Apical PeriodontitisNCT06625645
Comparative Evaluation of Antimicrobial Efficacy, Clinical and Radiographic Success of Calcium Hydroxide, Chlorhexidine, and Modified Triple Antibiotic Paste in Different Combination Forms As Intracanal Medicaments Against Enterococcus Faecalis in Primary Teeth
A study testing Modified triple antibiotic paste (TAP) mixed with chlorehexidine, Modified Triple Antibiotic Paste mixed with saline and Calcium Hydroxide mixed with chlorohexidine Intracanal medication in people with Apical Periodontitis and Necrotic Primary Molars, run by Mahy Abdel Raouf Aly Kamar.
Trial summary
Comparing between different intracanal medications with different combination forms of Modified Triple Antibiotic Paste, Calcium Hydroxide and Chlorehexidine, regarding antimicrobial efficacy through bacterial reduction count of enterococcus Faecalis and regarding clinical and radiographic success in non vital primary… Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Apical Periodontitis, Necrotic Primary Molars, Periapical Pathosis of Primary Molars
- What is being tested?
- Modified triple antibiotic paste (TAP) mixed with chlorehexidine, Modified Triple Antibiotic Paste mixed with saline and Calcium Hydroxide mixed with chlorohexidine Intracanal medication
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 1 Jan 2026
- 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 4 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Primary molars necessitating pulpectomy diagnosed with deep dental caries with pulp necrosis, apical periodontitis and periapical pathosis or both.
- Non-Vital pulps.
- Negative response to hot or cold pulp tester (ethyl chloride spray ).
- Decayed tooth with spontaneous unprovoked long dull aching pain showing signs of necrosis of the pulp
Who cannot join
- Medically compromised and uncooperative children
- Tooth indicated for extraction
- Mobile teeth (Miller's Grade 2 or more)
- teeth with more than two-thirds of root resorption
- previous endodontic treatment
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparative Evaluation of Antimicrobial Efficacy, Clinical and Radiographic Success of Calcium Hydroxide, Chlorhexidine, and Modified Triple Antibiotic Paste in Different Combination Forms As Intracanal Medicaments Against Enterococcus Faecalis in Primary Teeth: a Randomized Clinical Trial
Comparing between different intracanal medications with different combination forms of Modified Triple Antibiotic Paste, Calcium Hydroxide and Chlorehexidine, regarding antimicrobial efficacy through bacterial reduction count of enterococcus Faecalis and regarding clinical and radiographic success in non vital primary teeth necessitating pulpectomy with follow up time 1 year.
Read the detailed description
- Full medical and dental history will be obtained from the parents of the patients participating in this study.
- A thorough clinical and radiographic examination of the tooth to be treated will be done.
- The tooth will be anaesthetized using the inferior alveolar nerve block technique for lower molars and infiltration for upper molars
- Before isolation, antisepsis of the oral cavity will be performed by rinsing for 1 min with 10 mL chlorhexidine gluconate mouth-wash 0.2 %.
- The tooth will be properly isolated using rubber dam.
- Access cavity will be performed using a round bur.
- The root canals will be irrigated with 1 ml sterile saline solution.
- Patency of the root canal will be obtained using stainless steel hand k- files size #15
- Working length will be determined using apex locator
- The first microbial samples (S1) will be collected to assess bacterial count of the root canals using 1 sterile paper point size 20, which will be inserted into the widest root canal for 1 min with pumping movements (McGurkin-Smith et al., 2005)
- It will be placed inside sterile tubes containing a reduced transport medium of thioglycolate.
- The canals will be thoroughly irrigated using 3ml syringe of 1.25% Sodium hypochlorite. A side-vented needle will be used to control the possibility of irrigant apical extrusion.
- Mechanical preparation will be performed with rotary system for all the cases.
- Irrigation with saline solution will be used to neutralize all the previously used solutions.
- Then, a second microbial samples (S2) representing the antibacterial effect of the mechanical preparation will be obtained with the same procedure as the first sample (S1).
