Conventional free-hand, dynamic navigation and static guided implant surgery produce similar short-term patient-reported outcome measures and experiences

Abstract

Design A randomised controlled trial study comparing patient-reported outcome measures (PROMs) and experiences (PREs) using conventional brain-guided (free-hand), dynamic computer-assisted implant surgery (dCAIS) and static computer-assisted implant surgery (sCAIS) for dental implant placement.

Case selection Ninety subjects who met the inclusion criteria (that is, at least 20 years of age interested in dental implant treatment) accepted to participate in the trial and were randomly allocated to three groups between August 2019 and October 2020, according to the dental implant placement protocol, by means of block randomisation. The included subjects were required to undertake several self-administered questionnaires concerning: 1) pre-operative expectations (that is, five items evaluating patients' perceptions using a 5-point Likert scale and six items about patients' expectations concerning the planned surgery); 2) post-operative healing complications or events during the immediate post-operative week (that is, pain intensity assessment on a continuous visual analogue scale [VAS] 0-10, oedema or swelling evaluation on four grades ranging from no oedema [Grade 1] to extraoral oedema reaching beyond the surgical zone [Grade 4] and analgesic drugs intake); and 3) post-operative PROMs at a two-week follow-up (six items evaluating the post-operative symptoms experience and eight items measuring overall patient satisfaction using a 5-point Likert scale).

Data analysis Kolmogorov-Smirnov test determined a non-normal distribution. Consequently, Wilcoxon signed-rank test assessed the intra-group differences and Kruskal-Wallis test was applied for inter-group comparison using the Statistical Package for the Social Sciences (IBM SPSS version 24; Chicago, IL). Spearman's correlation test evaluated the relation of patients' or implant procedures' characteristics with the maximum mean pain score, analgesic intake and oedema grade. The significance level alpha was set to 0.05. Lastly, Cronbach's alpha was used to evaluate the internal consistency for perceptions (0.53), expectations (0.76) and satisfaction (0.85).

Results Only two subjects were excluded for missing the two-week follow-up visit. Both subjects belonged to the dCAIS group. Hence, 88 participants (mean age = 57.7 years) corresponding to 179 implants placed were evaluated. Sex was the only subjects' characteristic with a significant difference as more women were included (60%; p = 0.020). Most of the subjects had one (38%) and two (45%) dental implants at anterior (11%) and posterior sites (80%) with full-thickness flap operation (95%) but without simultaneous guided bone regeneration (57%). In terms of the surgical duration, sCAIS took the longest (89.70 ± 45.75 min), followed by dCAIS (70.95 ± 42.48 min) and brain-guided protocol (70.30 ± 47.08 min). Nevertheless, there was no significant inter-group surgical time difference (p = 0.076). Concerning the pre-operative patients' perspectives on dental implant intervention, most participants believed that implants would permit chew (93%), sound (88%) and appearance (91%) to be as close as with natural dentition. Interestingly, 32% believed that osseointegrated implants require less maintenance than natural dentition and 73% stated that implants last a lifetime. There was a significant difference between the groups regarding the both the amount of time they expected to be in pain postoperatively (p=.035) and the amount of post operative swelling they expected (p=0.006)

There was no significant inter-group difference in magnitude of post-operative pain, oedema and analgesic intake. The dCAIS group expected longer to adapt to speaking (p = 0.030). The inter-group analysis of expected chewing difficulties evidenced significant differences (p = 0.040). Regarding the PREs, significant inter-group differences were displayed in duration of post-operative pain (p = 0.010), phonetic limitations (p = 0.038) and impact on routine activities (p = 0.046). After one week, the conventional and the sCAIS groups still had the highest (1.40 ± 2.43) and lowest (0.77 ± 1.85) pain scores. Concerning the self-reported post-operative oedema grading, it peaked on day two and most participants referred intraoral oedema (Grade 2) to extraoral oedema (Grade 3). Again, no significant inter-group difference was detected in the six measured time points regarding pain, oedema or analgesic intake. The highest post-operative oedema at day two was significantly correlated with flap operation (p = 0.030). During the first post-operative week, there was a low mean analgesic intake (5.13 ± 5.52). The first post-operative day had the highest consumption of analgesic drugs and the highest group consumption was by the conventional group. The post-operative healing experience and functional limitations were considered acceptable by most participants. Oedema had the lowest acceptable proportion (59%), followed by oral hygiene care difficulty (64%) and chewing (65%). The only intra-group difference in patients' acceptance was evidenced in the post-operative speaking difficulties of the sCAIS group (p = 0.015). Ninety-two percent of participants were satisfied with the clinical service (median = 5.0) and 89% were satisfied with the overall implant surgery (median = 4.0).

Conclusions Placing dental implants with conventional brain-guided, sCAIS or dCAIS protocols obtained a similar post-operative level of patient satisfaction, analgesic intake, oedema and pain. Patients reported the dental implant post-operative symptoms to be acceptable even though they expected a shorter inflammation duration. The highest level of pain and oedema were experienced six hours and two days post-operative, respectively, regardless of the surgical protocol.