Post Operative PainNCT06771570
Postoperative Pain and Periapical Tissue Healing
A study testing Silver Nanoparticles Irrigation in people with Post Operative Pain and Necrotic Mandibular Molars, run by Radwa fath Ahmed at 1 site in Egypt.
Trial summary
The success of endodontic treatment derives from the complete elimination of microorganisms capable of causing an intraradicular or extra radicular infection. To achieve a more effective eradication of these microorganisms, endodontic instrumentation must always be implemented with abundant irrigation, which has to… Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pain, Necrotic Mandibular Molars
- What is being tested?
- Silver Nanoparticles Irrigation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Aug 2022to 15 Aug 2024
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Patients between the age group of 20 and 40 years old with no sex predilection, who agree to take partin the study and to sign a written informed consent.
- Asymptomatic necrotic mandibular molars:non-responsive to thermal pulp testing, with no pain to percussion, and distal root having typeI root canal system.
- Presence of periapical radiolucency not exceeding 5mm in diameter,confirmed with cone beam computed tomography scans.
Who cannot join
- Medically compromised patients, pregnant and lactating females.
- Patients were using medication such as analgesics or any kind of antiinflammatory drugs, or antibiotics 12 h preoperatively.
- Teeth with calcified root canals, external or internal root resorptions, periodontal problems as those with mobility greater than Grade I, or pocket depth exceeding 5 mm.
- Previously endodontically treated teeth, immature with open apex, severe damage and those having associated traumatic occlusion.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Hospital of Faculty of Dental Medicine for Girls, Al-Azhar University
Cairo
About this study
Official title: Postoperative Pain and Periapical Tissue Healing Following XP-Endo Finisher Activated Silver Nanoparticles Final Irrigation in Necrotic Mandibular Molars. A Randomized Clinical Trial
The success of endodontic treatment derives from the complete elimination of microorganisms capable of causing an intraradicular or extra radicular infection. To achieve a more effective eradication of these microorganisms, endodontic instrumentation must always be implemented with abundant irrigation, which has to achieve chemical, mechanical and biological effects.
The objectives of root canal irrigation are to dissolve vital or necrotic pulp tissues, disrupt endodontic biofilms, neutralize endotoxins and remove the smear layer. Antimicrobial activity and biofilm destruction appear to be the most important objectives targeted towards the etiology of pulp and periradicular infections.
Read the detailed description
The role of microorganisms in periradicular infection has been well established in endodontic literature, signifying that endodontic treatment will be afflicted with a higher chance of failure if microorganisms persist in the canals at the time of root canal Obturation .
Furthermore, anatomic complexities of the root canals as isthmuses, fins, ramifications, lateral Canals, and dentinal tubules make the situation much more difficult; bacteria harboring such areas become inaccessible to mechanical instrumentation, and protected by tissue residues, dentin, serum and dead cells that inactivate or diminish the efficiency of antimicrobial agents.
Sodium hypochlorite (NaOCl) is regarded as the most potent disinfectant in endodontics due to its excellent ability to dissolve vital and necrotic tissues in addition to its antimicrobial activity. However, intracanal irrigants are only effective when in contact with the surface, and they cannot penetrate deep into the surfaces because of anatomic barriers. NaOCl can penetrate into the dentinal tubules by 130 μm, whereas bacteria can penetrate into the dentinal tubules by 1000 μm.
Silver nanoparticles (AgNPs) can also be used for disinfection because of their optimal antimicrobial properties. They are effective against many microorganisms including E. faecalis . Nanomaterials has dimensions of 1- 100nm, presenting small sizes, large surface/area mass ratio and increased chemical reactivity , the small size of nanoparticles offers a larger surface area for a small volume of the particles. This allows them to exert action even when used in small quantities, the action of AgNPs differ according to size, concentration, and time of application. Moreover, the killing effect of AgNPs against gram-negative and grampositive bacteria increases with decreasing particle size.
Silver nano particles release silver ions which have an electrostatic attraction to sulfur proteins, that results in adherence and disruption of the bacterial membrane, Silver ions can also cause the denaturation of DNA and ribosomes directly. AgNPs can also interrupt signal transduction by dephosphorylation of tyrosine residues on the peptide substrates leading to cell death and apoptosis.
However, cell culture studies revealed that AgNPs are able to induce cytotoxicity in human cell lines including human bronchial epithelial cells, red blood cells, macrophages, liver cells, etc., particularly for those with sizes more than 10 nm, and the cytotoxicity of AgNPs has been reported to be contingent upon dose, size, and exposure time .
