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Effect of Nitroglycerin Hydrogel on Repairing Critical Bone Defects

Unlocking the Regenerative Potential: The Effect of Nitroglycerin Hydrogel on Repairing Critical Bone Defects (Experimental Study)

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06925763
Acronym
Nitro- Bone
Enrollment
33
Registered
2025-04-13
Start date
2025-04-01
Completion date
2025-08-01
Last updated
2025-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Regeneration, Healing Fracture of Bone, Periodontal Bone Loss

Keywords

nitroglycerin,, bone regeneration, critical size defect

Brief summary

Due to their osteoconductive, osteoinductive, and osteogenic qualities, autologous bone grafts are the gold standard for augmenting bone, (1). However, problems, insufficient bone quantity, and/ or quality at the donor location could prevent it from being used. Consequently, a variety of bone graft materials, such as allografts and/or xenografts, were developed to improve bone development and provide an osteoconductive matrix in the so-called hard tissue critical-size defect (CSD) (2). critically-sized defect is regarded as one that would not heal spontaneously despite surgical stabilization and requires further surgical intervention (3). The management of critical-sized bone defects remains a major clinical orthopedic challenge. Critical-sized bone defects are technically defined as those that will not heal spontaneously during the patient's lifetime. Bone loss greater than 2 times the diameter of the long bone diaphysis is unlikely to result in union despite appropriate stabilization methods (4). Nitroglycerin, also known as glyceryl trinitrate (GTN), is a medication commonly used to treat heart conditions like angina pectoris and chronic heart failure. It acts as a potent vasodilator, dilating the vascular system to improve blood flow. Nitroglycerin has been found to have a positive effect on bone formation. Studies indicate that Nitroglycerin when applied topically, can increase bone formation and reduce bone resorption. This effect is achieved through the stimulation of osteoblastic differentiation and proliferation (5). The mechanism of action of Nitroglycerin in bone formation involves its conversion into nitric oxide (NO), which plays a crucial role in stimulating bone formation. Nitric oxide released from nitroglycerin acts as a signaling molecule that enhances osteoblastic differentiation and proliferation of bone marrow-derived mesenchymal stem cells. This process leads to increased bone mineral density, improved bone geometry, and enhanced bone strength (5). Hydrogels are natural or synthetic biocompatible polymers that are widely used in periodontal tissue engineering as a delivery material for different biologics (6). Synthetic hydrogels have superiority in chemical and mechanical properties over natural hydrogels (7). Carbopol or polyacrylic acid (PAA) is one of the most widely used polymers as a hydrogel. It is an anionic polyelectrolyte that can be readily polymerized and crosslinked to form hydrogels with a swelling capacity greater than their dry weight (8).

Detailed description

Aim of the study Histomorphometric analysis of Regenerative Capacity of Nitroglycerin-loaded hydrogel in management of critical size bone defect in Experimental study. Materials and Methods

Interventions

DRUGNitroglycerin

cardiac disease treatment drug

Sponsors

Minia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Intervention model description

All the animals were adult, ranging in age from 3 to 7 months and in weight between 250 and 350 g. The control group: was filled with a placebo hydrogel negative control. while the study group 1: was filled with 30 μM Nitroglycerin-loaded hydrogel positive control. Study group 2: was filled with 50 μM Nitroglycerin-loaded hydrogel positive control. thirty-three rats will be sacrificed after two weeks, and the others will be saved.

Eligibility

Sex/Gender
ALL
Age
No minimum to 7 Months
Healthy volunteers
No

Inclusion criteria

* All animals were adult with an age ranging between 3 to 7 months and a weight ranging between 250 and 350 g

Exclusion criteria

* other than inclusion

Design outcomes

Primary

MeasureTime frameDescription
radiographic analysisbaseline, 2monthsbone formation in the critical size was evaluated by radiographic measurements

Countries

Egypt

Contacts

Primary Contactshaimaa Hamdy, lecturer of Periodontology
shimaa.3m.sh@gmail.com+201030576405

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026