PulpectomyNCT07702877
Comparative Evaluation of Pediatric Rotary Files and Hand Files in Primary Molars
A study testing Pulpectomy, Kedo-S Square rotary file and Manual K files in people with Pulpectomy and Primary Teeth Indicated for Pulp Therapy, run by Goa Dental College at 1 site in India.
Trial summary
The goal of this clinical trial is to evaluate and compare the efficacy of Kedo-Nano Plus rotary files, Kedo-S Square rotary files, and manual K-files for biomechanical preparation during pulpectomy of primary mandibular molars in children aged 5-8 years. Read more about this study
- Who is it for?
- Ages 5 to 8 years
- Conditions the study is for
- Pulpectomy, Primary Teeth Indicated for Pulp Therapy, Mandibular Molar Teeth With Symptomatic Irreversible Pulpitis
- What is being tested?
- Pulpectomy, Kedo-S Square rotary file and Manual K files
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- 15 Jan 2025to 3 Mar 2026
- 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 5 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Normal, healthy children between five and eight years of age
- Frankl's behavior rating: positive or definitely positive
- Primary mandibular molars diagnosed with irreversible pulpitis
- Intact crown structure suitable for rubber dam placement
- Intraoral periapical radiograph showing primary molars with at least two-thirds of each root remaining
Who cannot join
- Children with special healthcare needs or systemic medical conditions
- Frankl's behavior rating: negative or definitely negative
- Primary molars with unrestorable crown structure
- Teeth with severe mobility or pathological root resorption
- Children or parents who refused to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Evaluation of Two Pediatric Rotary Files and Hand Files In Primary Mandibular Molars With Regard to Obturation Quality and Postoperative Pain
The goal of this clinical trial is to evaluate and compare the efficacy of Kedo-Nano Plus rotary files, Kedo-S Square rotary files, and manual K-files for biomechanical preparation during pulpectomy of primary mandibular molars in children aged 5-8 years.
The main questions it aims to answer are:
Read more
- Does the use of Kedo-Nano Plus and Kedo-S Square rotary file systems result in better obturation quality compared with manual K-files during pulpectomy of primary mandibular molars?
- Does the use of Kedo-Nano Plus and Kedo-S Square rotary file systems reduce postoperative pain compared with manual K-files following pulpectomy?
Researchers will compare Kedo-Nano Plus rotary files, Kedo-S Square rotary files, and manual K-files to determine their effect on obturation quality and postoperative pain.
Participants will:
- Undergo clinical and radiographic evaluation of primary mandibular molars requiring pulpectomy.
- Be randomly allocated to one of three instrumentation groups: Kedo-Nano Plus rotary files, Kedo-S Square rotary files, or manual K-files.
- Receive pulpectomy treatment using the assigned instrumentation technique.
- Undergo radiographic assessment of obturation quality following treatment.
- Have postoperative pain assessed using the Wong-Baker Faces Pain Rating Scale at 6, 12, 24, and 48 hours after treatment.
- Conditions
- Pulpectomy, Primary Teeth Indicated for Pulp Therapy, Mandibular Molar Teeth With Symptomatic Irreversible Pulpitis
- Being tested
- Pulpectomy, Kedo-S Square rotary file, Manual K files, Kedo-Nano Plus rotary file
- Keywords
- Pulpectomy, Primary mandibular molars indicated for pulpectomy, pediatric rotary files
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PulpectomyProcedure or surgery
Also called Root canal treatment, Non-vital pulp therapy
Pulpectomy is performed in primary mandibular molars requiring endodontic treatment. Following administration of local anesthesia and rubber dam isolation, an access cavity is prepared and the root canals are identified. Working length is determined, followed by biomechanical preparation and irrigation of the root canals. The canals are then dried and obturated with a resorbable root canal filling material. The tooth is subsequently restored with an appropriate coronal restoration. Postoperative pain is assessed at predetermined intervals following treatment, and radiographic evaluation is performed to assess the quality of obturation.
Kedo-S Square rotary fileDevice
Also called Kedo S square
Kedo S Square pediatric rotary file system was used for biomechanical preparation/root canal instrumentation of primary teeth as per the study protocol.
Manual K filesDevice
Also called Hand files
Manual K files were used for biomechanical preparation/root canal instrumentation of primary teeth as per the study protocol.
