Necrotic Pulp with Symptomatic Apical PeriodontitisNCT06804330
Evaluation of Postoperative Pain and Antimicrobial Efficacy of Selenium Versus Calcium Hydroxide As Intracanal Medication in Mandibular First Molars with Necrotic Pulp and Symptomatic Apical Periodontitis
A study testing root canal treatment and intracanal medicament in people with Necrotic Pulp with Symptomatic Apical Periodontitis and Postoperative Dental Pain, run by Future University in Egypt.
Trial summary
The main rational behind intracanal medicament is to kill the bacteria inside the root canal and to avert reinfection. In absence of nutrients, the bacteria remains after obturation in root canal may not survive. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Necrotic Pulp with Symptomatic Apical Periodontitis, Postoperative Dental Pain, Antimicrobial Effect
- What is being tested?
- root canal treatment and intracanal medicament
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2025to 1 Oct 2025
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Medically free patients with no systemic disease: (American Society of Anesthesiologists / (ASA Class I or II).
- Age range is between 20 to 40 years.
- No sex predilection.
- Patients having necrotic pulp with symptomatic apical periodontitis in mandibular first molars.(type l distal root canal ) .
- Sensitive to percussion.
- Periapical radiographic appearance of teeth showed slight widening in lamina dura.
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- restorable teeth.
- Positive patient"s acceptance for participating in the study.
- Patients able to sign informed consent.
Who cannot join
- Medically compromised patients.
- Pregnant or lactating females.
- Psychologically disturbed patients.
- Patients with a history of allergy to any medication used in the study were excluded.
- If anti-inflammatory analgesics or antibiotics have been administrated by patient during the past 12 hours preoperatively.
- Patients with swelling or acute peri-apical abscess or fistulous tract.
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- Teeth that have:
- Wide or open apex.
- Vital pulp tissues.
- Periodontally affected with grade 2 or 3 mobility.
- Not restorable teeth.
- Abnormal anatomy and calcified canals.
- Previous root canal treatment.
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
The main rational behind intracanal medicament is to kill the bacteria inside the root canal and to avert reinfection. In absence of nutrients, the bacteria remains after obturation in root canal may not survive. Otherwise they may flourish \& If the root canal is not dressed properly with antiseptic medicaments between the visits, the residual bacteria may increase . Thus the use of effective intracanal medication for disinfection of root canal is necessitated . Medicament with long effect and least irritated to periradicular tissue has to be introduced to infiltrate the dentinal tubule eliminating bacteria . As the effect of intracanal medicaments is longer than irrigants, it is generally recommended to fill the root canal between appointments with intracanal medicaments. Calcium hydroxide is the most commonly recommended antimicrobial agent for interappointment medications. It serves as an effective intracanal medicament due to its alkaline pH, which inhibits bacterial growth. However, calcium hydroxide has limitations. .Recently selenium(Se) was introduced as intracanal medication .Se is a mineral essential for the formation of the amino acid selenocysteine, which is directly involved in the maintenance of the immune response. Selenium has been widely used in the medical field in the treatment of cancer, as an activator of bone metabolism, and as a stimulator of the immune system. In this study, it will show that the incorporation of Se, whether as intracanal medication alone or in conjunction with other medications, may potentiate periapical tissue repair after RCS cleaning and shaping procedures.
This study consists of 60 patients divided into 3 group each group having 20 patient.
Read more
Intervention 1: intracanal medication using selenium alone .
Intervention 2: intracanal medication using selenium with calcium hydroxide
- Conditions
- Necrotic Pulp with Symptomatic Apical Periodontitis, Postoperative Dental Pain, Antimicrobial Effect
- Being tested
- root canal treatment and intracanal medicament
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
root canal treatment and intracanal medicamentProcedure or surgery
Root canal biomechanical preparation followed by intracanal placement of intracanal medicament according to the arm
| Study group | Role | What they receive |
|---|---|---|
| Using Plain Selenium paste as intracanal medication . | Active comparator | Not described Receives: Procedure: root canal treatment and intracanal medicament |
| Using Selenium mixed with calcium hydroxide as intracanal medication . | Active comparator | Not described Receives: Procedure: root canal treatment and intracanal medicament |
| Using Calcium hydroxide as an intracanal medication . | Active comparator | Not described Receives: Procedure: root canal treatment and intracanal medicament |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain
Numerical rate scale (NRS) for measuring post-operative pain after 6 hours upto 96 hours 0-10 scale , with zero meaning ''no pain '' and 10 meaning ''the worst pain imaginable ''
Measured: 6 hours up to 96 hours
Secondary outcomes (1)
Bacterial Load
Serial dilution technique For measuring bacterial load preplacement of the medication and 2 weeks postplacement .
