Necrotic PulpNCT06653608
Clinical Efficacy of Novel Jasminum-based Calcium Hydroxide Medicament
A study testing Nano-reinforced calcium hydroxide medicament and Calcium hydroxide without nanoparicles in people with Necrotic Pulp and Acute Apical Periodontitis of Pulpal Origin, run by Pakistan Institute of Medical Sciences at 1 site in Pakistan.
Trial summary
A triple-blind, parallel group, randomized trial with an allocation ratio of 1:1. Participants randomly allocated into two groups A and B. In group A, nano-reinforced calcium hydroxide medicament was utilized while in group B, calcium hydroxide medicament without nanoparticles was used. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Necrotic Pulp, Acute Apical Periodontitis of Pulpal Origin
- What is being tested?
- Nano-reinforced calcium hydroxide medicament and Calcium hydroxide without nanoparicles
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 24 Apr 2024to 25 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants with good general health status
- Necrotic pulp with Symptomatic Apical Periodontitis
- Single rooted teeth
Who cannot join
- Non-restorable teeth
- Teeth associated with acute or chronic apical abscess
- Teeth with chronic periodontitis
- Teeth with anatomical complexities or complications like open apex, calcified canal, severe root dilaceration, root resorptive defects
- Participants who received antibiotic treatment during the last 3 months
- Pregnant females
- Participants on pre-treatment analgesics
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
School of Dentistry, Shaheed Zulfiqar Ali Bhutto Medical University
Islamabad
About this study
Official title: Clinical Efficacy of Novel Jasminum-based Nano-reinforced Calcium Hydroxide Medicament on Postoperative Pain: a Triple-blind Study
A triple-blind, parallel group, randomized trial with an allocation ratio of 1:1. Participants randomly allocated into two groups A and B. In group A, nano-reinforced calcium hydroxide medicament was utilized while in group B, calcium hydroxide medicament without nanoparticles was used. Post-operative pain was assessed after 4 hours, 24 hours, 48 hours, 72 hours, 96 hours.
Read the detailed description
This triple-blind parallel group, randomized clinical trial was conducted at the department of Operative Dentistry and Endodontics, School of Dentistry from April 24, 2024 to September 25, 2024. Participants were randomly distributed into two groups by Lottery method. A consecutive non-probability sampling technique was used. Before initiating treatment, participants were briefed about the intervention and their preoperative pain score was recorded. In both groups, endodontic treatment was initiated under rubber dam isolation. Access opening done and canals explored. Working length taken by radiographic method and reconfirmed by an electronic apex locator. Afterwards, canals were prepared till Master Apical File size F2 (4% Taper). In group A, Nano-reinforced calcium hydroxide medicament was placed while in group B, calcium hydroxide without nanoparticles was utilized. Participants were instructed to rate their postoperative pain record after 4hrs, 24hrs, 48hrs, 72hrs and 96hrs.
- Being tested
- Nano-reinforced calcium hydroxide medicament, Calcium hydroxide without nanoparicles
- Keywords
- Endodontic, Necrotic pulp, Apical Periodontitis
- Medical subject headings
- Dental Pulp Necrosis, Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nano-reinforced calcium hydroxide medicamentDrug
Also called Group A
Group A (Calcium hydroxide intracanal medicament reinforced with jasminum derived- titania nanoparticles)
Calcium hydroxide without nanopariclesDrug
Also called Group B
Group B ( Calcium hydroxide medicament without nanoparticles)
| Study group | Role | What they receive |
|---|---|---|
| Group A (Nano-reinforced Calcium hydroxide) | Experimental | Nano-reinforced Calcium hydroxide Medicament Receives: Drug: Nano-reinforced calcium hydroxide medicament |
| Group B (Conventional Calcium hydroxide) | Experimental | Calcium hydroxide without nanoparticles Receives: Drug: Calcium hydroxide without nanoparicles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain
Pain scores assessed by Visual Analogue Scale (VAS) score after 4hr, 24hrs, 48hrs, 72hrs, 96hrs. The minimum score is O (None) and the maximum score is 10 (Severe).
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start24 Apr 2024
- Primary completion25 Sep 2024
- Study completion25 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Necrotic PulpStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Medical Sciences
- Sponsor type
- Other government
- Responsible party
- Principal investigator, NEHAL AMIR, Pakistan Institute of Medical Sciences
- Investigators
- Nehal Amir, BDS, Principal investigator, Pakistan Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06653608
- Sponsor's protocol ID
- SOD/ERB/2024/58
- Status last verified
- Oct 2024
- First submitted
- 19 Oct 2024
- Last updated
- 30 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khan AM, Gangoo IKA, Ali NA, Khan M, Javed MQ, AlAttas MH, Abulhamael AM, Bahammam HA, Alsofi L, Yahya RSA. The Effect of Calcium Hydroxide, Triple Antibiotic Paste and Chlorhexidine on Pain in Teeth with Symptomatic Apical Periodontitis: A Randomised Controlled Trial. Int J Environ Res Public Health. 2023 Feb 10;20(4):3091. doi: 10.3390/ijerph20043091.
PubMed 36833788Ghanbarzadegan A, Ajami M, Aminsobhani M. The Effect of Different Combinations of Calcium Hydroxide as Intra-Canal Medicament on Endodontic Pain: A Randomized Clinical Trial Study. Iran Endod J. 2019 Winter;14(1):1-6. doi: 10.22037/iej.v14i1.22815.
