Dental ImplantsNCT06650280
Assessment of Rapid Osseointegration of Dental Implants with Different Coatings
A study testing Hyaluronic Acid (HA), nano-hydroxyapatite and sandblasted acid etched in people with Dental Implants and Hyaluronic Acid, run by October University for Modern Sciences and Arts at 1 site in Egypt.
Trial summary
The study will assess early osseointegration of dental implant with three different coating materials through secondary implant stability Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implants, Hyaluronic Acid
- What is being tested?
- Hyaluronic Acid (HA), nano-hydroxyapatite and sandblasted acid etched
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2023to 1 Jun 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.
About this study
Official title: Assessment of Osseointegration of Dental Implants with Three Different Coatings for Early Loading Purpose and Marginal Bone Loss in the Posterior Maxilla. a Randomized Clinical Trial
The study will assess early osseointegration of dental implant with three different coating materials through secondary implant stability
Read the detailed description
Dental implants with sandblasted acid itched coating, nano-hydroxyapatite coating, and hyalouronic acid coating will be placed in the posterior maxilla to restore a missing tooth. Implant stability by the use of Ostell will be measured immediately post-operative, 4, 6, and 12 weeks post-operative.
marginal bone loss around the implants will be compared immediately after final restoration delivery and after one year
- Conditions
- Dental Implants, Hyaluronic Acid
- Being tested
- Hyaluronic Acid (HA), nano-hydroxyapatite, sandblasted acid etched
- Keywords
- dental implants, rapid osseointegration, early loading
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic Acid (HA)Other
hyaluronic acid coated implants will be placed in posterior maxilla to evaluate rapid osseointegration
nano-hydroxyapatiteOther
nano-hydroxyapatite coated implants will be placed in posterior maxilla to assess rapid osseointegration
sandblasted acid etchedOther
SLA coated implants will be placed in posterior maxilla and implant stability will be evaluated
| Study group | Role | What they receive |
|---|---|---|
| sandblasted acid etched group | Experimental | sandblasted acid etched coated implants will be allocated to this arm Receives: Other: sandblasted acid etched |
| nano-hydroxyapatite group | Active comparator | nano-hydroxyapatite coated implants will be allocated to this arm Receives: Other: nano-hydroxyapatite |
| hyaluronic acid group | Experimental | hyaluronic acid coated implants will be allocated to this arm Receives: Other: Hyaluronic Acid (HA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
rapid osseintegration
rapid osteointegration of dental implants will be evaluated by the use of Ostell device which measures primary and secondary stability expressed as ISQ measures ranging from zero till 90
Measured: immediately post-operative, 4, 6, and 12 weeks post-operative
Secondary outcomes (1)
marginal bone loss
the bone height from implant's platform till implant's tip will be measured and compared between immediately after final restoration delivery and after one year
Measured: immediately after final restoration delivery and one year post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start1 Feb 2023
- Primary completion1 Feb 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 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 Hamdy, Lecturer, Principal investigator, Faculty of Dentistry, MSA University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06650280
- Sponsor's protocol ID
- 31910-4
- Status last verified
- Oct 2024
- First submitted
- 17 Oct 2024
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Atsumi M, Park SH, Wang HL. Methods used to assess implant stability: current status. Int J Oral Maxillofac Implants. 2007 Sep-Oct;22(5):743-54.
PubMed 17974108
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Osseointegration of Dental Implants with Three Different Coatings for Early Loading Purpose and Marginal Bone Loss in the Posterior Maxilla. a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06650280
- Acronym / sponsor ID
- 31910-4
- Conditions
- Dental Implants, Hyaluronic Acid
- Keywords
- dental implants, rapid osseointegration, early loading
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- October University for Modern Sciences and ArtsUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 21 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.
The study will assess early osseointegration of dental implant with three different coating materials through secondary implant stability
Detailed description
Dental implants with sandblasted acid itched coating, nano-hydroxyapatite coating, and hyalouronic acid coating will be placed in the posterior maxilla to restore a missing tooth. Implant stability by the use of Ostell will be measured immediately post-operative, 4, 6, and 12 weeks post-operative.
marginal bone loss around the implants will be compared immediately after final restoration delivery and after one year
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| sandblasted acid etched group | Experimental | Other: sandblasted acid etchedsandblasted acid etched coated implants will be allocated to this arm |
| nano-hydroxyapatite group | Active comparator | Other: nano-hydroxyapatitenano-hydroxyapatite coated implants will be allocated to this arm |
| hyaluronic acid group | Experimental | Other: Hyaluronic Acid (HA)hyaluronic acid coated implants will be allocated to this arm |
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 |
|---|---|---|
| Hyaluronic Acid (HA)hyaluronic acid coated implants will be placed in posterior maxilla to evaluate rapid osseointegration | Other | hyaluronic acid group |
| nano-hydroxyapatitenano-hydroxyapatite coated implants will be placed in posterior maxilla to assess rapid osseointegration | Other | nano-hydroxyapatite group |
| sandblasted acid etchedSLA coated implants will be placed in posterior maxilla and implant stability will be evaluated | Other | sandblasted acid etched group |
Primary outcome
rapid osseintegration
Time frame: immediately post-operative, 4, 6, and 12 weeks post-operative
rapid osteointegration of dental implants will be evaluated by the use of Ostell device which measures primary and secondary stability expressed as ISQ measures ranging from zero till 90
1 secondary outcome
marginal bone loss
Time frame: immediately after final restoration delivery and one year post-operative
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 21 Oct 2024.
- Background: PubMed 17974108Atsumi M, Park SH, Wang HL. Methods used to assess implant stability: current status. Int J Oral Maxillofac Implants. 2007 Sep-Oct;22(5):743-54.
- Individual participant dataSharing planned: No
Related trials for Dental Implants
Not yet recruiting
Free Soft Tissue Grafts (FSTG) Using Autograft Palatal Donor Tissue vs. Xenograft Collagen Matrix (Zderm™)
Gingival Recession Localized Moderate, Dental Implant
Not yet recruiting
Safety Assessment of Placing a Single Dental Implant Without Antibiotic Prophylaxis in Simple Cases: A Pilot Study
Tooth Loss and Rehabillitation, Dental Implant Failure
RecruitingObservational study
Clinical and Radiographic Evaluation of Dentsply Sirona PrimeTaper Implants
Dental Implants
Active, not recruiting
The Aim of the Study Will be Clinically and Radio Graphically Comparison of Two Implant Designs Used to Treat Atrophied Mandible . Implant Design Comparison Will Done for Implant Stability,Peri-implant Soft Tissue Health Changes and Bone Changes .Patients Will be Divided Randomly Into Two Group
Dental Implant Bone Loss, Peri-Implant Health
Not yet recruiting
Effect of Ascorbic Acid-Loaded I-PRF With Partially Demineralized Dentin Graft on Alveolar Ridge Preservation
Alveolar Ridge Preservation Post-Extraction Bone Healing Dental Implant Site Development Tooth Loss, Alveolar Bone Regeneration Following Odontectomy
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 Hamdy, Lecturer principal investigator
Faculty of Dentistry, MSA University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyaluronic Acid (HA), nano-hydroxyapatite and sandblasted acid etched in people with Dental Implants and Hyaluronic Acid, 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 21 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?
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?
rapid osseintegration (time frame: immediately post-operative, 4, 6, and 12 weeks post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06650280, which also lists 1 linked publication.
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 21 Oct 2024.