Method: This phase-I trial used a pre-post design to assess patient-centered outcomes in 18 edentate individuals (mean age 62.39 ± 7.65 years) who have received a 2-implant (unsplinted) mandibular overdenture through an immediate loading protocol. The McGill patient satisfaction questionnaire and a VAS instrument assessing expectations were used to evaluate patients’ outcomes at baseline, 2 weeks, 1 and 4 months. Socio-demographic and personality trait data were obtained using the Revised NEO Personality Inventory and a self-administered questionnaire. Change scores were calculated and non-parametrical tests were used to analyse the data.
Results: The participants had a wide range of expectations regarding the immediate loading protocol. Expectations included short-term positive impact on aesthetics (83.3%) and social life (55.7%). Other expectations included negative effects on speech (38.9%) and the ability to chew (22.2 %). The protocol satisfied 94.4% of the participants, regardless of socio-demographic and personality profiles. The preliminary analysis showed an overall satisfaction increase with a median change score of 66 (range=7-98), 68 (range=7- 95), and 70 (range= 17- 99), at 2 weeks, 1 month and 4 months respectively. There was a statistically significant improvement in overall satisfaction, comfort, perceived aesthetics, stability of the overdenture, and ability to chew at 2 weeks (p < 0,001). These changes remained stable during subsequent follow-ups. There was 100% agreement among patients on recommending this procedure to their peers.
Conclusions: The immediate loading protocol seems to fulfill patients’ satisfaction regardless of their expectations. Encouraging results from phase I should be confirmed and approved in Phase II clinical trials.
Clinicaltrials.gov Identifier: NCT01644058