Implant ComplicationNCT06263842
Elamrousy's Novel Approach to Socket Shield Technique
A study testing modified Elamrousy approach for socket shield technique, conventional socket shield and combined socket shild with xenograft in people with Implant Complication, 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 whole tooth graft (AWTG) with socket shield approach (SSA) and compared this approach to socket shield technique with… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Implant Complication
- What is being tested?
- modified Elamrousy approach for socket shield technique, conventional socket shield and combined socket shild with xenograft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Feb 2024to 19 Mar 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 45 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 sufficient bone volume and
- The primary stability at insertion not less than 35 N
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
Show all 14Show fewer
- , the presence of any systemic diseases;
- intake of drugs that may alter bone metabolism
- presence of acute infection
- infra-bony horizontal tooth fracture
- facial vertical root fracture;
- root resorption; mobile teeth
- malaligned teeth,
- active periodontitis at the implantation site.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Peri-implant Clinical and Radiographic Alterations Following Immediately Placed, Immediately Loaded Dental Implants Using Socket Shield Approach With Autogenous Whole Tooth Graft Versus Xenograft: Randomized Clinical Tial
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 whole tooth graft (AWTG) with socket shield approach (SSA) and compared this approach to socket shield technique with xenograft.
The present study included 63 patients, aged 20 to 45, with teeth that needed to be extracted. After Kafrelsheikh University research ethics committee approval, patients were randomized into 3 groups: group I patients underwent immediate implantation using socket shield protocol, while group II patients underwent the same procedure, but the shield/fixture jumping gap was grafted by xenograft. finally group III was grafted by AWTG that was created using the decoronated crown and the extracted palatal portion of the tooth; and then placed in the peri-implant gap defect.
Read the detailed description
It has been demonstrated that utilizing dental implants to replace lost teeth is a predictable clinical choice. Promising outcomes of immediate implant insertion in conjunction with immediate loading/provisionalization (Type 1A implant protocol according to Gallucci et al has been reported to provide major benefits in terms of better esthetic and psychosocial impacts, shorter treatment duration, minimal surgical interventions and preservation of peri-implant bone and soft tissue.
However, because of technically sensitive and sophisticated surgery required for Type 1A protocol, high risk of early implant failure was noticed particularly in conditions that might complicate that protocol as deficient facial bone plate, soft tissues deficiencies and thin gingival phenotype. Furthermore, those conditions also were found to be responsible for midfacial mucosal recession (MFMR), papillary recession and resorption of facial plate that deteriorates the clinical, radiological, and esthetic outcomes of Type 1A protocol. Consequently, alternate approaches would be suggested to improve the clinical and esthetic concerns associated with immediate implantation and loading such as buccal gap grafting, guided bone regeneration and socket shield approach.
In order to maintain the facial bone plate for prompt Type 1A protocol in esthetic zone, the SSA has been developed by Hürzeler et al. in 2010 as a potential therapeutic approach through maintaining the facial portion of the root and thus preserving the periodontal ligament and its vascularity that nourishes the tooth's bundle bone. The FSS functions as a natural barrier that prevents buccal bone resorption and enhances tissue contouring, both of which contribute to the achievement of predictable esthetic outcomes. Additionally, the FSS serves as a guide to ensure the implant is positioned correctly. SSA in conjunction with immediate loading reduces the frequency of clinical sessions and reduces the necessity for both soft and hard tissue grafts.
It has been recommended to palatally insert the implants in extraction sockets with at least 2 mm jumping gap between the fixture and the FSS. Significantly, this gap denotes the future buccal bone that will directly contribute to the buccal contour and impact the soft tissue levels. For jumping gaps smaller than 2 mm, bone heals spontaneously, while gaps bigger than 2 mm are advised to be augmented.
AWTG is obviously very advantageous as it exhibits superior osteoconductive and osteoinductive capacity with high biocompatibility and comparable physico-chemical characteristics to autogenous bones. AWTG was successfully employed for augmenting of peri-implant bone defects, with excellent clinical and radiographic outcomes. Similarly, both AWTG and autogenous demineralized dentin graft were equally effective at reducing dimensional losses in alveolar ridge preservation. The production of demineralized dentin is time-consuming, cost-intensive and complicated, which restricts its widespread use in clinics.
In the light of this, the current study was conducted to assess and compare the effectiveness of AWTG versus xenograft for augmenting the FSS/fixture jumping gap around immediately placed implants using SSA with immediate temporization in the maxillary esthetic zone.
To the best of our knowledge, this study is the first to use AWTG for filling the peri-implant jumping gap following SSA and highlight its impact on peri-implant soft and hard tissue parameters compared to xenograft.
