Edentulous MouthNCT04569929
3D-printed Implant Overdentures
A study testing (DLP)-printed photo-polymerizable PMMA Nextdent mandibular implant overdenture in people with Edentulous Mouth, run by October University for Modern Sciences and Arts at 1 site in Egypt.
Trial summary
A randomized clinical trial (RCT) was designed. Fourteen completely edentulous participants were randomly allocated into two equal groups. All participants received two implants in the inter-foraminal area with ball attachments. Read more about this study
- Who is it for?
- Ages 60 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Edentulous Mouth
- What is being tested?
- (DLP)-printed photo-polymerizable PMMA Nextdent mandibular implant overdenture
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 10 Aug 2020
- 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 60 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- completely edentulous
- ranging in age from 50 to 65 years
- Angle's class I skeletal relationship, normal facial symmetry.
- Adequate quantity of bone (class IV -VI ) and quality (classes 1 - 3 ) in the mandibular inter-foraminal area to accommodate standard implants of at least 11 mm length and 3.7 mm diameter
- appropriate inter-arch space of at least 15 mm (class I ) to accept all types of tested dentures
- Exclusion Criteria:Metabolic disorders affecting osseointegration such as hepatic disorders
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- osteoporosis and diabetes mellitus.
- Temporomandibular disorders, anticoagulant therapy or bleeding disorders
- sharp mandibular residual ridge or flabby tissues
- neuromuscular disorders, and class II and III Angle's classification skeletal relationship
- Smokers and patients on chemotherapy or radiotherapy or suffering from psychiatric conditions
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Implant Overdentures Fabricated Using 3D -Printing Technology Versus Conventional Fabrication Technique: A Randomized Trial
A randomized clinical trial (RCT) was designed. Fourteen completely edentulous participants were randomly allocated into two equal groups. All participants received two implants in the inter-foraminal area with ball attachments. Participants in the control group were rehabilitated with conventionally manufactured Polymethyl Methacrylate (PMMA) maxillary complete denture and mandibular implant overdentures while participants in intervention group received digital light processed (DLP)-printed photo-polymerizable PMMA Nextdent maxillary complete denture and mandibular implant overdentures. Follow-up appointments were scheduled at 3,6, and 12 months where data of Oral Health Impact Profile 19(OHIPEDENT19) was used to assess the OHRQoL (oral health related quality of life). In addition, denture retention was measured using digital force gauge device. Data were collected and statistically analyzed.
- Conditions
- Edentulous Mouth
- Being tested
- (DLP)-printed photo-polymerizable PMMA Nextdent mandibular implant overdenture
- Medical subject headings
- Mouth, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(DLP)-printed photo-polymerizable PMMA Nextdent mandibular implant overdentureOther
The bite registration records with their corresponding master casts were digitalized using an extra oral desktop 3D scanner (3shape D850) and then stored as standard triangulation language (STL) files (Figure 1). The STL files were then imported to Dental system PREMIUM3 design software (3Shape Dental System 2018) for model analysis, surveying and blocking out, designing full permanent denture bases, and for virtual teeth set-up following the recorded inter-arch space
| Study group | Role | What they receive |
|---|---|---|
| control | Active comparator | conventionally manufactured Polymethyl Methacrylate (PMMA) mandibular implant overdentures Receives: Other: (DLP)-printed photo-polymerizable PMMA Nextdent mandibular implant overdenture |
| intervention | Experimental | digital light processed (DLP)-printed photo-polymerizable PMMA Nextdent mandibular implant overdentures Receives: Other: (DLP)-printed photo-polymerizable PMMA Nextdent mandibular implant overdenture |
What is being measured
The primary outcome is the main question the study is designed to answer.
. OHRQoL (oral health related quality of life)
Oral Health Impact Profile 19 (OHIPEDENT19) was used to assess the OHRQoL (oral health related quality of life). The questionnaire was translated to Arabic and validated (S2).24 The profile consisted of 19 questions each with score 0 to 4 (impaired) on Likert scale; accordingly, for each patient the minimum score was 0 and maximum score was 76.
