Clinical Trial: Platform Switched Implant and Bone Level Alteration

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Influence of Soft Tissue Thickness and Insertion Depth of Platform Switched Implants on Crestal Bone Level Alteration

Brief Summary: This is a two-year prospective randomized clinical study to to evaluate whether the gingival thickness and insertion depth of dental implants have any influence on marginal bone levels changes around platform switched implants.

Detailed Summary:

Patient selection: Patients at the Department of Oral Implantology, Peking University School and Hospital of stomatology, Bei Jing, China, who seek for implant restoration for two continous posterior teeth are potentially recruited. Inclusion criteria are generally healthy (ASA score I), non-smoking, periodontally healthy, and sufficient bone volume to place an implant without augmentation procedure. Patients were excluded in cases of medical and/or psychiatric contraindications, local infection, pregnancy or lactating, poor oral hygiene, tissue deficiency, or not willing to participate in this study.

Randomization: The two implant sites of each subject are randomly assigned to two different group with a predefined randomization tables. In order to reduce the chance of unfavorable splits between groups in terms of key prognostic factors,the randomization process will take into account the following variables: patient's gender, age, presence of adjacent teeth, distal extension sites and site location in the dental arch. Assignment will perform using a sealed envelope.

Surgical protocol: Before the surgical procedure, prophylactic antibiotics of 1g amoxicillin will prescribed to the patient 1 h before surgery, and continued with 2 g/day for 6 days. After crestal incision, full thickness buccal flap was raised, whereas lingual part was not elevated. Thickness of soft tissues was measured with 1.0-mm marked periodontal probe on the top of bone crest in the center of the two future implant sites. This ensured direct visibility of mucosal thickness during measurement. After measurements, full-thickness lingual flap is raised and subsequent implant osteotomy is finished, Two dental implants (Dentsply Implants Manufacturing GmbH, Mannheim, Germany) with diameter of 3.5 mm are ready to torch into the bone cavities. In one site (gro
Sponsor: Beijing University Health Science Center

Current Primary Outcome: Changes of marginal bone levels of dental implant [ Time Frame: 3 months, 6 months, 1 year and 2 years post intervention (implant surgery) ]

Mesial and distal marginal bone level alterations at different time point compared with the base line. Marginal bone levels were measured with an image analysis software to the accuracy of 0.01 mm and the implant length is used as calibration for the measurement.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Bleeding on probing(BOP) [ Time Frame: 3 months, 6 months, 1 year and 2 years post intervention (implant surgery) ]
    bleeding index whiling probing the implant restorations
  • Probing pocket depth(PPD) [ Time Frame: 3 months, 6 months, 1 year and 2 years post intervention (implant surgery) ]
    probing depth of implant supported restorations
  • modified plaque index(PI) [ Time Frame: 3 months, 6 months, 1 year and 2 years post intervention (implant surgery) ]
    Modified plaque index to evaluate the oral hygiene conditions


Original Secondary Outcome: Same as current

Information By: Beijing University Health Science Center

Dates:
Date Received: July 24, 2016
Date Started: July 2016
Date Completion: December 2020
Last Updated: August 13, 2016
Last Verified: August 2016