Intracanal MedicamentPhase 1/2NCT07198919
Comparison of Inter-appointment Pain Reduction During Root Canal Treatment in Symptomatic Apical Periodontitis by Using Intracanal Medicaments; Chlorhexidine Gel and Single Antibiotic Paste Nitrofurantoin
A Phase 1/2 study testing Chlorhexidine gel and Nitrofurantoin 100 MG in people with Intracanal Medicament, run by Altamash Institute of Dental Medicine at 1 site in Pakistan.
Trial summary
This study is being conducted to find out which of two medications-Chlorhexidine Gel or Nitrofurantoin-works better in reducing pain between root canal treatment visits. Sometimes, patients with infected teeth (called symptomatic apical periodontitis) continue to feel pain between treatment appointments. Read more about this study
- Who is it for?
- Ages 16 to 45 years
- Conditions the study is for
- Intracanal Medicament
- What is being tested?
- Chlorhexidine gel and Nitrofurantoin 100 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 sitePakistan
- Study dates
- 20 May 2025to 30 Nov 2025
- Phase
- Phase 1/2
- 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 16 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with single rooted permanent teeth of both arches.
- Patients with a pulpal status of necrosis with or without periapical radiolucency, confirmed using Electric Pulp Test (EPT) and Cold Test.
- Male and female patients age of 16 to 45 yrs.
- Patients of both genders.
Who cannot join
- Patients with uncontrolled diabetes.
- Presence of periapical granuloma or cyst confirmed via radiographic evaluation.
- Patient is on any medication that affects pain, inflammation and infection like analgesic, antibiotics since last 7 days
- Patient requiring endodontic re-treatment.
- Patients with immature teeth with open apices.
- Patients with calcified canals.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of Inter-appointment Pain Reduction During Root Canal Treatment in Symptomatic Apical Periodontitis by Using Intracanal Medicaments Chlorhexidine Gel and Single Antibiotic Paste Nitrofurantoin
This study is being conducted to find out which of two medications-Chlorhexidine Gel or Nitrofurantoin-works better in reducing pain between root canal treatment visits. Sometimes, patients with infected teeth (called symptomatic apical periodontitis) continue to feel pain between treatment appointments. To help with this, dentists use medications inside the cleaned tooth canal.
In this trial, 220 patients will be divided into two groups. One group will receive Chlorhexidine Gel, and the other will receive Nitrofurantoin paste inside their tooth during the first treatment visit. Pain levels will be recorded before treatment, and again after 24 and 48 hours using a pain scale from 0 (no pain) to 10 (severe pain). No pain medicine will be given unless the patient feels very uncomfortable.
The study is taking place at the Altamash Institute of Dental Medicine in Karachi, and will help dentists understand which medication helps patients feel better faster during root canal treatment.
Read the detailed description
This randomized controlled trial is designed to evaluate and compare the efficacy of two commonly used intracanal medicaments-2% Chlorhexidine Gel and Single Antibiotic Paste (Nitrofurantoin)-in reducing inter-appointment pain during root canal treatment of teeth diagnosed with symptomatic apical periodontitis.
Pain between root canal visits is a common concern. The persistence of microbial infection within the root canal system can lead to inflammation of the peri-radicular tissues, causing discomfort. Intracanal medicaments are placed after chemo-mechanical preparation to enhance disinfection, reduce microbial load, and minimize postoperative complications such as pain.
While Chlorhexidine has long been used due to its broad-spectrum antimicrobial activity and substantivity, Nitrofurantoin, a nitrofuran antibiotic, has shown promising results against resistant organisms and may offer similar or enhanced pain relief when used as a local medicament.
A total of 220 patients, aged 16 to 45 years, presenting with single-rooted permanent teeth requiring primary root canal treatment and diagnosed with pulp necrosis and symptomatic apical periodontitis, will be enrolled at the Department of Operative Dentistry and Endodontics, Altamash Institute of Dental Medicine, Karachi. Patients will be randomly allocated into two equal groups (n=110 per group) using the lottery method.
Group 1 will receive Chlorhexidine Gel as the intracanal medicament.
Group 2 will receive Nitrofurantoin Paste, prepared by mixing crushed Nitrofurantoin tablets with saline.
Pain intensity will be measured using the Visual Analogue Scale (VAS) at three time points: preoperatively, 24 hours, and 48 hours after the first treatment visit. Inter-appointment pain reduction will be calculated using the formula:
[(Pre-treatment VAS score - Post-treatment VAS score) / Pre-treatment VAS score] × 100
Standardized root canal procedures, including anesthesia, canal preparation, irrigation, medicament placement, and obturation, will be performed by a single postgraduate trainee to ensure consistency. No analgesics will be prescribed unless requested by the patient due to severe discomfort. If needed, ibuprofen 200 mg will be provided and documented.
Data will be analyzed using SPSS version 20. Continuous variables (e.g., pain scores) will be assessed for normality. Depending on distribution, t-tests or non-parametric equivalents will be used to compare groups. Stratification will be done for potential confounders such as age, gender, and type of tooth. A p-value < 0.05 will be considered statistically significant.
The study's goal is to provide evidence on whether Nitrofurantoin is more effective than Chlorhexidine Gel in reducing pain between appointments, potentially offering a new and effective intracanal medicament option in endodontic practice.
- Conditions
- Intracanal Medicament
- Being tested
- Chlorhexidine gel, Nitrofurantoin 100 MG
- Keywords
- intracanal medicament
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine gelDrug
Also called Consepsis Ultradent
0.12% Chlorhexidine gel (Consepsis Ultradent)
Nitrofurantoin 100 MGDrug
Nitrofurantoin Tablets 100mg
| Study group | Role | What they receive |
|---|---|---|
| Chlorhexidine | Active comparator | Not described Receives: Drug: Chlorhexidine gel |
| Nitrofurantoin | Active comparator | Not described Receives: Drug: Nitrofurantoin 100 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Reduction in Inter-Appointment Pain Score
Change in patient-reported pain intensity, measured using the Visual Analogue Scale (VAS), from pre-treatment to 24 and 48 hours post-treatment. Pain reduction will be calculated using the formula:
[(Pre-treatment VAS score - Post-treatment VAS score) / Pre-treatment VAS score] × 100
Measured: Pain scores will be assessed before treatment, then at 24 hours and 48 hours after the first treatment visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start20 May 2025
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracanal MedicamentStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Altamash Institute of Dental Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fiza Bibi Alavi, Altamash Institute of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07198919
- Sponsor's protocol ID
- AIDM/ERC/03/2025/01
- Status last verified
- May 2025
- First submitted
- 28 May 2025
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Inter-appointment Pain Reduction During Root Canal Treatment in Symptomatic Apical Periodontitis by Using Intracanal Medicaments Chlorhexidine Gel and Single Antibiotic Paste Nitrofurantoin
- ClinicalTrials.gov ID
- NCT07198919
- Acronym / sponsor ID
- AIDM/ERC/03/2025/01
- Conditions
- Intracanal Medicament
- Keywords
- intracanal medicament
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Altamash Institute of Dental MedicineUniversity, hospital or other
- Study start
- 20 May 2025 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 30 Sep 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.
This study is being conducted to find out which of two medications-Chlorhexidine Gel or Nitrofurantoin-works better in reducing pain between root canal treatment visits. Sometimes, patients with infected teeth (called symptomatic apical periodontitis) continue to feel pain between treatment appointments. To help with this, dentists use medications inside the cleaned tooth canal.
In this trial, 220 patients will be divided into two groups. One group will receive Chlorhexidine Gel, and the other will receive Nitrofurantoin paste inside their tooth during the first treatment visit. Pain levels will be recorded before treatment, and again after 24 and 48 hours using a pain scale from 0 (no pain) to 10 (severe pain). No pain medicine will be given unless the patient feels very uncomfortable.
The study is taking place at the Altamash Institute of Dental Medicine in Karachi, and will help dentists understand which medication helps patients feel better faster during root canal treatment.
Detailed description
This randomized controlled trial is designed to evaluate and compare the efficacy of two commonly used intracanal medicaments-2% Chlorhexidine Gel and Single Antibiotic Paste (Nitrofurantoin)-in reducing inter-appointment pain during root canal treatment of teeth diagnosed with symptomatic apical periodontitis.
Pain between root canal visits is a common concern. The persistence of microbial infection within the root canal system can lead to inflammation of the peri-radicular tissues, causing discomfort. Intracanal medicaments are placed after chemo-mechanical preparation to enhance disinfection, reduce microbial load, and minimize postoperative complications such as pain.
While Chlorhexidine has long been used due to its broad-spectrum antimicrobial activity and substantivity, Nitrofurantoin, a nitrofuran antibiotic, has shown promising results against resistant organisms and may offer similar or enhanced pain relief when used as a local medicament.
