Complete Edentulism(Zr) - (Ti)NCT06643975
Patient Satisfaction and Crestal Bone Changes Around One-piece Zirconia(Zr) and Titanium(Ti) in Implant-Retained Mandibular Overdenture
A study testing One-piece zirconia dental implants and One-piece titanium dental implants in people with Complete Edentulism, run by Ain Shams University at 1 site in Egypt.
Trial summary
This interventional randomized clinical trial study is conducted to assess patient satisfaction and crestal bone changes around one-piece Zr and Ti Implants in mandibular implant-retained overdenture in completely edentulous male patients in the age group between (50-60)years old to know if there will be a significant… Read more about this study
- Who is it for?
- Ages 50 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Complete Edentulism
- What is being tested?
- One-piece zirconia dental implants and One-piece titanium dental implants
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2024to 15 Oct 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 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male patients
- The age range of 50 to 60 years old (average of 55).
- moderately developed mandibular residual ridges, covered with healthy mucosa, firmly attached to the underling bone and with average mucosal thickness (2-3) mm.
- At least 12 mm of vertical bone height in the mandible allowing for placement of a 10 mm implant (2 mm safety distance to inferior alveolar nerve).
- Patients were selected with Angle class-I maxillomandibular relationship with sufficient inter-arch space (13-15mm
Who cannot join
- Heavy smokers of more than 10 cigarettes a day
- Poor oral hygiene.
- Patients with temporomandibular joint disorders(TMD),
- Patients suffered of xerostomia,
- Patients exhibited Para-functional habits, or recent extractions were excluded.
- Patients with systemic diseases that might affect bone quality or quantity, or retard healing of the surgical wounds were excluded.
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- Patients receiving intravenous forms of bisphosphonates.
- Patients who have had radiation therapy to the head and neck region.
- Patients with existing implants in the jaws
- Patients with previous bone grafting in either the maxillary or mandibular jaws.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Ain Shams University
Cairo
Mohammad Eissa, masters, implanteeth@hotmail.com
Omnia Refaie, Phd, 00201202420046, omnia_refaie@dent.asu.edu.eg
About this study
Official title: Assessment of Patient Satisfaction and Crestal Bone Changes Around One-piece Zirconia and Titanium Implants in Mandibular Implant-Retained Overdenture: A Randomized Clinical Trial
This interventional randomized clinical trial study is conducted to assess patient satisfaction and crestal bone changes around one-piece Zr and Ti Implants in mandibular implant-retained overdenture in completely edentulous male patients in the age group between (50-60)years old to know if there will be a significant difference between the two types of dental implants through 12 months after the definitive prosthetic loading
- Conditions
- Complete Edentulism
- Being tested
- One-piece zirconia dental implants, One-piece titanium dental implants
- Keywords
- Zirconia, One-piece, Overdenture, Implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One-piece zirconia dental implantsOther
Also called Z-SYSTEMS, ceramic implants
One-piece zirconia dental implants with zirconia ball attachments, these implants are metal free made of oxide ceramics with cutting-edge Selective laser melting(SLM) surface treatment technology
One-piece titanium dental implantsOther
One-piece Titanium dental implants with titanium ball attachments, these implants are gold standard compatible implants
| Study group | Role | What they receive |
|---|---|---|
| Titanium dental implants group | Active comparator | Two-implants One-piece titanium dental implants with titanium ball attachments retaining mandibular overdentures Receives: Other: One-piece titanium dental implants |
| Zirconia dental implants group | Active comparator | Two-implants One-piece zirconia dental implants with zirconia ball attachments retaining mandibular overdentures Receives: Other: One-piece zirconia dental implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Crestal bone changes
Measuring the amount of marginal(crestal) bone changes either loss or gain around the dental implants using the cone beam computed tomography(CBCT) in millimeter scales about the original marginal bone height measured at the time of the visit of final (definitive) prosthetic loading.
The positive(+ve) values mean an increase (gain) in the marginal bone height around the implants, the more the +ve value, the more the gain in the bone height which is the better outcome, while the negative (-ve) values mean decrease (loss) in the marginal bone height around the implants, the more the -ve value, the more loss in the bone height, which is the worse outcome.
Measured: 12 months
Secondary outcomes (1)
Patients Satisfaction
measuring the degree of patient satisfaction using a Patient's Denture Assessment (PDA) questionnaire, via a Likert scale which uses a 5-point system from 1 to 5, All items are scored as follows: unsatisfactory =1 hardly satisfactory =2 moderately satisfactory=3 very satisfactory=4 excellent satisfaction=5 The greater (higher) the score, the more patient satisfaction, which is the better outcome, while the weaker (lower) the score, the less is patient satisfaction, which is the worse outcome.
