Post Operative PainPhase 1NaOClNCT05840679
Different Concentrations of Sodium Hypochlorite Affecting Post-endodontic Pain
A Phase 1 study testing Irrigation Solution in people with Post Operative Pain, run by Armed Forces Institute of Dentistry, Pakistan at 1 site in Pakistan.
Trial summary
This is a randomized, prospective, double-blind, clinical trial to assess the effect of 3% and 6% sodium hypochlorite (NaOCl) as irrigant on postendodontic pain and rescue medication intake following single visit root canal treatment Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Irrigation Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Apr 2023to 31 Oct 2023
- Phase
- Phase 1
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy individuals between 18 to 55 years
- First and second mandibular molar diagnosed with irreversible pulpitis due to caries
- Patients with moderate pain will be selected, VAS score (4 - 6).
- Normal periapical radiographic appearance
- Mild tender to percussion
- No allergies to articaine
Who cannot join
- Patients who have taken analgesic or anti-inflammatory drugs within 6 hours before treatment visit
- Pregnant or lactating patients
- Teeth with severe periodontal disease
- Teeth that cannot be isolated with rubber dam
- Teeth undergone over-instrumentation or overfilling beyond apex
- Teeth with calcifications/ resorptive defects
- History of allergy to any materials used in the study
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Armed Forces Institue Of Dentistry
Rawalpindi, Punjab Province, 46000
Kanza zafar, BDS, 00923337808809, kanzazafar6@gmail.com
About this study
Official title: Effect of Different Concentrations of Sodium Hypochlorite on Post Operative Pain Following Single Visit Root Canal Treatment
This is a randomized, prospective, double-blind, clinical trial to assess the effect of 3% and 6% sodium hypochlorite (NaOCl) as irrigant on postendodontic pain and rescue medication intake following single visit root canal treatment
Read the detailed description
Diagnostic procedures to include history taking and clinical and radiographic examination with all findings being recorded in patient's notes.
- A prolonged exaggerated response (more than 10 seconds) to a cold pulp sensibility test and a positive response to the electric pulp tester will be considered evidence for irreversible pulpitis.
Patients will be asked to rate their pre-treatment pain on a visual analogue scale from 0 to 10.
Patients with moderate pain will be selected, VAS score (4 - 6).
- ANESTHESIA Patients receive 2 cartridges of 2% Articaine with 1:80000 epinephrine in an Inferior Alveolar Nerve Block Injection
- Access opening, isolation and first rinse with NaOCl After access preparation, each tooth will be isolated using rubber dam. Patients will be randomly assigned to either of the following groups: 3% NaOCl or 6% NaOCl. The pulp chamber will be filled with 2mL irrigant for 2 min followed by saline irrigation.
- Hand Instrumentation The patency of canals will be established and an initial glidepath be prepared using size 10 and 15 K-files (Mani, Mani Inc., Tochigi, Japan)
- WORKING LENGHT WL will be determined using apex locator (DentaPort ZX, J.Morita USA) and confirmed radiographically to be 1 mm short of the radiographic apex.
- ROTARY INSTRUMENTATION Mechanical prep using a Niti rotary system (Protaper Universal, Dentsply Sirona) in a torque-controlled endodontic motor (X-Smart plus, Dentsply Maillefer) according to the manufacturer's sequence and recommendations of speed and torque. Canal prep with S1 and SX instruments in a crown-down sequence to shape the coronal two-thirds of canal.
- APICAL PREPARATION Apical patency will be maintained with a size 10 K file before each rotary-instrument change.The apical preparation will be done using S1, S2, F1 or F2 up to WL corresponding to tip size of F1 or F2.
- IRRIGATION
- Between instruments, the root canals will be irrigated with 2 mL of either 3% or 6% NaOCl with a 30G x 25mm side-perforated needle (Medic Endo Irrigation Needles, HDS).
- The tip of the needle will be kept 4mm short of WL. The needle will be repeatedly moved up and down in order to prevent locking in the canals.
- Volume of irrigant use after every instrumentation - 2ml
- Total volume of NaOCl used per canal - 8-10ml , per Tooth - 24 - 30 ml
- After NaOCl, canals will be flushed with 5ml normal saline irrigation.
