Osseointegration Failure of Dental ImplantNCT06758440
Effectiveness of Hydroxyapatite Reinforced Chitosan Hydrogel in Modulation of Osseointegration
A study testing chitosan in people with Osseointegration Failure of Dental Implant, run by Minia University at 1 site in Egypt.
Trial summary
Dental implant treatments have now become indispensable in clinical dental practice. The survival rate exceeds 90%; Modern oral implantology uses different devices, in terms of size, shape, length, thickness and composition, from pure titanium to titanium-aluminum-vanadium alloys, due to their biocompatibility and… Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Osseointegration Failure of Dental Implant
- What is being tested?
- chitosan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Mar 2023to 30 Mar 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy patients (class I category according to American society of anesthesiologists )
- Over 20 years and under 50 years of age
- Either gender
- Patients seeking extraction and placement of immediate dental implant for mandibular teeth.
Who cannot join
- Any acute infection in surgical sites
- Long term non-steroidal anti-inflammatory drug therapy
- Periodontal disease with bone loss
- Known allergy to any of the materials used in the study
- Patients with severely atrophic ridges requiring a staged grafting procedure
- Patients with significant medical condition
Show all 10Show fewer
- Alcoholic individuals
- Patients on drugs that affect the central nervous systems
- Patients who reported the use of drugs that might interfere with pain sensitivity
- Pregnant and lactating
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Hydroxyapatite Reinforced Chitosan Hydrogel in Modulation of Osseintegration Round Immediate Dental Implant Randomized Single Blind Control Study
Dental implant treatments have now become indispensable in clinical dental practice. The survival rate exceeds 90%; Modern oral implantology uses different devices, in terms of size, shape, length, thickness and composition, from pure titanium to titanium-aluminum-vanadium alloys, due to their biocompatibility and high corrosion resistance
Read the detailed description
Immediate implants placed in freshly extracted sockets are an alternative treatment for traditional dental implants reduces physiological resorption of alveolar ridge, provides fast and simple procedures , decreasing the number of dental appointments, shortening length of treatment time, lesser surgical intervention, and ideal axial orientation of the implant.
However, the biological response of tissues can be improved by different surface treatments that provide both bioactivity and osseointegration capacity. Many materials have been advocated for boosting up the bone regeneration.
Current trends are directed not only towards achieving optimal osseointegrative surfaces, but also towards antibacterial activity for prolonged periods of time, either by blocking microbial adhesion and preventing late infections.
Given their biocompatibility and biodegradability, natural polymers are widely used materials for bone grafting. Among them, chitosan, collagen, silk fibroin, gelatin, cellulose, alginate. Chitosan is an excellent candidate for bone reconstruction as it has antimicrobial properties, can generate porous structures suitable for cell growth and osteoconduction, and promotes osteoblast cell proliferation. Furthermore, its structure is similar to glycosaminoglycans, a component of the bone extracellular matrix.
Chitosan has been formulated in different systems for bone tissue engineering, including scaffolds, sponges, hydrogels, micro-nanospheres, and membranes, among others ; capable of accelerating the formation of new bone integrated into the host bone without causing adverse reactions .
A large number of studies on chitosan-based gel scaffolds for bone regeneration can be found in the literature. It is usual to develop systems that combine chitosan with other compounds as hydroxyapatite to improve properties such as osteoconductivity and mechanical properties and thus obtain materials that mimic natural bone as much as possible.
Hydrogels have also been studied for surgical applications. These systems consist of a liquid phase, which generally comprises 90% of the formulation, trapped in a solid phase that gives the gel its structure . This water content makes these systems highly biocompatible, and their soft consistency prevents damage to surrounding tissues. Chitosan hydrogels show similar mechanical properties to connective tissues, which favors tissue regeneration.
- Being tested
- chitosan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chitosanDrug
Also called hydroxyapatite hydrogel
Evaluate Effectiveness of hydroxyapatite reinforced chitosan hydrogel in modulation of osseintegration round immediate dental implant in a Randomized single blind control study
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | About 10 patients injected by chitosan/ hydroxyapatite hydrogel in the extracted socket in a back fill injection manner prior to immediate implant placement and then covered with HemCon dental dressing Pro Receives: Drug: chitosan |
| Group B | Active comparator | About 10 patients received dental immediate implant placement Spectra system Receives: Drug: chitosan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical assessment of osseintegration
Early follow up was performed daily for appearing any complications pre-operative or post-operative.
