Periapical LesionNCT07239739
Comparing Two Medicines for Healing Jaw Bone Infections After Root Canal Treatment
A study testing Triple Antibiotic Paste and Calcium Hydroxide (Ca(OH)2) in people with Periapical Lesion and Periapical Periodontitis, run by Faiz ur rahman.
Trial summary
This study compares two commonly used intracanal medicaments-Triple Antibiotic Paste and Calcium Hydroxide-in patients with infected single-rooted teeth. The purpose is to determine which medicament promotes faster healing of periapical lesions after root canal treatment by measuring reduction in lesion size and… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Periapical Lesion, Periapical Periodontitis
- What is being tested?
- Triple Antibiotic Paste and Calcium Hydroxide (Ca(OH)2)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2026to 15 Dec 2026
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Systemically healthy adult patients between 18 and 65 years of age.
- Presence of a single-rooted tooth diagnosed with pulpal necrosis and asymptomatic apical periodontitis or chronic apical abscess.
- Radiographic evidence of a distinct periapical radiolucency with a minimum diameter of 2mm.
- The involved tooth must be deemed restorable after endodontic treatment.
- Patient willingness and ability to provide informed consent and comply with the follow-up schedule
Who cannot join
- Patients under 18 or over 65 years of age.
- Presence of systemic diseases known to affect bone metabolism or immune response (e.g., uncontrolled diabetes).
- Pregnancy or lactation.
- Known allergies to any components of Triple Antibiotic Paste or calcium hydroxide.
- Teeth with previous root canal treatment, internal/external root resorption, root fractures, or non-endodontic periapical pathology.Exclusion Criteria:
- -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Triple Antibiotic Paste and Calcium Hydroxide on the Rate of Healing of Periapical Lesions in Single-Rooted Teeth: A Randomized Controlled Trial
This study compares two commonly used intracanal medicaments-Triple Antibiotic Paste and Calcium Hydroxide-in patients with infected single-rooted teeth. The purpose is to determine which medicament promotes faster healing of periapical lesions after root canal treatment by measuring reduction in lesion size and improvement in bone density over 3, 6, and 12 months.
Read the detailed description
This single-center, parallel-arm, randomized controlled trial aims to directly compare the efficacy of Triple Antibiotic Paste (TAP) and Calcium Hydroxide (CH) as intracanal medicaments on the rate of healing of periapical lesions in single-rooted teeth. Systemically healthy adults (18-65 years) with a diagnosis of pulpal necrosis and asymptomatic apical periodontitis or chronic apical abscess, presenting with a radiographically evident periapical radiolucency (≥2mm), will be enrolled. Following informed consent, chemomechanical preparation, and randomization, participants will receive either TAP (Ciprofloxacin:Metronidazole:Minocycline) or CH as the intracanal medicament. The primary outcome is the rate of healing, quantified by the percentage reduction in periapical lesion area and improvement in bone density scores assessed on standardized periapical radiographs or CBCT scans at 3, 6, and 12-month follow-ups. Secondary outcomes include clinical resolution (absence of pain, tenderness, sinus tract) and radiographic resolution (restoration of normal periapical architecture). Data will be analyzed using intention-to-treat analysis, with repeated-measures ANOVA to compare healing trajectories between groups.
- Conditions
- Periapical Lesion, Periapical Periodontitis
- Being tested
- Triple Antibiotic Paste, Calcium Hydroxide (Ca(OH)2)
- Keywords
- Triple Antibiotic Paste,, Calcium Hydroxide,, Periapical Healing, Intracanal Medicament
- Medical subject headings
- Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triple Antibiotic PasteDrug
Intracanal medicament paste composed of Ciprofloxacin, Metronidazole, and Minocycline. Placed in the root canal for several weeks.
Calcium Hydroxide (Ca(OH)2)Drug
Standard intracanal medicament with high pH, used for its antibacterial and tissue-stimulating properties. Placed in the root canal for several weeks
| Study group | Role | What they receive |
|---|---|---|
| Triple Antibiotic Paste (TAP) | Experimental | TAP placed as intracanal medicament following chemo-mechanical preparation; temporary restoration maintained for several weeks Receives: Drug: Triple Antibiotic Paste; Drug: Calcium Hydroxide (Ca(OH)2) |
| Calcium Hydroxide Group | Active comparator | Calcium Hydroxide intracanal dressing placed following chemo-mechanical preparation; sealed temporarily Receives: Drug: Triple Antibiotic Paste; Drug: Calcium Hydroxide (Ca(OH)2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Periapical Lesion Area
Percentage reduction in the area (mm²) of the periapical radiolucency from baseline, as measured on standardized periapical radiographs or CBCT scans.
