Periapical DiseasePhase 2NCT06342830
Comparing the Effect of Different Intracanal Dressing on Failed Root Canal Treated Cases on Periapical Healing
A Phase 2 study testing nanocurcumin gel, Curcumin Gel and Ciprofloxacin 500 mg +ibuprofen 400mg in people with Periapical Disease, run by Ain Shams University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to compare the effects of different intracanal medication between endodontic retreatment visits in previously failed root canal treatment patients (single root canal anteriors or premolars teeth). Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Periapical Disease
- What is being tested?
- nanocurcumin gel, Curcumin Gel and Ciprofloxacin 500 mg +ibuprofen 400mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jun 2024to 31 Oct 2025
- Phase
- Phase 2
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Medically free Patients
- both sex includes male and females
- Patients age between 20-60
- Patients agreement positively to share in the study
- patient able to sign informed consent
- on clinical and radiographic examinations, the included teeth maxillary and mandibular single root canal anteriors or premolars suffering from failed endodontic treatment with periapical lesion
Who cannot join
- badly broken down teeth indicated for extraction or with difficult isolation
- teeth with former procedural errors as ledge, perforation or instrument separation
- Medically compromised patients
- patients with history of receiving antibiotics within a month before starting study
- periodontally affected teeth by pocket depth \& > 4mm
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effects of Different Natural and Synthetic Intracanal Medicaments on the Healing of Periapical Lesion in Retreatment Cases (A Randomized Clinical Trial)
The goal of this clinical trial is to compare the effects of different intracanal medication between endodontic retreatment visits in previously failed root canal treatment patients (single root canal anteriors or premolars teeth). The main question it aims to answer are:
- Is natural and synthetic intracanal Medicament effective in reducing or complete healing of Periapical lesions or not? the researchers will compare the effect of different intracanal dressing including:
- nanocurcumin gel
- curcumin gel
- ciprofloxacin +ibuprofen gel
- calcium hydroxide Paste as control group in between the endodontic retreatment visits to see if these medicaments work well on periapical lesion healing this outcome measured by Cone beam CT at base and after 1 year follow up period
- Conditions
- Periapical Disease
- Being tested
- nanocurcumin gel, Curcumin Gel, Ciprofloxacin 500 mg +ibuprofen 400mg, Metapaste [calcium hydroxide paste (control group)]
- Medical subject headings
- Periapical Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nanocurcumin gelDrug
firstly patient anesthetized, rubber dam isolation , disinfect the crown with 10%H2O2, saline then sodium hypochlorite solution 2.5% then 5% sodium thiosulphate solution to inhibit the effect of NaOHCl then removal of old coronal restoration, disinfection of pulp chamber by the same previous protocol removal of old root canal filling with gates glidden drills and H files , taken first sample S1 from canal with paper point after using saline wash and scrubbing the canal wall the paper points left for 1 min in the canal then preparation of canal with edge endo files till size 45 taper 0.4 and NaOHCL 2.5% between each file and the next finally 5% sodium thiosulphate to inhibit the antibacterial effect of sodium hypochlorite irrigation then saline irrigation and scrubbing the canal wall and placement of paper points for 1min to taken second sample S2, then dryness of canal and placement of nanocurcumin gel until shown fill the canal under magnification and by using lentulospirals
Curcumin GelDrug
firstly patient anesthetized, rubber dam isolation , disinfect the crown with 10%H2O2, saline then sodium hypochlorite solution 2.5% then 5% sodium thiosulphate solution to inhibit the effect of NaOHCl then removal of old coronal restoration, disinfection of pulp chamber by the same previous protocol removal of old root canal filling with gates glidden drills and H files , taken first sample S1 from canal with paper point after using saline wash and scrubbing the canal wall the paper points left for 1 min in the canal then preparation of canal with edge endo files till size 45 taper 0.4 and NaOHCL 2.5% between each file and the next finally 5% sodium thiosulphate to inhibit the antibacterial effect of sodium hypochlorite irrigation then saline irrigation and scrubbing the canal wall and placement of paper points for 1min to taken second sample S2, then dryness of canal and placement of curcumin gel until shown fill the canal under magnification and by using lentulospirals
