Vertical Root Extraction for Immediate Implant

NCT07374627 | Not Yet Recruiting

• 1 other identifier: 25-056
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Immediate Dental Implant Loading; Implant Placement in Maxillary Esthetic Zone

Keywords

Dental Implant; root extraction

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Study Arms (2)

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.

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.

Procedure: Conventional exctraction

Interventions

Conventional exctraction PROCEDURE

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.

Control

vertical extraction PROCEDURE

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.

Benex

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, 11865, Egypt

Location

Study Officials

• Mahmoud Shalash

  National Research Centre, Egypt

  STUDY DIRECTOR

Central Study Contacts

Mihas Ibrahim, M.Sc

CONTACT

00201008551124; mihad.ibrahim@dentistry.cu.edu.eg

Dalia Ghalwash, PhD

CONTACT

00201114333923; dalia.ghalwash@bue.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: 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

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: January 29, 2026
• Study Start: February 1, 2026
• Primary Completion: April 15, 2026
• Study Completion: April 30, 2026
• Last Updated: January 29, 2026

Record last verified: 2026-01

Locations

EG (1)