Measured: 6 months
Secondary outcomes (1)
Radiographic assessment
Difference in bone density (in Hounsfield units) using CBC and marginal bone level in mm using CBCT
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start28 Mar 2023
- Primary completion20 Mar 2024
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osseointegration Failure of Dental ImplantStudies of the same condition, open and under way.
- More trials run by Minia 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarek Abdelbarry, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06758440
- Sponsor's protocol ID
- Osseintegration
- Status last verified
- Mar 2023
- First submitted
- 16 May 2023
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Hydroxyapatite Reinforced Chitosan Hydrogel in Modulation of Osseintegration Round Immediate Dental Implant Randomized Single Blind Control Study
- ClinicalTrials.gov ID
- NCT06758440
- Acronym / sponsor ID
- Osseintegration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 28 Mar 2023 (actual)
- Primary completion
- 20 Mar 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 3 Jan 2025 (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 implant treatments have now become indispensable in clinical dental practice. The survival rate exceeds 90%; Modern oral implantology uses different devices, in terms of size, shape, length, thickness and composition, from pure titanium to titanium-aluminum-vanadium alloys, due to their biocompatibility and high corrosion resistance
Detailed description
Immediate implants placed in freshly extracted sockets are an alternative treatment for traditional dental implants reduces physiological resorption of alveolar ridge, provides fast and simple procedures , decreasing the number of dental appointments, shortening length of treatment time, lesser surgical intervention, and ideal axial orientation of the implant.
However, the biological response of tissues can be improved by different surface treatments that provide both bioactivity and osseointegration capacity. Many materials have been advocated for boosting up the bone regeneration.
Current trends are directed not only towards achieving optimal osseointegrative surfaces, but also towards antibacterial activity for prolonged periods of time, either by blocking microbial adhesion and preventing late infections.
Given their biocompatibility and biodegradability, natural polymers are widely used materials for bone grafting. Among them, chitosan, collagen, silk fibroin, gelatin, cellulose, alginate. Chitosan is an excellent candidate for bone reconstruction as it has antimicrobial properties, can generate porous structures suitable for cell growth and osteoconduction, and promotes osteoblast cell proliferation. Furthermore, its structure is similar to glycosaminoglycans, a component of the bone extracellular matrix.
Chitosan has been formulated in different systems for bone tissue engineering, including scaffolds, sponges, hydrogels, micro-nanospheres, and membranes, among others ; capable of accelerating the formation of new bone integrated into the host bone without causing adverse reactions .
A large number of studies on chitosan-based gel scaffolds for bone regeneration can be found in the literature. It is usual to develop systems that combine chitosan with other compounds as hydroxyapatite to improve properties such as osteoconductivity and mechanical properties and thus obtain materials that mimic natural bone as much as possible.
Hydrogels have also been studied for surgical applications. These systems consist of a liquid phase, which generally comprises 90% of the formulation, trapped in a solid phase that gives the gel its structure . This water content makes these systems highly biocompatible, and their soft consistency prevents damage to surrounding tissues. Chitosan hydrogels show similar mechanical properties to connective tissues, which favors tissue regeneration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: chitosanAbout 10 patients injected by chitosan/ hydroxyapatite hydrogel in the extracted socket in a back fill injection manner prior to immediate implant placement and then covered with HemCon dental dressing Pro |
| Group B | Active comparator | Drug: chitosanAbout 10 patients received dental immediate implant placement Spectra system |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy patients (class I category according to American society of anesthesiologists )
- Over 20 years and under 50 years of age
- Either gender
- Patients seeking extraction and placement of immediate dental implant for mandibular teeth.
Key exclusion criteria (10 listed)
- Any acute infection in surgical sites
- Long term non-steroidal anti-inflammatory drug therapy
- Periodontal disease with bone loss
- Known allergy to any of the materials used in the study
- Patients with severely atrophic ridges requiring a staged grafting procedure
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 |
|---|---|---|
| chitosanAlso: hydroxyapatite hydrogelEvaluate Effectiveness of hydroxyapatite reinforced chitosan hydrogel in modulation of osseintegration round immediate dental implant in a Randomized single blind control study | Drug | Group A, Group B |
Primary outcome
Clinical assessment of osseintegration
Time frame: 6 months
Early follow up was performed daily for appearing any complications pre-operative or post-operative.
1 secondary outcome
Radiographic assessment
Time frame: 6 months
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 3 Jan 2025.
- 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.
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 chitosan in people with Osseointegration Failure of Dental Implant, run by Minia 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 4 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: finished, as of the sponsor's last update on 3 Jan 2025. 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?
Clinical assessment of osseintegration (time frame: 6 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 3 Jan 2025.