- According to the randomization sequence, patients will be assigned to one of 4 groups:
1- A mix of modified triple Antibiotic Paste (M-TAP) and normal saline (experimental).
2- A mix of Ca(OH)2 and 2% CHX gluconate solution(experimental). 3- A mix of M-TAP and 2% CHX gluconate solution(experimental). 4- A mix of Ca(OH)2 and normal saline (control) 17) The canals will be dried and filled with intracanal medication plugged into the canal by using a plugger.
- At the end of the first visit a piece of sterile cotton will be placed in the pulp chamber.
- All teeth will be dressed with intermediate restorative material (IRM) as a temporary filling, in order to ensure proper sealing with no leakage of any oral fluids inside the root canal, which might disturb the action of the intracanal medication.
- After 7 days, the temporary restoration will be removed. 21) Disinfection of the operative field will take place as performed previously using the same protocol.
- Irrigation of the root canals with 2 mL of saline to flush out the medicaments and the third bacteriological sample (S3) will be taken out.
- Later, canals will be filled with Metapex (Metabiomed, Korea), followed by the placement of stainless-steel crowns (3M ESPE).
- The samples will be placed in sterile vials with thioglycolate (transport medium). The vials will be sealed tightly to avoid contamination and labeled. The labeled vials will be kept in a freezer and will be sent to the laboratory within 1 hour of collection, and samples will be assessed for total E. faecalis count (Qamar et al., 2023).
- Being tested
- Modified triple antibiotic paste (TAP) mixed with chlorehexidine, Modified Triple Antibiotic Paste mixed with saline, Calcium Hydroxide mixed with chlorohexidine Intracanal medication, calcium hydroxide mixed with saline as intracanal medication
- Keywords
- Necrotic Primary Teeth, Apical Periodontitis, Non Vital primary teeth, periapical pathosis of primary teeth, intracanal medication, triple antibiotic paste, enterococcus faecalis, Microbiology, bacterial reduction
- Medical subject headings
- Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified triple antibiotic paste (TAP) mixed with chlorehexidineCombination product
M-TAP with CHX 2%
Modified Triple Antibiotic Paste mixed with salineCombination product
M-TAP mixed with saline
Calcium Hydroxide mixed with chlorohexidine Intracanal medicationCombination product
calcium hydroxide powder mixed with CHX 2% solution as intracanal medication
calcium hydroxide mixed with saline as intracanal medicationCombination product
calcium hydroxide mixed with saline as intracanal medication for necrotic primary molars
| Study group | Role | What they receive |
|---|---|---|
| Calcium Hydroxide mixed with saline as control intracanal medication | Active comparator | using calcium hydroxide with saline as control intracanal medication for necrotic primary molars Receives: Combination Product: calcium hydroxide mixed with saline as intracanal medication |
| different types and combinations of intracanal medications for necrotic primary molars | Experimental | Not described Receives: Combination Product: Modified triple antibiotic paste (TAP) mixed with chlorehexidine; Combination Product: Modified Triple Antibiotic Paste mixed with saline; Combination Product: Calcium Hydroxide mixed with chlorohexidine Intracanal medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enterococcus faecalis bacterial reduction
Samples from canal using paper point size 20 with pumping action from the widest canal three times one after the access and gaining patency, second one after chemomechanical preparation and the third one after 7 days from intracanal medication insertion in the canal, then the samples will be placed in sterile vials with thioglycolate (transport medium). The vials will be sealed tightly to avoid contamination and labeled. The labeled vials will be kept in a freezer and will be sent to the laboratory within 1 hour of collection, and samples will be assessed for total E. faecalis count.
