Comparison Between Two Type of Irrigation SystemsNCT07303478
Comparison of Obturation Quality and Lateral Canal Fill (by Sealer): Ultrasonic-Activated Versus Non-Ultrasonic Conventional Irrigation Techniques in Root Canal Treatment - A Randomized Controlled Trial
A study testing ULTRASONIC IRRIGATION TECHNIQUE and NON-ULTRASONIC CONVENTIONAL IRRIGATION TECHNIQUE in people with Comparison Between Two Type of Irrigation Systems, run by Prime Foundation at 1 site in Pakistan.
Trial summary
The main goal of clinical trail to compare obturation quality and lateral canal sealer fill between ultrasonic activated and conventional irrigation in root canal treatment. HYPOTHESIS There is a difference in obturation quality and lateral canal fill between ultrasonic activated irrigation results as compared to… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Comparison Between Two Type of Irrigation Systems
- What is being tested?
- ULTRASONIC IRRIGATION TECHNIQUE and NON-ULTRASONIC CONVENTIONAL IRRIGATION TECHNIQUE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2025to 30 May 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both male and female
- Age group adults 18 to 70 years
- Patients presenting with pain and sensitivity in mandibular molars and advised root canal treatment after examination and x ray
Who cannot join
- Teeth with complex root canal anatomy that may complicate the obturation process
- Pregnancy
- Medically compromised patients including uncontrolled diabetes -cardiovascular disease immunodeficiency disorders bleeding disorders and -severe respiratory disease
- Patients who refused to participate in this study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Peshawar Dental Collge
Peshawar, Khyber Pakhtoon Khawa(KPK)a, 25000
About this study
The main goal of clinical trail to compare obturation quality and lateral canal sealer fill between ultrasonic activated and conventional irrigation in root canal treatment.
HYPOTHESIS There is a difference in obturation quality and lateral canal fill between ultrasonic activated irrigation results as compared to conventional irrigation technique in root canal treatment.
Read more
Eligible patients will be recruited from the Endodontics Department at Peshawar Dental College who present with pain and sensitivity in mandibular teeth and are advised root canal treatment after clinical examination and X-ray. Patients will be screened according to inclusion and exclusion criteria and informed written consent will be taken. This will be a double-blinded study, and demographic and tooth-related information will be recorded.
Participants will be randomized into two groups using block randomization with a block size of six. The Non-Ultrasonic group will receive conventional irrigation using syringe, 3% sodium hypochlorite, and Tg sealer, while the Ultrasonic group will be irrigated using the VAT-3 ultrasonic activator with the same solution and sealer. Pre- and post-operative radiographs will be taken to evaluate obturation quality and lateral canal fill in terms of length, density, and taper using a standardized proforma.
- Being tested
- ULTRASONIC IRRIGATION TECHNIQUE, NON-ULTRASONIC CONVENTIONAL IRRIGATION TECHNIQUE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ULTRASONIC IRRIGATION TECHNIQUEOther
The utilization of theVAT-3 ultrasonic activator high frequency device (45KHz± 5kHz) [Refine] for the Ultrasonic Activated Irrigation group and same solution of 3% sodium hypochlorite and Tg Sealer will be used. Post-operative radiographs will be obtained to assess the obturation quality and lateral canal fill. A detailed radiographic proforma will be employed to evaluate the length, density, taper of the root canal filling, and lateral canal fill . Each of these components will be scored individually, and an overall Obturation Quality Score is calculated by summing these scores.
NON-ULTRASONIC CONVENTIONAL IRRIGATION TECHNIQUEOther
The root canal treatment is then performed as per the assigned group, with conventional irrigation involving the use of syringes and 3% sodium hypochlorite solution and Tg Sealer for the Non-Ultrasonic Conventional Irrigation group.A detailed radiographic proforma will be employed to evaluate the length, density, taper of the root canal filling, and lateral canal fill . Each of these components will be scored individually, and an overall Obturation Quality Score is calculated by summing these scores.
| Study group | Role | What they receive |
|---|---|---|
| ULTRASONIC IRRIGITATION TECHNIQUE | Other | Not described Receives: Other: ULTRASONIC IRRIGATION TECHNIQUE |
| NON-ULTRASONIC CONVENTIONAL IRRIGATION TECHNIQUE | Other | Not described Receives: Other: NON-ULTRASONIC CONVENTIONAL IRRIGATION TECHNIQUE |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare obturation quality and lateral canal sealer fill between ultrasonic activated and conventional irrigation in root canal treatment
Obturation Quality and Lateral Canal Fill:- This will involve evaluating the length of the root canal filling in the main canals, assessing the homogeneity (density) of the obturation material, determining the taper of the root canal filling, and examining the sealer's penetration into lateral canals using postoperative radiographs. The radiographs will be reviewed independently by two senior endodontists. A scoring system will be applied, and each of the three parameters will be individually assessed.
Lateral Canal:- A type of accessory canal located in the coronal or middle third of the root, usually extending horizontally from the main canal space.
