Clinical trial NCT06207565: Immediate Implant Placement Utilizing Vestibular Flap Versus Single Flap Approach With Bone Graft
Official title: Clinical and Radiographic Evaluation of Immediate Implant Placement Utilizing Vestibular Flap Versus Single Flap Approach With Bone Graft in Anterior Maxilla: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Immediate Implant Placement
Keywords: Immediate implant placement
Anterior Maxilla
Vestibular flap
single flap approach
Lead sponsor: Misr International University
Sponsor class: OTHER
First posted: 2024-01-17
Enrollment: 34
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Volumetric analysis of labial contour
timeFrame: 12 months
Secondary outcomes:
measure: Labio-palatal bone width
timeFrame: 12 months
measure: Mid facial recession
timeFrame: 12 months
measure: Interdental papillae height
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References: