Root Canal TreatmentNCT07270159
Effect of Probiotics, Double Antibiotic Paste, and Calcium Hydroxide on Postoperative Pain in Irreversible Pulpitis: A Randomized Trial
A study testing Probiotic in people with Root Canal Treatment and Irreversible Pulpitis With Apical Periodontitis, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial summary
The goal of this clinical trial is to learn whether probiotics, double antibiotic paste (DAP), or calcium hydroxide paste help reduce postoperative pain after root canal treatment in adults with symptomatic irreversible pulpitis. It will also learn about the safety of these medicaments. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Root Canal Treatment, Irreversible Pulpitis With Apical Periodontitis, Pulpitis - Irreversible
- What is being tested?
- Probiotic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2025to 10 Nov 2025
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients falling in ASA 1 category
- Suffering from symptomatic irreversible pulpitis with range from moderate to severe. In addition to this patient should also have experienced lingering of pain. VAS score will be used to record pain. (Confirmed by clinical and radiographic signs) with or without apical periodontitis.
- Multirooted teeth (Mandibular 1st and 2nd molars)
- Age 18-45 year
- Teeth with a Periapical Index (PAI) score of 1 -3, indicating a healthy periapical status or minimal changes in bone structure not necessarily associated with apical periodontitis, were included in this study.
Who cannot join
- Pregnant or lactating mothers
- Subjects taking chronic pain medications within last 24 hrs.
- Cracks, complex anatomy, pulp calcification
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EFFECT OF PROBIOTICS, DOUBLE ANTIBIOTIC AND CALCIUM HYDROXIDE PASTE AS INTRACANAL MEDICAMENTS ON POSTOPERATIVE PAIN IN SYMPTOMATIC IRREVERSIBLE PULPITIS PATIENTS. A RANDOMIZED CONTROLLED TRIAL
The goal of this clinical trial is to learn whether probiotics, double antibiotic paste (DAP), or calcium hydroxide paste help reduce postoperative pain after root canal treatment in adults with symptomatic irreversible pulpitis.
It will also learn about the safety of these medicaments.
Read more
The main questions it aims to answer are:
Do probiotics, DAP, or calcium hydroxide lower the amount of pain patients experience after the first visit of root canal treatment? What medical problems or side effects do participants experience when any of these medicaments are used? Researchers will compare probiotics, DAP, and calcium hydroxide to see which one works best to control postoperative pain.
Participants will:
Receive one of the three intracanal medicaments (probiotics, DAP, or Ca(OH)₂) placed inside their root canal Visit the clinic for follow-ups according to the treatment plan Report their pain levels using a Visual Analog Scale (VAS) at several time points (before treatment, 12 hrs, 24 hrs, 48 hrs, 3 days, and 7 days) Inform the research team about any discomfort, symptoms, or side effects during the week after treatment
Read the detailed description
This randomized controlled clinical trial aims to evaluate the effectiveness of three intracanal medicaments-probiotics, double antibiotic paste (DAP), and calcium hydroxide-in reducing postoperative pain in adult patients diagnosed with symptomatic irreversible pulpitis undergoing root canal treatment. The study will compare changes in pain intensity over time using the Visual Analog Scale (VAS) and assess any adverse effects associated with each medicament. A total of 75 participants will be randomly assigned to one of the three treatment groups. The study seeks to determine which medicament provides the greatest reduction in postoperative pain and whether probiotics may serve as a safe and effective alternative to commonly used intracanal materials.
Detailed Description Postoperative pain following root canal treatment remains a significant clinical concern, particularly among patients with symptomatic irreversible pulpitis. Although calcium hydroxide is the most widely used intracanal medicament, its limitations-including delayed onset of action, high solubility, and limited antibacterial effectiveness against certain microorganisms-have led to increasing interest in alternative options. Double antibiotic paste, containing metronidazole and ciprofloxacin, has shown strong antimicrobial activity, while probiotics have recently emerged as a potential biotherapeutic alternative with antibacterial and anti-inflammatory properties.
This randomized controlled trial will compare the pain-reducing effectiveness of three intracanal medicaments: calcium hydroxide paste, double antibiotic paste, and a probiotic paste consisting of Lactobacillus rhamnosus GG. Participants aged 18-45 years who are diagnosed with symptomatic irreversible pulpitis, with or without symptomatic apical periodontitis, will be enrolled. After standardized root canal preparation, one of the three medicaments will be placed inside the canal during the first appointment.