Ciprofloxacin 500 mg +ibuprofen 400mgDrug
firstly patient anesthetized, rubber dam isolation , disinfect the crown with 10%H2O2, saline then sodium hypochlorite solution 2.5% then 5% sodium thiosulphate solution to inhibit the effect of NaOHCl then removal of old coronal restoration, disinfection of pulp chamber by the same previous protocol removal of old root canal filling with gates glidden drills and H files , taken first sample S1 from canal with paper point after using saline wash and scrubbing the canal wall the paper points left for 1 min in the canal then preparation of canal with edge endo files till size 45 taper 0.4 and NaOHCL 2.5 % between each file and the next finally 5% sodium thiosulphate to inhibit the antibacterial effect of sodium hypochlorite irrigation then saline irrigation and scrubbing the canal wall and placement of paper points for 1min to taken second sample S2, then dryness of canal and placement of ciprofloxacin + ibuprofen gel until fill the canal under magnification and by using lentulospirals
Metapaste [calcium hydroxide paste (control group)]Drug
firstly patient anesthetized, rubber dam isolation , disinfect the crown with 10%H2O2, saline then sodium hypochlorite solution 2.5% then 5% sodium thiosulphate solution to inhibit the effect of NaOHCl then removal of old coronal restoration, disinfection of pulp chamber by the same previous protocol removal of old root canal filling with gates glidden drills and H files , taken first sample S1 from canal with paper point after using saline wash and scrubbing the canal wall the paper points left for 1 min in the canal then preparation of canal with edge endo files till size 45 taper 0.4 and NaOHCL 2.5 % between each file and the next finally 5% sodium thiosulphate to inhibit the antibacterial effect of sodium hypochlorite irrigation then saline irrigation and scrubbing the canal wall and placement of paper points for 1min to taken second sample S2, then dryness of canal and placement of calcium hydroxide paste until fill the canal under magnification by using lentulospirals
| Study group | Role | What they receive |
|---|---|---|
| Nanocurcumin gel . | Experimental | Preparation Method: Olive oil (5%), surfactant (Tween 80 (8%)) and co-surfactant (PEG 400 (2%)) were used as excipients and their selection was based on the solubility of curcumin. A high-energy ultrasonication techniquewas used to prepare the Cur-NE. Curcumin (0.3%) was dissolved in oil /surfactant/ co-surfactant mixture and stirred till obtaining clear solution. The mixture was microtitrated with distilled water (85 %) to achieve a coarse emulsion. A 20 kHz ultrasonic processor was used for the production of the desired nano-emulsion.
Gel Preparation:
0.4gm of Carboxymethyl cellulose (Loba CHIME, india) was sprinkled gently and gradually over the solution of Cur NE 0.3% under mild temperature with vigorous stirring to get homogenous gel Receives: Drug: nanocurcumin gel |
| Curcumin gel | Experimental | curcumin 250 mg powder + carboxymethyl cellulose 300mg+distilled water to 10ml Receives: Drug: Curcumin Gel |
| Ciprofloxacin 500 mg +Ibuprofen 400 mg | Experimental | Ciprofloxacin 500 mg +ibuprofen 400mg powder +carboxymethyl cellulose 300 mg +distilled water to 10 ml Receives: Drug: Ciprofloxacin 500 mg +ibuprofen 400mg |
| calcium hydroxide | Active comparator | Metapaste Receives: Drug: Metapaste [calcium hydroxide paste (control group)] |
What is being measured
The primary outcome is the main question the study is designed to answer.
healing of periapical lesion
measured radiographically the periapical lesion volmetric changes by CBCT between preoperative and after1 year follow up
Measured: 1 year
Secondary outcomes (2)
antibacterial effect (CFU)
Three samples S1 after removal of old root canal filling , S2 after mechanical Preparation , S3 after 7 days of placement of intracanal dressing measuring total bacterial count by colony forming unit each sample cultured and incubated for 24hours and bacterial counting measured
Measured: at first visit : S1 :baseline sample, S2 : sample immediately after chemomechanical procedure , at second visit S3: sample after 7 days of placement medication
Interappointment Pain
measured by Numerical Rating Scale (NRS) which is an 11-point scale consisting of numbers from 0 through 10 0 reading represents "no pain"
1- 3 readings represent "mild pain" 4- 6 readings represent "moderate pain" 7- 10 readings represent "severe pain" No or mild pain was considered as success while moderate or severe pain were regarded as failure.
