Implant Site ReactionNCT06043037
Elamrousy Modified Approach for Socket Shield Technique
A study testing Elamrousy Novel Approach for Immediate Implant Placement Using Socket Shield Technique and Immediate Implant Placement Using Socket Shield Technique alone in people with Implant Site Reaction and Tooth Extraction Status Nos, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
The current trial aim was to evaluate clinically and radiographically the changes around dental implants inserted immediately in maxillary anterior esthetic zone using a novel combination of autogenous demineralized dentin graft (ADDG) with socket shield technique (SST) and compared this approach to socket shield… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Implant Site Reaction, Tooth Extraction Status Nos, Dental Implant Failed
- What is being tested?
- Elamrousy Novel Approach for Immediate Implant Placement Using Socket Shield Technique and Immediate Implant Placement Using Socket Shield Technique alone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Jul 2023to 30 Aug 2026
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- above the age of 18years
- presence of non-restorable maxillary anterior tooth
- had intact socket walls following tooth extraction
- the gingival biotype was thick.
Who cannot join
- history of systemic condition
- history of using bisphosphonates or other drugs that might impact bone turnover
- a history of smoking during the previous five years,
- a history of any acute infections at the surgical site,
- teeth having root resorptions
- massive periodontal destruction
- buccally fractured root either vertically or horizontally beneath the alveolar crest.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
oral medicine and periodontology outpatient clinic, faculty of dentistry, kafrelsheikh University
Kafr ash Shaykh, Kafrelsheikh, 214312
About this study
Official title: Peri-implant Soft and Hard Tissue Changes Around Maxillary Anterior Immediate Implants Using Socket Shield Technique Versus a Combination of Socket Shield Technique and Autogenous Demineralized Dentin Graft: Randomized Clinical Trial
The current trial aim was to evaluate clinically and radiographically the changes around dental implants inserted immediately in maxillary anterior esthetic zone using a novel combination of autogenous demineralized dentin graft (ADDG) with socket shield technique (SST) and compared this approach to socket shield technique (SST) alone.
The present study included 50 participants, aged 20 to 45, with teeth that needed to be extracted. After Kafrelsheikh University research ethics committee approval, participants were randomized into 2 groups: the control group patients underwent immediate implantation using SS protocol, while the study group patients underwent the same procedure, but ADDG was created using the extracted palatal portion of the tooth; and then placed in the peri-implant gap defect.
Read the detailed description
However, Immediate placement protocol of dental implants reported favorable improvement of esthetic indices such as the Pink Esthetic Score (PES), mid-facial mucosal recession (MFMR) was the most common esthetic drawback. MFMR occurrences increase in case of thin gingival biotype, facial implant malposition, and thin or destroyed facial bone plate after tooth removal.
To avoid MFMR, dental implants should be placed immediately only when the clinical conditions are ideal including completely intact facial plate of bone, more than 1mm thick facial plate of bone, absence of periapical pathosis or infection at the extracted socket, thick gingival biotype, presence of sufficient bone palatal and apical to the extraction socket for proper positioning of the implant fixture and obtaining acceptable primary stability. These ideal conditions are rarely observed in the maxillary anterior region. Although proper patients' selection and treatment by specialists with high experience and skills, the esthetic outcomes of immediately placed dental implant showed unsatisfactory deteriorated facial tissues on the mid- to long-term.
Following root extraction, the thin delicate avascular cortical bone plate showed massive loss and deterioration due to loss of its vascular blood supply obtained from the root periodontal ligament. To overcome this negative esthetic outcome during immediate placement of dental implants, different materials and techniques were used around implants such as bone graft substitutes, growth factors and barrier membranes.
In 2010, Hurzeler and colleagues introduced a novel approach for immediate implantation called Socket Shield Technique (SST). This minimal invasive technique resulted in preservation of facial bone plate which in turn improved the esthetic outcomes. Partial extraction therapy, the root membrane technique and the modified SST are different terminologies and modifications of the original approch. In SST protocol, tooth decoronation followed by root splitting mesio-distally. The palatally splitted portion of the root is atraumatically extracted while the intact buccal root portion is kept in place with thickness of 1.5mm. The implant fixture is then placed palatally with 2mm gap distance in between. finally, that gap might be grafted or left without grafts.
SST showed enhancement of hard and soft tissue conditions around implants, implant stability and esthetic results compared with traditional immediate placement protocol of dental implants. Till now, few studies evaluated the effect of grafting the gap between the buccal tooth shield and the implant fixture.
