Immediate Implant Placement Utilizing Vestibular Flap Versus Single Flap Approach With Bone Graft

Misr International University

Status: Begins enrollment in 3 months

Conditions: Immediate Implant Placement

Treatments: Procedure: Vestibular Flap Group; Procedure: Single Flap Approach group

Study type: Interventional

Funder types: Other

Identifiers

NCT06207565

IDCE.N6

Details and patient eligibility

About

Due to the evolution of esthetic implant dentistry and tissue regeneration (hard and soft tissue), flap design plays a crucial role in the maintenance and regeneration of the marginal soft tissue and interdental papillae around dental implants. The present study aims to compare soft and hard tissue changes following immediate implant placement with ridge augmentation using the vestibular flap versus single flap approach.

Full description

Achieving and maintaining optimal esthetics around maxillary anterior single implants is a demanding task. Despite the high success rates achieved with osseointegrated implants, inevitable loss of soft and hard tissue following tooth extraction often results in compromised vertical and horizontal dimensions of the peri-implant soft tissue in terms of esthetics. Various surgical techniques have been advocated to overcome the expected alveolar ridge dimensional changes in immediate implant placement, including the use of connective tissue grafts, bone grafts, flapless implant placement protocol and the different flap designs .

Different flap designs available include vestibular incision, papilla sparing, envelope, triangular, and trapezoidal. Selection of the ideal flap design is case dependent, and is based on several factors such as, smile line, gingival biotype, width of the edentulous area, and the proposed treatment plan. It has also been reported that flapless implant placement is a predictable procedure with a high success rate and less patient discomfort, minimizing the overall procedure time, postoperative pain, and inflammation. However, flapless surgery has been regarded as a technique with limitations regarding bone augmentation.

Therefore, cases with labial bone defects during immediate implant placement require flap mobilization to achieve the needed coverage for ridge augmentation, despite of the proposed drawbacks to flap reflection, such as the increased postoperative sequelae, recovery time, and reduced blood supply after flap adaptation. A single flap approach, a modified form of the envelope flap, has been suggested as an alternative to allow for ridge augmentation in esthetic immediate implant cases with labial bone defects. Whereas the vestibular incision, one horizontal full-thickness incision in the vestibule is considered a minimally invasive aesthetic ridge augmentation technique away from the gingival margin and sulcus, intending to maintain the volume and contour of the supra crestal soft tissue.

Enrollment: 34 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients who have one non-restorable maxillary anterior (Canine to Canine region) with sound adjacent teeth.
• Intact thick biotype gingival tissue with at least 2mm band of keratinized tissue.
• Buccal bone thickness less than 1mm assessed in CBCT with good apical bone for implant primary stability.
• Good oral hygiene
• Patient accepts to provide an informed consent.

Exclusion criteria

• Smokers
• Pregnant and lactating females.
• Medically compromised patients.
• Patients with active infection related at the site of implant/bone graft placement.
• Patients with untreated active periodontal diseases.
• Patients with parafunctional habits.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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34 participants in 2 patient groups

Vestibular Flap Group

Experimental group

Description:

Vestibular Flap with immediate implant placement, bone graft and customized healing abutment.

Treatment:

Procedure: Vestibular Flap Group

Single Flap Approach group

Active Comparator group

Description:

Single Flap approach with immediate implant placement, bone graft and customized healing abutment.

Treatment:

Procedure: Single Flap Approach group