Pain will be assessed using a 10-point Visual Analog Scale (VAS) at the following intervals:
Preoperative 12 hours postoperative 24 hours 48 hours 3 days 7 days Any adverse events or additional symptoms-such as swelling, fever, or severe recurrent pain-will be documented. Participants may use prescribed analgesics only if necessary. The medicament will be removed at the second visit after one week, followed by completion of root canal filling.
The study will include 75 participants, allowing for potential dropout, with 25 participants per treatment group. Randomization will be computer-generated, and the trial will be double-blinded, ensuring that neither the participants nor the outcome assessors are aware of group allocations.
The primary outcome is the change in postoperative pain intensity over time. Secondary outcomes include the incidence of adverse reactions and any differences in analgesic use among the three groups.
This study will provide valuable evidence to guide the selection of intracanal medicaments, assess the potential benefits of probiotics in endodontic pain management, and support the development of safer and more effective treatment strategies for patients with symptomatic irreversible pulpitis
- Conditions
- Root Canal Treatment, Irreversible Pulpitis With Apical Periodontitis, Pulpitis - Irreversible, Post Operative Pain, Acute
- Being tested
- Probiotic
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDrug
New intracanal medicament used in RCT
| Study group | Role | What they receive |
|---|---|---|
| Calcium Hydroxide | Active comparator | Intrcanal medicament used in RCT Receives: Drug: Probiotic |
| Double Antibiotic Paste (DAP) | Active comparator | Intracanal medicament used in RCT Receives: Drug: Probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity
Change in postoperative pain levels following root canal treatment, measured using the Visual Analog Scale (VAS). VAS is a 10-point scale where 0 = no pain and 10 = worst possible pain. Participants will report their pain at multiple time points to evaluate how each intracanal medicament (Calcium Hydroxide, Double Antibiotic Paste, Probiotic Paste) influences pain reduction over time.
Measured: Preoperative 12 hours postoperative 24 hours postoperative 48 hours postoperative 3 days postoperative 7 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start1 Jun 2025
- Primary completion30 Oct 2025
- Study completion10 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Root Canal TreatmentStudies 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
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zainab Dua, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07270159
- Sponsor's protocol ID
- 181
- Status last verified
- May 2025
- First submitted
- 24 Nov 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF PROBIOTICS, DOUBLE ANTIBIOTIC AND CALCIUM HYDROXIDE PASTE AS INTRACANAL MEDICAMENTS ON POSTOPERATIVE PAIN IN SYMPTOMATIC IRREVERSIBLE PULPITIS PATIENTS. A RANDOMIZED CONTROLLED TRIAL
- ClinicalTrials.gov ID
- NCT07270159
- Acronym / sponsor ID
- 181
- Conditions
- Root Canal Treatment, Irreversible Pulpitis With Apical Periodontitis, Pulpitis - Irreversible, Post Operative Pain, Acute
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 10 Nov 2025 (actual)
- First posted
- 8 Dec 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.
The goal of this clinical trial is to learn whether probiotics, double antibiotic paste (DAP), or calcium hydroxide paste help reduce postoperative pain after root canal treatment in adults with symptomatic irreversible pulpitis.
It will also learn about the safety of these medicaments.
The main questions it aims to answer are:
Do probiotics, DAP, or calcium hydroxide lower the amount of pain patients experience after the first visit of root canal treatment? What medical problems or side effects do participants experience when any of these medicaments are used? Researchers will compare probiotics, DAP, and calcium hydroxide to see which one works best to control postoperative pain.
Participants will:
Receive one of the three intracanal medicaments (probiotics, DAP, or Ca(OH)₂) placed inside their root canal Visit the clinic for follow-ups according to the treatment plan Report their pain levels using a Visual Analog Scale (VAS) at several time points (before treatment, 12 hrs, 24 hrs, 48 hrs, 3 days, and 7 days) Inform the research team about any discomfort, symptoms, or side effects during the week after treatment
Detailed description
This randomized controlled clinical trial aims to evaluate the effectiveness of three intracanal medicaments-probiotics, double antibiotic paste (DAP), and calcium hydroxide-in reducing postoperative pain in adult patients diagnosed with symptomatic irreversible pulpitis undergoing root canal treatment. The study will compare changes in pain intensity over time using the Visual Analog Scale (VAS) and assess any adverse effects associated with each medicament. A total of 75 participants will be randomly assigned to one of the three treatment groups. The study seeks to determine which medicament provides the greatest reduction in postoperative pain and whether probiotics may serve as a safe and effective alternative to commonly used intracanal materials.
