Asymptomatic Irreversible PulpitisNCT07166679
Effect of Apical Third Enlargement to Different Taper and Master Apical Preparation Size on Periapical Healing and Postoperative Pain After Primary Single Sitting Non Surgical Root Canal Treatment
A study testing root canal treatment with 2% taper, root canal treatment with 4% taper and root canal treatment with 6 %taper in people with Asymptomatic Irreversible Pulpitis, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
To Determine Effect Of Apical Third enlargement To Different Taper And Master Apical Preparation Size On Periapical Healing And Postoperative Pain After Primary Single Sitting Non Surgical Root Canal Treatment : A Randomized Clinical Trial Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Asymptomatic Irreversible Pulpitis
- What is being tested?
- root canal treatment with 2% taper, root canal treatment with 4% taper and root canal treatment with 6 %taper
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteIndia
- Study dates
- 18 Apr 2025to 18 Apr 2027
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-65 years of age of either sex
- Asymptomatic teeth having pulpal necrosis with apical periodontitis in a mandibular molar (no response to EPT or cold test)
- Radiographic evidence of periapical radiolucency corresponding to a periapical index (PAI) score >/=3 in mesial root of mandibular molars
Who cannot join
- Patients who were medically compromised
- Patients with initial apical binding file (IABF) size more than 20
- Pregnancy; lactation \& contraceptives.
- Positive history of antibiotic use within the past month or required antibiotic premedication for dental treatment (including infective endocarditis or pros thetic joint prophylaxis -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
Pgids Rohtak
Rohtak
Dr shweta Mittal, MDS, 7015863706
SAHIL, MDS, 7015863706, sahil.saini130897@gmail.com
About this study
To Determine Effect Of Apical Third enlargement To Different Taper And Master Apical Preparation Size On Periapical Healing And Postoperative Pain After Primary Single Sitting Non Surgical Root Canal Treatment : A Randomized Clinical Trial
Read the detailed description
The primary goal of endodontic therapy is to eradicate microbial infection within the root canal system and prevent reinfection. Thorough debridement and disinfection of the apical third are crucial, as this region serves as a reservoir for residual microorganisms.
Till date, only four clinical trials have analysed the effect of apical canal preparation size on treatment outcomes. Out of the four clinical trials one retrospective in nature, Hoskinson study no improvement in radiographic and clinical outcome with an increase in the master apical file .
Souza (2012) conducted clinical trial in necrotic pulp and concluded that apical third enlargement does not alter endodontic treatment outcomes.
Saini (2012) stated that enlarging the canal three sizes beyond the first apical binding file is sufficient.
Fatima (2021) found that preparing the apical region in two sizes larger the initial apical binding file (IABF) with a 4% taper is inadequate, leading to significantly lower success rates compared to larger preparation sizes and greater tapers .
In both studies( Fatima and saini ) determination of apical enlargement size was based on the IABF (initial apical binding file). There was no mention of master apical size in different groups. Also the taper of apical one third was different in both these studies.Both master apical size and preparation taper can influence root canal shaping in apical third Various in-vitro studies suggest that increasing the taper has no significant effect on bacterial reduction.
According to Plotino(2014) the difference in the taper of the instruments did not result in different levels of disinfection in the apical region. They observed that amount of infected residual dentin \& the smear layer in the apical third of root canals were not significantly affected by preparations with 0.04 or 0.06 tapers when the apical diameter remained the same. Other studies examining bacterial reduction and different tapers agree with these results (Alimadadi, 2021; Usta 2023).
There is no impact on bacteria reduction when using different tapers with the same apical size #25 in the preparation of the mesial root canals of mandibular molars. ( Macedo, 2024) while clinical study by Fatima suggests that increasing the taper promotes better periapical healing. In Fatima study, a significantly high success rate was observed with apical preparation 2 sizes larger than the IABF and a 6% taper compared with the same preparation size with a 4%taper (92.8% vs 57.1%.).Till date there is no clinical study that combined the effect of different master apical file size and different taper on outcome of primary nonsurgical root canal treatment. Therefore, the present study was designed as a randomized clinical trial to examine the effect of apical third enlargement to different taper and master apical preparation size on periapical healing and postoperative pain after primary single sitting non surgical root canal treatment
Primary objective :
To evaluate and compare the radiographic outcome of periapical healing after primary non surgical single sitting root canal with different tapers and different master apical file size
Secondary objective :
To assess the post operative pain using VAS scale, postoperatively every 24 hours for 1 week after primary nonsurgical single sitting root canal treatment.
