Apical PeriodontitisPhase 2/3NCT06821763
To Measure Post Operative Pain Severity by Using Two Different Intra Canal Medicaments Calcium Hydroxide and Triple Antibiotic Paste in Teeth with Single Roots and Periapical Disease Called Apical Periodontitis
A Phase 2/3 study testing Calcium Hydroxide Intracanal medication and triple antibiotic paste (TAP) in people with Apical Periodontitis and Irreversible Pulpitis with Apical Periodontitis, run by Komal Ashraf Khan at 1 site in Pakistan.
Trial summary
The aim of this study is to compare post operative pain effectiveness between two most commonly available intra canal medicaments that are Triple Antibiotic Paste and Calcium Hydroxide during root canal treatment of single rooted teeth with symptomatic apical periodontitis. Read more about this study
- Who is it for?
- Ages 12 to 45 years
- Conditions the study is for
- Apical Periodontitis, Irreversible Pulpitis with Apical Periodontitis
- What is being tested?
- Calcium Hydroxide Intracanal medication and triple antibiotic paste (TAP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2025to 1 Nov 2025
- Phase
- Phase 2/3
- 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 12 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients of both genders having age 12-45 years
- Newly diagnosed cases fulfilling the criteria of INTERNATIONAL ASSOCIATES FOR THE STUDY OF PAIN definition of pain.
- A Single rooted teeth (Anterior or Posterior)
- Teeth with symptomatic apical periodontitis
- Teeth with necrotic pulp that gave a negative response to vitality testing.
Who cannot join
- Patients who have allergies, sensitivity or unable to take medications, periodontal disease, acute endodontic or periodontal abscess, requiring prophylactic antibiotics, systemic diseases like hypertension, diabetes, liver dysfunction renal failure and mental disabilities were excluded.
- Pregnant ladies or patients on nursing were also excluded from the sample.
- Teeth with anatomical difficulties such as open apices.
- Teeth with severe dilacerations, calcified canals, occlusal interferences, chronic periodontitis, internal/external root resorption.
- Patients with serious medical illness, systemic disorders, immunocompromised diseases such as AIDS or HBV.
Trial locations and contacts
1 site in 1 country.
Dr. Lubna Pasha contact
Pakistan1 site
Margalla Institute Of Health Sciences Quaid e Azam Avenue, Gulraiz phase 3, Gulraiz housing scheme Rawalpindi
Rawalpindi, Punjab Province, 46000
Prof Dr Amjad Mehmood Dean MIHS, 051-5509640, hod_cdm@margalla.edu.pk
About this study
Official title: Effect of Calcium Hydroxide on Post Operative Pain Severity in Single Rooted Teeth with Symptomatic Apical Periodontitis
- The aim of this study is to compare post operative pain effectiveness between two most commonly available intra canal medicaments that are Triple Antibiotic Paste and Calcium Hydroxide during root canal treatment of single rooted teeth with symptomatic apical periodontitis.
- Patients visiting OPD will be selected after fulfilment of inclusion criteria and randomly divided into two groups i.e group A patients receiving calcium hydroxide and group B with patients receiving Triple Antibiotic Paste as intra canal medicaments
- Patient will be called at 48hrs 72hrs and 96hrs postoperatively.
- Effectiveness of intra canal medicaments will be measured as no mild moderate severe on visual analogue scale(VAS).
Read the detailed description
- This randomized control study is done to compare post operative pain effectiveness of two medicaments that are triple antibiotic paste (TAP)(ciprofloxacin, metronidazole and minocycline in ratio 1:1:1) and calcium hydroxide(CH) during root canal treatment of single rooted teeth with symptomatic apical periodontitis.
- Calcium hydroxide being strong base exerts antimicrobial efficiency in reducing and eliminating microorganisms in entire root canal system
- TAP is efficient against calcium hydroxide resistant bacteria called as enterococcus faecalis and provides antimicrobial efficiency to inner depths of root canal up to 400 microns.
- This study will add further to literature regarding better intracanal medicament among two most widely used.
- Sample size includes total 180 participants having two groups each containing 90.
