Dental ImplantsNCT05194813
Surface Treatment of the Dental Implant on the Osseointegration
A study testing Aqua alvim CM, neodent implant (Test) in people with Dental Implants and Surface Treatment, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
Dental implants have become a widely accepted treatment modality for the replacement of missing single or multiple teeth in the recent years. In order to meet patients' needs for shorter treatment times and the necessity of dealing with more challenging clinical situations, implants and implant therapies have… Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Dental Implants, Surface Treatment
- What is being tested?
- Aqua alvim CM, neodent implant (Test)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2020to 15 Jun 2021
- 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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Missing mandibular posterior teeth.
- Good oral hygiene (plaque index less than 10 %)
- Good compliance to the treatment.
- Participants are free from local or systemic disease
- Willingness and ability to commit to follow-up placement.
- Adequate bone height and width to accommodate implant placement and sufficient keratinzed mucosa.
- At least 3months after tooth extraction
- Sufficient interocclusal distance
Who cannot join
- Presence of persistent and unresolved infection in the implant site
- Parafunctional habits.
- Heavy Smokers.
- Uncontrolled systemic disease that impedes bone healing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Surface Treatment of the Dental Implant on the Osseointegration in Mandibular Posterior Missing Teeth
Dental implants have become a widely accepted treatment modality for the replacement of missing single or multiple teeth in the recent years. In order to meet patients' needs for shorter treatment times and the necessity of dealing with more challenging clinical situations, implants and implant therapies have undergone continuous improvement to improve the function and longevity of the implants. Recently the constant search for improvements in modern implant have been focused on surface modifications so a new era of surface treatment have been showed up; the chemically modified hydrophilic surfaces.
- Conditions
- Dental Implants, Surface Treatment
- Being tested
- Aqua alvim CM, neodent implant (Test), Neoporous alvim CM, neodent implant (Control)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aqua alvim CM, neodent implant (Test)Other
Acqua, Hydrophilic sandblasted, and acid-etched dental implants
Neoporous alvim CM, neodent implant (Control)Other
Neoporous, Hydrophilic sandblasted, and acid-etched dental implants
| Study group | Role | What they receive |
|---|---|---|
| Hydrophilic sandblasted and acid-etched dental implants | Experimental | Not described Receives: Other: Aqua alvim CM, neodent implant (Test) |
| Conventional hydrophobic sandblasted and acid-etched dental implant | Active comparator | Not described Receives: Other: Neoporous alvim CM, neodent implant (Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in implant stability
The implant stability measurement was examined at the time of insertion of the implants (primary stability) and 6 months (secondary stability) for the two groups of patients using the resonance Frequency Analysis (RFA) via the Osstell ISQ system
Measured: at baseline and 6 months
Change in bone density
Cone beam Computerized tomography was used to assess bone denisty
Measured: at baseline and 6 months
Change in ridge height
Cone beam Computerized tomography was used to assess ridge height
Measured: at baseline and 6 months
Biochemical assessment of bone formation
Done by measuring of Runt-related transcription factor 2 (RUNX2) as a bone marker by Enzyme-Linked Immunosorbent Assay
Measured: at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start1 Nov 2020
- Primary completion15 Jun 2021
- Study completion15 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantsStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05194813
- Sponsor's protocol ID
- Implants2022
- Status last verified
- Jan 2022
- First submitted
- 4 Jan 2022
- Last updated
- 18 Jan 2022
- 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 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Surface Treatment of the Dental Implant on the Osseointegration in Mandibular Posterior Missing Teeth
- ClinicalTrials.gov ID
- NCT05194813
- Acronym / sponsor ID
- Implants2022
- Conditions
- Dental Implants, Surface Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 18 Jan 2022 (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.
Dental implants have become a widely accepted treatment modality for the replacement of missing single or multiple teeth in the recent years. In order to meet patients' needs for shorter treatment times and the necessity of dealing with more challenging clinical situations, implants and implant therapies have undergone continuous improvement to improve the function and longevity of the implants. Recently the constant search for improvements in modern implant have been focused on surface modifications so a new era of surface treatment have been showed up; the chemically modified hydrophilic surfaces.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrophilic sandblasted and acid-etched dental implants | Experimental | Other: Aqua alvim CM, neodent implant (Test) |
| Conventional hydrophobic sandblasted and acid-etched dental implant | Active comparator | Other: Neoporous alvim CM, neodent implant (Control) |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Missing mandibular posterior teeth.
- Good oral hygiene (plaque index less than 10 %)
- Good compliance to the treatment.
- Participants are free from local or systemic disease
- Willingness and ability to commit to follow-up placement.
Key exclusion criteria (4 listed)
- Presence of persistent and unresolved infection in the implant site
- Parafunctional habits.
- Heavy Smokers.
- Uncontrolled systemic disease that impedes bone healing
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 |
|---|---|---|
| Aqua alvim CM, neodent implant (Test)Acqua, Hydrophilic sandblasted, and acid-etched dental implants | Other | Hydrophilic sandblasted and acid-etched dental implants |
| Neoporous alvim CM, neodent implant (Control)Neoporous, Hydrophilic sandblasted, and acid-etched dental implants | Other | Conventional hydrophobic sandblasted and acid-etched dental implant |
Primary outcome
Change in implant stability
Time frame: at baseline and 6 months
The implant stability measurement was examined at the time of insertion of the implants (primary stability) and 6 months (secondary stability) for the two groups of patients using the resonance Frequency Analysis (RFA) via the Osstell ISQ system
Change in bone density
Time frame: at baseline and 6 months
Cone beam Computerized tomography was used to assess bone denisty
Change in ridge height
Time frame: at baseline and 6 months
Cone beam Computerized tomography was used to assess ridge height
Biochemical assessment of bone formation
Time frame: at 3 months
Done by measuring of Runt-related transcription factor 2 (RUNX2) as a bone marker by Enzyme-Linked Immunosorbent Assay
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 18 Jan 2022.
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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.
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 Aqua alvim CM, neodent implant (Test) in people with Dental Implants and Surface Treatment, run by Hams Hamed Abdelrahman 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 8 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 18 Jan 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?
Change in implant stability (time frame: at baseline and 6 months). 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 18 Jan 2022.