Measured: 6,12, 24, 48, 72 hours after 1st visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start20 Jun 2024
- Primary completion20 Sep 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periapical DiseaseStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rawda Baghdady, Ain Shams University
- Investigators
- Rawda MO Baghdady, Principal investigator, faculty of dentistry, zagazig universitysarah H Fahmy, Study chair, faculty of dentistry, Ain Shams universitykarim M El Batouty, Study director, faculty of dentistry, Ain Shams university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06342830
- Sponsor's protocol ID
- End 20-05 P
- Status last verified
- Nov 2025
- First submitted
- 14 Mar 2024
- Last updated
- 17 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Different Natural and Synthetic Intracanal Medicaments on the Healing of Periapical Lesion in Retreatment Cases (A Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT06342830
- Acronym / sponsor ID
- End 20-05 P
- Conditions
- Periapical Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- 20 Sep 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 2 Apr 2024 (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 compare the effects of different intracanal medication between endodontic retreatment visits in previously failed root canal treatment patients (single root canal anteriors or premolars teeth). The main question it aims to answer are:
- Is natural and synthetic intracanal Medicament effective in reducing or complete healing of Periapical lesions or not? the researchers will compare the effect of different intracanal dressing including:
- nanocurcumin gel
- curcumin gel
- ciprofloxacin +ibuprofen gel
- calcium hydroxide Paste as control group in between the endodontic retreatment visits to see if these medicaments work well on periapical lesion healing this outcome measured by Cone beam CT at base and after 1 year follow up period
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Nanocurcumin gel . | Experimental | Drug: nanocurcumin gelPreparation Method: Olive oil (5%), surfactant (Tween 80 (8%)) and co-surfactant (PEG 400 (2%)) were used as excipients and their selection was based on the solubility of curcumin. A high-energy ultrasonication techniquewas used to prepare the Cur-NE. Curcumin (0.3%) was dissolved in oil /surfactant/ co-surfactant mixture and stirred till obtaining clear solution. The mixture was microtitrated with distilled water (85 %) to achieve a coarse emulsion. A 20 kHz ultrasonic processor was used for the production of the desired nano-emulsion. Gel Preparation: 0.4gm of Carboxymethyl cellulose (Loba CHIME, india) was sprinkled gently and gradually over the solution of Cur NE 0.3% under mild temperature with vigorous stirring to get homogenous gel |
| Curcumin gel | Experimental | Drug: Curcumin Gelcurcumin 250 mg powder + carboxymethyl cellulose 300mg+distilled water to 10ml |
| Ciprofloxacin 500 mg +Ibuprofen 400 mg | Experimental | Drug: Ciprofloxacin 500 mg +ibuprofen 400mgCiprofloxacin 500 mg +ibuprofen 400mg powder +carboxymethyl cellulose 300 mg +distilled water to 10 ml |
| calcium hydroxide | Active comparator | Drug: Metapaste [calcium hydroxide paste (control group)]Metapaste |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Medically free Patients
- both sex includes male and females
- Patients age between 20-60
- Patients agreement positively to share in the study
- patient able to sign informed consent
Key exclusion criteria (5 listed)
- badly broken down teeth indicated for extraction or with difficult isolation
- teeth with former procedural errors as ledge, perforation or instrument separation
- Medically compromised patients
- patients with history of receiving antibiotics within a month before starting study
- periodontally affected teeth by pocket depth \& > 4mm
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 |
|---|---|---|
| nanocurcumin gelfirstly patient anesthetized, rubber dam isolation , disinfect the crown with 10%H2O2, saline then sodium hypochlorite solution 2.5% then 5% sodium thiosulphate solution to inhibit the effect of NaOHCl then removal of old coronal restoration, disinfection of pulp chamber by the same previous protocol removal of old root canal filling with gates glidden drills and H files , taken first sample S1 from canal with paper point after using saline wash and scrubbing the canal wall the paper points left for 1 min in the canal then preparation of canal with edge endo files till size 45 taper 0.4 and NaOHCL 2.5% between each file and the next finally 5% sodium thiosulphate to inhibit the antibacterial effect of sodium hypochlorite irrigation then saline irrigation and scrubbing the canal wall and placement of paper points for 1min to taken second sample S2, then dryness of canal and placement of nanocurcumin gel until shown fill the canal under magnification and by using lentulospirals | Drug | Nanocurcumin gel . |
