Implant Placement in Maxillary Esthetic ZoneBenexNCT07374627
Vertical Root Extraction for Immediate Implant
A study testing vertical extraction and Conventional exctraction in people with Implant Placement in Maxillary Esthetic Zone and Immediate Dental Implant Loading, run by Cairo University at 1 site in Egypt.
Trial summary
Immediate implant placement in the esthetic zone has become a preferred treatment modality due to its potential to shorten treatment duration, reduce surgical interventions, and preserve the natural contour of peri-implant tissues (Chen \& Buser, 2009; Lang et al., 2012). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Implant Placement in Maxillary Esthetic Zone, Immediate Dental Implant Loading
- What is being tested?
- vertical extraction and Conventional exctraction
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2026to 30 Apr 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- dults aged 18 to 55 years. Classified as ASA I-II (healthy or mild systemic condition, fit for surgery). The presence of a single hopeless maxillary anterior tooth (incisor or canine) indicated for extraction.
- Adequate palatal and apical bone volume to achieve primary stability for immediate implant placement.
- Patients are able and willing to provide informed consent and comply with study visits.
Who cannot join
- Smokers consuming more than 10 cigarettes per day. Pregnant or lactating women. Patients with systemic contraindications to surgery (e.g., chemotherapy, radiotherapy, bisphosphonate therapy).
- Patients with untreated periodontal disease. Presence of active local infection at the surgical site.
- -
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
Cairo University
Cairo, 11865
Mihad Ibrahim, M.Sc, 00201008551124, mihad.ibrahim@dentistry.cu.edu.eg
About this study
Official title: Vertical Root Extraction for Immediate Implant Placement : A Prospective Clinical And Radiographic Single Arm Study.
Immediate implant placement in the esthetic zone has become a preferred treatment modality due to its potential to shorten treatment duration, reduce surgical interventions, and preserve the natural contour of peri-implant tissues (Chen \& Buser, 2009; Lang et al., 2012). Despite these advantages, the technique remains surgically demanding, especially in the anterior maxilla, where the labial plate is often thin and highly susceptible to post-extraction resorption (Spray et al., 2000; Chappuis et al., 2017).
The greatest dimensional changes in alveolar ridge volume occur within the first 8-12 weeks after tooth extraction, with reductions in both height and width of the buccal bone crest (Araújo \& Lindhe, 2005; Tan et al., 2012). This remodeling compromises mucogingival architecture, often leading to mid-facial soft tissue recession and esthetic failures. Conventional extraction methods, which apply rotational or lateral forces using elevators and forceps, risk fracturing the socket walls and accelerating bone loss (Araujo \& Lindhe, 2009; Oghli \& Steveling, 2010).
Read more
The introduction of atraumatic extraction systems aimed to address this challenge. The Benex vertical extraction system operates by inserting a screw into the root canal and applying controlled vertical traction. This approach minimizes lateral stress on socket walls, theoretically preserving the thin labial plate, which is critical for esthetic success (Muska et al., 2013; Canellas et al., 2021). Vertical traction avoids socket expansion and microfractures, enabling safer immediate implant placement in compromised situations.
Case reports and retrospective series have demonstrated encouraging clinical results with Benex, including intact labial plates on CBCT, high implant survival, and favorable Pink Esthetic Scores (Fürhauser et al., 2005; Canellas et al., 2021). Patients also report reduced discomfort and trauma perception, suggesting potential psychosocial benefits. However, most of the current evidence is based on small-scale case series (Blus \& Szmukler-Moncler, 2010; Singla \& Sharma, 2020), and randomized controlled trials comparing Benex-assisted extraction with conventional atraumatic extraction are lacking.
A robust RCT evaluating both objective esthetic outcomes (Midfacial mucosal recession, PES, CBCT bone preservation) and subjective patient-reported outcomes (PROMs) is therefore essential to validate the clinical value of the Benex system in the esthetic zone.
