24 Chapter 2 Outcome measures The primary outcome measure was marginal bone level change (MBLC). Implant survival rate, overdenture survival rate, clinical characteristics, biological complications, technical complications and patient related outcome measures (PROMs) were the secondary outcome measures. Clinical and radiographic evaluations took place at one month (T1), 12 months (T12) and 60 months (T60) after the prosthetic loading. The PROMs were evaluated before treatment (T0), at T12 and T60. Marginal bone level change The radiographs were taken with an Extension Cone Paralleling Photostimulable Phosphor holder (RINN, Dentsply, Elgin, IL, USA). Linear measurements were performed by one blinded experienced observer (HJAM) with measurement software (Biomedical Engineering, University Medical Center Groningen, the Netherlands). Prior to analysis, the superstructures were cropped from the digital radiographs to facilitate blinded measurements. The neck of the implant was used as a reference line for all the measurements. The images were calibrated using the implant’s dimensions. Measurements were done at the mesial and distal side of each implant. MBLC was defined as the difference in bone height between the radiograph taken at T1 (baseline) and T12 or T60. The side having the largest MBLC (mesial or distal) of each individual implant was used for analysis. Implant and overdenture survival rate Implant survival rate was defined as the percentage of implants still present and not mobile at the follow-up evaluation. Percussion testing was done to assess implant mobility. The bar group’s assessment occurred after the bar was removed. Maxillary overdenture survival rate was defined as the percentage of the initially placed overdentures still present at the follow-up. Clinical parameters For each implant, the following clinical characteristics were assessed: • The presence of plaque using the index described by Loë and Silness12 (score 0: no detection of plaque; score 1: plaque can be detected by running a probe across the smooth marginal surface of the abutment and implant; score 2: plaque can be seen by the naked eye; score 3: an abundance of plaque). For each participant, the implant with the highest score was used for analysis. • The presence of calculus with a score of 0 or 1 (the absence or presence of calculus, respectively). For each participant, the implant with the highest score was used for analysis. • Peri-implant mucosa health using the modified Löe and Silness index12(score 0: normal peri-implant mucosa; score 1: mild inflammation, slight change in colour, slight oedema; score 2: moderate inflammation, redness, oedema and glazing; score 3: severe inflammation, marked redness and oedema, ulceration). For each participant, the implant with the highest score was used for analysis.
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