Immediate Dental Implant PlacementNCT07303374
Flapless Immediate Implant Placement With Socket Shield Technique Versus Connective Tissue Graft in Anterior Maxilla
A study testing IIP+Socket Shield and IIP+CTG in people with Immediate Dental Implant Placement and Connective Tissue Graft, run by International Dental Contiuing Education at 1 site in Egypt.
Trial summary
The present study aims to compare the dimensional stability of the supra-implant complex following flapless immediate implant placement using two socket management approaches: the connective tissue graft and the socket shield technique. Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Immediate Dental Implant Placement, Connective Tissue Graft, Socket Shield Technique
- What is being tested?
- IIP+Socket Shield and IIP+CTG
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2026to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Initial intact thick gingival biotype
- 2 mm band of keratinized tissue,
- Thin intact labial bone plate (< 1mm)
- Good apical bone for primary stability
- Patients who had provided an informed consent.
Who cannot join
- Immediate implants with bone grafts or guided bone regeneration procedures
- Uncontrolled diabetes mellitus
- Patients taking IV bisphosphonates for treatment of osteoporosis
- Patients with active infection related at the site of implant
- Patients with untreated active periodontal diseases.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
International Dental contiuing education
Cairo
Nourhan Gamal Dr. Nourhan Gamal, Masters, +201064249442, Nourhannegamal259@gmail.com
About this study
Official title: Supra-Implant Complex Stability Following Flapless Immediate Implant Placement With Socket Shield Technique Versus Connective Tissue Graft in Anterior Maxilla 1-Year Randomized Clinical Trial
The present study aims to compare the dimensional stability of the supra-implant complex following flapless immediate implant placement using two socket management approaches: the connective tissue graft and the socket shield technique. Three-dimensional volumetric analysis and cone-beam computed tomography (CBCT) will be employed to assess and quantify changes in soft and hard tissue thickness and height surrounding the implant site.
Read the detailed description
The current study will include 28 non-restorable single maxillary anterior teeth indicated for extraction. Patients will be randomly allocated into two equal groups. The test group will undergo immediate implant placement combined with the socket shield technique and a customized healing abutment, whereas the control group will receive immediate implant placement with connective tissue grafting and a customized healing abutment. A pilot surgical guide will be used for both groups. The primary outcome measure will be labio-palatal ridge dimension changes changes. Secondary outcome measures included labial soft-tissue volumetric changes, bone formation labial to the implant, vertical bone level changes and pink esthetic score. All outcomes will be evaluated after a 12-month follow-up period.
- Being tested
- IIP+Socket Shield, IIP+CTG
- Keywords
- Socket Shield, Connective tissue graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IIP+Socket ShieldProcedure or surgery
The socket shield technique, which preserves a labial root fragment to maintain periodontal ligament support.
IIP+CTGProcedure or surgery
connective tissue grafting which increases soft-tissue volume
| Study group | Role | What they receive |
|---|---|---|
| IIP+ Socket sheild | Experimental | The socket shield technique, which preserves a labial root fragment to maintain periodontal ligament support Receives: Procedure: IIP+Socket Shield |
| IIP+CTG | Active comparator | connective tissue grafting which increases soft-tissue volume Receives: Procedure: IIP+CTG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Soft tissue Volume gain/loss
The volumetric analysis in this clinical trial will be performed to obtain profilometric measurements. intraoral scans will be taken at baseline, 6- and 12-month post-operative for each patient. The best-fit algorithm will be used to superimpose digital surface models, when comparing each area of interest (AOI) throughout out the follow up period. Unchanged neighboring teeth surfaces will be used as a reference for proper superimposition. In each patient, the AOI will be kept constant for all pairwise comparisons. The volumetric analysis software will calculate the overall buccal soft tissue volume loss/gain (mm3) within the AOI for each patient.
