PainPhase 4NCT05600023
The Effectiveness of Single Antibiotic Paste Nitrofurantoin Versus Double Antibiotic Paste
A Phase 4 study testing Nitrofurantoin and Double Antibiotic in people with Pain and Symptomatic Irreversible Pulpitis, run by Altamash Institute of Dental Medicine at 1 site in Pakistan.
Trial summary
In our study, we used nitrofurantoin as a root canal medication in patients suffering from symptomatic irreversible pulpitis in alleviating pain compared with double antibiotic paste. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Symptomatic Irreversible Pulpitis
- What is being tested?
- Nitrofurantoin and Double Antibiotic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2022to 24 Oct 2022
- Phase
- Phase 4
- 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
- No medical history
- no history of allergy to medications used in root canal treatment
- patients suffering from Symptomatic Irreversible Pulpitis
Who cannot join
- Patients who were not suitable for conventional root canal treatment
- multirooted teeth
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Single Antibiotic Paste Nitrofurantoin V/S Double Antibiotic Paste in Alleviation of Post-Operative Pain in Adult Patients Symptomatic Irreversible Pulpitis
In our study, we used nitrofurantoin as a root canal medication in patients suffering from symptomatic irreversible pulpitis in alleviating pain compared with double antibiotic paste.
Read the detailed description
This study aims to compare the efficacy in alleviating pain between intracanal medicaments Nitrofurantoin versus double antibiotic paste.
- Conditions
- Pain, Symptomatic Irreversible Pulpitis
- Being tested
- Nitrofurantoin, Double Antibiotic
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NitrofurantoinDrug
Nitrofurantoin has been found to successfully eradicate gram-negative bacteria such as Enterococcus faecalis that one of the most important bacteria in endodontic lesions
Double AntibioticDrug
DAP is a combination of two antibiotics which are ciprofloxacin and metronidazole
| Study group | Role | What they receive |
|---|---|---|
| Nitrofurantoin | Experimental | Not described Receives: Drug: Nitrofurantoin |
| Double antibiotic paste | Experimental | Not described Receives: Drug: Double Antibiotic |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To alleviate dental pain
Dental pain will be measured by using Visual Analogue Scale(VAS) which is an 10-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured
Measured: 12 hours upto 72 hours following placement of intracanal medicament
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start1 Aug 2022
- Primary completion24 Oct 2022
- Study completion24 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Altamash Institute of Dental Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hira Abbasi, Altamash Institute of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05600023
- Sponsor's protocol ID
- Intracanal medication
- Status last verified
- Oct 2022
- First submitted
- 25 Oct 2022
- Last updated
- 31 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Single Antibiotic Paste Nitrofurantoin V/S Double Antibiotic Paste in Alleviation of Post-Operative Pain in Adult Patients Symptomatic Irreversible Pulpitis
- ClinicalTrials.gov ID
- NCT05600023
- Acronym / sponsor ID
- Intracanal medication
- Conditions
- Pain, Symptomatic Irreversible Pulpitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Altamash Institute of Dental MedicineUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 24 Oct 2022 (actual)
- Study completion
- 24 Oct 2022 (actual)
- First posted
- 31 Oct 2022 (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.
In our study, we used nitrofurantoin as a root canal medication in patients suffering from symptomatic irreversible pulpitis in alleviating pain compared with double antibiotic paste.
Detailed description
This study aims to compare the efficacy in alleviating pain between intracanal medicaments Nitrofurantoin versus double antibiotic paste.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nitrofurantoin | Experimental | Drug: Nitrofurantoin |
| Double antibiotic paste | Experimental | Drug: Double Antibiotic |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- No medical history
- no history of allergy to medications used in root canal treatment
- patients suffering from Symptomatic Irreversible Pulpitis
Key exclusion criteria (2 listed)
- Patients who were not suitable for conventional root canal treatment
- multirooted teeth
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 |
|---|---|---|
| NitrofurantoinNitrofurantoin has been found to successfully eradicate gram-negative bacteria such as Enterococcus faecalis that one of the most important bacteria in endodontic lesions | Drug | Nitrofurantoin |
| Double AntibioticDAP is a combination of two antibiotics which are ciprofloxacin and metronidazole | Drug | Double antibiotic paste |
Primary outcome
To alleviate dental pain
Time frame: 12 hours upto 72 hours following placement of intracanal medicament
Dental pain will be measured by using Visual Analogue Scale(VAS) which is an 10-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured
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 31 Oct 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nitrofurantoin and Double Antibiotic in people with Pain and Symptomatic Irreversible Pulpitis, run by Altamash Institute of Dental Medicine 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 2 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 31 Oct 2022. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
To alleviate dental pain (time frame: 12 hours upto 72 hours following placement of intracanal medicament). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Oct 2022.