Edentulism; Implant-retained Mandibular Overdentures
Conditions
Brief summary
This clinical study evaluated whether adding a small amount (0.5 wt%) of silicon dioxide (SiO₂) nanoparticles to a 3D-printable acrylic denture material could improve the clinical performance of implant-retained mandibular overdentures. the results showed that the SiO₂-modified denture bases had smoother surfaces and were associated with better peri-implant soft tissue measurements than the conventional 3D-printed denture bases. The modified denture bases also showed lower bacterial counts and reduced Candida albicans levels during follow-up. No implant failures were reported during the study period.
Interventions
DEVICEStandard 3D-printed acrylic resin denture base
Fabrication of mandibular overdentures using standard 3D-printable acrylic resin without any nanoparticle modification. The dentures are retained by two bilateral mandibular implants with ball attachments.
DEVICESIO2 nanoparticle-modified 3D-printed acrylic resin denture base
Fabrication of mandibular overdentures using 3D-printable acrylic resin incorporated with $0.5 wt% silanized SIO2 nanoparticles (homogenized using a high-speed homogenizer). The dentures are retained by two bilateral mandibular implants with ball attachments.
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Dentally Edentulous Status: Completely edentulous patients in both arches requiring a maxillary complete denture and a mandibular implant-retained overdenture. * Bone Volume: Patients with adequate mandibular bone height and width to accommodate bilateral implant placement in the canine region. * General Health: Good general health status permitting standard dental implant surgical procedures. * Oral Hygiene: Acceptable oral hygiene status and motivation to maintain oral health. * Compliance: Patient willingness and capability to comply with all scheduled follow-up visits and clinical evaluations.
Exclusion criteria
* Systemic Health Conditions: Patients with compromised systemic conditions or uncontrolled systemic diseases that adversely affect bone healing, soft tissue response, or osseointegration (e.g., uncontrolled diabetes mellitus). * Oncological Therapy: History of previous head and neck radiotherapy or active/past chemotherapy. * Tobacco Use: Heavy smoking * Parafunctional Habits: Presence of severe bruxism or other parafunctional oral habits. * Patient Compliance: Poor patient compliance or inability/unwillingness to commit to the required follow-up schedule and maintenance protocols.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surface Roughness of the Denture Base Fitting Surface | Baseline (denture insertion), 3 months, and 6 months post-insertion | Measured in micrometers using a 3D optical profilometer to assess surface micro-irregularities. Standardized areas on both the right and left sides of the denture base fitting surface are evaluated to calculate the mean value. Lower values indicate a smoother surface. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified Gingival Index (GI) | 1 month, 3 months, and 6 months post-denture insertion | Categorical assessment of peri-implant mucosal health and inflammation, evaluated at the implant sites. |
| Modified Plaque Index (PI) | 1 month, 3 months, and 6 months post-denture insertion | Categorical assessment of plaque accumulation surrounding the implant abutments and underneath the overdenture. |
| Modified Probing Depth (PD) | 1 month, 3 months, and 6 months post-denture insertion | Measured in millimeters ($\\text{mm}$) using a calibrated plastic periodontal probe at four sites per implant to evaluate peri-implant sulcus depth |
| Aerobic Bacterial Count | 1 week, 1 month, 3 months, and 6 months post-denture insertion | Quantified total aerobic bacterial colonization from microbiological swabs of the denture fitting surface, measured in colony-forming units per milliliter |
| Candida albicans Colony Count | 1 week, 1 month, 3 months, and 6 months post-denture insertion | Quantified fungal adhesion and growth from microbiological swabs of the denture fitting surface, measured in colony-forming units per milliliter |
Countries
Egypt
Outcome results
None listed