About this trial
The present study aims to compare the dimensional stability of the supra-implant complex following flapless immediate implant placement using two socket management approaches: the connective tissue graft and the socket shield technique. Three-dimensional volumetric analysis and cone-beam computed tomography (CBCT) will be employed to assess and quantify changes in soft and hard tissue thickness and height surrounding the implant site.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Initial intact thick gingival biotype
2 mm band of keratinized tissue,
Thin intact labial bone plate (< 1mm)
Good apical bone for primary stability
Disqualifiers
Immediate implants with bone grafts or guided bone regeneration procedures
Uncontrolled diabetes mellitus
Patients taking IV bisphosphonates for treatment of osteoporosis
Patients with active infection related at the site of implant
Trial design
Parallel
Treatments tested in this trial
IIP+Socket Shield
Procedure/SurgeryThe socket shield technique, which preserves a labial root fragment to maintain periodontal ligament support.
IIP+CTG
Procedure/Surgeryconnective tissue grafting which increases soft-tissue volume
Treatment groups
Trial outcomes
Primary outcomes
Soft tissue Volume gain/loss
The volumetric analysis in this clinical trial will be performed to obtain profilometric measurements. intraoral scans will be taken at baseline, 6- and 12-month post-operative for each patient. The best-fit algorithm will be used to superimpose digital surface models, when comparing each area of interest (AOI) throughout out the follow up period. Unchanged neighboring teeth surfaces will be used as a reference for proper superimposition. In each patient, the AOI will be kept constant for all pairwise comparisons. The volumetric analysis software will calculate the overall buccal soft tissue volume loss/gain (mm3) within the AOI for each patient.
Secondary outcomes
Mid-facial gingival margin level
linear change of the Mid-facial gingival margin pre- and after one year
Sponsors and contacts
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