About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
vertical extraction
Procedure/SurgeryParticipants 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 exctraction
Procedure/SurgeryTooth 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: