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Clinical Trials/NCT06207565
NCT06207565
Not Yet Recruiting
N/A

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

Misr International University0 sites34 target enrollmentSeptember 1, 2025

Overview

Phase
N/A
Intervention
Not specified
Conditions
Immediate Implant Placement
Sponsor
Misr International University
Enrollment
34
Primary Endpoint
Volumetric analysis of labial contour
Status
Not Yet Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2025
End Date
August 1, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ahmed Abo El Futtouh

Clinical director of implant speciality program

Misr International University

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

  • 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.

Outcomes

Primary Outcomes

Volumetric analysis of labial contour

Time Frame: 12 months

To evaluate tissue volume changes, Intra oral scans of the esthetic zone will be obtained. Changes in the soft tissue profile will be calculated as the difference between the digitized surface outline of the different profiles at the given time of maturation of the site. All the images recorded by the intra-oral scanner will be transmitted to a 3D viewer software (Exocad Gmbh) to assess and compare the linear and volumetric changes in the labial soft tissue contour in comparison to the original, at 2, 4 and 6 mm from the pre-operative gingival margin. All the scans will be superimposed to the pre-operative scan using 3-point alignment method that ensure standardization of the images.

Secondary Outcomes

  • Labio-palatal bone width(12 months)
  • Mid facial recession(12 months)
  • Interdental papillae height(12 months)

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