The objective of this study is to make a comparison between two surgical techniques used when implanting a Ponto bone anchored hearing system.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
64
Maastricht University Medical Centre
Maastricht, Netherlands
Incidence of inflammation (Holgers index ≥ 2)
Time frame: 3 months post surgery
Presence of dehiscence after surgery (Noted in a binary fashion (present/not present))
Time frame: 3 months post surgery
Visual Analogue Scale (VAS) pain scale > 6 (Noted on a scale from 0 - 10)
Time frame: 3 months post surgery
Loss of sensibility (Measured in mm outwards from the abutment)
Time frame: 3 months post surgery
Soft tissue overgrowth (mm)
Time frame: 3 months post surgery
Extrusion rate (number of implants lost)
Time frame: 3 months post surgery
Implant stability quotient (ISQ) measurements (ISQ units 1-100)
Time frame: 3 months post surgery
Surgical time (minutes)
Time frame: 3 months post surgery
Wound healing time (time to reach healed)
Time frame: 3 months post surgery
Holgers index ≥ 2 at any time point
Time frame: 24 months post surgery
Presence of dehiscence after surgery (present/not present)
Time frame: 24 months post surgery
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Visual Analogue Scale (VAS) pain scale > 6 (Noted on a scale from 0 - 10)
Time frame: 24 months post surgery
Loss of sensibility (Measured in mm outwards from the abutment)
Time frame: 24 months post surgery
Soft tissue overgrowth (mm)
Time frame: 24 months post surgery
Extrusion rate (number of implants lost)
Time frame: 24 months post surgery
Implant stability quotient (ISQ) measurements (ISQ units 1-100)
Measured in ISQ units (1-100)
Time frame: 24 months post surgery
Cosmetic result (10 point scale)
Scored using a 10-point scale and are compared to the healthy, normal contralateral situation
Time frame: 24 months post surgery