Clinical Trial: Influence of Thickness of the Peri-implant Soft Tissue on Marginal Bone Remodeling

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Influence Of Thickness Of the Peri-implant Soft Tissue On Marginal Bone Remodeling Around Bone Level Implant: A Multicenter Observational Clinical Study

Brief Summary: 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.

Detailed Summary:

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
Sponsor: International Piezosurgery Academy

Current Primary Outcome: peri-implant bone resorption [ Time Frame: from baseline to twelve months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: International Piezosurgery Academy

Dates:
Date Received: January 25, 2017
Date Started: January 15, 2017
Date Completion: July 15, 2018
Last Updated: March 7, 2017
Last Verified: March 2017