
- First posted
- 20 Dec 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.
immediate implant placement versus socket shield approach
Detailed description
This study was a randomized controlled clinical trial; patients were randomly allocated to two groups: the study group: ten dental implants were placed in the maxillary esthetic zone, implants were placed using the socket shield technique with immediate loading; and the control group: ten implants were placed immediately with immediate loading. Preoperative and 6 months postoperative CBCT were performed for both groups to assess the dimensional changes in the labial bone plates. Implant stability quotients (ISQs), pink esthetic scores and attachment loss were measured at the time of implant placement and 6 months postoperatively.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Study group (socket shield) vs. Control group (immediate implants)
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Procedure: socket sheildimmediate implant placement |
| study group | Active comparator | Procedure: socket sheildsocket shield immediate implant placement |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients of 20-45 years of both sexes. Good oral hygiene Demonstrating non-restorable maxillary anterior single rooted teeth in the esthetic zone with as far diagnosable.
- Fairly intact buccal periodontal tissues. Patients' acceptance to sign the informed consent. Labial bone plates less than 1.5 mm in thickness or cases with labial root curvatures.
- Intact root with no mobility in the tooth and no sub-gingival caries.
Key exclusion criteria (3 listed)
- Patients with systemic diseases that would interfere with the normal healing such as uncontrolled diabetes mellitus.
- History of radiation therapy to the head and neck. No history of bruxism/ para-functional habits. (119) Teeth with periodontal disease, vertical root fracture, horizontal fracture at or below the bone level, and teeth with local pathologic incidents that affect the labial part of the root as external or internal root resorption were also excluded.
- Maxillary 1st and 2nd premolars. Pregnant and lactating females.
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 |
|---|---|---|
| socket sheildAlso: partial extraction therapiesthe socket shield technique, in which a partial root fragment was retained around an immediately placed implant with the aim of avoiding tissue alterations after tooth extraction. Histologic evaluation in a beagle dog showed no resorption of the root fragment and new cementum formed on the implant surface. | Procedure or surgery | control group, study group |
Primary outcome
radiographic bone level
Time frame: 6 months
vertical and horizontal bone loss
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 20 Dec 2022.
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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 socket sheild in people with Bone Loss, run by Alexandria 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 3 inclusion and 3 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 20 Dec 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?
radiographic bone level (time frame: 6 months). 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 20 Dec 2022.