- Conditions
- Implant Complication
- Being tested
- modified Elamrousy approach for socket shield technique, conventional socket shield, combined socket shild with xenograft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified Elamrousy approach for socket shield techniqueProcedure or surgery
the jumping gap will be filled with AWTG
conventional socket shieldProcedure or surgery
the jumping gap will be left ungrafted
combined socket shild with xenograftProcedure or surgery
the jumping gap will be filled with xenograft
| Study group | Role | What they receive |
|---|---|---|
| Immediate Implant Placement Using Socket Shield Technique alone | 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: conventional socket shield |
| Immediate Implant Placement Using Socket Shield Technique with xenograft | Experimental | the shield/fixture jumping gap will be grafted with xenograft Receives: Procedure: combined socket shild with xenograft |
| Modified Elamrousy Approach for Immediate Implant Placement Using Socket Shield Technique | Experimental | Immediate Implant Placement Using Socket Shield Technique with autogenous whole tooth graft after immediate implantation using Socket Shield Technique, the palatal root portion and the decoronated crown will be converted to autogenous whole tooth graft and used for grafting the defect between the socket shield and the implant fixture Receives: Procedure: modified Elamrousy approach for socket shield technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stability Quotient of dental implant (SQDI)
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, investigators now know that high stability means >70 ISQ, between 60-69 is medium stability and < 60 ISQ is considered as low stability.
Measured: 24-month.
pink esthetic score (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: 24-month.
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: 24-month.
Secondary outcomes (1)
facial marginal bone level (FMBL)
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: 24-month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start14 Feb 2024
- Primary completion15 Mar 2026
- Study completion19 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant ComplicationStudies 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 63 participants, aged 20 to 45, with teeth that needed to be extracted. After Kafrelsheikh University research ethics committee approval, patients were randomized into 3 groups: group I patients underwent immediate implantation using SSA protocol without grafting, while group II was grafted by xenograft, but group II was grafted with AWTG was created using the decoronated crown and 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), stability quotient of dental implants (SQDI) were observed at baseline, six and twelve months after implantation. Moreover, baseline, 6- and 12-months alterations of radiographic horizontal buccolingual ridge width (HBLRW), facial marginal bone level (FMBL), peri-implant Density of bone (PIDB) and peri-implant vertical bone defect depth (PIVBDD) changes were assessed using cone beam computed tomography (CBCT).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 63 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
- NCT06263842
- Sponsor's protocol ID
- KFSIRB200-132
- Status last verified
- Mar 2026
- First submitted
- 7 Feb 2024
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri-implant Clinical and Radiographic Alterations Following Immediately Placed, Immediately Loaded Dental Implants Using Socket Shield Approach With Autogenous Whole Tooth Graft Versus Xenograft: Randomized Clinical Tial
- ClinicalTrials.gov ID
- NCT06263842
- Acronym / sponsor ID
- KFSIRB200-132
- Conditions
- Implant Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 14 Feb 2024 (actual)
- Primary completion
- 15 Mar 2026 (actual)
- Study completion
- 19 Mar 2026 (actual)
- First posted
- 16 Feb 2024 (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 whole tooth graft (AWTG) with socket shield approach (SSA) and compared this approach to socket shield technique with xenograft.
The present study included 63 patients, aged 20 to 45, with teeth that needed to be extracted. After Kafrelsheikh University research ethics committee approval, patients were randomized into 3 groups: group I patients underwent immediate implantation using socket shield protocol, while group II patients underwent the same procedure, but the shield/fixture jumping gap was grafted by xenograft. finally group III was grafted by AWTG that was created using the decoronated crown and the extracted palatal portion of the tooth; and then placed in the peri-implant gap defect.
Detailed description
It has been demonstrated that utilizing dental implants to replace lost teeth is a predictable clinical choice. Promising outcomes of immediate implant insertion in conjunction with immediate loading/provisionalization (Type 1A implant protocol according to Gallucci et al has been reported to provide major benefits in terms of better esthetic and psychosocial impacts, shorter treatment duration, minimal surgical interventions and preservation of peri-implant bone and soft tissue.
However, because of technically sensitive and sophisticated surgery required for Type 1A protocol, high risk of early implant failure was noticed particularly in conditions that might complicate that protocol as deficient facial bone plate, soft tissues deficiencies and thin gingival phenotype. Furthermore, those conditions also were found to be responsible for midfacial mucosal recession (MFMR), papillary recession and resorption of facial plate that deteriorates the clinical, radiological, and esthetic outcomes of Type 1A protocol. Consequently, alternate approaches would be suggested to improve the clinical and esthetic concerns associated with immediate implantation and loading such as buccal gap grafting, guided bone regeneration and socket shield approach.