- Inclusion criteria have patients with age group 12-45, single rooted teeth, having symptomatic apical periodontitis, patients fulfilling international associates definition of pain
- Exclusion criteria includes patients having allergies, unable to take medications, medical conditions like diabetes etc, pregnant patients, teeth with tooth abnormalities like dilacerations open apices etc
- Patients will be selected from OPD after fulfilment of inclusion criteria randomly divided into two groups using lottery method
- Group A receiving calcium hydroxide group B receiving triple antibiotic paste
- Patients will be called post operatively after 48hrs 72hrs and 96hrs
- Post operative pain effectiveness will be measured as no mild moderate and severe on visual analogue scale (VAS)
- The data will be analyzed in statistical software SPSS v 25. Chi square test will be applied to compare effectiveness in both groups keeping p value less than 0.05 as significant.
- Being tested
- Calcium Hydroxide Intracanal medication, triple antibiotic paste (TAP)
- Medical subject headings
- Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium Hydroxide Intracanal medicationDrug
non setting calcium hydroxide(CH) mixed with normal saline and placed as intra canal medicament during first visit of root canal treatment. effectiveness measured after 48hrs, 72hrs and 96hrs
triple antibiotic paste (TAP)Drug
mix metronidazole, ciprofloxacin and minocycline in ratio 1:1:1 with normal saline and placed as intra canal medicament during first visit of root canal treatment.
| Study group | Role | What they receive |
|---|---|---|
| Group A( calcium hydroxide) | Active comparator | patients receiving calcium hydroxide as intra canal medicament Receives: Drug: Calcium Hydroxide Intracanal medication |
| Group B( Triple Antibiotic Paste) | Active comparator | Patients receiving triple antibiotic paste as intra canal medicament Receives: Drug: triple antibiotic paste (TAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
post operative pain
post operative pain measured through visual analogue scale( VAS) from readings no pain 0, mild taken as 0-2, moderate as 2-5, severe taken as 5-10
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start1 May 2025 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apical PeriodontitisStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Komal Ashraf Khan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Komal Ashraf Khan, Margalla Institute of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06821763
- Sponsor's protocol ID
- DK/248/24
- Status last verified
- Sep 2024
- First submitted
- 20 Jan 2025
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- 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 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Calcium Hydroxide on Post Operative Pain Severity in Single Rooted Teeth with Symptomatic Apical Periodontitis
- ClinicalTrials.gov ID
- NCT06821763
- Acronym / sponsor ID
- DK/248/24
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Komal Ashraf KhanUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 12 Feb 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 aim of this study is to compare post operative pain effectiveness between two most commonly available intra canal medicaments that are Triple Antibiotic Paste and Calcium Hydroxide during root canal treatment of single rooted teeth with symptomatic apical periodontitis.
- Patients visiting OPD will be selected after fulfilment of inclusion criteria and randomly divided into two groups i.e group A patients receiving calcium hydroxide and group B with patients receiving Triple Antibiotic Paste as intra canal medicaments
- Patient will be called at 48hrs 72hrs and 96hrs postoperatively.
- Effectiveness of intra canal medicaments will be measured as no mild moderate severe on visual analogue scale(VAS).
Detailed description
- This randomized control study is done to compare post operative pain effectiveness of two medicaments that are triple antibiotic paste (TAP)(ciprofloxacin, metronidazole and minocycline in ratio 1:1:1) and calcium hydroxide(CH) during root canal treatment of single rooted teeth with symptomatic apical periodontitis.
- Calcium hydroxide being strong base exerts antimicrobial efficiency in reducing and eliminating microorganisms in entire root canal system
- TAP is efficient against calcium hydroxide resistant bacteria called as enterococcus faecalis and provides antimicrobial efficiency to inner depths of root canal up to 400 microns.
- This study will add further to literature regarding better intracanal medicament among two most widely used.
- Sample size includes total 180 participants having two groups each containing 90.