- Smear layer will be removed by irrigation with 17% EDTA, (EDTA; Glycle File Prep, Dentsply Maillefer) followed by 5 mL normal saline irrigation.
- DRYING CANALS At the same visit, the root canals will be dried with paper points (GAPADENT Absorbent paper points)
- OBTURATION Shall be filled with matched size gutta-percha cones (Meta Biomed Co, Korea) and sealar (Endoplus Root Canal Sealer 13,5g President Dental Germany) using the single cone technique.
- Sealed with Temporary restoration (Cavit, 3M ESPE, Germany) Patients will receive a rescue bag of 10 Ibuprofen in case they have pain with instructions for ondemand use.
- Conditions
- Post Operative Pain
- Being tested
- Irrigation Solution
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irrigation SolutionDrug
Also called Root Canal Disinfection
Different concentrations of NaOCl are being used as the endodontic irrigant.
| Study group | Role | What they receive |
|---|---|---|
| 3% NaOCl concentration group | Experimental | Participants in this group will receive endodontic irrigation with lower conc 3% sodium hypochlorite Receives: Drug: Irrigation Solution |
| 6% NaOCl concentration group | Experimental | Participants in this group will receive endodontic irrigation with higher conc 6% sodium hypochlorite Receives: Drug: Irrigation Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain after root canal treatment
Post-operative pain will be assessed using a self-report questionnaire using a numerical visual analogue scale (VAS) from 0 to 10.
0 = No pain
1 - 3 = Mild pain 4 - 6 = Moderate pain 7 -10 = Severe pain Pain recording will be done after 6hrs, 12hrs, 24hrs, 48hrs and 72 hrs. (Participants to be contacted by the investigator at each time point to check on them and remind them to record their pain) The given questionnaire shall be collected when the participant comes for final restoration one week later.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start30 Apr 2023 (estimated)
- Primary completion30 Oct 2023 (estimated)
- Study completion31 Oct 2023 (estimated)
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Armed Forces Institute of Dentistry, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kanza Zafar, Armed Forces Institute of Dentistry, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05840679
- Sponsor's protocol ID
- Sodium Hypochlorite NaOCl
- Acronym
- NaOCl
- Status last verified
- Apr 2023
- First submitted
- 5 Apr 2023
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Concentrations of Sodium Hypochlorite on Post Operative Pain Following Single Visit Root Canal Treatment
- ClinicalTrials.gov ID
- NCT05840679
- Acronym / sponsor ID
- NaOCl / Sodium Hypochlorite NaOCl
- Conditions
- Post Operative Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Armed Forces Institute of Dentistry, PakistanUniversity, hospital or other
- Study start
- 30 Apr 2023 (estimated)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 31 Oct 2023 (estimated)
- First posted
- 3 May 2023 (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.
This is a randomized, prospective, double-blind, clinical trial to assess the effect of 3% and 6% sodium hypochlorite (NaOCl) as irrigant on postendodontic pain and rescue medication intake following single visit root canal treatment
Detailed description
Diagnostic procedures to include history taking and clinical and radiographic examination with all findings being recorded in patient's notes.
- A prolonged exaggerated response (more than 10 seconds) to a cold pulp sensibility test and a positive response to the electric pulp tester will be considered evidence for irreversible pulpitis.
Patients will be asked to rate their pre-treatment pain on a visual analogue scale from 0 to 10.
Patients with moderate pain will be selected, VAS score (4 - 6).
- ANESTHESIA Patients receive 2 cartridges of 2% Articaine with 1:80000 epinephrine in an Inferior Alveolar Nerve Block Injection
- Access opening, isolation and first rinse with NaOCl After access preparation, each tooth will be isolated using rubber dam. Patients will be randomly assigned to either of the following groups: 3% NaOCl or 6% NaOCl. The pulp chamber will be filled with 2mL irrigant for 2 min followed by saline irrigation.