In order to maintain the facial bone plate for prompt Type 1A protocol in esthetic zone, the SSA has been developed by Hürzeler et al. in 2010 as a potential therapeutic approach through maintaining the facial portion of the root and thus preserving the periodontal ligament and its vascularity that nourishes the tooth's bundle bone. The FSS functions as a natural barrier that prevents buccal bone resorption and enhances tissue contouring, both of which contribute to the achievement of predictable esthetic outcomes. Additionally, the FSS serves as a guide to ensure the implant is positioned correctly. SSA in conjunction with immediate loading reduces the frequency of clinical sessions and reduces the necessity for both soft and hard tissue grafts.
It has been recommended to palatally insert the implants in extraction sockets with at least 2 mm jumping gap between the fixture and the FSS. Significantly, this gap denotes the future buccal bone that will directly contribute to the buccal contour and impact the soft tissue levels. For jumping gaps smaller than 2 mm, bone heals spontaneously, while gaps bigger than 2 mm are advised to be augmented.
AWTG is obviously very advantageous as it exhibits superior osteoconductive and osteoinductive capacity with high biocompatibility and comparable physico-chemical characteristics to autogenous bones. AWTG was successfully employed for augmenting of peri-implant bone defects, with excellent clinical and radiographic outcomes. Similarly, both AWTG and autogenous demineralized dentin graft were equally effective at reducing dimensional losses in alveolar ridge preservation. The production of demineralized dentin is time-consuming, cost-intensive and complicated, which restricts its widespread use in clinics.
In the light of this, the current study was conducted to assess and compare the effectiveness of AWTG versus xenograft for augmenting the FSS/fixture jumping gap around immediately placed implants using SSA with immediate temporization in the maxillary esthetic zone.
To the best of our knowledge, this study is the first to use AWTG for filling the peri-implant jumping gap following SSA and highlight its impact on peri-implant soft and hard tissue parameters compared to xenograft.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- The present study included 63 participants, aged 20 to 45, with teeth that needed to be extracted. After Kafrelsheikh University research ethics committee approval, patients were randomized into 3 groups: group I patients underwent immediate implantation using SSA protocol without grafting, while group II was grafted by xenograft, but group II was grafted with AWTG was created using the decoronated crown and 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), stability quotient of dental implants (SQDI) were observed at baseline, six and twelve months after implantation. Moreover, baseline, 6- and 12-months alterations of radiographic horizontal buccolingual ridge width (HBLRW), facial marginal bone level (FMBL), peri-implant Density of bone (PIDB) and peri-implant vertical bone defect depth (PIVBDD) changes were assessed using cone beam computed tomography (CBCT).
| Arm | Type | Receives |
|---|---|---|
| Immediate Implant Placement Using Socket Shield Technique alone | Experimental | Procedure: conventional socket shieldafter insertion of immediate implant Using Socket Shield Technique, the bone defect between the socket shield and the implant fixture will be left ungrafted |
| Immediate Implant Placement Using Socket Shield Technique with xenograft | Experimental | Procedure: combined socket shild with xenograftthe shield/fixture jumping gap will be grafted with xenograft |
| Modified Elamrousy Approach for Immediate Implant Placement Using Socket Shield Technique | Experimental | Procedure: modified Elamrousy approach for socket shield techniqueImmediate Implant Placement Using Socket Shield Technique with autogenous whole tooth graft after immediate implantation using Socket Shield Technique, the palatal root portion and the decoronated crown will be converted to autogenous whole tooth graft and used for grafting the defect between the socket shield and the implant fixture |
Who may qualify
- Ages
- 18 to 45 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 sufficient bone volume and
- The primary stability at insertion not less than 35 N
Key exclusion criteria (14 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 |
|---|---|---|
| modified Elamrousy approach for socket shield techniquethe jumping gap will be filled with AWTG | Procedure or surgery | Modified Elamrousy Approach for Immediate Implant Placement Using Socket Shield Technique |
| conventional socket shieldthe jumping gap will be left ungrafted | Procedure or surgery | Immediate Implant Placement Using Socket Shield Technique alone |
| combined socket shild with xenograftthe jumping gap will be filled with xenograft | Procedure or surgery | Immediate Implant Placement Using Socket Shield Technique with xenograft |
Primary outcome
Stability Quotient of dental implant (SQDI)
Time frame: 24-month.
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, investigators now know that high stability means >70 ISQ, between 60-69 is medium stability and < 60 ISQ is considered as low stability.
pink esthetic score (PES)
Time frame: 24-month.
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
Midfacial Mucosal Alterations
Time frame: 24-month.
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
1 secondary outcome
facial marginal bone level (FMBL)
Time frame: 24-month.
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 2 Apr 2026.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers
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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 modified Elamrousy approach for socket shield technique, conventional socket shield and combined socket shild with xenograft in people with Implant Complication, 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 14 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 2 Apr 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?
Stability Quotient of dental implant (SQDI) (time frame: 24-month.). The study lists 3 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 2 Apr 2026.