Jaw, Edentulous
Conditions
Interventions
This is a randomized-controlled clinical trial, a crossover of three interventions, and blinded. Where complete dentures with interchangeable systems of posterior teeth were made (conventional (bilate
Sponsors
Universidade Estadual Paulista Júlio de Mesquita Filho
Universidade Estadual Paulista Júlio de Mesquita Filho
Faculdade de Odontologia - Campus Araraquara - Universidade Estadual Paulista
Eligibility
Age
45 Years to No maximum
Inclusion criteria
Inclusion criteria: Participants of both sexes. Aged 45 years or older. Complete denture wearers with a need for replacement based on patient desire or clinical judgment, such as inadequate intermaxillary relationships and/or severe wear of artificial teeth. Individuals willing to participate in the research and receive the proposed treatment. Good comprehension of spoken Portuguese. Mandibular ridges classified as resorbed according to the methods described by Marcello-Machado et al. and Cawood and Howell. Normal unstimulated salivary flow rate between 0.3 and 0.4 mL/min. Edentulism time of at least 1 year prior to denture replacement
Exclusion criteria
Exclusion criteria: Debilitating systemic changes. Signs/symptoms of temporomandibular disorders. Refusal to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome found 1: The null hypothesis that there is no difference in satisfaction with the prostheses for the different occlusions in the two evaluated periods, 3 and 6 months, was accepted. At baseline, the mean (SD) values of general satisfaction with the existing complete dentures (N = 16) (n=1, did not perform the baseline assessment and subsequently left the study) (Question 1) were 56.1 (24.3) mm. This implies that the participants were generally dissatisfied with their prostheses prior to replacement, although the values varied widely. The generalized estimating equations analysis (N = 12) showed no significant effect of the occlusal scheme on patient satisfaction (Wald ?2 = 2.93; p = 0.231). Satisfaction scores did not differ between the 3 and 6-month follow-up assessments (Wald ?2 = 0.23; p = 0.632), and the treatment x time interaction was not significant (Wald ?2 = 3.54; p = 0.170), indicating that changes over time were similar among the occlusal schemes. No significant period effect was observed (Wald ?2 = 2.96; p = 0.227). It is relevant to note that there was no evidence of carryover effects between treatment periods (Wald ?2 = 2.94; p = 0.400), supporting the validity of the crossover design. For occlusion, the satisfaction means (N = 12) were higher for the bilateral balanced occlusion scheme (BBO) (95.7; 95% CI: 88.9 to 102.6 mm), followed by the lingualized occlusion scheme (LO) (91.6; 95% CI: 81.6 to 101.6 mm) and the monoplane occlusion scheme (MO) (87.3; 95% CI: 70.5 to 104.1 mm). Regarding time, the mean satisfaction at 3 months was 91.3 mm (95% CI: 81.4 to 100.9), being comparable to the 6-month assessment (91.9 mm; 95% CI: 79.7 to 104.2). The mean (SD) satisfaction for each occlusion, as a function of time, was: at 3 months, BBO: 95.7 (7.3), LO: 91.5 (16.2), MO: 87.7 (23.2); at 6 months, BBO: 95.2 (12.7), LO: 93.3 (15.2), MO: 89.9 (27.1). All comparisons between the occlusal schemes showed no significant differences in any of the questions. T | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome found 2: For the oral health-related quality of life with the OHIP-EDENT, a baseline value of 12.4 (7.9) was observed. The occlusal scheme (Wald ?2 = 4.25; p = 0.120) and time (Wald ?2 = 0.03; p = 0.863) did not significantly influence the post-intervention results. The interaction between them was not significant (Wald ?2 = 0.594; p = 0.743). The mean scores (SD) at 3 months were: bilateral balanced occlusion (BBO): 2.7 (3.8); lingualized occlusion (LO): 2.3 (3.3); monoplane occlusion (MO): 3.4 (4.5). At 6 months, the scores were: BBO: 3.2 (4.4); LO: 2.3 (3.4); MO: 3.2 (4.3). The mean (SD) baseline values for the GOHAI instrument were 42.0 (5.6). The occlusal scheme (Wald ?2 = 1.92; p = 0.384), time (Wald ?2 = 0.401; p = 0.527), and the interaction (Wald ?2 = 0.823; p = 0.663) were not significant (N = 12). The mean results at 3 months for each occlusal scheme were: BBO: 46.9 (2.1); LO: 46.3 (2.1); MO: 45.4 (3.8). At 6 months: BBO: 46.5 (2.5); LO: 46.7 (2.5); MO: 46.3 (2.8). The mean MNA score at baseline (SD) was 11.69 (2.82). The occlusal scheme exerted a significant influence on the MNA scores (Wald ?2 = 8.92; p = 0.012), while time (Wald ?2 = 0.02; p = 0.884) and the interaction (Wald ?2 = 0.08; p = 0.960) were not significant (N = 12). Post-test comparisons between the different schemes (Bonferroni test), however, found no significant differences, with the following mean values: BBO: 13.3 (95% CI: 12.8 to 13.8); LO: 12.6 (95% CI: 11.5 to 13.8); MO: 12.8 (95% CI: 12.2 to 13.5). For masticatory performance by the sieve method, the following mean values (SD) were observed at 20 and 50 cycles, according to the occlusion group and time: 20 cycles, at 3 months, BBO: 10.2 (8.5), LO: 8.4 (7.8), MO: 9.7 (6.2). With 20 cycles, at 6 months, BBO: 9.1 (5.0), LO: 9.5 (5.0), MO: 7.2 (4.7). With 50 cycles, at 3 months, BBO: 31.3 (16.5), LO: 22.6 (15.1), MO: 23.2 (14.9). And with 50 cycles, at 6 months, BBO: 24.6 (9.6), LO: 27.7 (12.3), MO: 22.7 (14.4). At 20 cycles, t | — |
Countries
BR
Contacts
Public ContactAna;Hamile Pero;Viotto
Universidade Estadual Paulista Júlio de Mesquita Filho;Faculdade de Odontologia de Araraquara - UNESP
Outcome results
None listed