Measured: Baseline, 3 months, 6 months, 12 months
Secondary outcomes (1)
Change in Periapical Bone Density Score
Improvement in a standardized bone density score or grayscale value of the periapical bone from baseline
Measured: Baseline, 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start15 Jun 2026 (estimated)
- Primary completion15 Nov 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periapical LesionStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Faiz ur rahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Faiz ur rahman, College of Physicians and Surgeons Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07239739
- Sponsor's protocol ID
- SCD-Endo-001
- Status last verified
- Mar 2026
- First submitted
- 16 Nov 2025
- Last updated
- 18 Mar 2026
- 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 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Triple Antibiotic Paste and Calcium Hydroxide on the Rate of Healing of Periapical Lesions in Single-Rooted Teeth: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07239739
- Acronym / sponsor ID
- SCD-Endo-001
- Conditions
- Periapical Lesion, Periapical Periodontitis
- Keywords
- Triple Antibiotic Paste,, Calcium Hydroxide,, Periapical Healing, Intracanal Medicament
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Faiz ur rahmanUniversity, hospital or other
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 20 Nov 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 compares two commonly used intracanal medicaments-Triple Antibiotic Paste and Calcium Hydroxide-in patients with infected single-rooted teeth. The purpose is to determine which medicament promotes faster healing of periapical lesions after root canal treatment by measuring reduction in lesion size and improvement in bone density over 3, 6, and 12 months.
Detailed description
This single-center, parallel-arm, randomized controlled trial aims to directly compare the efficacy of Triple Antibiotic Paste (TAP) and Calcium Hydroxide (CH) as intracanal medicaments on the rate of healing of periapical lesions in single-rooted teeth. Systemically healthy adults (18-65 years) with a diagnosis of pulpal necrosis and asymptomatic apical periodontitis or chronic apical abscess, presenting with a radiographically evident periapical radiolucency (≥2mm), will be enrolled. Following informed consent, chemomechanical preparation, and randomization, participants will receive either TAP (Ciprofloxacin:Metronidazole:Minocycline) or CH as the intracanal medicament. The primary outcome is the rate of healing, quantified by the percentage reduction in periapical lesion area and improvement in bone density scores assessed on standardized periapical radiographs or CBCT scans at 3, 6, and 12-month follow-ups. Secondary outcomes include clinical resolution (absence of pain, tenderness, sinus tract) and radiographic resolution (restoration of normal periapical architecture). Data will be analyzed using intention-to-treat analysis, with repeated-measures ANOVA to compare healing trajectories between groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Triple Antibiotic Paste (TAP) | Experimental | Drug: Triple Antibiotic Paste, Drug: Calcium Hydroxide (Ca(OH)2)TAP placed as intracanal medicament following chemo-mechanical preparation; temporary restoration maintained for several weeks |
| Calcium Hydroxide Group | Active comparator | Drug: Triple Antibiotic Paste, Drug: Calcium Hydroxide (Ca(OH)2)Calcium Hydroxide intracanal dressing placed following chemo-mechanical preparation; sealed temporarily |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Systemically healthy adult patients between 18 and 65 years of age.
- Presence of a single-rooted tooth diagnosed with pulpal necrosis and asymptomatic apical periodontitis or chronic apical abscess.
- Radiographic evidence of a distinct periapical radiolucency with a minimum diameter of 2mm.
- The involved tooth must be deemed restorable after endodontic treatment.
- Patient willingness and ability to provide informed consent and comply with the follow-up schedule
Key exclusion criteria (6 listed)
- Patients under 18 or over 65 years of age.
- Presence of systemic diseases known to affect bone metabolism or immune response (e.g., uncontrolled diabetes).
- Pregnancy or lactation.
- Known allergies to any components of Triple Antibiotic Paste or calcium hydroxide.
- Teeth with previous root canal treatment, internal/external root resorption, root fractures, or non-endodontic periapical pathology.Exclusion Criteria:
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 |
|---|---|---|
| Triple Antibiotic PasteIntracanal medicament paste composed of Ciprofloxacin, Metronidazole, and Minocycline. Placed in the root canal for several weeks. | Drug | Calcium Hydroxide Group, Triple Antibiotic Paste (TAP) |
| Calcium Hydroxide (Ca(OH)2)Standard intracanal medicament with high pH, used for its antibacterial and tissue-stimulating properties. Placed in the root canal for several weeks | Drug | Calcium Hydroxide Group, Triple Antibiotic Paste (TAP) |
Primary outcome
Change in Periapical Lesion Area
Time frame: Baseline, 3 months, 6 months, 12 months
Percentage reduction in the area (mm²) of the periapical radiolucency from baseline, as measured on standardized periapical radiographs or CBCT scans.
1 secondary outcome
Change in Periapical Bone Density Score
Time frame: Baseline, 3 months, 6 months, 12 months
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 18 Mar 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Triple Antibiotic Paste and Calcium Hydroxide (Ca(OH)2) in people with Periapical Lesion and Periapical Periodontitis, run by Faiz ur rahman.
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 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: opening soon, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Contact Faiz Rahman (+923451505838, faizr3702@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Periapical Lesion Area (time frame: Baseline, 3 months, 6 months, 12 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 18 Mar 2026.