Kedo-Nano Plus rotary fileDevice
Also called Kedo-Nano Plus
Kedo Nano Plus pediatric rotary file system was used for biomechanical preparation/root canal instrumentation of primary teeth as per the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Manual K-file group | Experimental | Primary mandibular pulpectomy done by manual K- files Receives: Procedure: Pulpectomy; Device: Manual K files |
| Kedo-S Square rotary file group | Experimental | Primary mandibular pulpectomy done by Kedo-S Square rotary file Receives: Procedure: Pulpectomy; Device: Kedo-S Square rotary file |
| Kedo-Nano Plus rotary file group | Experimental | Primary mandibular pulpectomy done by Kedo-Nano Plus rotary file Receives: Procedure: Pulpectomy; Device: Kedo-Nano Plus rotary file |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the quality of obturation between Kedo- Nano Plus, Kedo- S Square pediatric rotary single file systems and manual K files after pulpectomy in primary mandibular molars
Quality of obturation will be assessed radiographically following pulpectomy in primary mandibular molars. The obturation will be categorized as optimal fill, underfill, or overfill based on the extent of obturation material in relation to the radiographic apex. The outcome measure will be used to compare the effectiveness of the instrumentation techniques in achieving adequate root canal filling.
Measured: At the end of the pulpectomy procedure, immediately following obturation.
Secondary outcomes (1)
To evaluate the intensity of post-operative pain following pulpectomy performed using Kedo- Nano Plus, Kedo- S Square pediatric rotary single file systems and manual K files at the interval of 6,12,24 and 48 hours postoperatively.
Postoperative pain will be assessed following pulpectomy in primary mandibular molars using the Wong-Baker Faces Pain Rating Scale. Pain intensity will be recorded at 6, 12, 24, and 48 hours after completion of the procedure. The outcome measure will be used to compare the level and progression of postoperative pain among the study groups over time.
Measured: From completion of the pulpectomy procedure to 48 hours postoperatively, with assessments at 6, 12, 24, and 48 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start15 Jan 2025
- Primary completion2 Jan 2026
- Study completion3 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PulpectomyStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goa Dental College
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Pooja Vilas More, Goa Dental College
- Investigators
- Paul Chalakkal, MDS, Study director, Goa Dental College and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07702877
- Sponsor's protocol ID
- GDCH/IRB/VI-2024/RPN45-41
- Status last verified
- Jul 2026
- First submitted
- 25 Jun 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Two Pediatric Rotary Files and Hand Files In Primary Mandibular Molars With Regard to Obturation Quality and Postoperative Pain
- ClinicalTrials.gov ID
- NCT07702877
- Acronym / sponsor ID
- GDCH/IRB/VI-2024/RPN45-41
- Conditions
- Pulpectomy, Primary Teeth Indicated for Pulp Therapy, Mandibular Molar Teeth With Symptomatic Irreversible Pulpitis
- Keywords
- Pulpectomy, Primary mandibular molars indicated for pulpectomy, pediatric rotary files
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Goa Dental CollegeOther government
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 2 Jan 2026 (actual)
- Study completion
- 3 Mar 2026 (actual)
- First posted
- 14 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 goal of this clinical trial is to evaluate and compare the efficacy of Kedo-Nano Plus rotary files, Kedo-S Square rotary files, and manual K-files for biomechanical preparation during pulpectomy of primary mandibular molars in children aged 5-8 years.
The main questions it aims to answer are:
- Does the use of Kedo-Nano Plus and Kedo-S Square rotary file systems result in better obturation quality compared with manual K-files during pulpectomy of primary mandibular molars?
- Does the use of Kedo-Nano Plus and Kedo-S Square rotary file systems reduce postoperative pain compared with manual K-files following pulpectomy?
Researchers will compare Kedo-Nano Plus rotary files, Kedo-S Square rotary files, and manual K-files to determine their effect on obturation quality and postoperative pain.
Participants will:
- Undergo clinical and radiographic evaluation of primary mandibular molars requiring pulpectomy.
- Be randomly allocated to one of three instrumentation groups: Kedo-Nano Plus rotary files, Kedo-S Square rotary files, or manual K-files.
- Receive pulpectomy treatment using the assigned instrumentation technique.
