Bone RegenerationNitro- BoneNCT06925763
Effect of Nitroglycerin Hydrogel on Repairing Critical Bone Defects
A study testing Nitroglycerin in people with Bone Regeneration and Periodontal Bone Loss, run by Minia University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 7 months
- Conditions the study is for
- Bone Regeneration, Periodontal Bone Loss, Healing Fracture of Bone
- What is being tested?
- Nitroglycerin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2025to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Up to 7 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All animals were adult with an age ranging between 3 to 7 months and a weight ranging between 250 and 350 g
Who cannot join
- other than inclusion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
shaimaa Hamdy, lecturer of Periodontology contact
About this study
Official title: Unlocking the Regenerative Potential: The Effect of Nitroglycerin Hydrogel on Repairing Critical Bone Defects (Experimental Study)
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).
Read more
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).
Read the 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
- Being tested
- Nitroglycerin
- Keywords
- nitroglycerin,, bone regeneration, critical size defect
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NitroglycerinDrug
cardiac disease treatment drug
| Study group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | Not described Receives: Drug: Nitroglycerin |
| the study group 1 | Experimental | was filled with 30 μM Nitroglycerin-loaded hydrogel (positive control) Receives: Drug: Nitroglycerin |
| Study group 2 | Experimental | was filled with 50 μM Nitroglycerin-loaded hydrogel (positive control). Receives: Drug: Nitroglycerin |
What is being measured
The primary outcome is the main question the study is designed to answer.
radiographic analysis
bone formation in the critical size was evaluated by radiographic measurements
Measured: baseline, 2months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study start1 Apr 2025 (estimated)
- Primary completion3 Apr 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bone RegenerationStudies 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
- 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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, shaimaa hamdy, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06925763
- Sponsor's protocol ID
- Nitroglycerin bone healing
- Other IDs
- ethical committee no. 108
- Acronym
- Nitro- Bone
- Status last verified
- Jan 2025
- First submitted
- 7 Apr 2025
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38796750
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unlocking the Regenerative Potential: The Effect of Nitroglycerin Hydrogel on Repairing Critical Bone Defects (Experimental Study)
- ClinicalTrials.gov ID
- NCT06925763
- Acronym / sponsor ID
- Nitro- Bone / Nitroglycerin bone healing
- Keywords
- nitroglycerin,, bone regeneration, critical size defect
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 3 Apr 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 13 Apr 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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Drug: Nitroglycerin |
| the study group 1 | Experimental | Drug: Nitroglycerinwas filled with 30 μM Nitroglycerin-loaded hydrogel (positive control) |
| Study group 2 | Experimental | Drug: Nitroglycerinwas filled with 50 μM Nitroglycerin-loaded hydrogel (positive control). |
Who may qualify
- Ages
- Up to 7 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All animals were adult with an age ranging between 3 to 7 months and a weight ranging between 250 and 350 g
Key exclusion criteria (1 listed)
- other than inclusion
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 |
|---|---|---|
| Nitroglycerincardiac disease treatment drug | Drug | Study group 2, control group, the study group 1 |
Primary outcome
radiographic analysis
Time frame: baseline, 2months
bone formation in the critical size was evaluated by radiographic measurements
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
- Background: PubMed 38796750Rodriguez-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.
- Nitroglycerin in bone regenerationLink provided by the sponsor.
- 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.
shaimaa Hamdy, lecturer of Periodontology contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nitroglycerin in people with Bone Regeneration and Periodontal Bone Loss, 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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 13 Apr 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact shaimaa Hamdy, lecturer of Periodontology (+201030576405 ext. +201555035523, shimaa.3m.sh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
radiographic analysis (time frame: baseline, 2months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06925763, which also lists 1 linked publication.
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 13 Apr 2025.