Alveolar Bone Loss Clinical Trial
Official title:
Influence Of Thickness Of the Peri-implant Soft Tissue On Marginal Bone Remodeling Around Bone Level Implant: A Multicenter Observational Clinical Study
The aim of this observational study is the evaluation of marginal bone remodeling after surgical implant placement, correlating the gingival thickness with the bone resorption rate.
The present study was designed as a multicenter prospective clinical trial. Five clinical
centers will treat patients through the placement of a single dental implant. The fixtures
will be prosthetic loaded three months after placement and will be acquired periapical
radiographs at each timepoint (base-two months-three-months-6 months-12 months). For every
inserted implants the experimental parameters will be collected for the following 2 years.
Surgical procedure. All patients will receive antibiotic prophylaxis with 2 g of amoxicillin
one hour before surgery. Crestal incision is performed under local anesthesia with articaine
4% with epinephrine, taking care to preserve the keratinized tissue. With the help of a
periosteal elevator, it will be set up carefully buccal flap total thickness, and the
vertical thickness of the soft tissue will be measured with a labeled probe every 1.0 mm. If
the vertical thickness of the soft tissue will be 2 mm or less, it will be considered thin.
If mucosal thickness will be greater than 2 mm, it will be considered thick. After
measurement, the lingual flap will be raised to full-thickness, and will be prepared the site
for implant placement. The implant site will be at least 1.5 mm from the tooth / teeth
adjacent, and must be surrounded by at least 1 mm of bone is buccal to lingual. With a
platform switching facility a millimeter will be placed below the level of the bone crest
with a one-stage approach as per the manufacturer's recommendations. After insertion, it will
be screwed a healing abutment, and the flaps will be sutured without tension with interrupted
sutures 4/0. Patients of both groups will be instructed to disinfect the site through a rinse
twice a day for a week for 1 minute with 0.12% chlorhexidine digluconate. Patients will be
advised to avoid chewing on the operated site and cleaning the healing abutments with an
ultra soft toothbrush. After 2 months of healing, it will be evaluated clinical stability and
the radiographic appearance of the plants. All plants will be rehabilitated by the
prosthetist with single screwed restorations. After the prosthetic treatment, patients will
receive oral hygiene instruction and will be monitored through calls to ensure periodontal
health (Bleeding on Probing <20% and Plaque Index <25%) throughout the study period.
Radiographic evaluation Intraoral radiographs will be captured in high-resolution mode with a
film, customized support from a jig polyvinylsiloxane, using the technique of parallel rays.
Intraoral radiographs will be acquired after implant placement (baseline-assessment of
inclusion fairness), after 2 months of healing (osseointegration rating), after insertion of
the crown (3 months-adaptation assessment of the restoration prosthetic), after 6 months
(early loading of evaluation) and after a year of recovery (of the medium-term load rating).
The number of intraoral radiographs will be the same which normally is carried out in the
course of an implant-prosthetic rehabilitation. The images will be obtained in such a way
that the implant-abutment interface is clearly visible. Measurements of bone level will be
performed by a blinded central reader using a dedicated program at 20 times magnification.
Before the calculation of the crestal bone changes, the RVG images will be calibrated with
the implant diameter. bone loss will be calculated by comparing the radiographs at baseline
with the radiographs obtained during follow-up visits. The system board and the first contact
radiographic bone-implant will be selected as reference points to calculate bone loss. The
average of the mesial and distal measurements will be recorded for each implant.
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