Preservation of the Labial BoneNCT03587597
Socket Shield vs Conventional Immediate Implant
A study testing socket shield technique and conventional immediate implant placement with immediate temporization in people with Preservation of the Labial Bone, run by Cairo University at 1 site in Egypt.
Trial summary
eighteen implants will be placed in patients with non-restorable maxillary teeth in the aesthetic area.the recruited patients will be divided into two groups .group 1 will undergo socket shield technique with immediate temporization ,while group 2 will undergo conventional immediate implant placement with immediate… Read more about this study
- Who is it for?
- Ages 25 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Preservation of the Labial Bone
- What is being tested?
- socket shield technique and conventional immediate implant placement with immediate temporization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- 15 May 2019to Dec 2019
- 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 25 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with non-restorable maxillary anterior teeth in the esthetic zone indicated for implant placement.
- Both sexes.
- No intraoral soft and hard tissue pathology
- No systemic condition that contraindicate implant placement
Who cannot join
- Heavy smokers more than 20 cigarettes per day.
- Patients with systemic disease that may affect normal healing.
- Psychiatric problems
- Disorders to implant are related to history of radiation therapy to the head and neck neoplasia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Esthetic Zone Socket Shield Technique With Immediate Temporization vs. Conventional Immediate Implant Placement With Immediate Temporization Randomized Clinical Trial
eighteen implants will be placed in patients with non-restorable maxillary teeth in the aesthetic area.the recruited patients will be divided into two groups .group 1 will undergo socket shield technique with immediate temporization ,while group 2 will undergo conventional immediate implant placement with immediate temporization. to compare bone loss and aesthetic outcomes in the two techniques.
- Conditions
- Preservation of the Labial Bone
- Being tested
- socket shield technique, conventional immediate implant placement with immediate temporization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
socket shield techniqueProcedure or surgery
socket shield technique with immediate temporization
conventional immediate implant placement with immediate temporizationProcedure or surgery
conventional immediate implant placement with immediate temporization
| Study group | Role | What they receive |
|---|---|---|
| socket shield technique | Experimental | socket shield technique with immediate temporization Receives: Procedure: socket shield technique |
| conventional immediate implant | Active comparator | conventional implant placement with immediate temporization Receives: Procedure: conventional immediate implant placement with immediate temporization |
What is being measured
The primary outcome is the main question the study is designed to answer.
implant stability
implant stability will be measured using osstell device
Measured: immediately after implant placement
Secondary outcomes (1)
Amount of bone loss
Will be measured using linear measurements from CBCT
Measured: after 3 month from implant insertion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2018
- Study start15 May 2019 (estimated)
- Primary completionNov 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preservation of the Labial BoneStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abd El Rahman, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03587597
- Sponsor's protocol ID
- 03021984
- Status last verified
- Feb 2019
- First submitted
- 9 Jun 2018
- Last updated
- 6 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esthetic Zone Socket Shield Technique With Immediate Temporization vs. Conventional Immediate Implant Placement With Immediate Temporization Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03587597
- Acronym / sponsor ID
- 03021984
- Conditions
- Preservation of the Labial Bone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 May 2019 (estimated)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 16 Jul 2018 (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.
eighteen implants will be placed in patients with non-restorable maxillary teeth in the aesthetic area.the recruited patients will be divided into two groups .group 1 will undergo socket shield technique with immediate temporization ,while group 2 will undergo conventional immediate implant placement with immediate temporization. to compare bone loss and aesthetic outcomes in the two techniques.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| socket shield technique | Experimental | Procedure: socket shield techniquesocket shield technique with immediate temporization |
| conventional immediate implant | Active comparator | Procedure: conventional immediate implant placement with immediate temporizationconventional implant placement with immediate temporization |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with non-restorable maxillary anterior teeth in the esthetic zone indicated for implant placement.
- Both sexes.
- No intraoral soft and hard tissue pathology
- No systemic condition that contraindicate implant placement
Key exclusion criteria (4 listed)
- Heavy smokers more than 20 cigarettes per day.
- Patients with systemic disease that may affect normal healing.
- Psychiatric problems
- Disorders to implant are related to history of radiation therapy to the head and neck neoplasia
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 shield techniquesocket shield technique with immediate temporization | Procedure or surgery | socket shield technique |
| conventional immediate implant placement with immediate temporizationconventional immediate implant placement with immediate temporization | Procedure or surgery | conventional immediate implant |
Primary outcome
implant stability
Time frame: immediately after implant placement
implant stability will be measured using osstell device
1 secondary outcome
Amount of bone loss
Time frame: after 3 month from implant insertion.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2019.
- Individual participant dataSharing planned: Undecided
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.
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 shield technique and conventional immediate implant placement with immediate temporization in people with Preservation of the Labial Bone, run by Cairo 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 4 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: status not confirmed, as of the sponsor's last update on 6 Feb 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Abd El Rahman, BDS (01005261204, airplayer2003@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
implant stability (time frame: immediately after implant placement). 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 6 Feb 2019.