- Undergo radiographic assessment of obturation quality following treatment.
- Have postoperative pain assessed using the Wong-Baker Faces Pain Rating Scale at 6, 12, 24, and 48 hours after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Manual K-file group | Experimental | Procedure: Pulpectomy, Device: Manual K filesPrimary mandibular pulpectomy done by manual K- files |
| Kedo-S Square rotary file group | Experimental | Procedure: Pulpectomy, Device: Kedo-S Square rotary filePrimary mandibular pulpectomy done by Kedo-S Square rotary file |
| Kedo-Nano Plus rotary file group | Experimental | Procedure: Pulpectomy, Device: Kedo-Nano Plus rotary filePrimary mandibular pulpectomy done by Kedo-Nano Plus rotary file |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Normal, healthy children between five and eight years of age
- Frankl's behavior rating: positive or definitely positive
- Primary mandibular molars diagnosed with irreversible pulpitis
- Intact crown structure suitable for rubber dam placement
- Intraoral periapical radiograph showing primary molars with at least two-thirds of each root remaining
Key exclusion criteria (5 listed)
- Children with special healthcare needs or systemic medical conditions
- Frankl's behavior rating: negative or definitely negative
- Primary molars with unrestorable crown structure
- Teeth with severe mobility or pathological root resorption
- Children or parents who refused to participate in the 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 |
|---|---|---|
| PulpectomyAlso: Root canal treatment, Non-vital pulp therapyPulpectomy is performed in primary mandibular molars requiring endodontic treatment. Following administration of local anesthesia and rubber dam isolation, an access cavity is prepared and the root canals are identified. Working length is determined, followed by biomechanical preparation and irrigation of the root canals. The canals are then dried and obturated with a resorbable root canal filling material. The tooth is subsequently restored with an appropriate coronal restoration. Postoperative pain is assessed at predetermined intervals following treatment, and radiographic evaluation is performed to assess the quality of obturation. | Procedure or surgery | Kedo-Nano Plus rotary file group, Kedo-S Square rotary file group, Manual K-file group |
| Kedo-S Square rotary fileAlso: Kedo S squareKedo S Square pediatric rotary file system was used for biomechanical preparation/root canal instrumentation of primary teeth as per the study protocol. | Device | Kedo-S Square rotary file group |
| Manual K filesAlso: Hand filesManual K files were used for biomechanical preparation/root canal instrumentation of primary teeth as per the study protocol. | Device | Manual K-file group |
| Kedo-Nano Plus rotary fileAlso: Kedo-Nano PlusKedo Nano Plus pediatric rotary file system was used for biomechanical preparation/root canal instrumentation of primary teeth as per the study protocol. | Device | Kedo-Nano Plus rotary file group |
Primary outcome
To assess the quality of obturation between Kedo- Nano Plus, Kedo- S Square pediatric rotary single file systems and manual K files after pulpectomy in primary mandibular molars
Time frame: At the end of the pulpectomy procedure, immediately following obturation.
Quality of obturation will be assessed radiographically following pulpectomy in primary mandibular molars. The obturation will be categorized as optimal fill, underfill, or overfill based on the extent of obturation material in relation to the radiographic apex. The outcome measure will be used to compare the effectiveness of the instrumentation techniques in achieving adequate root canal filling.
1 secondary outcome
To evaluate the intensity of post-operative pain following pulpectomy performed using Kedo- Nano Plus, Kedo- S Square pediatric rotary single file systems and manual K files at the interval of 6,12,24 and 48 hours postoperatively.
Time frame: From completion of the pulpectomy procedure to 48 hours postoperatively, with assessments at 6, 12, 24, and 48 hours.
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 14 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. This study is not recruiting at the moment.
Paul Chalakkal, MDS study director
Goa Dental College and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulpectomy, Kedo-S Square rotary file and Manual K files in people with Pulpectomy and Primary Teeth Indicated for Pulp Therapy, run by Goa Dental College at 1 site in India.
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 5 inclusion and 5 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 14 Jul 2026. 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 India. 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?
To assess the quality of obturation between Kedo- Nano Plus, Kedo- S Square pediatric rotary single file systems and manual K files after pulpectomy in primary mandibular molars (time frame: At the end of the pulpectomy procedure, immediately following obturation.). 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 14 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.