Read the detailed description
The esthetic zone poses unique challenges for immediate implant placement due to the delicate nature of the labial bone. Several systematic reviews have shown that the thickness of the facial bone strongly influences marginal bone loss and soft tissue stability (Spray et al., 2000; Chappuis et al., 2017). Thin buccal plates (<1 mm) are particularly prone to resorption, with poor prognosis for soft tissue esthetics if damaged during extraction.
Ridge alterations after extraction. Araújo \& Lindhe (2005) in an experimental model, and Tan et al. (2012) in humans, confirmed substantial horizontal and vertical resorption within weeks of extraction, with the labial wall showing the greatest reduction. Botticelli et al. (2004) and Iasella et al. (2003) demonstrated that ridge preservation measures reduce, but do not eliminate, resorption.
Atraumatic extraction techniques. Conventional methods using forceps and elevators often damage interproximal and buccal bone (Araujo \& Lindhe, 2009). To counter this, atraumatic extraction devices were developed, such as periotomes (Sharma et al., 2015), piezosurgery (Blus \& Szmukler-Moncler, 2010), and vertical extraction systems like Benex, Physics Forceps, and Sapian kits (Muska et al., 2013; Jain \& Sridevi, 2016). These techniques reduce trauma and facilitate immediate implant placement, though operator skill and case selection remain crucial.
Benex system evidence. Muska et al. (2013) provided proof-of-principle for vertical extraction, showing intact socket walls and reduced risk of root fracture compared to forceps. Case series using Benex reported intact labial plates and favorable implant outcomes, but highlighted limitations in multirooted teeth and endodontically treated roots (Hong et al., 2018). Canellas et al. (2021) systematically reviewed atraumatic extractions, concluding that while vertical extraction devices appear promising, evidence is limited and heterogeneous.
Pink Esthetic Score (PES). Introduced by Fürhauser et al. (2005), the PES provides a standardized evaluation of peri-implant esthetics, including papillae, soft tissue level, contour, and color. PES has become the benchmark for clinical trials assessing esthetic outcomes of immediate implant protocols. High PES scores are closely linked to intact labial plates and preserved soft tissue contours (Chappuis et al., 2017).
Recent clinical trials. Ghallab et al. (2022) conducted a randomized controlled trial comparing vestibular and incisal extraction techniques within a vestibular socket therapy protocol. The vestibular approach demonstrated superior soft tissue stability and higher PES compared to incisal extraction. This supports the hypothesis that the extraction method critically determines esthetic outcomes. However, RCTs specifically testing vertical extraction systems like Benex are absent.
Knowledge gap. Current evidence suggests that vertical extraction systems may preserve bone and soft tissue better than conventional atraumatic methods. Yet, without randomized trials, their true clinical value remains uncertain. This trial aims to fill that gap by systematically evaluating Benex-assisted extraction versus conventional atraumatic extraction, focusing on both radiographic and patient-reported outcomes at 6 months.
- Being tested
- vertical extraction, Conventional exctraction
- Keywords
- Dental Implant, root extraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vertical extractionProcedure or surgery
Participants in this arm will undergo flapless vertical root extraction using the Benex system, followed immediately by implant placement with a standardized guided surgical protocol. The Benex system applies controlled vertical traction through a screw anchored in the root canal, minimizing lateral forces and reducing trauma to the socket walls. All patients will receive the same implant system, grafting material if indicated, provisional restoration, and final prosthesis according to the study protocol.
Conventional exctractionProcedure or surgery
Tooth extraction is one of the most common procedures in dentistry, forming a cornerstone of both general dental practice and surgical specialties such as oral surgery and periodontology. Traditional extraction methods often involved the use of elevators and forceps to apply significant lateral and rotational forces, which could traumatize the alveolar bone and soft tissues. Over the past few decades, with the rise of implant dentistry and the need to preserve bone for future prosthetic rehabilitation, clinicians have shifted towards atraumatic extraction techniques. These methods aim to remove teeth while minimizing damage to surrounding hard and soft tissues, particularly the delicate alveolar socket walls.