Measured: 12 months
Secondary outcomes (1)
Overdentures' retention
The retention was measured at baseline (day of delivery), three months thereafter, after six months then after 12m by a digital force gauge device (Extech's Model 475055 Digital Force Gauge FLIR Commercial Systems, Inc.) that measures tension or compression force (pull/push) to values of up to 980 Newton.25 The snap hook of the device engaged a screw fixed to the geometric center of denture bases using self-cure acrylic resin. Then pulling action was applied till the denture separation recording the amount of retention in Newton.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study start1 Jan 2019
- Primary completion5 Jun 2020
- Study completion10 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous MouthStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- October University for Modern Sciences and Arts
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina ElAwady, October University for Modern Sciences and Arts
- Investigators
- Dina Elawady, PHD, Principal investigator, MSA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04569929
- Sponsor's protocol ID
- Modern Science and Art Uni
- Status last verified
- Dec 2020
- First submitted
- 23 Sep 2020
- Last updated
- 16 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Implant Overdentures Fabricated Using 3D -Printing Technology Versus Conventional Fabrication Technique: A Randomized Trial
- ClinicalTrials.gov ID
- NCT04569929
- Acronym / sponsor ID
- Modern Science and Art Uni
- Conditions
- Edentulous Mouth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- October University for Modern Sciences and ArtsUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 5 Jun 2020 (actual)
- Study completion
- 10 Aug 2020 (actual)
- First posted
- 30 Sep 2020 (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.
A randomized clinical trial (RCT) was designed. Fourteen completely edentulous participants were randomly allocated into two equal groups. All participants received two implants in the inter-foraminal area with ball attachments. Participants in the control group were rehabilitated with conventionally manufactured Polymethyl Methacrylate (PMMA) maxillary complete denture and mandibular implant overdentures while participants in intervention group received digital light processed (DLP)-printed photo-polymerizable PMMA Nextdent maxillary complete denture and mandibular implant overdentures. Follow-up appointments were scheduled at 3,6, and 12 months where data of Oral Health Impact Profile 19(OHIPEDENT19) was used to assess the OHRQoL (oral health related quality of life). In addition, denture retention was measured using digital force gauge device. Data were collected and statistically analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Active comparator | Other: (DLP)-printed photo-polymerizable PMMA Nextdent mandibular implant overdentureconventionally manufactured Polymethyl Methacrylate (PMMA) mandibular implant overdentures |
| intervention | Experimental | Other: (DLP)-printed photo-polymerizable PMMA Nextdent mandibular implant overdenturedigital light processed (DLP)-printed photo-polymerizable PMMA Nextdent mandibular implant overdentures |
Who may qualify
- Ages
- 60 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- completely edentulous
- ranging in age from 50 to 65 years
- Angle's class I skeletal relationship, normal facial symmetry.
- Adequate quantity of bone (class IV -VI ) and quality (classes 1 - 3 ) in the mandibular inter-foraminal area to accommodate standard implants of at least 11 mm length and 3.7 mm diameter
- appropriate inter-arch space of at least 15 mm (class I ) to accept all types of tested dentures
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| (DLP)-printed photo-polymerizable PMMA Nextdent mandibular implant overdentureThe bite registration records with their corresponding master casts were digitalized using an extra oral desktop 3D scanner (3shape D850) and then stored as standard triangulation language (STL) files (Figure 1). The STL files were then imported to Dental system PREMIUM3 design software (3Shape Dental System 2018) for model analysis, surveying and blocking out, designing full permanent denture bases, and for virtual teeth set-up following the recorded inter-arch space | Other | control, intervention |
Primary outcome
. OHRQoL (oral health related quality of life)
Time frame: 12 months
Oral Health Impact Profile 19 (OHIPEDENT19) was used to assess the OHRQoL (oral health related quality of life). The questionnaire was translated to Arabic and validated (S2).24 The profile consisted of 19 questions each with score 0 to 4 (impaired) on Likert scale; accordingly, for each patient the minimum score was 0 and maximum score was 76.
1 secondary outcome
Overdentures' retention
Time frame: 12 months
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 16 Dec 2020.
- Individual participant dataSharing planned: No
Related trials for Edentulous Mouth
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Comparison Between Neutral Zone and Admixed Impression Techniques for Atrophic Mandibular Ridges
Atrophic Mandibular Ridge in Edentulous Patients
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Evaluating the Barrier Function, Regenerative Capacity, and Soft Tissue Outcomes of Acellular Dermal Matrix
Acellular Dermal Matrix, Bone Grafting
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Biological Aging Following Full-Arch Implant-Supported Fixed Rehabilitation in Edentulous Patients
Edentulism, Biological Aging
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Dynamic vs. Static Jaw Relations in Implant-Supported Prostheses: Chewing Efficiency
Chewing Efficiency in Completely Edentulous Patients Rehabilitated With Implant-Supported Full-Arch Prostheses
Not yet recruiting
Clinical and Radiographic Comparison of Two Implant-Abutment Connections
Dental Implant, Edentulous Alveolar Ridge
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.
Dina Elawady, PHD principal investigator
MSA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing (DLP)-printed photo-polymerizable PMMA Nextdent mandibular implant overdenture in people with Edentulous Mouth, run by October University for Modern Sciences and Arts 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 11 inclusion and 0 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 16 Dec 2020. 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?
. OHRQoL (oral health related quality of life) (time frame: 12 months). 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 16 Dec 2020.