Edentulous MouthNCT04366895
3D -Printed Single Implant Overdentures
A study testing conventional single implant overdenture and 3d printed single 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. The participants were randomly allocated into either of the two groups intervention or control group each of 14 participants. Participants in control group (Group-A) received conventional manufactured implant overdenture while participants in intervention group (Group-B)… Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Edentulous Mouth
- What is being tested?
- conventional single implant overdenture and 3d printed single implant overdenture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jan 2021to 21 Aug 2022
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the participant should be completely edentulous ranging in age from 35 to 75 years
- Angle's class I skeletal relationship
- normal facial symmetry
- adequate inter-arch space not less than 12mm
- should be a cooperative patient -
Who cannot join
- temporomandibular disorders
- uncontrolled diabetes
- bleeding disorders or anticoagulant therapy
- flabby tissues or sharp mandibular residual ridge
- neuromuscular disorders
- Angle's class II and III skeletal relationship.
- Patients who were heavy smokers
- chemotherapy or radiotherapy or with severe psychiatric disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 3D Printing/Additive Manufacturing of Single- Implant Overdentures. A Randomized Controlled Clinical Trial.
A randomized clinical trial (RCT) was designed. The participants were randomly allocated into either of the two groups intervention or control group each of 14 participants. Participants in control group (Group-A) received conventional manufactured implant overdenture while participants in intervention group (Group-B) received CAD-CAM manufactured implant overdenture.
Read the detailed description
Introduction: Mandibular single implant overdenture is a well-established treatment modality that address limited financial resources of patients and simultaneously enabled the management of conventional complete denture problems. CAD/CAM technology helped to mitigate the problems encountered with conventional fabrication techniques, which results in improved dentures fit and retention. Therefore, the aim of the current trial study was to evaluate whether overdentures fabricated using CAD/CAM printed technology exhibited improved patient satisfaction, denture retention, implant survival rate and decreased post-insertion maintenance or not compared to overdentures manufactured using conventional techniques.
Methods: A randomized clinical trial (RCT) was designed. The participants were randomly allocated into either of the two groups intervention or control group each of seven participants. Participants in control group (Group-A) received conventional manufactured implant overdenture while participants in intervention group (Group-B) received CAD-CAM manufactured implant overdenture.
- Conditions
- Edentulous Mouth
- Being tested
- conventional single implant overdenture, 3d printed single 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.
conventional single implant overdentureOther
conventional manufactured implant overdenture
3d printed single implant overdentureOther
CAD-CAM manufactured implant overdenture.
| Study group | Role | What they receive |
|---|---|---|
| control | Experimental | Participants in control group (Group-A) received conventional manufactured implant overdenture Receives: Other: conventional single implant overdenture |
| intervention | Experimental | participants in intervention group (Group-B) received CAD-CAM manufactured implant overdenture. Receives: Other: 3d printed single implant overdenture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant survival
The implants were considered surviving if they were clinically stable, functioning without any mobility
Measured: 1 year
Secondary outcomes (2)
Survival rate of overdentures
urvival rate of overdentures: (calculated by Incidence of mid-line fracture)
Measured: 1 year
maximum biting force (MBF)
MBF was achieved bilaterally using Flexiforce A 301® force sensor and Arduino microcontroller with a crystal displa
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start20 Jan 2021
- Primary completion20 Jun 2022
- Study completion21 Aug 2022
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 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, Lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04366895
- Sponsor's protocol ID
- MSA
- Status last verified
- Nov 2022
- First submitted
- 21 Apr 2020
- Last updated
- 9 Nov 2022
- 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 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Printing/Additive Manufacturing of Single- Implant Overdentures. A Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT04366895
- Acronym / sponsor ID
- MSA
- Conditions
- Edentulous Mouth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- October University for Modern Sciences and ArtsUniversity, hospital or other
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 20 Jun 2022 (actual)
- Study completion
- 21 Aug 2022 (actual)
- First posted
- 29 Apr 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. The participants were randomly allocated into either of the two groups intervention or control group each of 14 participants. Participants in control group (Group-A) received conventional manufactured implant overdenture while participants in intervention group (Group-B) received CAD-CAM manufactured implant overdenture.
Detailed description
Introduction: Mandibular single implant overdenture is a well-established treatment modality that address limited financial resources of patients and simultaneously enabled the management of conventional complete denture problems. CAD/CAM technology helped to mitigate the problems encountered with conventional fabrication techniques, which results in improved dentures fit and retention. Therefore, the aim of the current trial study was to evaluate whether overdentures fabricated using CAD/CAM printed technology exhibited improved patient satisfaction, denture retention, implant survival rate and decreased post-insertion maintenance or not compared to overdentures manufactured using conventional techniques.
Methods: A randomized clinical trial (RCT) was designed. The participants were randomly allocated into either of the two groups intervention or control group each of seven participants. Participants in control group (Group-A) received conventional manufactured implant overdenture while participants in intervention group (Group-B) received CAD-CAM manufactured implant overdenture.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Experimental | Other: conventional single implant overdentureParticipants in control group (Group-A) received conventional manufactured implant overdenture |
| intervention | Experimental | Other: 3d printed single implant overdentureparticipants in intervention group (Group-B) received CAD-CAM manufactured implant overdenture. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- the participant should be completely edentulous ranging in age from 35 to 75 years
- Angle's class I skeletal relationship
- normal facial symmetry
- adequate inter-arch space not less than 12mm
- should be a cooperative patient -
Key exclusion criteria (8 listed)
- temporomandibular disorders
- uncontrolled diabetes
- bleeding disorders or anticoagulant therapy
- flabby tissues or sharp mandibular residual ridge
- neuromuscular disorders
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 |
|---|---|---|
| conventional single implant overdentureconventional manufactured implant overdenture | Other | control |
| 3d printed single implant overdentureCAD-CAM manufactured implant overdenture. | Other | intervention |
Primary outcome
Implant survival
Time frame: 1 year
The implants were considered surviving if they were clinically stable, functioning without any mobility
2 secondary outcomes
Survival rate of overdentures
Time frame: 1 year
maximum biting force (MBF)
Time frame: 1 year
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 9 Nov 2022.
- Individual participant dataSharing planned: No
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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
Lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional single implant overdenture and 3d printed single 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 5 inclusion and 8 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 9 Nov 2022. 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?
Implant survival (time frame: 1 year). 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 9 Nov 2022.