About this trial
The goal of this clinical trial is to learn if vertical position of the dental implant will affect the bone around the implant in place of a missing tooth that happens to be bounded by two natural teeth. It will also measure esthetics and patient satisfaction. The main questions it aims to answer are:
Does vertical implant position below the crest of the bone lead to less marginal bone loss? Will it affect implant survival as well as quality of soft tissue, esthetics and patient satisfaction?
Participants will:
Have an implant placed at the bone level or 2 mm below the bone level Visit the clinic once every 3 months for checkups, radiographs, and readings
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with single missing upper anterior or premolar teeth
Patients with minimum buccolingual width of 6 mm and mesiodistal width of 6 mm
Patients with thin soft tissue phenotype
Patients with healthy systemic conditions.
Disqualifiers
Patients with inadequate bone volume and/ or quality
Patients with local root remnants
Patients with inadequate wound healing
Patients with signs of acute infection related to the area of interest.
Trial design
Parallel
Treatments tested in this trial
Delayed implant with immediate temporization placed 2 mm subcrestal level
Procedure/Surgery2 mm subcrestal placement
Delayed implant with immediate temporization placed at the crestal level
Procedure/Surgerycrestal level placement
Treatment groups
Trial outcomes
Primary outcomes
Marginal bone loss (crestal bone loss)
measured linearly in mm by comparing periapical radiographs
Secondary outcomes
Midfacial recession
Corono-apical distance measured from the incisal edge/cusp tip to the peri-implant soft tissue margin
Pink Esthetic Score (PES)
The pink esthetic score will be calculated on the parameters defined by (Fürhauser et al. 2005). Clinical photographs will be taken to evaluate peri-implant soft tissue through evaluating seven variables compared to a natural reference tooth including: mesial papilla, distal papilla, soft tissue level, soft tissue contour, alveolar process deficiency, soft tissue color and soft tissue texture, all using a 0-1-2 scoring system, 0 being the lowest and 2 the highest value. The maximum achievable PES is 14.
Gingival thickness
Gingival thickness will be measured using an anesthetic needle with a rubber stopper, trans-gingivally piercing tissues horizontally perpendicular to the long axis of the tooth/implant until the needle contacts bone, at 3 different points. Three readings will be taken mid-buccally at three different levels; 2 mm, 4 mm and 6 mm apical to the gingival margin. The length of the part of the instrument that penetrates into the soft tissue is measured in mm using a caliper.
Implant survival
A binary outcome, the definition of implant success was based on the clinical and radiographic criteria described by Buser et al. 1990; 1) absence of clinically detectable implant mobility; 2) absence of pain or any subjective sensation; 3) absence of recurrent peri-implant infection; and 4) absence of persistent radiolucency around the implant after 12 months of loading (Buser, Weber and Lang, 1990)
Sponsors and contacts
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