Bone DensityNCT07761442
Comparison Between Socket Shield and Conventional Techniques in Immediate Implant Placement.
A study testing Conventional Technique and Socket-Shield Technique in people with Bone Density and Bone Level, run by Minia University at 1 site in Egypt.
Trial summary
The goal of this randomized clinical trial is to compare whether immediate implant placement using the socket-shield technique can better preserve bone density, bone level, and peri-implant tissue health compared to conventional immediate implant placement in patients requiring tooth extraction in the maxillary… Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Bone Density, Bone Level, Peri-Implant Tissues
- What is being tested?
- Conventional Technique and Socket-Shield Technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Oct 2025to Nov 2026
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged between 20 and 60 years of both genders
- All participants should be systemically healthy, as assessed using the dental modification of the Cornell Medical Index.
- Gingival and periodontal health to be confirmed according to the criteria outlined in the new classification system proposed by Caton et al. (2018).
- Presence of non-restorable teeth due to trauma, complicated crowns or root fractures.
- Presence of extensive destructive caries making the tooth unsalvageable, particularly in esthetic zones.
- Clinical indication for immediate implant placement, especially in cases where minimizing post-extraction bone resorption and soft tissue collapse is critical.
- Availability of adequate interocclusal space to accommodate the necessary prosthetic components without occlusal interference.
Who cannot join
- (for socket-shield technique)
- Pregnant female.
- Patients with parafunctional habits (e.g., bruxism, clenching).
- Smokers.
- Teeth with clinical mobility.
- Teeth with root fractures extending below the alveolar bone level.
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- Periodontal ligament space widening.
- Signs of internal or external root resorption.
- Current or previous periodontal disease
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, 1 recruiting
- Recruiting
Minia University
Minya
Minia University, 086 2347768, ddent.office@mu.edu.eg
About this study
Official title: Comparative Study Between Using Socket Shield And Conventional Techniques In Immediate Implant Placement (A Randomized Clinical Trial)
The goal of this randomized clinical trial is to compare whether immediate implant placement using the socket-shield technique can better preserve bone density, bone level, and peri-implant tissue health compared to conventional immediate implant placement in patients requiring tooth extraction in the maxillary esthetic zone.
This study is conducted in systemically healthy adult patients aged 20-60 years who have non-restorable maxillary anterior teeth indicated for immediate implant placement.
Read more
The main questions this study aims to answer are:
Does the socket-shield technique result in better peri-implant bone density and bone level preservation compared to the conventional immediate implant technique?
Does the socket-shield technique lead to improved clinical peri-implant parameters, including probing depth, bleeding on probing, keratinized tissue width, and soft tissue thickness?
participants will be divided into two groups: (both groups will receive immediate implant placement of a tooth requiring extraction in the maxillary esthetic zone.) First group: will recieve immediate implant using conventional technique. second group: will recieve immediate implant using socket shield technique.
Participants will:
- Undergo clinical and radiographic examinations, including cone beam computed tomography (CBCT).
- Receive immediate implant placement using either the conventional technique or the socket-shield technique.
- Be followed up clinically and radiographically for 9 months to assess bone and soft tissue healing.
- Attend regular postoperative and follow-up visits for evaluation of implant stability and peri-implant tissue health.
- Conditions
- Bone Density, Bone Level, Peri-Implant Tissues, Socket Shield Technique Implant Placement, Immediate Implant Placement, Root Submergence Technique
- Being tested
- Conventional Technique, Socket-Shield Technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional TechniqueProcedure or surgery
Immediate Implant Placement Using Conventional Technique
Socket-Shield TechniqueProcedure or surgery
Immediate Implant Placement Using Socket-Shield Technique
| Study group | Role | What they receive |
|---|---|---|
| GROUP I | Active comparator | Immediate Implant Placement Using Conventional Technique Receives: Procedure: Conventional Technique |
| GROUP II | Experimental | Immediate Implant Placement Using Socket-Shield Technique Receives: Procedure: Socket-Shield Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Bone Density Around Immediate Implants.