Measured: 3 times, one after the access and gaining patency, second one after chemomechanical preparation and the third one after 7 days from intracanal medication insertion in the canal
Secondary outcomes (1)
Clinical success
measuring pain through presence or absence of pain Visual inspection of any changes (Redness or swelling of vestibular area (presence or absence of any change) Tenderness upon percussion ( positive or negative response) Tenderness upon touching of the vestibulum ( positive or negative response)
Measured: 3,6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start1 Jan 2025 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 Jan 2026 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahy Abdel Raouf Aly Kamar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mahy Abdel Raouf Aly Kamar, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06625645
- Sponsor's protocol ID
- 14422023573623
- Other IDs
- main investigator
- Status last verified
- Oct 2024
- First submitted
- 28 Sep 2024
- Last updated
- 17 Oct 2024
- 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 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Antimicrobial Efficacy, Clinical and Radiographic Success of Calcium Hydroxide, Chlorhexidine, and Modified Triple Antibiotic Paste in Different Combination Forms As Intracanal Medicaments Against Enterococcus Faecalis in Primary Teeth: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06625645
- Acronym / sponsor ID
- 14422023573623
- Keywords
- Necrotic Primary Teeth, Apical Periodontitis, Non Vital primary teeth, periapical pathosis of primary teeth, intracanal medication, triple antibiotic paste, enterococcus faecalis, Microbiology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Mahy Abdel Raouf Aly KamarUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 3 Oct 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.
Comparing between different intracanal medications with different combination forms of Modified Triple Antibiotic Paste, Calcium Hydroxide and Chlorehexidine, regarding antimicrobial efficacy through bacterial reduction count of enterococcus Faecalis and regarding clinical and radiographic success in non vital primary teeth necessitating pulpectomy with follow up time 1 year.
Detailed description
- Full medical and dental history will be obtained from the parents of the patients participating in this study.
- A thorough clinical and radiographic examination of the tooth to be treated will be done.
- The tooth will be anaesthetized using the inferior alveolar nerve block technique for lower molars and infiltration for upper molars
- Before isolation, antisepsis of the oral cavity will be performed by rinsing for 1 min with 10 mL chlorhexidine gluconate mouth-wash 0.2 %.
- The tooth will be properly isolated using rubber dam.
- Access cavity will be performed using a round bur.
- The root canals will be irrigated with 1 ml sterile saline solution.
- Patency of the root canal will be obtained using stainless steel hand k- files size #15
- Working length will be determined using apex locator
- The first microbial samples (S1) will be collected to assess bacterial count of the root canals using 1 sterile paper point size 20, which will be inserted into the widest root canal for 1 min with pumping movements (McGurkin-Smith et al., 2005)
- It will be placed inside sterile tubes containing a reduced transport medium of thioglycolate.
- The canals will be thoroughly irrigated using 3ml syringe of 1.25% Sodium hypochlorite. A side-vented needle will be used to control the possibility of irrigant apical extrusion.
- Mechanical preparation will be performed with rotary system for all the cases.
- Irrigation with saline solution will be used to neutralize all the previously used solutions.
- Then, a second microbial samples (S2) representing the antibacterial effect of the mechanical preparation will be obtained with the same procedure as the first sample (S1).
- According to the randomization sequence, patients will be assigned to one of 4 groups:
1- A mix of modified triple Antibiotic Paste (M-TAP) and normal saline (experimental).
2- A mix of Ca(OH)2 and 2% CHX gluconate solution(experimental). 3- A mix of M-TAP and 2% CHX gluconate solution(experimental). 4- A mix of Ca(OH)2 and normal saline (control) 17) The canals will be dried and filled with intracanal medication plugged into the canal by using a plugger.
- At the end of the first visit a piece of sterile cotton will be placed in the pulp chamber.
- All teeth will be dressed with intermediate restorative material (IRM) as a temporary filling, in order to ensure proper sealing with no leakage of any oral fluids inside the root canal, which might disturb the action of the intracanal medication.
- After 7 days, the temporary restoration will be removed. 21) Disinfection of the operative field will take place as performed previously using the same protocol.
- Irrigation of the root canals with 2 mL of saline to flush out the medicaments and the third bacteriological sample (S3) will be taken out.
- Later, canals will be filled with Metapex (Metabiomed, Korea), followed by the placement of stainless-steel crowns (3M ESPE).