| Curcumin Gelfirstly patient anesthetized, rubber dam isolation , disinfect the crown with 10%H2O2, saline then sodium hypochlorite solution 2.5% then 5% sodium thiosulphate solution to inhibit the effect of NaOHCl then removal of old coronal restoration, disinfection of pulp chamber by the same previous protocol removal of old root canal filling with gates glidden drills and H files , taken first sample S1 from canal with paper point after using saline wash and scrubbing the canal wall the paper points left for 1 min in the canal then preparation of canal with edge endo files till size 45 taper 0.4 and NaOHCL 2.5% between each file and the next finally 5% sodium thiosulphate to inhibit the antibacterial effect of sodium hypochlorite irrigation then saline irrigation and scrubbing the canal wall and placement of paper points for 1min to taken second sample S2, then dryness of canal and placement of curcumin gel until shown fill the canal under magnification and by using lentulospirals | Drug | Curcumin gel |
| Ciprofloxacin 500 mg +ibuprofen 400mgfirstly patient anesthetized, rubber dam isolation , disinfect the crown with 10%H2O2, saline then sodium hypochlorite solution 2.5% then 5% sodium thiosulphate solution to inhibit the effect of NaOHCl then removal of old coronal restoration, disinfection of pulp chamber by the same previous protocol removal of old root canal filling with gates glidden drills and H files , taken first sample S1 from canal with paper point after using saline wash and scrubbing the canal wall the paper points left for 1 min in the canal then preparation of canal with edge endo files till size 45 taper 0.4 and NaOHCL 2.5 % between each file and the next finally 5% sodium thiosulphate to inhibit the antibacterial effect of sodium hypochlorite irrigation then saline irrigation and scrubbing the canal wall and placement of paper points for 1min to taken second sample S2, then dryness of canal and placement of ciprofloxacin + ibuprofen gel until fill the canal under magnification and by using lentulospirals | Drug | Ciprofloxacin 500 mg +Ibuprofen 400 mg |
| Metapaste [calcium hydroxide paste (control group)]firstly patient anesthetized, rubber dam isolation , disinfect the crown with 10%H2O2, saline then sodium hypochlorite solution 2.5% then 5% sodium thiosulphate solution to inhibit the effect of NaOHCl then removal of old coronal restoration, disinfection of pulp chamber by the same previous protocol removal of old root canal filling with gates glidden drills and H files , taken first sample S1 from canal with paper point after using saline wash and scrubbing the canal wall the paper points left for 1 min in the canal then preparation of canal with edge endo files till size 45 taper 0.4 and NaOHCL 2.5 % between each file and the next finally 5% sodium thiosulphate to inhibit the antibacterial effect of sodium hypochlorite irrigation then saline irrigation and scrubbing the canal wall and placement of paper points for 1min to taken second sample S2, then dryness of canal and placement of calcium hydroxide paste until fill the canal under magnification by using lentulospirals | Drug | calcium hydroxide |
Primary outcome
healing of periapical lesion
Time frame: 1 year
measured radiographically the periapical lesion volmetric changes by CBCT between preoperative and after1 year follow up
2 secondary outcomes
antibacterial effect (CFU)
Time frame: at first visit : S1 :baseline sample, S2 : sample immediately after chemomechanical procedure , at second visit S3: sample after 7 days of placement medication
Interappointment Pain
Time frame: 6,12, 24, 48, 72 hours after 1st visit
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 17 Nov 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.
Rawda MO Baghdady principal investigator
faculty of dentistry, zagazig university
sarah H Fahmy study chair
faculty of dentistry, Ain Shams university
karim M El Batouty study director
faculty of dentistry, Ain Shams university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing nanocurcumin gel, Curcumin Gel and Ciprofloxacin 500 mg +ibuprofen 400mg in people with Periapical Disease, run by Ain Shams University at 1 site in Egypt.
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 6 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: finished, as of the sponsor's last update on 17 Nov 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 Egypt. 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 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?
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?
healing of periapical lesion (time frame: 1 year). 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 17 Nov 2025.