The Effect of Platform-Matching Versus Platform-Switching Dental Implants on Peri-implant Hard and Soft Tissue Healing
Condition: Missing Tooth
MeSH terms: Tooth Loss; Anodontia
Study type: Interventional

Summary: 
      To compare platform-switched implants to platform-matched implants for replacement of a
      single missing tooth and their effect on: 1) Interproximal alveolar crest level in relation
      to implant platform. 2) Buccal implant recession. 3) Presence or absence of black triangle
      apical to the contact point. 4) Implant Success. 5) Adequate buccal tissue thickness.
    

Detailed description: 
      Thirty patients will have a dental implant placed. Fifteen patients will be randomly selected
      by a coin toss to receive a platform-switched implant while the other fifteen will receive
      platform-matched implant. Each patient will receive a diagnostic work-up including
      standardized radiographs (periapicals), study casts, clinical photographs, and a clinical
      examination of teeth adjacent to the edentulous sites. Pre-surgical preparation will include
      detailed oral hygiene instructions. Baseline data will be collected at initial exam, and at
      2, 4, 6, and 12 months. Parameters measured will include: plaque index, gingival index,
      probing depth, keratinized tissue, bleeding on probing, and digital radiographic examination.
      Pre-surgical measurements will include: cemento-enamel junction to osseous crest on adjacent
      teeth by direct measurement at surgery, and by radiograph at baseline, 2, 4, 6, and 12
      months, periodontal form, periodontal biotype, tooth shape, and papilla harmony. Patients
      will be randomly selected for treatment group assignment using a coin toss before surgery by
      the mentor. One investigator who is unaware of group assignment will perform all baseline
      examinations and all follow-up examinations. Means and standard deviations will be calculated
      for all parameters. A paired t-test will be used to evaluate the statistical significance of
      the differences between initial and final data. An unpaired t-test will be used to evaluate
      statistical differences between the test and control groups. A sample size of 15 gives 80%
      statistical power to detect a difference of 0.5 mm of implant bone loss between groups. All
      surgical procedures will be completed by one operator under the direction of one mentor.
      Pre-surgical measurements will be taken first. Local anesthesia will be administered. The
      surgical procedure will consist of the reflection of full thickness flaps to expose the
      alveolar crest. The implant platform will be placed 3 to 4 mm apical to the mid-facial
      gingival margin using dental implant osteotomy drills for preparation of the site. The
      surgical procedures will be documented with clinical photographs. Sutures will be used to
      close the flap and bury the implant under the tissue. Records will be kept of healing
      periodically for the first 8 weeks, then at 4, 6 and 12 months. The test group will use a
      BioHorizons Tapered Internal Plus "platform-switched" implant. The control group will be
      BioHorizons standard Internal "platform-matched" implant. All patients will be seen at 1-2,
      4, 6 and 8 weeks to monitor healing. At week 8 the implant will be uncovered surgically and
      provisionalized, and at the 4 month visit the final crown will be placed. Subsequent
      examinations will take place at 6 and 12 months. Post-surgically, patients will take an
      antibiotic (doxycycline hyclate 100 mg once a day for two weeks), an analgesic (Vicodin ES
      every 4-6 hours as needed for pain), and an anti-inflammatory agent (Naproxen 375mg every 12
      hours for one week). At post-operative visits plaque removal, and oral hygiene instruction,
      as needed, will be performed along with clinical photographs and standardized radiographs as
      scheduled. The results of this study will allow comparison of peri-implant soft and hard
      tissue healing following placement of a BioHorizons "platform-switched" Tapered Internal Plus
      implant versus a standard Internal "platform-matched" implant in terms of the effect on
      marginal bone loss, buccal recession, and papilla fill.
    

Intervention name(s): Platform-matched dental implant; Platform-switched dental implant
Intervention type(s): Procedure; Procedure
Intervention description(s): A platform-matched dental implant will be placed surgically, restored with a crown and evaluated for up to 12 months.; A platform-switched dental implant will be placed surgically, restored with a crown and evaluated for up to 12 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dental Implant