Comparative assessment of the quality of life and patient satisfaction in orthopedic treatment with digitally and conventionally fabricated complete removable dentures: a randomized controlled trial

Background:

Complete secondary edentia remains one of the most prevalent and socially significant problems of modern gerostomatology. Despite the growing number of publications, there is still a lack of prospective controlled studies in the domestic literature assessing the impact of digital technologies on quality of life.

Aim:

To conduct a comparative evaluation of the impact of digital (CAD/CAM) versus conventional complete removable dentures on oral health-related quality of life (OHRQoL) and subjective patient satisfaction in edentulous patients over 3 months of prosthetic treatment; to assess clinical adaptation parameters and to substantiate the integration of digital protocols into the teledentistry framework for remote and rural populations.

Methods:

A prospective randomized controlled clinical trial with parallel groups (RCT) was conducted in accordance with the CONSORT 2010 guidelines and the Declaration of Helsinki. Of 87 screened patients, 17 were excluded (11 did not meet inclusion criteria, 4 declined to participate, 2 for other reasons); 70 patients aged 50–75 years (mean age 64.7 ± 6.6 years; 35 male, 35 female) were allocated using 1:1 block randomization (SNOSE envelopes) into two groups of 35: Group 1 received CAD/CAM complete removable dentures; Group 2 received conventional acrylic dentures. Follow-up was carried out at four time points (T0 — baseline; T1 — 14 days; T2 — 1 month; T3 — 3 months). The primary endpoint was the total OHIP-14 score; secondary endpoints included VAS satisfaction (5 domains), adaptation time, number of adjustments, and overall treatment rating. Statistical analysis was performed in Python 3.11 (pandas 2.2, SciPy 1.13, statsmodels 0.14) using the Student's t-test, Shapiro–Wilk test, Spearman correlation coefficient, and multiple linear regression. Primary analysis was performed per-protocol (PP, n = 60); a supplementary intention-to-treat (ITT) analysis (n = 70) was carried out using multiple imputation (MICE, m = 20).

Results:

Baseline OHIP-14 scores did not differ between groups (t = –0.96; p = 0.34). At T3, the total OHIP-14 score decreased to 15.7 ± 3.6 in the digital group and to 22.7 ± 4.7 in the conventional group (Δ = 6.99; 95% CI [4.84; 9.14]; t = –6.53; p < 0.0001; Cohen's d = 1.64), exceeding the minimal clinically important difference (MCID = 5 points). Mean VAS scores were 81.4 ± 5.8 mm in the CAD/CAM group vs. 62.9 ± 7.1 mm in controls (Δ = 18.5 mm; p < 0.0001). Full functional adaptation time was reduced from 17.2 ± 4.8 to 9.0 ± 3.3 days (Δ = 8.3 days; p < 0.0001); the mean number of adjustments dropped from 2.88 ± 1.78 to 1.56 ± 1.48 visits (45.8 % reduction; p = 0.003). "Excellent" ratings were given by 92.6 % of CAD/CAM patients vs. 24.2 % of controls (p < 0.0001). Multiple regression confirmed the independent effect of the fabrication method (β = –7.01; p < 0.0001; R² = 0.449). The ITT analysis demonstrated robustness of results (Δ = 7.39; p = 0.003; d = 1.03).

Conclusion:

CAD/CAM complete removable dentures provide statistically and clinically significant advantages over conventional acrylic dentures in terms of quality of life (OHIP-14), patient satisfaction (VAS), adaptation time, and number of adjustments. These findings substantiate the priority implementation of the CAD/CAM protocol for complete removable prosthodontics in clinical practice and provide an evidence base for its integration into the teledentistry system serving remote, rural, and hard-to-access populations of the Russian Federation.