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Journal of Oral Science & Rehabilitation No. 2, 2017

F i x e d - r e m o v a b l e s o l u t i o n f o r a t r o p h i c m a n d i b l e s 10 = fully satisfied, 5 = satisfied and 1 = not satisfied. Quality of life was assessed by the Oral Health Impact Profile (OHIP-21) question- naire, which was completed by the partici- pants. The questionnaire consists of seven subscales (functional limitations, physical pain, psychological discomfort, physical dis- ability, psychological disability, social disabil- ity, and handicap) with two to four questions each. Participants chose from five possible responses for each question as follows: never, hardly ever, occasionally, fairly often and very often. Items were scored on a five-point ordi- nal scale ranging from 1 (never) to 5 (very often). Lower OHIP total scores are suggestive of improvement in oral health-related quality of life. The questionnaire was administered before treatment and one year after definitive prosthesis delivery. – Bleeding index and plaque index were evalu- ated at four sites around each implant– abutment interface at the one-year examina- tion with a periodontal probe (PCPUNC156, Hu-Friedy, Milan, Italy). An independent dentist (EX) evaluated the im- plant and prosthetic survival and success rates and administered the patient satisfaction and OHIP questionnaires. Complications were as- sessed and treated by the treating clinician (MT), who was nonblinded. Marginal bone level changes were evaluated by an independent ra- diologist. An independent blinded dental hygien- ist who was otherwise not involved in the study performed all of the periodontal measurements. All data analysis was carried out according to a pre-established analysis plan using software (IBM SPSS Statistics for Macintosh, Version 22.0, IBM, Armonk, N.Y., U.S.). Descriptive analy sis was performed using means, standard deviations and a 95% confidence interval. Com- parison of the means for marginal bone level changes, patient satisfaction and OHIP scores between the baseline and one-year follow-up examinations was performed by paired tests. A biostatistician with expertise in dentistry analy- zed the data. Results A total of 16 Osstem TSIII implants (14 regular platform and two mini platform) were placed in four consecutive edentulous participants. All of the participants were followed up for a minimum of one year (mean: 13.8 months; range: 12–16) after definitive loading. All of the treated pa- tients were female with an average age of 71.5 (range: 64–82). The main patient and implant characteristics are shown in Table 1. No partic- ipants dropped out, and no deviation from the original protocol occurred. At the one-year follow- up, no implants or prosthesis had failed, resulting in cumulative implant and prosthetic survival rates of 100%. No biological or tech- nical complications occurred during the follow- up, resulting in cumulative implant and pros- thetic success rates of 100%. At the one-year follow- up, the mean marginal bone loss was 0.23 ± 0.07 mm. The OHIP summary scores demonstrated a significant decrease (P = 0.0002) throughout the study, from 66.5 ± 3.7 to 19.3 ± 2.8. At the one-year follow- up, the bleeding index was 1.6% and the plaque index was 4.7%. All of the data are summarized in Table 1. Discussion This prospective study was designed to evalu- ate the one-year clinical and radiographic out- comes and patient satisfaction of Cawood and Howell Class VI patients treated with a fixed- removable overdenture supported by four im- plants, placed using guided surgery, and a CAD/ CAM titanium bar. Because it was designed as a single-cohort, proof-of-concept study, the main limitations were the lack of a control group and a small sample size. Hence, this in- vestigation should be considered as a pilot for future multicenter randomized clinical trials with control group comparison. The results of the present one-year prelimi- nary prospective case series study reported im- plant and prosthetic survival and success rates of 100% and greater patient satisfaction, indicat- ing that patients with extremely atrophic mandi- bles (Cawood and Howell Class VI) may be reha- bilitated using this fixed-removable solution. Complete maxillary and mandibular den- tures have been the conventional standard of care for edentulous patients. However, most patients report significant problems adapting to their mandibular dentures owing to a lack of comfort, retention and stability and to the in- ability to chew and eat properly, resulting in pain and discomfort. Recent evidence from studies carried out over the past decade has determined that the two-implant overdenture is considered 38 Volume 3 | Issue 2/2017 Journal of Oral Science & Rehabilitation

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