Effectiveness of Hydroxyapatite Reinforced Chitosan Hydrogel in Modulation of Osseointegration

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

Study Overview

• Status: Completed
• Conditions: Osseointegration Failure of Dental Implant
• Intervention / Treatment: Drug: chitosan

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Minya, Egypt, 2431412
    • Faculty of dentistry, Minia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; 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	Drug: chitosan; Evaluate Effectiveness of hydroxyapatite reinforced chitosan hydrogel in modulation of osseintegration round immediate dental implant in a Randomized single blind control study; Other Names: hydroxyapatite hydrogel
Active Comparator: Group B; About 10 patients received dental immediate implant placement Spectra system	Drug: chitosan; Evaluate Effectiveness of hydroxyapatite reinforced chitosan hydrogel in modulation of osseintegration round immediate dental implant in a Randomized single blind control study; Other Names: hydroxyapatite hydrogel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical assessment of osseintegration	Early follow up was performed daily for appearing any complications pre-operative or post-operative.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic assessment	Difference in bone density (in Hounsfield units) using CBC and marginal bone level in mm using CBCT	6 months

Collaborators and Investigators

• Sponsor: Minia University

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2023
• Primary Completion (Actual): March 20, 2024
• Study Completion (Actual): March 30, 2024

Study Registration Dates

• First Submitted: May 16, 2023
• First Submitted That Met QC Criteria: January 2, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 2, 2025
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Hemostatics; Coagulants; Antimetabolites; Chelating Agents; Sequestering Agents; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Chitosan
• Other Study ID Numbers: Osseintegration

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No