Globally, extracted teeth are regarded as infectious waste. Teeth are made up of organic matrix and inorganic hydroxyapatite reinforcing phase, that's why teeth are gaining popularity as a potential resource for alveolar bone repair. Non-demineralized tooth grafts produced positive outcomes, but bone and tooth demineralization enhances the bioavailability of non-collagenous proteins associated with the matrix, such as osteocalcin, osteonectin, bone sialoprotein, phosphophoryn, and bone morphogenetic protein, which could promote the creation of new bone. A valuable three-dimensional biological scaffold with osteopromotive and osteoconductive properties is provided by ADDG. Additionally, it saves the patient money on the cost of other graft materials and lowers the worldwide amount of infectious dental waste.
The specific question of the current research was: Does using ADDG for grafting the gap between the tooth shield and the implant fixture in immediate dental implantation with SST improve the clinical and radiographic outcomes in comparison to immediate implant placement with SST alone without using bone graft?
- Being tested
- Elamrousy Novel Approach for Immediate Implant Placement Using Socket Shield Technique, Immediate Implant Placement Using Socket Shield Technique alone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elamrousy Novel Approach for Immediate Implant Placement Using Socket Shield TechniqueProcedure or surgery
Also called Immediate Implant Placement Using Socket Shield Technique grafted by autogenous demineralized dentin graft
The flapless strategy was used. To prepare the SS, tooth decoronation followed by root splitting mesio-distally. The palatally splitted portion of the root is atraumatically extracted while the intact buccal root portion is kept in place with thickness of 1.5mm.(12) The implant fixture is then placed palatally with 2mm gap distance in between. finally, that gap was grafted with ADDG
Immediate Implant Placement Using Socket Shield Technique aloneProcedure or surgery
The flapless strategy was used. To prepare the SS, tooth decoronation followed by root splitting mesio-distally. The palatally splitted portion of the root is atraumatically extracted while the intact buccal root portion is kept in place with thickness of 1.5mm.(12) The implant fixture is then placed palatally with 2mm gap distance in between. finally, that gap was left without grafts.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Implant Placement Using Socket Shield Technique with autogenous demineralized dentin graft | Active comparator | after immediate implantation using Socket Shield Technique, the palatal root portion will be converted to autogenous demineralized dentin graft and used for grafting the defect between the socket shield and the implant fixture Receives: Procedure: Elamrousy Novel Approach for Immediate Implant Placement Using Socket Shield Technique |
| Immediate Implant Placement Using Socket Shield Technique only without grafting the defect | Experimental | after insertion of immediate implant Using Socket Shield Technique, the bone defect between the socket shield and the implant fixture will be left ungrafted Receives: Procedure: Immediate Implant Placement Using Socket Shield Technique alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
crestal bone thickness
Utilizing CBCT sagittal sections, the crestal bone thickness was evaluated by computerized analysis. Navigation was done on the multiplanar display until the implant's precise same-view location was established on the reformatted cross-sectional section and panoramic view.
Measured: 36-month.
Secondary outcomes (4)
buccal marginal bone level (BMBL)
Utilizing CBCT sagittal sections, the BMBL was evaluated by computerized analysis. Navigation was done on the multiplanar display until the implant's precise same-view location was established on the reformatted cross-sectional section and panoramic view.
Measured: 36-months
Midfacial Mucosal Alterations
, digital intraoral scans were recorded. To quantify the vertical changes in the soft tissues around implants buccally, the collected scans were digitally superimposed via matching Gom inspect software
Measured: 36-months
PES
The pink esthetic score (PES) evaluates the esthetic outcome of soft tissue around implant-supported single crowns in the anterior zone by awarding seven points for the mesial and distal papilla, soft-tissue level, soft-tissue contour, soft-tissue color, soft-tissue texture, and alveolar process deficiency.Using a 0-1-2 scoring system, 0 being the lowest, 2 being the highest value, the maximum achievable PES was 14.
Measured: 36-months
Implant Stability Quotient (ISQ)
Osstell TM was used to record the primary stability.ISQ, or Implant Stability Quotient, is a scale from 1 to 100 and is a measure of the stability of an implant. The ISQ scale has a non-linear correlation to micro mobility. With more than 1400 scientific references, we now know that high stability means >70 ISQ, between 60-69 is medium stability and < 60 ISQ is considered as low stability.
