About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Smokers
Pregnant and lactating females.
Medically compromised patients.
Patients with active infection related at the site of implant/bone graft placement.
Trial design
Parallel
Treatments tested in this trial
Vestibular Flap Group
Procedure/SurgeryAchieving the vestibular flap, a 1-cm long horizontal vestibular access incision using a 15c blade 3-4mm apical to the mucogingival junction of the hopeless tooth, exposing the alveolar bone. Flap dissection in a coronal direction to detach the periosteum is completed, forming a sub-periosteal tunnel.
Single Flap Approach group
Procedure/SurgeryA modified envelope flap originally reported as an access flap for single implant insertion in areas of esthetic relevance will be performed. A sulcular incision on the labial aspect extending at least one tooth mesial and distal to the implant site (permitting enough accessibility for bone augmentation) is done. The flap is reflected by performing a split-thickness flap elevation starting from the interproximal incisions, leaving the anatomical papillae in situ. While the full-thickness flap elevation is performed on the labial aspect of the included surgical area, starting at the sulcus, and reaching at least 3 mm apical to the bone crest.
Treatment groups
Trial outcomes
Primary outcomes
Volumetric analysis of labial contour
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
Two CBCT scans will be attained, primary (preoperative) scan (T0) and a secondary (Postoperative) scan 12 months after. In order to ensure standardization and reproducibility of the CBCT cross sectional images that will be used in this study, superimposition of DICOM sets of each patient using Fusion module of Ondemand 3D App software will be done (Koerich et al., 2016). This 3D superimposition technique allows for sub-voxel accuracy and highly strong registration. Both files will be loaded in the Fusion module at the same time, first manual registration will be done by approximation of the secondary scan to the primary one in axial, sagittal and coronal cuts, then automatic registration by the software. The labiopalatal width will be measured at 2 points; 2 mm apical to the crest of the palatal bone and 5mm apical to the 1st line
Mid facial recession
Will be measured in mm from the intraoral scans at T1, T2, T3 and compared to that of T0. The reference point will be the most apical part of the midfacial gingival level.
Interdental papillae height
Will be measured in mm from the intraoral scans at T1, T2, T3 and compared to that of T0. Mesial and distal papillae will be evaluated individually.
Locations
Sponsors and contacts
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