AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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
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

Other trials in Egypt

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.

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 groups in NCT06771570
Study groupRoleWhat they receive
Group IActive comparatorAbout 16 Persons injected by 5 ml 2.5% NaOCl using conventional Needle Irrigation
Receives: Biological: Silver Nanoparticles Irrigation
Group IIActive comparatorAbout 16 Persons injected by 5 ml AgNPs using conventional Needle Irrigation.
Receives: Biological: Silver Nanoparticles Irrigation
Group IIIActive comparatorAbout 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.

  1. 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)
  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.

  1. First posted13 Jan 2025
  2. Study start15 Aug 2022
  3. Primary completion10 Aug 2024
  4. Study completion15 Aug 2024

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in