- Hand Instrumentation The patency of canals will be established and an initial glidepath be prepared using size 10 and 15 K-files (Mani, Mani Inc., Tochigi, Japan)
- WORKING LENGHT WL will be determined using apex locator (DentaPort ZX, J.Morita USA) and confirmed radiographically to be 1 mm short of the radiographic apex.
- ROTARY INSTRUMENTATION Mechanical prep using a Niti rotary system (Protaper Universal, Dentsply Sirona) in a torque-controlled endodontic motor (X-Smart plus, Dentsply Maillefer) according to the manufacturer's sequence and recommendations of speed and torque. Canal prep with S1 and SX instruments in a crown-down sequence to shape the coronal two-thirds of canal.
- APICAL PREPARATION Apical patency will be maintained with a size 10 K file before each rotary-instrument change.The apical preparation will be done using S1, S2, F1 or F2 up to WL corresponding to tip size of F1 or F2.
- IRRIGATION
- Between instruments, the root canals will be irrigated with 2 mL of either 3% or 6% NaOCl with a 30G x 25mm side-perforated needle (Medic Endo Irrigation Needles, HDS).
- The tip of the needle will be kept 4mm short of WL. The needle will be repeatedly moved up and down in order to prevent locking in the canals.
- Volume of irrigant use after every instrumentation - 2ml
- Total volume of NaOCl used per canal - 8-10ml , per Tooth - 24 - 30 ml
- After NaOCl, canals will be flushed with 5ml normal saline irrigation.
- Smear layer will be removed by irrigation with 17% EDTA, (EDTA; Glycle File Prep, Dentsply Maillefer) followed by 5 mL normal saline irrigation.
- DRYING CANALS At the same visit, the root canals will be dried with paper points (GAPADENT Absorbent paper points)
- OBTURATION Shall be filled with matched size gutta-percha cones (Meta Biomed Co, Korea) and sealar (Endoplus Root Canal Sealer 13,5g President Dental Germany) using the single cone technique.
- Sealed with Temporary restoration (Cavit, 3M ESPE, Germany) Patients will receive a rescue bag of 10 Ibuprofen in case they have pain with instructions for ondemand use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3% NaOCl concentration group | Experimental | Drug: Irrigation SolutionParticipants in this group will receive endodontic irrigation with lower conc 3% sodium hypochlorite |
| 6% NaOCl concentration group | Experimental | Drug: Irrigation SolutionParticipants in this group will receive endodontic irrigation with higher conc 6% sodium hypochlorite |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy individuals between 18 to 55 years
- First and second mandibular molar diagnosed with irreversible pulpitis due to caries
- Patients with moderate pain will be selected, VAS score (4 - 6).
- Normal periapical radiographic appearance
- Mild tender to percussion
Key exclusion criteria (7 listed)
- Patients who have taken analgesic or anti-inflammatory drugs within 6 hours before treatment visit
- Pregnant or lactating patients
- Teeth with severe periodontal disease
- Teeth that cannot be isolated with rubber dam
- Teeth undergone over-instrumentation or overfilling beyond apex
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 |
|---|---|---|
| Irrigation SolutionAlso: Root Canal DisinfectionDifferent concentrations of NaOCl are being used as the endodontic irrigant. | Drug | 3% NaOCl concentration group, 6% NaOCl concentration group |
Primary outcome
Post-operative pain after root canal treatment
Time frame: 1 week
Post-operative pain will be assessed using a self-report questionnaire using a numerical visual analogue scale (VAS) from 0 to 10. 0 = No pain 1 - 3 = Mild pain 4 - 6 = Moderate pain 7 -10 = Severe pain Pain recording will be done after 6hrs, 12hrs, 24hrs, 48hrs and 72 hrs. (Participants to be contacted by the investigator at each time point to check on them and remind them to record their pain) The given questionnaire shall be collected when the participant comes for final restoration one week later.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Irrigation Solution in people with Post Operative Pain, run by Armed Forces Institute of Dentistry, Pakistan at 1 site in Pakistan.
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 7 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 3 May 2023. 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 Pakistan. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Kanza Zafar, BDS (00923337808809, kanzazafar6@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative pain after root canal treatment (time frame: 1 week). 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 3 May 2023.