Since irrigant needs to reach and disrupt the biofilm matrix in less accessible areas of the root canal system, several agitation and activation methods have been proposed to improve efficacy, including sonic \& ultrasonic activation, negative apical pressure irrigation, laser activation and physical agitation using XP-Endo Finisher. Several studies have shown that compared to conventional irrigation, the application of ultrasonic activation or XP-Endo Finisher enhances the efficacy of NaOCl in reducing intra-canal bacteria and removing biofilms from the main canal lumen, the apical third root surface and shallow or deep layers of root dentine.
Pain following root canal treatment is an important patient-centered outcome that has been related to the patient's quality of life, with an incidence of 3-58% following treatment. It could be associated with mechanical and chemical injuries, along with the presence of microorganisms in the periapical region. However, Advancements in material science and metallurgy have improved the predictability and efficiency of delivering endodontic treatment either following single-visit or multiple-visit root canal treatment, even in teeth with necrotic pulps.
- Conditions
- Post Operative Pain, Necrotic Mandibular Molars
- Being tested
- Silver Nanoparticles Irrigation
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silver Nanoparticles IrrigationBiological
Also called conventional needle irrigation
to evaluate the postoperative pain, antimicrobial efficiency, and periapical tissue healing following the use of silver nano particles solution as a final irrigation, using either conventional needle irrigation or XP-Endo Finisher activation, in necrotic mandibular molar teeth.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Active comparator | About 16 Persons injected by 5 ml 2.5% NaOCl using conventional Needle Irrigation Receives: Biological: Silver Nanoparticles Irrigation |
| Group II | Active comparator | About 16 Persons injected by 5 ml AgNPs using conventional Needle Irrigation. Receives: Biological: Silver Nanoparticles Irrigation |
| Group III | Active comparator | About 16 Persons injected by 5 ml AgNPs using XP-Endo Finisher activation. Receives: Biological: Silver Nanoparticles Irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative Pain
Following the treatment, patients will be asked to record their pain level on a modified VAS at 4, 24, 48, 72, and 96 h.
Measured: 4 days
Secondary outcomes (1)
Digital periapical radiographs (DPR)
The patients evaluated by Digital periapical radiographs after irrigation to assess the periapical tissue healing, and confirmed with cone beam computed tomography scans
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start15 Aug 2022
- Primary completion10 Aug 2024
- Study completion15 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies 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
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radwa fath Ahmed
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Radwa fath Ahmed, Faculty of Dental Medicine for Girls
- Investigators
- Wael Hussein Kamel, Professor, Study chair, Faculty of Dental Medicine for Girls, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06771570
- Sponsor's protocol ID
- Necrotic Mandibular Molars
- Status last verified
- Aug 2022
- First submitted
- 8 Jan 2025
- Last updated
- 13 Jan 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 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain and Periapical Tissue Healing Following XP-Endo Finisher Activated Silver Nanoparticles Final Irrigation in Necrotic Mandibular Molars. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06771570
- Acronym / sponsor ID
- Necrotic Mandibular Molars
- Conditions
- Post Operative Pain, Necrotic Mandibular Molars
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Radwa fath AhmedOther government
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 10 Aug 2024 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 13 Jan 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 success of endodontic treatment derives from the complete elimination of microorganisms capable of causing an intraradicular or extra radicular infection. To achieve a more effective eradication of these microorganisms, endodontic instrumentation must always be implemented with abundant irrigation, which has to achieve chemical, mechanical and biological effects.
The objectives of root canal irrigation are to dissolve vital or necrotic pulp tissues, disrupt endodontic biofilms, neutralize endotoxins and remove the smear layer. Antimicrobial activity and biofilm destruction appear to be the most important objectives targeted towards the etiology of pulp and periradicular infections.
Detailed description
The role of microorganisms in periradicular infection has been well established in endodontic literature, signifying that endodontic treatment will be afflicted with a higher chance of failure if microorganisms persist in the canals at the time of root canal Obturation .
Furthermore, anatomic complexities of the root canals as isthmuses, fins, ramifications, lateral Canals, and dentinal tubules make the situation much more difficult; bacteria harboring such areas become inaccessible to mechanical instrumentation, and protected by tissue residues, dentin, serum and dead cells that inactivate or diminish the efficiency of antimicrobial agents.
Sodium hypochlorite (NaOCl) is regarded as the most potent disinfectant in endodontics due to its excellent ability to dissolve vital and necrotic tissues in addition to its antimicrobial activity. However, intracanal irrigants are only effective when in contact with the surface, and they cannot penetrate deep into the surfaces because of anatomic barriers. NaOCl can penetrate into the dentinal tubules by 130 μm, whereas bacteria can penetrate into the dentinal tubules by 1000 μm.