- Conditions
- Asymptomatic Irreversible Pulpitis
- Being tested
- root canal treatment with 2% taper, root canal treatment with 4% taper, root canal treatment with 6 %taper
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
root canal treatment with 2% taperProcedure or surgery
root canal treatment with 2%taper
root canal treatment with 4% taperProcedure or surgery
root canal treatment with 4 %taper
root canal treatment with 6 %taperProcedure or surgery
root canal treatment with 6 %taper
| Study group | Role | What they receive |
|---|---|---|
| GROUP A HAVING MASTER APICAL FILE SIZE # 25 | Experimental | group a is further dived into 3 further subgroup a1 2% taper a2 4% taper a3 6% taper Receives: Procedure: root canal treatment with 2% taper; Procedure: root canal treatment with 4% taper; Procedure: root canal treatment with 6 %taper |
| GROUP B HAVING MASTER APICAL FILE SIZE # 30 | Experimental | GROUP B is further divide into 3 further subgroup b1 2% taper b2 4 % taper b3 6 % taper Receives: Procedure: root canal treatment with 2% taper; Procedure: root canal treatment with 4% taper; Procedure: root canal treatment with 6 %taper |
| GROUP C HAVING MASTER APICAL FILE SIZE # 35 | Experimental | GROUP C is further divide into 3 subgroups c1 2 % taper c2 4 % taper c3 6 % taper Receives: Procedure: root canal treatment with 2% taper; Procedure: root canal treatment with 4% taper; Procedure: root canal treatment with 6 %taper |
What is being measured
The primary outcome is the main question the study is designed to answer.
periapical healing using the Periapical index score
Description: Periodical status will be assessed in periapical radiograph • Periapical status will be checked according to periapical index given by Orstavik
- Scoring of periapical radiolucency of each tooth will be done according to the following 5 point scale (PAI score)
- Score 1- Normal periapical structure
- Score 2- Small changes in bone structure
- Score 3- Changes in bone structure with some mineral loss
- Score 4- Periodontitis with well-defined radiolucent area
- Score 5- Severe periodontitis with exacerbating features
Time Frame: 12MONTHS
Measured: 12 month follow up
Secondary outcomes (1)
post operative pain
Post Operative Pain To assess incidence and intensity of pain postoperatively at every 24 hours till 7 days using Visual analogue Scale of 0 to 100 millimeter line. Score 0 means no pain and Score100 means maximum pain. To assess incidence and intensity of pain postoperatively at every 24 hours till 7 days using Visual analogue Scale of 0 to 100 millimeter line. Score 0 means no pain and Score 100 means maximum pain
Measured: Baseline and at 24 hours, Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7 after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start18 Apr 2025
- Primary completion18 Apr 2026 (estimated)
- Study completion18 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asymptomatic Irreversible PulpitisStudies of the same condition, open and under way.
- More trials run by Postgraduate Institute of Dental Sciences RohtakThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr shweta MITTAL, MDS, Principal investigator, PDIDS ROHTAK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07166679
- Sponsor's protocol ID
- sahil
- Status last verified
- Aug 2025
- First submitted
- 25 Aug 2025
- Last updated
- 10 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Apical Third Enlargement to Different Taper and Master Apical Preparation Size on Periapical Healing and Postoperative Pain After Primary Single Sitting Non Surgical Root Canal Treatment
- ClinicalTrials.gov ID
- NCT07166679
- Acronym / sponsor ID
- sahil
- Conditions
- Asymptomatic Irreversible Pulpitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 18 Apr 2025 (actual)
- Primary completion
- 18 Apr 2026 (estimated)
- Study completion
- 18 Apr 2027 (estimated)
- First posted
- 10 Sep 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.
To Determine Effect Of Apical Third enlargement To Different Taper And Master Apical Preparation Size On Periapical Healing And Postoperative Pain After Primary Single Sitting Non Surgical Root Canal Treatment : A Randomized Clinical Trial
Detailed description
The primary goal of endodontic therapy is to eradicate microbial infection within the root canal system and prevent reinfection. Thorough debridement and disinfection of the apical third are crucial, as this region serves as a reservoir for residual microorganisms.
Till date, only four clinical trials have analysed the effect of apical canal preparation size on treatment outcomes. Out of the four clinical trials one retrospective in nature, Hoskinson study no improvement in radiographic and clinical outcome with an increase in the master apical file .
Souza (2012) conducted clinical trial in necrotic pulp and concluded that apical third enlargement does not alter endodontic treatment outcomes.
Saini (2012) stated that enlarging the canal three sizes beyond the first apical binding file is sufficient.
Fatima (2021) found that preparing the apical region in two sizes larger the initial apical binding file (IABF) with a 4% taper is inadequate, leading to significantly lower success rates compared to larger preparation sizes and greater tapers .
In both studies( Fatima and saini ) determination of apical enlargement size was based on the IABF (initial apical binding file). There was no mention of master apical size in different groups. Also the taper of apical one third was different in both these studies.Both master apical size and preparation taper can influence root canal shaping in apical third Various in-vitro studies suggest that increasing the taper has no significant effect on bacterial reduction.
According to Plotino(2014) the difference in the taper of the instruments did not result in different levels of disinfection in the apical region. They observed that amount of infected residual dentin \& the smear layer in the apical third of root canals were not significantly affected by preparations with 0.04 or 0.06 tapers when the apical diameter remained the same. Other studies examining bacterial reduction and different tapers agree with these results (Alimadadi, 2021; Usta 2023).