Measured: Before intracanal medication injection and 2 weeks following the procedure and before obturating the root canals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start1 Apr 2025 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Necrotic Pulp with Symptomatic 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Wael Mahmoud, Future University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06804330
- Sponsor's protocol ID
- FUE.REC(15)/6-2024
- Status last verified
- Mar 2025
- First submitted
- 5 Aug 2024
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Postoperative Pain and Antimicrobial Efficacy of Selenium Versus Calcium Hydroxide As Intracanal Medication in Mandibular First Molars with Necrotic Pulp and Symptomatic Apical Periodontitis
- ClinicalTrials.gov ID
- NCT06804330
- Acronym / sponsor ID
- FUE.REC(15)/6-2024
- Conditions
- Necrotic Pulp with Symptomatic Apical Periodontitis, Postoperative Dental Pain, Antimicrobial Effect
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 3 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 main rational behind intracanal medicament is to kill the bacteria inside the root canal and to avert reinfection. In absence of nutrients, the bacteria remains after obturation in root canal may not survive. Otherwise they may flourish \& If the root canal is not dressed properly with antiseptic medicaments between the visits, the residual bacteria may increase . Thus the use of effective intracanal medication for disinfection of root canal is necessitated . Medicament with long effect and least irritated to periradicular tissue has to be introduced to infiltrate the dentinal tubule eliminating bacteria . As the effect of intracanal medicaments is longer than irrigants, it is generally recommended to fill the root canal between appointments with intracanal medicaments. Calcium hydroxide is the most commonly recommended antimicrobial agent for interappointment medications. It serves as an effective intracanal medicament due to its alkaline pH, which inhibits bacterial growth. However, calcium hydroxide has limitations. .Recently selenium(Se) was introduced as intracanal medication .Se is a mineral essential for the formation of the amino acid selenocysteine, which is directly involved in the maintenance of the immune response. Selenium has been widely used in the medical field in the treatment of cancer, as an activator of bone metabolism, and as a stimulator of the immune system. In this study, it will show that the incorporation of Se, whether as intracanal medication alone or in conjunction with other medications, may potentiate periapical tissue repair after RCS cleaning and shaping procedures.
This study consists of 60 patients divided into 3 group each group having 20 patient.
Intervention 1: intracanal medication using selenium alone .
Intervention 2: intracanal medication using selenium with calcium hydroxide
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Using Plain Selenium paste as intracanal medication . | Active comparator | Procedure: root canal treatment and intracanal medicament |
| Using Selenium mixed with calcium hydroxide as intracanal medication . | Active comparator | Procedure: root canal treatment and intracanal medicament |
| Using Calcium hydroxide as an intracanal medication . | Active comparator | Procedure: root canal treatment and intracanal medicament |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Medically free patients with no systemic disease: (American Society of Anesthesiologists / (ASA Class I or II).
Key exclusion criteria (13 listed)
- Medically compromised patients.
- Wide or open apex.
- Vital pulp tissues.
- Periodontally affected with grade 2 or 3 mobility.
- Not restorable teeth.
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 |
|---|---|---|
| root canal treatment and intracanal medicamentRoot canal biomechanical preparation followed by intracanal placement of intracanal medicament according to the arm | Procedure or surgery | Using Calcium hydroxide as an intracanal medication ., Using Plain Selenium paste as intracanal medication ., Using Selenium mixed with calcium hydroxide as intracanal medication . |
Primary outcome
Post-operative pain
Time frame: 6 hours up to 96 hours
Numerical rate scale (NRS) for measuring post-operative pain after 6 hours upto 96 hours 0-10 scale , with zero meaning ''no pain '' and 10 meaning ''the worst pain imaginable ''
1 secondary outcome
Bacterial Load
Time frame: Before intracanal medication injection and 2 weeks following the procedure and before obturating the root canals
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 19 Mar 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Necrotic Pulp with Symptomatic Apical Periodontitis
Active, not recruitingEarly Phase 1
Comparing the Effectiveness of Hyalone and Calcium Hydroxide in Reducing Post-operative Pain and Promoting Periapical Healing.
Pain Management
Active, not recruitingPhase 2
Evaluation of Postoperative Pain and Bacterial Load After Hyalone or Calcium Hydroxide Medication in Mandibular First Molars
Bacterial Load Reduction, Postoperative Pain
Active, not recruiting
The Impact of Using Different Final Irrigation Modes on Postoperative Pain Following Root Canal Treatment of Non-vital Mandibular First Molar With Periapical Lesion.
Necrotic Pulp With Symptomatic Apical Periodontitis
Active, not recruiting
Evaluation of the Impact of Different Final Irrigation Activation Modes on Healing of Periapical Lesions Related to Permanent Mandibular First Molars Using CBCT.
Necrotic Pulp With Symptomatic 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.
Questions about this trial
What is this clinical trial studying?
A study testing root canal treatment and intracanal medicament in people with Necrotic Pulp with Symptomatic Apical Periodontitis and Postoperative Dental Pain, run by Future University 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 9 inclusion and 13 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 19 Mar 2025. 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 Mohamed Wael Mahmoud, Bachelor (+201156800995, Mohamed.Bakheet@Fue.edu.eg), 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 hours up to 96 hours). 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 19 Mar 2025.