Edentulism; Implant-retained Mandibular OverdenturesNCT07817420
Effect of Adding Silicon Dioxide (SiO₂) Nanoparticles to a Printable Acrylic Resin Denture Base
A study testing Standard 3D-printed acrylic resin denture base and SIO2 nanoparticle-modified 3D-printed acrylic resin denture base in people with Edentulism; Implant-retained Mandibular Overdentures, run by Mansoura University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Edentulism; Implant-retained Mandibular Overdentures
- What is being tested?
- Standard 3D-printed acrylic resin denture base and SIO2 nanoparticle-modified 3D-printed acrylic resin denture base
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2023to 10 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Adding Silicon Dioxide (SiO₂) Nanoparticles to a Printable Acrylic Resin Denture Base Material for Implant Overdentures: A Clinical Comparative Study
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.
- Being tested
- Standard 3D-printed acrylic resin denture base, SIO2 nanoparticle-modified 3D-printed acrylic resin denture base
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard 3D-printed acrylic resin denture baseDevice
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.
SIO2 nanoparticle-modified 3D-printed acrylic resin denture baseDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Conventional 3D-Printed Denture Base | Active comparator | Completely edentulous patients receiving two-implant-retained mandibular overdentures fabricated using standard, unmodified 3D-printable acrylic resin. Receives: Device: Standard 3D-printed acrylic resin denture base |
| SIO2 Nanoparticle-Modified 3D-Printed Denture Base | Experimental | Completely edentulous patients receiving two-implant-retained mandibular overdentures fabricated using 3D-printable acrylic resin modified with $0.5 wt% silanized silicon dioxide SiO2 nanoparticles. Receives: Device: SIO2 nanoparticle-modified 3D-printed acrylic resin denture base |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surface Roughness of the Denture Base Fitting Surface
Measured in micrometers using a 3D optical profilometer to assess surface micro-irregularities. Standardized areas on both the right and left sides of the denture base fitting surface are evaluated to calculate the mean value. Lower values indicate a smoother surface.
Measured: Baseline (denture insertion), 3 months, and 6 months post-insertion
Secondary outcomes (5)
Modified Gingival Index (GI)
Categorical assessment of peri-implant mucosal health and inflammation, evaluated at the implant sites.
Measured: 1 month, 3 months, and 6 months post-denture insertion
Modified Plaque Index (PI)
Categorical assessment of plaque accumulation surrounding the implant abutments and underneath the overdenture.
Measured: 1 month, 3 months, and 6 months post-denture insertion
Modified Probing Depth (PD)
Measured in millimeters ($\text{mm}$) using a calibrated plastic periodontal probe at four sites per implant to evaluate peri-implant sulcus depth
Measured: 1 month, 3 months, and 6 months post-denture insertion
Aerobic Bacterial Count
Quantified total aerobic bacterial colonization from microbiological swabs of the denture fitting surface, measured in colony-forming units per milliliter
Measured: 1 week, 1 month, 3 months, and 6 months post-denture insertion
Candida albicans Colony Count
Quantified fungal adhesion and growth from microbiological swabs of the denture fitting surface, measured in colony-forming units per milliliter
Measured: 1 week, 1 month, 3 months, and 6 months post-denture insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start1 Feb 2023
- Primary completion1 May 2025
- Study completion10 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulism; Implant-retained Mandibular OverdenturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07817420
- Sponsor's protocol ID
- A08012023RP
- Status last verified
- May 2025
- First submitted
- 8 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adding Silicon Dioxide (SiO₂) Nanoparticles to a Printable Acrylic Resin Denture Base Material for Implant Overdentures: A Clinical Comparative Study
- ClinicalTrials.gov ID
- NCT07817420
- Acronym / sponsor ID
- A08012023RP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 10 Sep 2025 (actual)
- First posted
- 14 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional 3D-Printed Denture Base | Active comparator | Device: Standard 3D-printed acrylic resin denture baseCompletely edentulous patients receiving two-implant-retained mandibular overdentures fabricated using standard, unmodified 3D-printable acrylic resin. |
| SIO2 Nanoparticle-Modified 3D-Printed Denture Base | Experimental | Device: SIO2 nanoparticle-modified 3D-printed acrylic resin denture baseCompletely edentulous patients receiving two-implant-retained mandibular overdentures fabricated using 3D-printable acrylic resin modified with $0.5 wt% silanized silicon dioxide SiO2 nanoparticles. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard 3D-printed acrylic resin denture baseFabrication 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. | Device | Conventional 3D-Printed Denture Base |
| SIO2 nanoparticle-modified 3D-printed acrylic resin denture baseFabrication 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. | Device | SIO2 Nanoparticle-Modified 3D-Printed Denture Base |
Primary outcome
Surface Roughness of the Denture Base Fitting Surface
Time frame: 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.
5 secondary outcomes
Modified Gingival Index (GI)
Time frame: 1 month, 3 months, and 6 months post-denture insertion
Modified Plaque Index (PI)
Time frame: 1 month, 3 months, and 6 months post-denture insertion
Modified Probing Depth (PD)
Time frame: 1 month, 3 months, and 6 months post-denture insertion
Aerobic Bacterial Count
Time frame: 1 week, 1 month, 3 months, and 6 months post-denture insertion
Candida albicans Colony Count
Time frame: 1 week, 1 month, 3 months, and 6 months post-denture insertion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard 3D-printed acrylic resin denture base and SIO2 nanoparticle-modified 3D-printed acrylic resin denture base in people with Edentulism; Implant-retained Mandibular Overdentures, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surface Roughness of the Denture Base Fitting Surface (time frame: Baseline (denture insertion), 3 months, and 6 months post-insertion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026; AzTrials last refreshed its copy on 31 Oct 2026.