Dental ImplantPhase 4NCT04882761
Socket Shield With Immediate Implant Stability
A Phase 4 study testing Dental implant in people with Dental Implant, run by Ain Shams University at 1 site in Egypt.
Trial summary
To evaluate socket shield technique either placing implant in direct contact to tooth fragment versus gap created between the tooth and implant. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Dental Implant
- What is being tested?
- Dental implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Apr 2017to 24 Feb 2021
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Patients with a non-restorable tooth located in anterior maxillary arch (upper right second premolar to upper left second premolar). Tooth to be extracted is endodontically treated and free from periapical infection.
- Systemic free patients according to modified Cornell medical index (Brodmank and Erdmann 1949).
- Patients with good compliance.
Who cannot join
- Teeth with current acute periapical infection or sinus tracts.
- Heavy smokers and patients with bruxism habits.
- Patients with poor oral hygiene or not willing to perform oral hygiene measures.
- Vulnerable groups (as pregnant females and decisionally impaired individuals).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Soft Tissue Stability and Labial Plate of Bone of Immediate Implant in Direct Contact Versus Gap With Socket Shield (A Randomized Clinical Study)
To evaluate socket shield technique either placing implant in direct contact to tooth fragment versus gap created between the tooth and implant.
Read the detailed description
Patients with a non-restorable tooth located in anterior maxillary arch was included in this study, patients were divided into two groups, eight implants per group, both groups had socket shield, group 1 will have implant in direct contact with shield, second group had a gap between dental implant and shield. soft tissue stability, bone width and implant stability was assessed preoperatively, immediate and 6 months postoperative.
- Conditions
- Dental Implant
- Being tested
- Dental implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental implantDevice
Comparative
| Study group | Role | What they receive |
|---|---|---|
| Socket shield in direct contact with dental implant | Active comparator | eight partially extracted sockets where implant (Neobiotech) was placed in direct contact to socket shield Receives: Device: Dental implant |
| Socket shield with gap and xenograft with dental implant | Active comparator | eight partially extracted sockets where a gap was left between implant (Neobiotech) and socket shield Receives: Device: Dental implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Soft tissue stability
Pink esthetic score
Measured: 6 months postoperatively
Secondary outcomes (1)
Bone stability
By Ostell
Measured: 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start12 Apr 2017
- Primary completion20 Jan 2021
- Study completion24 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa Adel Salah Khattab, Ain Shams University
- Investigators
- Doaa Adel-Khattab, PhD, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04882761
- Sponsor's protocol ID
- 13875
- Status last verified
- May 2021
- First submitted
- 27 Feb 2021
- Last updated
- 12 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Soft Tissue Stability and Labial Plate of Bone of Immediate Implant in Direct Contact Versus Gap With Socket Shield (A Randomized Clinical Study)
- ClinicalTrials.gov ID
- NCT04882761
- Acronym / sponsor ID
- 13875
- Conditions
- Dental Implant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 12 Apr 2017 (actual)
- Primary completion
- 20 Jan 2021 (actual)
- Study completion
- 24 Feb 2021 (actual)
- First posted
- 12 May 2021 (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.
To evaluate socket shield technique either placing implant in direct contact to tooth fragment versus gap created between the tooth and implant.
Detailed description
Patients with a non-restorable tooth located in anterior maxillary arch was included in this study, patients were divided into two groups, eight implants per group, both groups had socket shield, group 1 will have implant in direct contact with shield, second group had a gap between dental implant and shield. soft tissue stability, bone width and implant stability was assessed preoperatively, immediate and 6 months postoperative.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Socket shield in direct contact with dental implant | Active comparator | Device: Dental implanteight partially extracted sockets where implant (Neobiotech) was placed in direct contact to socket shield |
| Socket shield with gap and xenograft with dental implant | Active comparator | Device: Dental implanteight partially extracted sockets where a gap was left between implant (Neobiotech) and socket shield |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with a non-restorable tooth located in anterior maxillary arch (upper right second premolar to upper left second premolar). Tooth to be extracted is endodontically treated and free from periapical infection.
- Systemic free patients according to modified Cornell medical index (Brodmank and Erdmann 1949).
- Patients with good compliance.
Key exclusion criteria (4 listed)
- Teeth with current acute periapical infection or sinus tracts.
- Heavy smokers and patients with bruxism habits.
- Patients with poor oral hygiene or not willing to perform oral hygiene measures.
- Vulnerable groups (as pregnant females and decisionally impaired individuals).
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 |
|---|---|---|
| Dental implantComparative | Device | Socket shield in direct contact with dental implant, Socket shield with gap and xenograft with dental implant |
Primary outcome
Soft tissue stability
Time frame: 6 months postoperatively
Pink esthetic score
1 secondary outcome
Bone stability
Time frame: 6 months postoperatively
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 12 May 2021.
- Individual participant dataSharing planned: No
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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.
Doaa Adel-Khattab, PhD study director
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dental implant in people with Dental Implant, run by Ain Shams 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 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: finished, as of the sponsor's last update on 12 May 2021. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Soft tissue stability (time frame: 6 months postoperatively). 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 12 May 2021; AzTrials last refreshed its copy on 28 Oct 2026.