| Study group | Role | What they receive |
|---|---|---|
| Benex | Experimental | Participants in this arm will undergo flapless vertical root extraction using the Benex system, followed immediately by implant placement with a standardized guided surgical protocol. The Benex system applies controlled vertical traction through a screw anchored in the root canal, minimizing lateral forces and reducing trauma to the socket walls. All patients will receive the same implant system, grafting material if indicated, provisional restoration, and final prosthesis according to the study protocol. Receives: Procedure: vertical extraction |
| Control | Active comparator | Participants in this arm will undergo atraumatic incisal extraction using periotomes and forceps, followed immediately by implant placement with the same implant system and surgical protocol as the test group. This represents the current conventional method of atraumatic extraction. All subsequent implant placement, grafting (if needed), provisionalization, and final restoration steps will be standardized and identical to the test group. Receives: Procedure: Conventional exctraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mid facial recession
The vertical change in the soft tissue margin at the mid-facial aspect of the implant crown compared to baseline (immediately after provisionalization). This will be measured in millimeters using standardized calibrated intraoral photographs. Positive values indicate soft tissue recession, and negative values indicate coronal migration.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start1 Feb 2026 (estimated)
- Primary completion15 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant Placement in Maxillary Esthetic ZoneStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- This study is designed as a prospective, randomized, two-arm, parallel assignment clinical trial with a 1:1 allocation ratio. Eligible participants with a single hopeless maxillary anterior tooth indicated for extraction will be randomly assigned to one of two groups: Test Group (Benex Vertical Extraction): Patients will undergo flapless vertical root extraction using the Benex system, followed immediately by implant placement using a standardized guided protocol. Control Group (Conventional Atraumatic Extraction): Patients will undergo atraumatic incisal extraction with periotomes and forceps, followed immediately by implant placement using the same implant system and surgical protocol. Both groups will follow identical implant placement, grafting (if needed), provisionalization, and restoration procedures. The only variable between the groups is the extraction technique. Randomization will be computer-generated and concealed in sealed opaque envelopes. Surgeons cannot be blinded due
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mihad Ibrahim, Cairo University
- Investigators
- Mahmoud Shalash, Study director, National Research Centre, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07374627
- Sponsor's protocol ID
- 25-056
- Acronym
- Benex
- Status last verified
- Jan 2026
- First submitted
- 21 Jan 2026
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vertical Root Extraction for Immediate Implant Placement : A Prospective Clinical And Radiographic Single Arm Study.
- ClinicalTrials.gov ID
- NCT07374627
- Acronym / sponsor ID
- Benex / 25-056
- Keywords
- Dental Implant, root extraction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 15 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 29 Jan 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.
Immediate implant placement in the esthetic zone has become a preferred treatment modality due to its potential to shorten treatment duration, reduce surgical interventions, and preserve the natural contour of peri-implant tissues (Chen \& Buser, 2009; Lang et al., 2012). Despite these advantages, the technique remains surgically demanding, especially in the anterior maxilla, where the labial plate is often thin and highly susceptible to post-extraction resorption (Spray et al., 2000; Chappuis et al., 2017).
The greatest dimensional changes in alveolar ridge volume occur within the first 8-12 weeks after tooth extraction, with reductions in both height and width of the buccal bone crest (Araújo \& Lindhe, 2005; Tan et al., 2012). This remodeling compromises mucogingival architecture, often leading to mid-facial soft tissue recession and esthetic failures. Conventional extraction methods, which apply rotational or lateral forces using elevators and forceps, risk fracturing the socket walls and accelerating bone loss (Araujo \& Lindhe, 2009; Oghli \& Steveling, 2010).
The introduction of atraumatic extraction systems aimed to address this challenge. The Benex vertical extraction system operates by inserting a screw into the root canal and applying controlled vertical traction. This approach minimizes lateral stress on socket walls, theoretically preserving the thin labial plate, which is critical for esthetic success (Muska et al., 2013; Canellas et al., 2021). Vertical traction avoids socket expansion and microfractures, enabling safer immediate implant placement in compromised situations.