Silver nanoparticles (AgNPs) can also be used for disinfection because of their optimal antimicrobial properties. They are effective against many microorganisms including E. faecalis . Nanomaterials has dimensions of 1- 100nm, presenting small sizes, large surface/area mass ratio and increased chemical reactivity , the small size of nanoparticles offers a larger surface area for a small volume of the particles. This allows them to exert action even when used in small quantities, the action of AgNPs differ according to size, concentration, and time of application. Moreover, the killing effect of AgNPs against gram-negative and grampositive bacteria increases with decreasing particle size.
Silver nano particles release silver ions which have an electrostatic attraction to sulfur proteins, that results in adherence and disruption of the bacterial membrane, Silver ions can also cause the denaturation of DNA and ribosomes directly. AgNPs can also interrupt signal transduction by dephosphorylation of tyrosine residues on the peptide substrates leading to cell death and apoptosis.
However, cell culture studies revealed that AgNPs are able to induce cytotoxicity in human cell lines including human bronchial epithelial cells, red blood cells, macrophages, liver cells, etc., particularly for those with sizes more than 10 nm, and the cytotoxicity of AgNPs has been reported to be contingent upon dose, size, and exposure time .
Since irrigant needs to reach and disrupt the biofilm matrix in less accessible areas of the root canal system, several agitation and activation methods have been proposed to improve efficacy, including sonic \& ultrasonic activation, negative apical pressure irrigation, laser activation and physical agitation using XP-Endo Finisher. Several studies have shown that compared to conventional irrigation, the application of ultrasonic activation or XP-Endo Finisher enhances the efficacy of NaOCl in reducing intra-canal bacteria and removing biofilms from the main canal lumen, the apical third root surface and shallow or deep layers of root dentine.
Pain following root canal treatment is an important patient-centered outcome that has been related to the patient's quality of life, with an incidence of 3-58% following treatment. It could be associated with mechanical and chemical injuries, along with the presence of microorganisms in the periapical region. However, Advancements in material science and metallurgy have improved the predictability and efficiency of delivering endodontic treatment either following single-visit or multiple-visit root canal treatment, even in teeth with necrotic pulps.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Biological: Silver Nanoparticles IrrigationAbout 16 Persons injected by 5 ml 2.5% NaOCl using conventional Needle Irrigation |
| Group II | Active comparator | Biological: Silver Nanoparticles IrrigationAbout 16 Persons injected by 5 ml AgNPs using conventional Needle Irrigation. |
| Group III | Active comparator | Biological: Silver Nanoparticles IrrigationAbout 16 Persons injected by 5 ml AgNPs using XP-Endo Finisher activation. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy Patients between the age group of 20 and 40 years old with no sex predilection, who agree to take partin the study and to sign a written informed consent.
- Asymptomatic necrotic mandibular molars:non-responsive to thermal pulp testing, with no pain to percussion, and distal root having typeI root canal system.
- Presence of periapical radiolucency not exceeding 5mm in diameter,confirmed with cone beam computed tomography scans.
Key exclusion criteria (4 listed)
- Medically compromised patients, pregnant and lactating females.
- Patients were using medication such as analgesics or any kind of antiinflammatory drugs, or antibiotics 12 h preoperatively.
- Teeth with calcified root canals, external or internal root resorptions, periodontal problems as those with mobility greater than Grade I, or pocket depth exceeding 5 mm.
- Previously endodontically treated teeth, immature with open apex, severe damage and those having associated traumatic occlusion.
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 |
|---|---|---|
| Silver Nanoparticles IrrigationAlso: conventional needle irrigationto evaluate the postoperative pain, antimicrobial efficiency, and periapical tissue healing following the use of silver nano particles solution as a final irrigation, using either conventional needle irrigation or XP-Endo Finisher activation, in necrotic mandibular molar teeth. | Biological | Group I, Group II, Group III |
Primary outcome
Post operative Pain
Time frame: 4 days
Following the treatment, patients will be asked to record their pain level on a modified VAS at 4, 24, 48, 72, and 96 h.
1 secondary outcome
Digital periapical radiographs (DPR)
Time frame: 12 Months
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 13 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
Wael Hussein Kamel, Professor study chair
Faculty of Dental Medicine for Girls, Al-Azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silver Nanoparticles Irrigation in people with Post Operative Pain and Necrotic Mandibular Molars, run by Radwa fath Ahmed 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 3 inclusion and 4 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 13 Jan 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.
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?
Post operative Pain (time frame: 4 days). 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 13 Jan 2025.