The Role of a New Prosthodontics Device in Hard and Soft Tissue Changes After Subcrestal Implant Placement
Condition: Edentulous Alveolar Ridge
MeSH terms: Mouth, Edentulous
Study type: Interventional

Summary: 
      The present randomized controlled trial aims to assess the influence of a new prosthodontics
      device (Gingival Former Abutment -GFA) on peri-implant bone loss and soft tissue changes and
      health after subcrestal oral implant placement.

      The participants will be divided in two groups and receive either crestal implant placement
      and traditional healing abutment or subcrestal implant placement and GFA.

      Clinical and radiographic examination will be performed at implant placement surgery,
      prosthetic load, 6 and 12 months follow-up.
    

Detailed description: 
      According to current literature, physiological bone loss around oral implants is expected
      after placement and load (1 mm during the first year and 0.2 mm each subsequent year).
      Different implant designs and surgical protocols have been tested to minimize bone
      resorption, and subcrestal implant placement partially seems to overcome this issue. However,
      if this procedure increases the length of the transmucosal tunnel, increasing the risk of
      peri-implant soft tissue infection.

      The GFA was created to limit both the loss of peri-implant crestal bone and the extension of
      the transmucosal tunnel. The GFA follows the "one abutment one time" concept, which is
      believed to limit disturbances of the peri-implant hard and soft tissues healing due to the
      removal of the traditional healing abutments during prosthetic load procedures. Our objective
      is to validate or deny this claim.

      The study is a monocentric, pragmatic, single-blinded, randomized clinical trial (RCT) of
      parallel design. The trial will have a one-year duration, with data collection at the
      surgical phase, at implant load and 6 and 12 months after load. The primary outcome will be
      radiographical MBL (marginal bone level) changes around the implant. Secondary outcomes will
      be the assessment of the peri-implant soft tissues.
    

Intervention name(s): Gingival Former Abutment; Subcrestal Implant; Healing Abutment; Prosthetic Crown; Crestal Implant
Intervention type(s): Device; Procedure; Device; Device; Procedure
Intervention description(s): GFA is positioned on the sub-crestal implant during the surgery and it is no longer removed. This follows the "one abutment one time" concept and should prevent bone loss and transmucosal tunnel.; Placement of the endosseous sub-crestal dental implant through dedicated drills with 35 Newton insertion torque. It is positioned 2 mm under the crestal bone.; A healing abutment is positioned on crestal implant during surgery. It is removed at prosthetic finalization.; A zirconia prosthetic crown finalizes the implant rehabilitation.; Placement of the endosseous crestal implant through dedicated drills with 35 Newton insertion torque at level of the alveolar bone.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Monocentric, single blinded, randomized clinical trial, parallel design.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Oral Implants; Abutment; Subcrestal