- Inclusion criteria have patients with age group 12-45, single rooted teeth, having symptomatic apical periodontitis, patients fulfilling international associates definition of pain
- Exclusion criteria includes patients having allergies, unable to take medications, medical conditions like diabetes etc, pregnant patients, teeth with tooth abnormalities like dilacerations open apices etc
- Patients will be selected from OPD after fulfilment of inclusion criteria randomly divided into two groups using lottery method
- Group A receiving calcium hydroxide group B receiving triple antibiotic paste
- Patients will be called post operatively after 48hrs 72hrs and 96hrs
- Post operative pain effectiveness will be measured as no mild moderate and severe on visual analogue scale (VAS)
- The data will be analyzed in statistical software SPSS v 25. Chi square test will be applied to compare effectiveness in both groups keeping p value less than 0.05 as significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A( calcium hydroxide) | Active comparator | Drug: Calcium Hydroxide Intracanal medicationpatients receiving calcium hydroxide as intra canal medicament |
| Group B( Triple Antibiotic Paste) | Active comparator | Drug: triple antibiotic paste (TAP)Patients receiving triple antibiotic paste as intra canal medicament |
Who may qualify
- Ages
- 12 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Patients of both genders having age 12-45 years
- Newly diagnosed cases fulfilling the criteria of INTERNATIONAL ASSOCIATES FOR THE STUDY OF PAIN definition of pain.
- A Single rooted teeth (Anterior or Posterior)
- Teeth with symptomatic apical periodontitis
- Teeth with necrotic pulp that gave a negative response to vitality testing.
Key exclusion criteria (5 listed)
- Patients who have allergies, sensitivity or unable to take medications, periodontal disease, acute endodontic or periodontal abscess, requiring prophylactic antibiotics, systemic diseases like hypertension, diabetes, liver dysfunction renal failure and mental disabilities were excluded.
- Pregnant ladies or patients on nursing were also excluded from the sample.
- Teeth with anatomical difficulties such as open apices.
- Teeth with severe dilacerations, calcified canals, occlusal interferences, chronic periodontitis, internal/external root resorption.
- Patients with serious medical illness, systemic disorders, immunocompromised diseases such as AIDS or HBV.
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 |
|---|---|---|
| Calcium Hydroxide Intracanal medicationnon setting calcium hydroxide(CH) mixed with normal saline and placed as intra canal medicament during first visit of root canal treatment. effectiveness measured after 48hrs, 72hrs and 96hrs | Drug | Group A( calcium hydroxide) |
| triple antibiotic paste (TAP)mix metronidazole, ciprofloxacin and minocycline in ratio 1:1:1 with normal saline and placed as intra canal medicament during first visit of root canal treatment. | Drug | Group B( Triple Antibiotic Paste) |
Primary outcome
post operative pain
Time frame: 6 months
post operative pain measured through visual analogue scale( VAS) from readings no pain 0, mild taken as 0-2, moderate as 2-5, severe taken as 5-10
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Apical Periodontitis
Recruiting
Effect of Cyperus Articulatus on Bacterial Reduction and Postoperative Pain
Chronic Apical Periodontitis
Not yet recruiting
Photobiomodulation After Nonsurgical Root Canal Treatment
Symptomatic Apical Periodontitis, Postoperative Pain
Not yet recruiting
Comparison of Postoperative Pain After Root Canal Treatment Using Hand-Held vs Rotary ProTaper Files: A Randomized Controlled Trial
Symptomatic Irreversible Pulpitis (SIP), Symptomatic Apical Periodontitis
Not yet recruiting
Post-operative Pain and Apical Healing After Root Canal (re)Treatment With Laser-activated Irrigation Versus Sonic or no Activation
Apical Periodontitis, Post Operative Pain, Acute
Not yet recruitingObservational study
Neurokinin A and Matrix Metalloproteinase 9 Levels in Gingival Crevicular Fluid Samples of Teeth With Symptomatic Irreversible Pulpitis With Symptomatic Apical Periodontitis
Symptomatic Irreversible Pulpitis With Apical Peridontitis
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.
Dr. Lubna Pasha contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Calcium Hydroxide Intracanal medication and triple antibiotic paste (TAP) in people with Apical Periodontitis and Irreversible Pulpitis with Apical Periodontitis, run by Komal Ashraf Khan 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 5 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: status not confirmed, as of the sponsor's last update on 12 Feb 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Komal Ashraf Khan (+92 3129433556, komalashraf152@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post operative pain (time frame: 6 months). 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 12 Feb 2025.