Measured: Immediate, after completion of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start1 Dec 2025 (estimated)
- Primary completion30 May 2026 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Comparison Between Two Type of Irrigation SystemsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prime Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Syed Shahbaz Ali Shah, Prime Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07303478
- Sponsor's protocol ID
- Prime Foundation
- Status last verified
- Dec 2025
- First submitted
- 27 Nov 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Obturation Quality and Lateral Canal Fill (by Sealer): Ultrasonic-Activated Versus Non-Ultrasonic Conventional Irrigation Techniques in Root Canal Treatment - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07303478
- Acronym / sponsor ID
- Prime Foundation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Prime FoundationUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 24 Dec 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 goal of clinical trail to compare obturation quality and lateral canal sealer fill between ultrasonic activated and conventional irrigation in root canal treatment.
HYPOTHESIS There is a difference in obturation quality and lateral canal fill between ultrasonic activated irrigation results as compared to conventional irrigation technique in root canal treatment.
Eligible patients will be recruited from the Endodontics Department at Peshawar Dental College who present with pain and sensitivity in mandibular teeth and are advised root canal treatment after clinical examination and X-ray. Patients will be screened according to inclusion and exclusion criteria and informed written consent will be taken. This will be a double-blinded study, and demographic and tooth-related information will be recorded.
Participants will be randomized into two groups using block randomization with a block size of six. The Non-Ultrasonic group will receive conventional irrigation using syringe, 3% sodium hypochlorite, and Tg sealer, while the Ultrasonic group will be irrigated using the VAT-3 ultrasonic activator with the same solution and sealer. Pre- and post-operative radiographs will be taken to evaluate obturation quality and lateral canal fill in terms of length, density, and taper using a standardized proforma.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ULTRASONIC IRRIGITATION TECHNIQUE | Other | Other: ULTRASONIC IRRIGATION TECHNIQUE |
| NON-ULTRASONIC CONVENTIONAL IRRIGATION TECHNIQUE | Other | Other: NON-ULTRASONIC CONVENTIONAL IRRIGATION TECHNIQUE |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Both male and female
- Age group adults 18 to 70 years
- Patients presenting with pain and sensitivity in mandibular molars and advised root canal treatment after examination and x ray
Key exclusion criteria (4 listed)
- Teeth with complex root canal anatomy that may complicate the obturation process
- Pregnancy
- Medically compromised patients including uncontrolled diabetes -cardiovascular disease immunodeficiency disorders bleeding disorders and -severe respiratory disease
- Patients who refused to participate in this study
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 |
|---|---|---|
| ULTRASONIC IRRIGATION TECHNIQUEThe utilization of theVAT-3 ultrasonic activator high frequency device (45KHz± 5kHz) [Refine] for the Ultrasonic Activated Irrigation group and same solution of 3% sodium hypochlorite and Tg Sealer will be used. Post-operative radiographs will be obtained to assess the obturation quality and lateral canal fill. A detailed radiographic proforma will be employed to evaluate the length, density, taper of the root canal filling, and lateral canal fill . Each of these components will be scored individually, and an overall Obturation Quality Score is calculated by summing these scores. | Other | ULTRASONIC IRRIGITATION TECHNIQUE |
| NON-ULTRASONIC CONVENTIONAL IRRIGATION TECHNIQUEThe root canal treatment is then performed as per the assigned group, with conventional irrigation involving the use of syringes and 3% sodium hypochlorite solution and Tg Sealer for the Non-Ultrasonic Conventional Irrigation group.A detailed radiographic proforma will be employed to evaluate the length, density, taper of the root canal filling, and lateral canal fill . Each of these components will be scored individually, and an overall Obturation Quality Score is calculated by summing these scores. | Other | NON-ULTRASONIC CONVENTIONAL IRRIGATION TECHNIQUE |
Primary outcome
To compare obturation quality and lateral canal sealer fill between ultrasonic activated and conventional irrigation in root canal treatment
Time frame: Immediate, after completion of procedure
Obturation Quality and Lateral Canal Fill:- This will involve evaluating the length of the root canal filling in the main canals, assessing the homogeneity (density) of the obturation material, determining the taper of the root canal filling, and examining the sealer's penetration into lateral canals using postoperative radiographs. The radiographs will be reviewed independently by two senior endodontists. A scoring system will be applied, and each of the three parameters will be individually assessed. Lateral Canal:- A type of accessory canal located in the coronal or middle third of the root, usually extending horizontally from the main canal space.
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 24 Dec 2025.
- Individual participant dataSharing planned: Yes
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ULTRASONIC IRRIGATION TECHNIQUE and NON-ULTRASONIC CONVENTIONAL IRRIGATION TECHNIQUE in people with Comparison Between Two Type of Irrigation Systems, run by Prime Foundation 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 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: opening soon, as of the sponsor's last update on 24 Dec 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 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.
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 Dr. Syed Shahbaz Ali Shah (0092 3155119119, shahbazali2288@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare obturation quality and lateral canal sealer fill between ultrasonic activated and conventional irrigation in root canal treatment (time frame: Immediate, after completion of 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 24 Dec 2025.