Effectiveness of Hydroxyapatite Reinforced Chitosan Hydrogel in Modulation of Osseointegration
1 other identifier
interventional
20
1 country
1
Brief 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 high corrosion resistance
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 28, 2023
CompletedFirst Submitted
Initial submission to the registry
May 16, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 20, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2024
CompletedFirst Posted
Study publicly available on registry
January 3, 2025
CompletedJanuary 3, 2025
March 1, 2023
12 months
May 16, 2023
January 2, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical assessment of osseintegration
Early follow up was performed daily for appearing any complications pre-operative or post-operative.
6 months
Secondary Outcomes (1)
Radiographic assessment
6 months
Study Arms (2)
Group A
ACTIVE COMPARATORAbout 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 COMPARATORAbout 10 patients received dental immediate implant placement Spectra system
Interventions
Evaluate Effectiveness of hydroxyapatite reinforced chitosan hydrogel in modulation of osseintegration round immediate dental implant in a Randomized single blind control study
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Minia Universitylead
Study Sites (1)
Faculty of Dentistry, Minia University
Minya, 2431412, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of Oral and Maxillofacial Surgery
Study Record Dates
First Submitted
May 16, 2023
First Posted
January 3, 2025
Study Start
March 28, 2023
Primary Completion
March 20, 2024
Study Completion
March 30, 2024
Last Updated
January 3, 2025
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share