Assessment of bone mineral density using Gray scale values (GSV) derived from Cone Beam Computed Tomography (CBCT) scans. Measurements will be evaluated at the buccal bone adjacent to the retained root fragment (Socket Shield Group) and adjacent to the implant surface (Conventional Immediate Placement Group). The change will be calculated by subtracting the baseline value from the 9-month follow-up value.
Unit of Measure: Gray scale values Time Frame: Baseline to 9 months post-implant placement
Measure Description:
Bone density measured using average gray values extracted from CBCT DICOM files at the buccal aspect of the implant site. Gray scale values reflect the radiographic attenuation/pixel intensity of the surrounding bone.
Measured: At baseline of implant placement then after 9 months
Change in Marginal Bone Level Around Immediate Implants.
- Linear measurement of the distance from the implant platform to the first bone-to-implant contact point to assess crestal bone stability.
- Unit of measure : Millimeters (mm).
Measured: At baseline of implant placement then after 9 months.
Secondary outcomes (5)
Change in Probing Depth (PD)
Measurement of the distance from the peri-implant mucosal margin to the bottom of the clinical pocket using a calibrated periodontal probe.
Unit of Measure: Millimeters (mm)
Measured: 3 months, 6 months, and 9 months post-surgery.
Modified Gingival Index (MGI)
Assessment of the visual signs of inflammation of the peri-implant soft tissues. Scores range from 0 to 4 (0 = Normal, 1 = Mild inflammation, 2 = Mild inflammation with color change, 3 = Moderate inflammation, 4 = Severe inflammation).
Unit of Measure: Score on a scale (0-4)
Measured: 3 months, 6 months, and 9 months post-surgery.
Modified Plaque Index (MPI)
Assessment of the amount of plaque on the implant/restoration surface. Scores range from 0 to 3 :
- 0 = No plaque
- 1 = Plaque only recognized by running a probe
- 2 = Plaque visible to the naked eye
- 3 = Abundance of soft matter).
Unit of Measure: Score on a scale (0-3)
Measured: 3 months, 6 months, and 9 months post-surgery.
Gingival Thickness (GT)
Assessment of the thickness of the peri-implant mucosa. This will be measured using a digital caliper or endodontic file with a rubber stopper 2mm apical to the gingival margin.
Unit of Measure: Millimeters (mm)
Measured: Baseline, 3 months, 6 months, and 9 months post-surgery.
Width of Keratinized Tissue (KTW)
Measured from the gingival margin to the mucogingival junction at the mid-facial aspect of the implant site.
Unit of Measure: Millimeters (mm)
Measured: Baseline, 3 months, 6 months, and 9 months post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start20 Oct 2025
- Primary completionOct 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone DensityStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Ibrahim Wahedi, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07761442
- Sponsor's protocol ID
- MU-EC Research No.1187
- Status last verified
- Aug 2026
- First submitted
- 15 Dec 2025
- Last updated
- 12 Aug 2026
- 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 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Using Socket Shield And Conventional Techniques In Immediate Implant Placement (A Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT07761442
- Acronym / sponsor ID
- MU-EC Research No.1187
- Conditions
- Bone Density, Bone Level, Peri-Implant Tissues, Socket Shield Technique Implant Placement, Immediate Implant Placement, Root Submergence Technique
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 20 Oct 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 12 Aug 2026 (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 goal of this randomized clinical trial is to compare whether immediate implant placement using the socket-shield technique can better preserve bone density, bone level, and peri-implant tissue health compared to conventional immediate implant placement in patients requiring tooth extraction in the maxillary esthetic zone.
This study is conducted in systemically healthy adult patients aged 20-60 years who have non-restorable maxillary anterior teeth indicated for immediate implant placement.
The main questions this study aims to answer are:
Does the socket-shield technique result in better peri-implant bone density and bone level preservation compared to the conventional immediate implant technique?