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 posted16 Oct 2024
- Study start15 Jun 2024
- Primary completion15 Sep 2025 (estimated)
- Study completion15 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complete EdentulismStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Eissa Mohammad Irakky, Benha University
- Investigators
- Mohammad Irakky, masters, Principal investigator, Faculty of Dentistry, Benha UniversityOmnia M. Refai, PHD, Study director, Faculty of Dentistry, Ain Shams UniveristyNoha Helmy Nawar, PHD, Study director, Faculty of Dentistry, Ain Shams Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06643975
- Sponsor's protocol ID
- 1372
- Acronym
- (Zr) - (Ti)
- Status last verified
- Oct 2024
- First submitted
- 14 Oct 2024
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Patient Satisfaction and Crestal Bone Changes Around One-piece Zirconia and Titanium Implants in Mandibular Implant-Retained Overdenture: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06643975
- Acronym / sponsor ID
- (Zr) - (Ti) / 1372
- Conditions
- Complete Edentulism
- Keywords
- Zirconia, One-piece, Overdenture, Implant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Jun 2024 (actual)
- Primary completion
- 15 Sep 2025 (estimated)
- Study completion
- 15 Oct 2025 (estimated)
- First posted
- 16 Oct 2024 (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 interventional randomized clinical trial study is conducted to assess patient satisfaction and crestal bone changes around one-piece Zr and Ti Implants in mandibular implant-retained overdenture in completely edentulous male patients in the age group between (50-60)years old to know if there will be a significant difference between the two types of dental implants through 12 months after the definitive prosthetic loading
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Titanium dental implants group | Active comparator | Other: One-piece titanium dental implantsTwo-implants One-piece titanium dental implants with titanium ball attachments retaining mandibular overdentures |
| Zirconia dental implants group | Active comparator | Other: One-piece zirconia dental implantsTwo-implants One-piece zirconia dental implants with zirconia ball attachments retaining mandibular overdentures |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male patients
- The age range of 50 to 60 years old (average of 55).
- moderately developed mandibular residual ridges, covered with healthy mucosa, firmly attached to the underling bone and with average mucosal thickness (2-3) mm.
- At least 12 mm of vertical bone height in the mandible allowing for placement of a 10 mm implant (2 mm safety distance to inferior alveolar nerve).
- Patients were selected with Angle class-I maxillomandibular relationship with sufficient inter-arch space (13-15mm
Key exclusion criteria (10 listed)
- Heavy smokers of more than 10 cigarettes a day
- Poor oral hygiene.
- Patients with temporomandibular joint disorders(TMD),
- Patients suffered of xerostomia,
- Patients exhibited Para-functional habits, or recent extractions were excluded.
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 |
|---|---|---|
| One-piece zirconia dental implantsAlso: Z-SYSTEMS, ceramic implantsOne-piece zirconia dental implants with zirconia ball attachments, these implants are metal free made of oxide ceramics with cutting-edge Selective laser melting(SLM) surface treatment technology | Other | Zirconia dental implants group |
| One-piece titanium dental implantsOne-piece Titanium dental implants with titanium ball attachments, these implants are gold standard compatible implants | Other | Titanium dental implants group |
Primary outcome
Crestal bone changes
Time frame: 12 months
Measuring the amount of marginal(crestal) bone changes either loss or gain around the dental implants using the cone beam computed tomography(CBCT) in millimeter scales about the original marginal bone height measured at the time of the visit of final (definitive) prosthetic loading. The positive(+ve) values mean an increase (gain) in the marginal bone height around the implants, the more the +ve value, the more the gain in the bone height which is the better outcome, while the negative (-ve) values mean decrease (loss) in the marginal bone height around the implants, the more the -ve value, the more loss in the bone height, which is the worse outcome.
1 secondary outcome
Patients Satisfaction
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
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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.
Mohammad Irakky, masters principal investigator
Faculty of Dentistry, Benha University
Omnia M. Refai, PHD study director
Faculty of Dentistry, Ain Shams Univeristy
Noha Helmy Nawar, PHD study director
Faculty of Dentistry, Ain Shams Univeristy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One-piece zirconia dental implants and One-piece titanium dental implants in people with Complete Edentulism, run by Ain Shams 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 10 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: status not confirmed, as of the sponsor's last update on 22 Oct 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammad Irakky, masters (00201111232777, implanteeth@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Crestal bone changes (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 22 Oct 2024.