Measured: one year
Secondary outcomes (1)
Mid-facial gingival margin level
linear change of the Mid-facial gingival margin pre- and after one year
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study startFeb 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immediate Dental Implant PlacementStudies 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
- Model description
- Patients will be randomly allocated into two equal groups. The test group will undergo immediate implant placement combined with the socket shield technique and a customized healing abutment, whereas the control group will receive immediate implant placement with connective tissue grafting and a customized healing abutment. A pilot surgical guide will be used for both groups. The primary outcome measure will be labio-palatal ridge dimension changes changes. Secondary outcome measures included labial soft-tissue volumetric changes, bone formation labial to the implant, vertical bone level changes and pink esthetic score. All outcomes will be evaluated after a 12-month follow-up period.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Dental Contiuing Education
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Nael Adel Mina, Masters, Principal investigator, International Dental Contiuing Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07303374
- Sponsor's protocol ID
- IDCE-38122025
- Status last verified
- Dec 2025
- First submitted
- 8 Dec 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supra-Implant Complex Stability Following Flapless Immediate Implant Placement With Socket Shield Technique Versus Connective Tissue Graft in Anterior Maxilla 1-Year Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07303374
- Acronym / sponsor ID
- IDCE-38122025
- Keywords
- Socket Shield, Connective tissue graft
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- International Dental Contiuing EducationResearch network
- Study start
- Feb 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 24 Dec 2025 (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 present study aims to compare the dimensional stability of the supra-implant complex following flapless immediate implant placement using two socket management approaches: the connective tissue graft and the socket shield technique. Three-dimensional volumetric analysis and cone-beam computed tomography (CBCT) will be employed to assess and quantify changes in soft and hard tissue thickness and height surrounding the implant site.
Detailed description
The current study will include 28 non-restorable single maxillary anterior teeth indicated for extraction. Patients will be randomly allocated into two equal groups. The test group will undergo immediate implant placement combined with the socket shield technique and a customized healing abutment, whereas the control group will receive immediate implant placement with connective tissue grafting and a customized healing abutment. A pilot surgical guide will be used for both groups. The primary outcome measure will be labio-palatal ridge dimension changes changes. Secondary outcome measures included labial soft-tissue volumetric changes, bone formation labial to the implant, vertical bone level changes and pink esthetic score. All outcomes will be evaluated after a 12-month follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomly allocated into two equal groups. The test group will undergo immediate implant placement combined with the socket shield technique and a customized healing abutment, whereas the control group will receive immediate implant placement with connective tissue grafting and a customized healing abutment. A pilot surgical guide will be used for both groups. The primary outcome measure will be labio-palatal ridge dimension changes changes. Secondary outcome measures included labial soft-tissue volumetric changes, bone formation labial to the implant, vertical bone level changes and pink esthetic score. All outcomes will be evaluated after a 12-month follow-up period.
| Arm | Type | Receives |
|---|---|---|
| IIP+ Socket sheild | Experimental | Procedure: IIP+Socket ShieldThe socket shield technique, which preserves a labial root fragment to maintain periodontal ligament support |
| IIP+CTG | Active comparator | Procedure: IIP+CTGconnective tissue grafting which increases soft-tissue volume |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Initial intact thick gingival biotype
- 2 mm band of keratinized tissue,
- Thin intact labial bone plate (< 1mm)
- Good apical bone for primary stability
- Patients who had provided an informed consent.
Key exclusion criteria (5 listed)
- Immediate implants with bone grafts or guided bone regeneration procedures
- Uncontrolled diabetes mellitus
- Patients taking IV bisphosphonates for treatment of osteoporosis
- Patients with active infection related at the site of implant
- Patients with untreated active periodontal diseases.
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 |
|---|---|---|
| IIP+Socket ShieldThe socket shield technique, which preserves a labial root fragment to maintain periodontal ligament support. | Procedure or surgery | IIP+ Socket sheild |
| IIP+CTGconnective tissue grafting which increases soft-tissue volume | Procedure or surgery | IIP+CTG |
Primary outcome
Soft tissue Volume gain/loss
Time frame: one year
The volumetric analysis in this clinical trial will be performed to obtain profilometric measurements. intraoral scans will be taken at baseline, 6- and 12-month post-operative for each patient. The best-fit algorithm will be used to superimpose digital surface models, when comparing each area of interest (AOI) throughout out the follow up period. Unchanged neighboring teeth surfaces will be used as a reference for proper superimposition. In each patient, the AOI will be kept constant for all pairwise comparisons. The volumetric analysis software will calculate the overall buccal soft tissue volume loss/gain (mm3) within the AOI for each patient.
1 secondary outcome
Mid-facial gingival margin level
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- 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.
Nael Adel Mina, Masters principal investigator
International Dental Contiuing Education
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IIP+Socket Shield and IIP+CTG in people with Immediate Dental Implant Placement and Connective Tissue Graft, run by International Dental Contiuing Education 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 5 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: opening soon, as of the sponsor's last update on 24 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nourhan Gamal AbdelAziz, Masters (+201064249441, Nourhannegamal259@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Soft tissue Volume gain/loss (time frame: one year). 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 24 Dec 2025.