Does the socket-shield technique lead to improved clinical peri-implant parameters, including probing depth, bleeding on probing, keratinized tissue width, and soft tissue thickness?
participants will be divided into two groups: (both groups will receive immediate implant placement of a tooth requiring extraction in the maxillary esthetic zone.) First group: will recieve immediate implant using conventional technique. second group: will recieve immediate implant using socket shield technique.
Participants will:
- Undergo clinical and radiographic examinations, including cone beam computed tomography (CBCT).
- Receive immediate implant placement using either the conventional technique or the socket-shield technique.
- Be followed up clinically and radiographically for 9 months to assess bone and soft tissue healing.
- Attend regular postoperative and follow-up visits for evaluation of implant stability and peri-implant tissue health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP I | Active comparator | Procedure: Conventional TechniqueImmediate Implant Placement Using Conventional Technique |
| GROUP II | Experimental | Procedure: Socket-Shield TechniqueImmediate Implant Placement Using Socket-Shield Technique |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients aged between 20 and 60 years of both genders
- All participants should be systemically healthy, as assessed using the dental modification of the Cornell Medical Index.
- Gingival and periodontal health to be confirmed according to the criteria outlined in the new classification system proposed by Caton et al. (2018).
- Presence of non-restorable teeth due to trauma, complicated crowns or root fractures.
- Presence of extensive destructive caries making the tooth unsalvageable, particularly in esthetic zones.
Key exclusion criteria (9 listed)
- (for socket-shield technique)
- Pregnant female.
- Patients with parafunctional habits (e.g., bruxism, clenching).
- Smokers.
- Teeth with clinical mobility.
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 |
|---|---|---|
| Conventional TechniqueImmediate Implant Placement Using Conventional Technique | Procedure or surgery | GROUP I |
| Socket-Shield TechniqueImmediate Implant Placement Using Socket-Shield Technique | Procedure or surgery | GROUP II |
Primary outcome
Change in Bone Density Around Immediate Implants.
Time frame: At baseline of implant placement then after 9 months
Assessment of bone mineral density using Gray scale values (GSV) derived from Cone Beam Computed Tomography (CBCT) scans. Measurements will be evaluated at the buccal bone adjacent to the retained root fragment (Socket Shield Group) and adjacent to the implant surface (Conventional Immediate Placement Group). The change will be calculated by subtracting the baseline value from the 9-month follow-up value. Unit of Measure: Gray scale values Time Frame: Baseline to 9 months post-implant placement Measure Description: Bone density measured using average gray values extracted from CBCT DICOM files at the buccal aspect of the implant site. Gray scale values reflect the radiographic attenuation/pixel intensity of the surrounding bone.
Change in Marginal Bone Level Around Immediate Implants.
Time frame: At baseline of implant placement then after 9 months.
* Linear measurement of the distance from the implant platform to the first bone-to-implant contact point to assess crestal bone stability. * Unit of measure : Millimeters (mm).
5 secondary outcomes
Change in Probing Depth (PD)
Time frame: 3 months, 6 months, and 9 months post-surgery.
Modified Gingival Index (MGI)
Time frame: 3 months, 6 months, and 9 months post-surgery.
Modified Plaque Index (MPI)
Time frame: 3 months, 6 months, and 9 months post-surgery.
Gingival Thickness (GT)
Time frame: Baseline, 3 months, 6 months, and 9 months post-surgery.
Width of Keratinized Tissue (KTW)
Time frame: Baseline, 3 months, 6 months, and 9 months post-surgery.
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 12 Aug 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Technique and Socket-Shield Technique in people with Bone Density and Bone Level, run by Minia 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 7 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 12 Aug 2026. 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 Omar I Wahedi (+201064769520, wahdi3031@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Bone Density Around Immediate Implants. (time frame: At baseline of implant placement then after 9 months). The study lists 2 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 12 Aug 2026.