Effect of Nitroglycerin Hydrogel on Repairing Critical Bone Defects

NCT06925763 | Not Yet Recruiting

• 2 other identifiers: Nitroglycerin bone healingethical committee no. 108
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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).

Conditions

Bone Regeneration; Periodontal Bone Loss; Healing Fracture of Bone

Keywords

nitroglycerin,; bone regeneration; critical size defect

Outcome Measures

Primary Outcomes (1)

• radiographic analysis

  bone formation in the critical size was evaluated by radiographic measurements

  baseline, 2months

Study Arms (3)

control group

PLACEBO COMPARATOR

Drug: Nitroglycerin

the study group 1

EXPERIMENTAL

was filled with 30 μM Nitroglycerin-loaded hydrogel (positive control)

Drug: Nitroglycerin

Study group 2

EXPERIMENTAL

was filled with 50 μM Nitroglycerin-loaded hydrogel (positive control).

Drug: Nitroglycerin

Interventions

Nitroglycerin DRUG

cardiac disease treatment drug

Study group 2; control group; the study group 1

Eligibility Criteria

• Age: Up to 7 Months
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Shaimaa Hamdy

Cairo, Cairo- Egypt, 12345, Egypt

Location

Related Publications (1)

• Rodriguez-Eguren A, Bueno-Fernandez C, Gomez-Alvarez M, Frances-Herrero E, Pellicer A, Bellver J, Seli E, Cervello I. Evolution of biotechnological advances and regenerative therapies for endometrial disorders: a systematic review. Hum Reprod Update. 2024 Oct 1;30(5):584-613. doi: 10.1093/humupd/dmae013.

  PMID: 38796750 BACKGROUND

Related Links

• Nitroglycerin in bone regeneration

MeSH Terms

Conditions

Alveolar Bone Loss

Interventions

Nitroglycerin

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Nitro Compounds; Organic Chemicals

Central Study Contacts

shaimaa Hamdy, lecturer of Periodontology

CONTACT

+201030576405; shimaa.3m.sh@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Shaimaa Hamdy principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 13, 2025
• Study Start: April 1, 2025
• Primary Completion: April 3, 2025
• Study Completion: August 1, 2025
• Last Updated: April 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)