Case reports and retrospective series have demonstrated encouraging clinical results with Benex, including intact labial plates on CBCT, high implant survival, and favorable Pink Esthetic Scores (Fürhauser et al., 2005; Canellas et al., 2021). Patients also report reduced discomfort and trauma perception, suggesting potential psychosocial benefits. However, most of the current evidence is based on small-scale case series (Blus \& Szmukler-Moncler, 2010; Singla \& Sharma, 2020), and randomized controlled trials comparing Benex-assisted extraction with conventional atraumatic extraction are lacking.
A robust RCT evaluating both objective esthetic outcomes (Midfacial mucosal recession, PES, CBCT bone preservation) and subjective patient-reported outcomes (PROMs) is therefore essential to validate the clinical value of the Benex system in the esthetic zone.
Detailed description
The esthetic zone poses unique challenges for immediate implant placement due to the delicate nature of the labial bone. Several systematic reviews have shown that the thickness of the facial bone strongly influences marginal bone loss and soft tissue stability (Spray et al., 2000; Chappuis et al., 2017). Thin buccal plates (<1 mm) are particularly prone to resorption, with poor prognosis for soft tissue esthetics if damaged during extraction.
Ridge alterations after extraction. Araújo \& Lindhe (2005) in an experimental model, and Tan et al. (2012) in humans, confirmed substantial horizontal and vertical resorption within weeks of extraction, with the labial wall showing the greatest reduction. Botticelli et al. (2004) and Iasella et al. (2003) demonstrated that ridge preservation measures reduce, but do not eliminate, resorption.
Atraumatic extraction techniques. Conventional methods using forceps and elevators often damage interproximal and buccal bone (Araujo \& Lindhe, 2009). To counter this, atraumatic extraction devices were developed, such as periotomes (Sharma et al., 2015), piezosurgery (Blus \& Szmukler-Moncler, 2010), and vertical extraction systems like Benex, Physics Forceps, and Sapian kits (Muska et al., 2013; Jain \& Sridevi, 2016). These techniques reduce trauma and facilitate immediate implant placement, though operator skill and case selection remain crucial.
Benex system evidence. Muska et al. (2013) provided proof-of-principle for vertical extraction, showing intact socket walls and reduced risk of root fracture compared to forceps. Case series using Benex reported intact labial plates and favorable implant outcomes, but highlighted limitations in multirooted teeth and endodontically treated roots (Hong et al., 2018). Canellas et al. (2021) systematically reviewed atraumatic extractions, concluding that while vertical extraction devices appear promising, evidence is limited and heterogeneous.
Pink Esthetic Score (PES). Introduced by Fürhauser et al. (2005), the PES provides a standardized evaluation of peri-implant esthetics, including papillae, soft tissue level, contour, and color. PES has become the benchmark for clinical trials assessing esthetic outcomes of immediate implant protocols. High PES scores are closely linked to intact labial plates and preserved soft tissue contours (Chappuis et al., 2017).
Recent clinical trials. Ghallab et al. (2022) conducted a randomized controlled trial comparing vestibular and incisal extraction techniques within a vestibular socket therapy protocol. The vestibular approach demonstrated superior soft tissue stability and higher PES compared to incisal extraction. This supports the hypothesis that the extraction method critically determines esthetic outcomes. However, RCTs specifically testing vertical extraction systems like Benex are absent.