Measured: 36-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start18 Jul 2023
- Primary completion31 Jul 2026
- Study completion30 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant Site ReactionStudies 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
- The present study included 50 participants, aged 20 to 45, with teeth that needed to be extracted. After Kafrelsheikh University research ethics committee approval, participants were randomized into 2 groups: the control group patients underwent immediate implantation using SS protocol, while the study group patients underwent the same procedure, but ADDG was created using the extracted palatal portion of the tooth; and then placed in the peri-implant gap defect. Clinically, pink aesthetic score (PES), midfacial mucosal alterations (MFMA), implant stability quotient (ISQ) were observed at baseline, six and twelve months after implantation. Moreover, baseline, 6- and 12-months alterations of radiographic horizontal bone dimension (HBD), buccal marginal bone level (BMBL), peri-implant Bone Density (PIBD) and peri-implant vertical bone defect (PIVBD) changes were assessed using cone beam computed tomography (CBCT).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walid Elamrousy, Kafrelsheikh University
- Investigators
- Walid AH Elamrousy, PhD, Principal investigator, Faculty of Oral and Dental Medicine, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06043037
- Sponsor's protocol ID
- KFSIRB200-82
- Status last verified
- Sep 2026
- First submitted
- 15 Jul 2023
- Last updated
- 3 Sep 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 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri-implant Soft and Hard Tissue Changes Around Maxillary Anterior Immediate Implants Using Socket Shield Technique Versus a Combination of Socket Shield Technique and Autogenous Demineralized Dentin Graft: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06043037
- Acronym / sponsor ID
- KFSIRB200-82
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 18 Jul 2023 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 30 Aug 2026 (actual)
- First posted
- 21 Sep 2023 (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 current trial aim was to evaluate clinically and radiographically the changes around dental implants inserted immediately in maxillary anterior esthetic zone using a novel combination of autogenous demineralized dentin graft (ADDG) with socket shield technique (SST) and compared this approach to socket shield technique (SST) alone.
The present study included 50 participants, aged 20 to 45, with teeth that needed to be extracted. After Kafrelsheikh University research ethics committee approval, participants were randomized into 2 groups: the control group patients underwent immediate implantation using SS protocol, while the study group patients underwent the same procedure, but ADDG was created using the extracted palatal portion of the tooth; and then placed in the peri-implant gap defect.
Detailed description
However, Immediate placement protocol of dental implants reported favorable improvement of esthetic indices such as the Pink Esthetic Score (PES), mid-facial mucosal recession (MFMR) was the most common esthetic drawback. MFMR occurrences increase in case of thin gingival biotype, facial implant malposition, and thin or destroyed facial bone plate after tooth removal.
To avoid MFMR, dental implants should be placed immediately only when the clinical conditions are ideal including completely intact facial plate of bone, more than 1mm thick facial plate of bone, absence of periapical pathosis or infection at the extracted socket, thick gingival biotype, presence of sufficient bone palatal and apical to the extraction socket for proper positioning of the implant fixture and obtaining acceptable primary stability. These ideal conditions are rarely observed in the maxillary anterior region. Although proper patients' selection and treatment by specialists with high experience and skills, the esthetic outcomes of immediately placed dental implant showed unsatisfactory deteriorated facial tissues on the mid- to long-term.
Following root extraction, the thin delicate avascular cortical bone plate showed massive loss and deterioration due to loss of its vascular blood supply obtained from the root periodontal ligament. To overcome this negative esthetic outcome during immediate placement of dental implants, different materials and techniques were used around implants such as bone graft substitutes, growth factors and barrier membranes.
In 2010, Hurzeler and colleagues introduced a novel approach for immediate implantation called Socket Shield Technique (SST). This minimal invasive technique resulted in preservation of facial bone plate which in turn improved the esthetic outcomes. Partial extraction therapy, the root membrane technique and the modified SST are different terminologies and modifications of the original approch. In SST protocol, tooth decoronation followed by root splitting mesio-distally. The palatally splitted portion of the root is atraumatically extracted while the intact buccal root portion is kept in place with thickness of 1.5mm. The implant fixture is then placed palatally with 2mm gap distance in between. finally, that gap might be grafted or left without grafts.
SST showed enhancement of hard and soft tissue conditions around implants, implant stability and esthetic results compared with traditional immediate placement protocol of dental implants. Till now, few studies evaluated the effect of grafting the gap between the buccal tooth shield and the implant fixture.
Globally, extracted teeth are regarded as infectious waste. Teeth are made up of organic matrix and inorganic hydroxyapatite reinforcing phase, that's why teeth are gaining popularity as a potential resource for alveolar bone repair. Non-demineralized tooth grafts produced positive outcomes, but bone and tooth demineralization enhances the bioavailability of non-collagenous proteins associated with the matrix, such as osteocalcin, osteonectin, bone sialoprotein, phosphophoryn, and bone morphogenetic protein, which could promote the creation of new bone. A valuable three-dimensional biological scaffold with osteopromotive and osteoconductive properties is provided by ADDG. Additionally, it saves the patient money on the cost of other graft materials and lowers the worldwide amount of infectious dental waste.
