Root Canal InfectionNCT07718607
Postoperative Pain After Using a Minimally Invasive Reciprocating Single-file System in Mandibular Molars With Symptomatic Irreversible Pulpitis
A study testing Reciprocating rotary single-file system and Wave One Gold rotary file system in people with Root Canal Infection, run by Minia University.
Trial summary
The aim of the present study is to assess the incidence and severity of postoperative pain after root canal preparation of mandibular molars with symptomatic irreversible pulpitis using a minimally invasive reciprocating single-file system in comparison to Wave One Gold. Read more about this study
- Who is it for?
- Ages 19 to 45 years
- Conditions the study is for
- Root Canal Infection
- What is being tested?
- Reciprocating rotary single-file system and Wave One Gold rotary file system
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- 31 Jul 2026to 31 Oct 2026
- 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 19 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients who have vital mandibular molar teeth with irreversible pulpitis without apical periodontitis.
- Medically free patients.
Who cannot join
- Pregnancy or lactation
- Patients with para functional habits.
- Teeth with non-vital pulps and periapical lesions.
- The presence of swelling or a fistulous tract.
- Any periodontal pockets with a depth more than 5 mm.
- Previous endodontic fillings.
- Patients with a history of any systemic diseases.
- Severely curved canals and calcified ones.
About this study
The aim of the present study is to assess the incidence and severity of postoperative pain after root canal preparation of mandibular molars with symptomatic irreversible pulpitis using a minimally invasive reciprocating single-file system in comparison to Wave One Gold.
- Conditions
- Root Canal Infection
- Being tested
- Reciprocating rotary single-file system, Wave One Gold rotary file system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reciprocating rotary single-file systemProcedure or surgery
One glider will be used then (25/6) will be used to prepare narrow and curved canals as mesials in lower molars, and the large file (45/4) will be used for large canals. Three in-and-out motions were applied with motions until attaining full working length
Wave One Gold rotary file systemProcedure or surgery
Wave One Gold glider will be used then primary (25\7) to prepare narrow and curved canals as mesials in lower molars, and the file (45/5) will be used for large canals. Three in-and-out motions will be applied with motions until attaining full working length
| Study group | Role | What they receive |
|---|---|---|
| Reciprocating rotary single-file system | Active comparator | root canal preparation by one reciprocating rotary single-file system Receives: Procedure: Reciprocating rotary single-file system |
| Wave One Gold rotary file system | Active comparator | root canal preparation by Wave One Gold rotary file system Receives: Procedure: Wave One Gold rotary file system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessment
assessment of pain on Visual Analog Scale (VAS) scoring system
Measured: after (6) hours, (12) hours, (24) hours, (48) and (72) hours of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start31 Jul 2026 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Root Canal InfectionStudies 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
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Tarek Khairy, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07718607
- Sponsor's protocol ID
- 1080-2025
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain After Using a Minimally Invasive Reciprocating Single-file System in Mandibular Molars With Symptomatic Irreversible Pulpitis
- ClinicalTrials.gov ID
- NCT07718607
- Acronym / sponsor ID
- 1080-2025
- Conditions
- Root Canal Infection
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 31 Jul 2026 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 22 Jul 2026 (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 aim of the present study is to assess the incidence and severity of postoperative pain after root canal preparation of mandibular molars with symptomatic irreversible pulpitis using a minimally invasive reciprocating single-file system in comparison to Wave One Gold.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reciprocating rotary single-file system | Active comparator | Procedure: Reciprocating rotary single-file systemroot canal preparation by one reciprocating rotary single-file system |
| Wave One Gold rotary file system | Active comparator | Procedure: Wave One Gold rotary file systemroot canal preparation by Wave One Gold rotary file system |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Adult patients who have vital mandibular molar teeth with irreversible pulpitis without apical periodontitis.
- Medically free patients.
Key exclusion criteria (8 listed)
- Pregnancy or lactation
- Patients with para functional habits.
- Teeth with non-vital pulps and periapical lesions.
- The presence of swelling or a fistulous tract.
- Any periodontal pockets with a depth more than 5 mm.
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 |
|---|---|---|
| Reciprocating rotary single-file systemOne glider will be used then (25/6) will be used to prepare narrow and curved canals as mesials in lower molars, and the large file (45/4) will be used for large canals. Three in-and-out motions were applied with motions until attaining full working length | Procedure or surgery | Reciprocating rotary single-file system |
| Wave One Gold rotary file systemWave One Gold glider will be used then primary (25\7) to prepare narrow and curved canals as mesials in lower molars, and the file (45/5) will be used for large canals. Three in-and-out motions will be applied with motions until attaining full working length | Procedure or surgery | Wave One Gold rotary file system |
Primary outcome
Pain assessment
Time frame: after (6) hours, (12) hours, (24) hours, (48) and (72) hours of the procedure
assessment of pain on Visual Analog Scale (VAS) scoring system
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 22 Jul 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Reciprocating rotary single-file system and Wave One Gold rotary file system in people with Root Canal Infection, run by Minia University.
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 2 inclusion and 8 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 22 Jul 2026. 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?
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?
Pain assessment (time frame: after (6) hours, (12) hours, (24) hours, (48) and (72) hours of the procedure). 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 22 Jul 2026.