A total of 220 patients, aged 16 to 45 years, presenting with single-rooted permanent teeth requiring primary root canal treatment and diagnosed with pulp necrosis and symptomatic apical periodontitis, will be enrolled at the Department of Operative Dentistry and Endodontics, Altamash Institute of Dental Medicine, Karachi. Patients will be randomly allocated into two equal groups (n=110 per group) using the lottery method.
Group 1 will receive Chlorhexidine Gel as the intracanal medicament.
Group 2 will receive Nitrofurantoin Paste, prepared by mixing crushed Nitrofurantoin tablets with saline.
Pain intensity will be measured using the Visual Analogue Scale (VAS) at three time points: preoperatively, 24 hours, and 48 hours after the first treatment visit. Inter-appointment pain reduction will be calculated using the formula:
[(Pre-treatment VAS score - Post-treatment VAS score) / Pre-treatment VAS score] × 100
Standardized root canal procedures, including anesthesia, canal preparation, irrigation, medicament placement, and obturation, will be performed by a single postgraduate trainee to ensure consistency. No analgesics will be prescribed unless requested by the patient due to severe discomfort. If needed, ibuprofen 200 mg will be provided and documented.
Data will be analyzed using SPSS version 20. Continuous variables (e.g., pain scores) will be assessed for normality. Depending on distribution, t-tests or non-parametric equivalents will be used to compare groups. Stratification will be done for potential confounders such as age, gender, and type of tooth. A p-value < 0.05 will be considered statistically significant.
The study's goal is to provide evidence on whether Nitrofurantoin is more effective than Chlorhexidine Gel in reducing pain between appointments, potentially offering a new and effective intracanal medicament option in endodontic practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chlorhexidine | Active comparator | Drug: Chlorhexidine gel |
| Nitrofurantoin | Active comparator | Drug: Nitrofurantoin 100 MG |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients with single rooted permanent teeth of both arches.
- Patients with a pulpal status of necrosis with or without periapical radiolucency, confirmed using Electric Pulp Test (EPT) and Cold Test.
- Male and female patients age of 16 to 45 yrs.
- Patients of both genders.
Key exclusion criteria (6 listed)
- Patients with uncontrolled diabetes.
- Presence of periapical granuloma or cyst confirmed via radiographic evaluation.
- Patient is on any medication that affects pain, inflammation and infection like analgesic, antibiotics since last 7 days
- Patient requiring endodontic re-treatment.
- Patients with immature teeth with open apices.
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 |
|---|---|---|
| Chlorhexidine gelAlso: Consepsis Ultradent0.12% Chlorhexidine gel (Consepsis Ultradent) | Drug | Chlorhexidine |
| Nitrofurantoin 100 MGNitrofurantoin Tablets 100mg | Drug | Nitrofurantoin |
Primary outcome
Percentage Reduction in Inter-Appointment Pain Score
Time frame: Pain scores will be assessed before treatment, then at 24 hours and 48 hours after the first treatment visit.
Change in patient-reported pain intensity, measured using the Visual Analogue Scale (VAS), from pre-treatment to 24 and 48 hours post-treatment. Pain reduction will be calculated using the formula: [(Pre-treatment VAS score - Post-treatment VAS score) / Pre-treatment VAS score] × 100
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 30 Sep 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Intracanal Medicament
Active, not recruiting
Early Healing of Apical Periodontitis After Root Canal Treatment With Bioceramic and Calcium Hydroxide Medicaments: Evaluation Using PAI and ImageJ
Apical Periodontitis, Root Canal Treatment
Recruiting
Antibacterial Efficacy of Bioceramic and Calcium Hydroxide Intracanal Medicaments
Periapical Periodontitis, Root Canal Infection
Active, not recruiting
Effectiveness of Oleanolic Acid as Intracanal Medicament on Infectious/Inflammatory Contents in Teeth With Apical Periodontitis
Intracanal Medicaments, Inflammatory Cytokines
Active, not recruiting
The Success of Root Canal Treatments Performed Using Two Different Intracanal Medicaments
Root Canal Treatment, Intracanal Medicament
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.
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 1/2 study testing Chlorhexidine gel and Nitrofurantoin 100 MG in people with Intracanal Medicament, 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 4 inclusion and 6 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: enrolling by invitation, as of the sponsor's last update on 30 Sep 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 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Percentage Reduction in Inter-Appointment Pain Score (time frame: Pain scores will be assessed before treatment, then at 24 hours and 48 hours after the first treatment visit.). 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 30 Sep 2025.