The specific question of the current research was: Does using ADDG for grafting the gap between the tooth shield and the implant fixture in immediate dental implantation with SST improve the clinical and radiographic outcomes in comparison to immediate implant placement with SST alone without using bone graft?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The present study included 50 participants, aged 20 to 45, with teeth that needed to be extracted. After Kafrelsheikh University research ethics committee approval, participants were randomized into 2 groups: the control group patients underwent immediate implantation using SS protocol, while the study group patients underwent the same procedure, but ADDG was created using the extracted palatal portion of the tooth; and then placed in the peri-implant gap defect. Clinically, pink aesthetic score (PES), midfacial mucosal alterations (MFMA), implant stability quotient (ISQ) were observed at baseline, six and twelve months after implantation. Moreover, baseline, 6- and 12-months alterations of radiographic horizontal bone dimension (HBD), buccal marginal bone level (BMBL), peri-implant Bone Density (PIBD) and peri-implant vertical bone defect (PIVBD) changes were assessed using cone beam computed tomography (CBCT).
| Arm | Type | Receives |
|---|---|---|
| Immediate Implant Placement Using Socket Shield Technique with autogenous demineralized dentin graft | Active comparator | Procedure: Elamrousy Novel Approach for Immediate Implant Placement Using Socket Shield Techniqueafter immediate implantation using Socket Shield Technique, the palatal root portion will be converted to autogenous demineralized dentin graft and used for grafting the defect between the socket shield and the implant fixture |
| Immediate Implant Placement Using Socket Shield Technique only without grafting the defect | Experimental | Procedure: Immediate Implant Placement Using Socket Shield Technique aloneafter insertion of immediate implant Using Socket Shield Technique, the bone defect between the socket shield and the implant fixture will be left ungrafted |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- above the age of 18years
- presence of non-restorable maxillary anterior tooth
- had intact socket walls following tooth extraction
- the gingival biotype was thick.
Key exclusion criteria (7 listed)
- history of systemic condition
- history of using bisphosphonates or other drugs that might impact bone turnover
- a history of smoking during the previous five years,
- a history of any acute infections at the surgical site,
- teeth having root resorptions
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 |
|---|---|---|
| Elamrousy Novel Approach for Immediate Implant Placement Using Socket Shield TechniqueAlso: Immediate Implant Placement Using Socket Shield Technique grafted by autogenous demineralized dentin graftThe flapless strategy was used. To prepare the SS, tooth decoronation followed by root splitting mesio-distally. The palatally splitted portion of the root is atraumatically extracted while the intact buccal root portion is kept in place with thickness of 1.5mm.(12) The implant fixture is then placed palatally with 2mm gap distance in between. finally, that gap was grafted with ADDG | Procedure or surgery | Immediate Implant Placement Using Socket Shield Technique with autogenous demineralized dentin graft |
| Immediate Implant Placement Using Socket Shield Technique aloneThe flapless strategy was used. To prepare the SS, tooth decoronation followed by root splitting mesio-distally. The palatally splitted portion of the root is atraumatically extracted while the intact buccal root portion is kept in place with thickness of 1.5mm.(12) The implant fixture is then placed palatally with 2mm gap distance in between. finally, that gap was left without grafts. | Procedure or surgery | Immediate Implant Placement Using Socket Shield Technique only without grafting the defect |
Primary outcome
crestal bone thickness
Time frame: 36-month.
Utilizing CBCT sagittal sections, the crestal bone thickness was evaluated by computerized analysis. Navigation was done on the multiplanar display until the implant's precise same-view location was established on the reformatted cross-sectional section and panoramic view.
4 secondary outcomes
buccal marginal bone level (BMBL)
Time frame: 36-months
Midfacial Mucosal Alterations
Time frame: 36-months
PES
Time frame: 36-months
Implant Stability Quotient (ISQ)
Time frame: 36-months
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 3 Sep 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. This study is not recruiting at the moment.
Walid AH Elamrousy, PhD principal investigator
Faculty of Oral and Dental Medicine, Kafrelsheikh University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elamrousy Novel Approach for Immediate Implant Placement Using Socket Shield Technique and Immediate Implant Placement Using Socket Shield Technique alone in people with Implant Site Reaction and Tooth Extraction Status Nos, run by Kafrelsheikh 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 7 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 3 Sep 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?
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?
crestal bone thickness (time frame: 36-month.). 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 3 Sep 2026.