- The samples will be placed in sterile vials with thioglycolate (transport medium). The vials will be sealed tightly to avoid contamination and labeled. The labeled vials will be kept in a freezer and will be sent to the laboratory within 1 hour of collection, and samples will be assessed for total E. faecalis count (Qamar et al., 2023).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calcium Hydroxide mixed with saline as control intracanal medication | Active comparator | Combination Product: calcium hydroxide mixed with saline as intracanal medicationusing calcium hydroxide with saline as control intracanal medication for necrotic primary molars |
| different types and combinations of intracanal medications for necrotic primary molars | Experimental | Combination Product: Modified triple antibiotic paste (TAP) mixed with chlorehexidine, Combination Product: Modified Triple Antibiotic Paste mixed with saline, Combination Product: Calcium Hydroxide mixed with chlorohexidine Intracanal medication |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Primary molars necessitating pulpectomy diagnosed with deep dental caries with pulp necrosis, apical periodontitis and periapical pathosis or both.
- Non-Vital pulps.
- Negative response to hot or cold pulp tester (ethyl chloride spray ).
- Decayed tooth with spontaneous unprovoked long dull aching pain showing signs of necrosis of the pulp
Key exclusion criteria (5 listed)
- Medically compromised and uncooperative children
- Tooth indicated for extraction
- Mobile teeth (Miller's Grade 2 or more)
- teeth with more than two-thirds of root resorption
- previous endodontic treatment
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 |
|---|---|---|
| Modified triple antibiotic paste (TAP) mixed with chlorehexidineM-TAP with CHX 2% | Combination product | different types and combinations of intracanal medications for necrotic primary molars |
| Modified Triple Antibiotic Paste mixed with salineM-TAP mixed with saline | Combination product | different types and combinations of intracanal medications for necrotic primary molars |
| Calcium Hydroxide mixed with chlorohexidine Intracanal medicationcalcium hydroxide powder mixed with CHX 2% solution as intracanal medication | Combination product | different types and combinations of intracanal medications for necrotic primary molars |
| calcium hydroxide mixed with saline as intracanal medicationcalcium hydroxide mixed with saline as intracanal medication for necrotic primary molars | Combination product | Calcium Hydroxide mixed with saline as control intracanal medication |
Primary outcome
Enterococcus faecalis bacterial reduction
Time frame: 3 times, one after the access and gaining patency, second one after chemomechanical preparation and the third one after 7 days from intracanal medication insertion in the canal
Samples from canal using paper point size 20 with pumping action from the widest canal three times one after the access and gaining patency, second one after chemomechanical preparation and the third one after 7 days from intracanal medication insertion in the canal, then the samples will be placed in sterile vials with thioglycolate (transport medium). The vials will be sealed tightly to avoid contamination and labeled. The labeled vials will be kept in a freezer and will be sent to the laboratory within 1 hour of collection, and samples will be assessed for total E. faecalis count.
1 secondary outcome
Clinical success
Time frame: 3,6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Apical Periodontitis
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
Not yet recruiting
PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
Pulp Necrosis, Apical Periodontitis
Not yet recruiting
Influence of Continuous Rotation Versus Reciprocation Motion of MG3 Blue Rotary File on Postoperative Pain and Intracanal Bacterial Reduction of Teeth With Necrotic Pulps.
Necrotic Pulps With no Apical Periodontitis
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.
Questions about this trial
What is this clinical trial studying?
A study testing Modified triple antibiotic paste (TAP) mixed with chlorehexidine, Modified Triple Antibiotic Paste mixed with saline and Calcium Hydroxide mixed with chlorohexidine Intracanal medication in people with Apical Periodontitis and Necrotic Primary Molars, run by Mahy Abdel Raouf Aly Kamar.
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 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 17 Oct 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahy kamar Mahy A.Raouf Kamar, Assistant Lecturer (01550831173, Mahy_kamar@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enterococcus faecalis bacterial reduction (time frame: 3 times, one after the access and gaining patency, second one after chemomechanical preparation and the third one after 7 days from intracanal medication insertion in the canal). 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 Oct 2024.