Detailed Description Postoperative pain following root canal treatment remains a significant clinical concern, particularly among patients with symptomatic irreversible pulpitis. Although calcium hydroxide is the most widely used intracanal medicament, its limitations-including delayed onset of action, high solubility, and limited antibacterial effectiveness against certain microorganisms-have led to increasing interest in alternative options. Double antibiotic paste, containing metronidazole and ciprofloxacin, has shown strong antimicrobial activity, while probiotics have recently emerged as a potential biotherapeutic alternative with antibacterial and anti-inflammatory properties.
This randomized controlled trial will compare the pain-reducing effectiveness of three intracanal medicaments: calcium hydroxide paste, double antibiotic paste, and a probiotic paste consisting of Lactobacillus rhamnosus GG. Participants aged 18-45 years who are diagnosed with symptomatic irreversible pulpitis, with or without symptomatic apical periodontitis, will be enrolled. After standardized root canal preparation, one of the three medicaments will be placed inside the canal during the first appointment.
Pain will be assessed using a 10-point Visual Analog Scale (VAS) at the following intervals:
Preoperative 12 hours postoperative 24 hours 48 hours 3 days 7 days Any adverse events or additional symptoms-such as swelling, fever, or severe recurrent pain-will be documented. Participants may use prescribed analgesics only if necessary. The medicament will be removed at the second visit after one week, followed by completion of root canal filling.
The study will include 75 participants, allowing for potential dropout, with 25 participants per treatment group. Randomization will be computer-generated, and the trial will be double-blinded, ensuring that neither the participants nor the outcome assessors are aware of group allocations.
The primary outcome is the change in postoperative pain intensity over time. Secondary outcomes include the incidence of adverse reactions and any differences in analgesic use among the three groups.
This study will provide valuable evidence to guide the selection of intracanal medicaments, assess the potential benefits of probiotics in endodontic pain management, and support the development of safer and more effective treatment strategies for patients with symptomatic irreversible pulpitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calcium Hydroxide | Active comparator | Drug: ProbioticIntrcanal medicament used in RCT |
| Double Antibiotic Paste (DAP) | Active comparator | Drug: ProbioticIntracanal medicament used in RCT |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients falling in ASA 1 category
- Suffering from symptomatic irreversible pulpitis with range from moderate to severe. In addition to this patient should also have experienced lingering of pain. VAS score will be used to record pain. (Confirmed by clinical and radiographic signs) with or without apical periodontitis.
- Multirooted teeth (Mandibular 1st and 2nd molars)
- Age 18-45 year
- Teeth with a Periapical Index (PAI) score of 1 -3, indicating a healthy periapical status or minimal changes in bone structure not necessarily associated with apical periodontitis, were included in this study.
Key exclusion criteria (3 listed)
- Pregnant or lactating mothers
- Subjects taking chronic pain medications within last 24 hrs.
- Cracks, complex anatomy, pulp calcification
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 |
|---|---|---|
| ProbioticNew intracanal medicament used in RCT | Drug | Calcium Hydroxide, Double Antibiotic Paste (DAP) |
Primary outcome
Postoperative Pain Intensity
Time frame: Preoperative 12 hours postoperative 24 hours postoperative 48 hours postoperative 3 days postoperative 7 days postoperative
Change in postoperative pain levels following root canal treatment, measured using the Visual Analog Scale (VAS). VAS is a 10-point scale where 0 = no pain and 10 = worst possible pain. Participants will report their pain at multiple time points to evaluate how each intracanal medicament (Calcium Hydroxide, Double Antibiotic Paste, Probiotic Paste) influences pain reduction over time.
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 8 Dec 2025.
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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 study testing Probiotic in people with Root Canal Treatment and Irreversible Pulpitis With Apical Periodontitis, run by Dow University of Health 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 5 inclusion and 3 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 8 Dec 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.
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?
Postoperative Pain Intensity (time frame: Preoperative 12 hours postoperative 24 hours postoperative 48 hours postoperative 3 days postoperative 7 days postoperative). 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 8 Dec 2025.