Implant Site ReactionNCT05936775
Assessment of Osseointegration Properties of Nano-Hydroxy Apatite Coated Titanium Implant
A study testing nano-hydroxy apatite coated titanium implants and sandblasted large acid itched coated titanium implant in people with Implant Site Reaction, run by October University for Modern Sciences and Arts at 1 site in Egypt.
Trial summary
the purpose of this trial is to evaluate the osseointegration properties of nano-hydroxy apatite coated titanium implants in posterior maxilla. 30 patients will be included in this trial divided into two groups, control and intervention. Primary and secondary implant stability will be measured Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Implant Site Reaction
- What is being tested?
- nano-hydroxy apatite coated titanium implants and sandblasted large acid itched coated titanium implant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Jun 2023to 5 Apr 2024
- 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 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with missing at least one maxillary posterior tooth
- Patients free from any systemic disease
- Patients who approve to be included in the trial and sign the informed consent
- Patients with no intra-bony defect.
- Adults aged 18 years old and above
Who cannot join
- Patients who are allergic to titanium
- Heavy smoker patient
- Patients receiving chemotherapy or radiotherapy
- Patients who refused to be included in the trial
Trial locations and contacts
1 site in 1 country.
Egypt1 site
October University for Modern Sciences and Arts faulty of Dentistry
Giza
About this study
Official title: Assessment of Osseointegration Properties of Nano-Hydroxy Apatite Coated Titanium Implant Versus Sandblasted Large Thread Acid Etched Implants in Posterior Maxilla. A Randomized Clinical Trial
the purpose of this trial is to evaluate the osseointegration properties of nano-hydroxy apatite coated titanium implants in posterior maxilla. 30 patients will be included in this trial divided into two groups, control and intervention. Primary and secondary implant stability will be measured
- Conditions
- Implant Site Reaction
- Being tested
- nano-hydroxy apatite coated titanium implants, sandblasted large acid itched coated titanium implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nano-hydroxy apatite coated titanium implantsOther
titanium implants with surface treatment of nano-hydroxy apatite
sandblasted large acid itched coated titanium implantOther
titanium implants with SLA surface treatment
| Study group | Role | What they receive |
|---|---|---|
| Nano-hydroxy apatite arm | Experimental | in this groups patients will receive nano-hydroxy apatite coated titanium implants Receives: Other: nano-hydroxy apatite coated titanium implants |
| SLA arm | Active comparator | in this group patients will receive sandblasted large thread acid etched titanium implants Receives: Other: sandblasted large acid itched coated titanium implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant stability
implant stability will be measured by radiofrequency analysis
Measured: immediately post-operative
Implant stability
implant stability will be measured by radiofrequency analysis
Measured: 4 weeks post-operative
Implant stability
implant stability will be measured by radiofrequency analysis
Measured: 6 weeks post-operative
Implant stability
implant stability will be measured by radiofrequency analysis
Measured: 12 weeks post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start22 Jun 2023
- Primary completion1 Apr 2024
- Study completion5 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant Site ReactionStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- October University for Modern Sciences and Arts
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Hamdy Mahmoud Ismail, October University for Modern Sciences and Arts
- Investigators
- Mohamed H Mahmoud, PhD, Principal investigator, october university for modern science and arts faculty of dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05936775
- Sponsor's protocol ID
- 2
- Status last verified
- Apr 2024
- First submitted
- 22 Jun 2023
- Last updated
- 9 Apr 2024
- Results posted
- 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 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Osseointegration Properties of Nano-Hydroxy Apatite Coated Titanium Implant Versus Sandblasted Large Thread Acid Etched Implants in Posterior Maxilla. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05936775
- Acronym / sponsor ID
- 2
- Conditions
- Implant Site Reaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- October University for Modern Sciences and ArtsUniversity, hospital or other
- Study start
- 22 Jun 2023 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 5 Apr 2024 (actual)
- First posted
- 10 Jul 2023 (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.
the purpose of this trial is to evaluate the osseointegration properties of nano-hydroxy apatite coated titanium implants in posterior maxilla. 30 patients will be included in this trial divided into two groups, control and intervention. Primary and secondary implant stability will be measured
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nano-hydroxy apatite arm | Experimental | Other: nano-hydroxy apatite coated titanium implantsin this groups patients will receive nano-hydroxy apatite coated titanium implants |
| SLA arm | Active comparator | Other: sandblasted large acid itched coated titanium implantin this group patients will receive sandblasted large thread acid etched titanium implants |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients with missing at least one maxillary posterior tooth
- Patients free from any systemic disease
- Patients who approve to be included in the trial and sign the informed consent
- Patients with no intra-bony defect.
- Adults aged 18 years old and above
Key exclusion criteria (4 listed)
- Patients who are allergic to titanium
- Heavy smoker patient
- Patients receiving chemotherapy or radiotherapy
- Patients who refused to be included in the trial
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 |
|---|---|---|
| nano-hydroxy apatite coated titanium implantstitanium implants with surface treatment of nano-hydroxy apatite | Other | Nano-hydroxy apatite arm |
| sandblasted large acid itched coated titanium implanttitanium implants with SLA surface treatment | Other | SLA arm |
Primary outcome
Implant stability
Time frame: immediately post-operative
implant stability will be measured by radiofrequency analysis
Implant stability
Time frame: 4 weeks post-operative
implant stability will be measured by radiofrequency analysis
Implant stability
Time frame: 6 weeks post-operative
implant stability will be measured by radiofrequency analysis
Implant stability
Time frame: 12 weeks post-operative
implant stability will be measured by radiofrequency analysis
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 Apr 2024.
- 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.
Mohamed H Mahmoud, PhD principal investigator
october university for modern science and arts faculty of dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nano-hydroxy apatite coated titanium implants and sandblasted large acid itched coated titanium implant in people with Implant Site Reaction, 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 4 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 Apr 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?
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 stability (time frame: immediately post-operative). The study lists 4 primary outcomes in all. 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 Apr 2024.