Knowledge gap. Current evidence suggests that vertical extraction systems may preserve bone and soft tissue better than conventional atraumatic methods. Yet, without randomized trials, their true clinical value remains uncertain. This trial aims to fill that gap by systematically evaluating Benex-assisted extraction versus conventional atraumatic extraction, focusing on both radiographic and patient-reported outcomes at 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is designed as a prospective, randomized, two-arm, parallel assignment clinical trial with a 1:1 allocation ratio. Eligible participants with a single hopeless maxillary anterior tooth indicated for extraction will be randomly assigned to one of two groups: Test Group (Benex Vertical Extraction): Patients will undergo flapless vertical root extraction using the Benex system, followed immediately by implant placement using a standardized guided protocol. Control Group (Conventional Atraumatic Extraction): Patients will undergo atraumatic incisal extraction with periotomes and forceps, followed immediately by implant placement using the same implant system and surgical protocol. Both groups will follow identical implant placement, grafting (if needed), provisionalization, and restoration procedures. The only variable between the groups is the extraction technique. Randomization will be computer-generated and concealed in sealed opaque envelopes. Surgeons cannot be blinded due
| Arm | Type | Receives |
|---|---|---|
| Benex | Experimental | Procedure: vertical extractionParticipants in this arm will undergo flapless vertical root extraction using the Benex system, followed immediately by implant placement with a standardized guided surgical protocol. The Benex system applies controlled vertical traction through a screw anchored in the root canal, minimizing lateral forces and reducing trauma to the socket walls. All patients will receive the same implant system, grafting material if indicated, provisional restoration, and final prosthesis according to the study protocol. |
| Control | Active comparator | Procedure: Conventional exctractionParticipants in this arm will undergo atraumatic incisal extraction using periotomes and forceps, followed immediately by implant placement with the same implant system and surgical protocol as the test group. This represents the current conventional method of atraumatic extraction. All subsequent implant placement, grafting (if needed), provisionalization, and final restoration steps will be standardized and identical to the test group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- dults aged 18 to 55 years. Classified as ASA I-II (healthy or mild systemic condition, fit for surgery). The presence of a single hopeless maxillary anterior tooth (incisor or canine) indicated for extraction.
- Adequate palatal and apical bone volume to achieve primary stability for immediate implant placement.
- Patients are able and willing to provide informed consent and comply with study visits.
Key exclusion criteria (3 listed)
- Smokers consuming more than 10 cigarettes per day. Pregnant or lactating women. Patients with systemic contraindications to surgery (e.g., chemotherapy, radiotherapy, bisphosphonate therapy).
- Patients with untreated periodontal disease. Presence of active local infection at the surgical site.
- -
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 |
|---|---|---|
| vertical extractionParticipants in this arm will undergo flapless vertical root extraction using the Benex system, followed immediately by implant placement with a standardized guided surgical protocol. The Benex system applies controlled vertical traction through a screw anchored in the root canal, minimizing lateral forces and reducing trauma to the socket walls. All patients will receive the same implant system, grafting material if indicated, provisional restoration, and final prosthesis according to the study protocol. | Procedure or surgery | Benex |
| Conventional exctractionTooth extraction is one of the most common procedures in dentistry, forming a cornerstone of both general dental practice and surgical specialties such as oral surgery and periodontology. Traditional extraction methods often involved the use of elevators and forceps to apply significant lateral and rotational forces, which could traumatize the alveolar bone and soft tissues. Over the past few decades, with the rise of implant dentistry and the need to preserve bone for future prosthetic rehabilitation, clinicians have shifted towards atraumatic extraction techniques. These methods aim to remove teeth while minimizing damage to surrounding hard and soft tissues, particularly the delicate alveolar socket walls. | Procedure or surgery | Control |
Primary outcome
Mid facial recession
Time frame: 6 months
The vertical change in the soft tissue margin at the mid-facial aspect of the implant crown compared to baseline (immediately after provisionalization). This will be measured in millimeters using standardized calibrated intraoral photographs. Positive values indicate soft tissue recession, and negative values indicate coronal migration.
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 29 Jan 2026.
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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.
Mahmoud Shalash study director
National Research Centre, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vertical extraction and Conventional exctraction in people with Implant Placement in Maxillary Esthetic Zone and Immediate Dental Implant Loading, run by Cairo 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 3 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 29 Jan 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 Mihas Ibrahim, M.Sc (00201008551124, mihad.ibrahim@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mid facial recession (time frame: 6 months). 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 29 Jan 2026.