There is no impact on bacteria reduction when using different tapers with the same apical size #25 in the preparation of the mesial root canals of mandibular molars. ( Macedo, 2024) while clinical study by Fatima suggests that increasing the taper promotes better periapical healing. In Fatima study, a significantly high success rate was observed with apical preparation 2 sizes larger than the IABF and a 6% taper compared with the same preparation size with a 4%taper (92.8% vs 57.1%.).Till date there is no clinical study that combined the effect of different master apical file size and different taper on outcome of primary nonsurgical root canal treatment. Therefore, the present study was designed as a randomized clinical trial to examine the effect of apical third enlargement to different taper and master apical preparation size on periapical healing and postoperative pain after primary single sitting non surgical root canal treatment
Primary objective :
To evaluate and compare the radiographic outcome of periapical healing after primary non surgical single sitting root canal with different tapers and different master apical file size
Secondary objective :
To assess the post operative pain using VAS scale, postoperatively every 24 hours for 1 week after primary nonsurgical single sitting root canal treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GROUP A HAVING MASTER APICAL FILE SIZE # 25 | Experimental | Procedure: root canal treatment with 2% taper, Procedure: root canal treatment with 4% taper, Procedure: root canal treatment with 6 %tapergroup a is further dived into 3 further subgroup a1 2% taper a2 4% taper a3 6% taper |
| GROUP B HAVING MASTER APICAL FILE SIZE # 30 | Experimental | Procedure: root canal treatment with 2% taper, Procedure: root canal treatment with 4% taper, Procedure: root canal treatment with 6 %taperGROUP B is further divide into 3 further subgroup b1 2% taper b2 4 % taper b3 6 % taper |
| GROUP C HAVING MASTER APICAL FILE SIZE # 35 | Experimental | Procedure: root canal treatment with 2% taper, Procedure: root canal treatment with 4% taper, Procedure: root canal treatment with 6 %taperGROUP C is further divide into 3 subgroups c1 2 % taper c2 4 % taper c3 6 % taper |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-65 years of age of either sex
- Asymptomatic teeth having pulpal necrosis with apical periodontitis in a mandibular molar (no response to EPT or cold test)
- Radiographic evidence of periapical radiolucency corresponding to a periapical index (PAI) score >/=3 in mesial root of mandibular molars
Key exclusion criteria (4 listed)
- Patients who were medically compromised
- Patients with initial apical binding file (IABF) size more than 20
- Pregnancy; lactation \& contraceptives.
- Positive history of antibiotic use within the past month or required antibiotic premedication for dental treatment (including infective endocarditis or pros thetic joint prophylaxis -
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 |
|---|---|---|
| root canal treatment with 2% taperroot canal treatment with 2%taper | Procedure or surgery | GROUP A HAVING MASTER APICAL FILE SIZE # 25, GROUP B HAVING MASTER APICAL FILE SIZE # 30, GROUP C HAVING MASTER APICAL FILE SIZE # 35 |
| root canal treatment with 4% taperroot canal treatment with 4 %taper | Procedure or surgery | GROUP A HAVING MASTER APICAL FILE SIZE # 25, GROUP B HAVING MASTER APICAL FILE SIZE # 30, GROUP C HAVING MASTER APICAL FILE SIZE # 35 |
| root canal treatment with 6 %taperroot canal treatment with 6 %taper | Procedure or surgery | GROUP A HAVING MASTER APICAL FILE SIZE # 25, GROUP B HAVING MASTER APICAL FILE SIZE # 30, GROUP C HAVING MASTER APICAL FILE SIZE # 35 |
Primary outcome
periapical healing using the Periapical index score
Time frame: 12 month follow up
Description: Periodical status will be assessed in periapical radiograph • Periapical status will be checked according to periapical index given by Orstavik * Scoring of periapical radiolucency of each tooth will be done according to the following 5 point scale (PAI score) * Score 1- Normal periapical structure * Score 2- Small changes in bone structure * Score 3- Changes in bone structure with some mineral loss * Score 4- Periodontitis with well-defined radiolucent area * Score 5- Severe periodontitis with exacerbating features Time Frame: 12MONTHS
1 secondary outcome
post operative pain
Time frame: Baseline and at 24 hours, Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7 after the treatment
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 10 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Asymptomatic Irreversible Pulpitis
Not yet recruiting
Comparing Post Operative Pain With and Without Apical Patency Technique in Asymptomatic Irreversible Pulpitis Teeth
Asymptomatic Irreversible Pulpitis
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.
Dr shweta MITTAL, MDS principal investigator
PDIDS ROHTAK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing root canal treatment with 2% taper, root canal treatment with 4% taper and root canal treatment with 6 %taper in people with Asymptomatic Irreversible Pulpitis, run by Postgraduate Institute of Dental Sciences Rohtak 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 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: looking for participants now, as of the sponsor's last update on 10 Sep 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 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?
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 shweta mittal, MDS (9255596960, shwetagoelendo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
periapical healing using the Periapical index score (time frame: 12 month follow up). 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 10 Sep 2025.