PubMed 36879602Amir N, Mansoor E, Eeman N, Ahmed MN, Mansoor E, Mansoor E, Hussain K, Afreixo V, Mansoor A, Brochado Martins JF, Palma PJ. Jasminum-based Nano-reinforced Calcium Hydroxide Reduces Postoperative Pain in Symptomatic Apical Periodontitis: A Randomized Controlled Trial. J Endod. 2025 Aug;51(8):996-1005. doi: 10.1016/j.joen.2025.05.016. Epub 2025 Jun 2.
PubMed 40466913
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Novel Jasminum-based Nano-reinforced Calcium Hydroxide Medicament on Postoperative Pain: a Triple-blind Study
- ClinicalTrials.gov ID
- NCT06653608
- Acronym / sponsor ID
- SOD/ERB/2024/58
- Keywords
- Endodontic, Necrotic pulp, Apical Periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Pakistan Institute of Medical SciencesOther government
- Study start
- 24 Apr 2024 (actual)
- Primary completion
- 25 Sep 2024 (actual)
- Study completion
- 25 Sep 2024 (actual)
- First posted
- 22 Oct 2024 (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.
A triple-blind, parallel group, randomized trial with an allocation ratio of 1:1. Participants randomly allocated into two groups A and B. In group A, nano-reinforced calcium hydroxide medicament was utilized while in group B, calcium hydroxide medicament without nanoparticles was used. Post-operative pain was assessed after 4 hours, 24 hours, 48 hours, 72 hours, 96 hours.
Detailed description
This triple-blind parallel group, randomized clinical trial was conducted at the department of Operative Dentistry and Endodontics, School of Dentistry from April 24, 2024 to September 25, 2024. Participants were randomly distributed into two groups by Lottery method. A consecutive non-probability sampling technique was used. Before initiating treatment, participants were briefed about the intervention and their preoperative pain score was recorded. In both groups, endodontic treatment was initiated under rubber dam isolation. Access opening done and canals explored. Working length taken by radiographic method and reconfirmed by an electronic apex locator. Afterwards, canals were prepared till Master Apical File size F2 (4% Taper). In group A, Nano-reinforced calcium hydroxide medicament was placed while in group B, calcium hydroxide without nanoparticles was utilized. Participants were instructed to rate their postoperative pain record after 4hrs, 24hrs, 48hrs, 72hrs and 96hrs.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Nano-reinforced Calcium hydroxide) | Experimental | Drug: Nano-reinforced calcium hydroxide medicamentNano-reinforced Calcium hydroxide Medicament |
| Group B (Conventional Calcium hydroxide) | Experimental | Drug: Calcium hydroxide without nanopariclesCalcium hydroxide without nanoparticles |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participants with good general health status
- Necrotic pulp with Symptomatic Apical Periodontitis
- Single rooted teeth
Key exclusion criteria (7 listed)
- Non-restorable teeth
- Teeth associated with acute or chronic apical abscess
- Teeth with chronic periodontitis
- Teeth with anatomical complexities or complications like open apex, calcified canal, severe root dilaceration, root resorptive defects
- Participants who received antibiotic treatment during the last 3 months
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 |
|---|---|---|
| Nano-reinforced calcium hydroxide medicamentAlso: Group AGroup A (Calcium hydroxide intracanal medicament reinforced with jasminum derived- titania nanoparticles) | Drug | Group A (Nano-reinforced Calcium hydroxide) |
| Calcium hydroxide without nanopariclesAlso: Group BGroup B ( Calcium hydroxide medicament without nanoparticles) | Drug | Group B (Conventional Calcium hydroxide) |
Primary outcome
Post-operative pain
Time frame: One week
Pain scores assessed by Visual Analogue Scale (VAS) score after 4hr, 24hrs, 48hrs, 72hrs, 96hrs. The minimum score is O (None) and the maximum score is 10 (Severe).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2024.
- Background: PubMed 36833788Khan AM, Gangoo IKA, Ali NA, Khan M, Javed MQ, AlAttas MH, Abulhamael AM, Bahammam HA, Alsofi L, Yahya RSA. The Effect of Calcium Hydroxide, Triple Antibiotic Paste and Chlorhexidine on Pain in Teeth with Symptomatic Apical Periodontitis: A Randomised Controlled Trial. Int J Environ Res Public Health. 2023 Feb 10;20(4):3091. doi: 10.3390/ijerph20043091.
- Background: PubMed 36879602Ghanbarzadegan A, Ajami M, Aminsobhani M. The Effect of Different Combinations of Calcium Hydroxide as Intra-Canal Medicament on Endodontic Pain: A Randomized Clinical Trial Study. Iran Endod J. 2019 Winter;14(1):1-6. doi: 10.22037/iej.v14i1.22815.
- Derived from this study: PubMed 40466913Amir N, Mansoor E, Eeman N, Ahmed MN, Mansoor E, Mansoor E, Hussain K, Afreixo V, Mansoor A, Brochado Martins JF, Palma PJ. Jasminum-based Nano-reinforced Calcium Hydroxide Reduces Postoperative Pain in Symptomatic Apical Periodontitis: A Randomized Controlled Trial. J Endod. 2025 Aug;51(8):996-1005. doi: 10.1016/j.joen.2025.05.016. Epub 2025 Jun 2.
- 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. This study is not recruiting at the moment.
Nehal Amir, BDS principal investigator
Pakistan Institute of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nano-reinforced calcium hydroxide medicament and Calcium hydroxide without nanoparicles in people with Necrotic Pulp and Acute Apical Periodontitis of Pulpal Origin, run by Pakistan Institute of Medical Sciences at 1 site in Pakistan.
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 30 Oct 2024. 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 Pakistan. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative pain (time frame: One week). 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 NCT06653608, which also lists 3 linked publications.
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 30 Oct 2024.