Pulpitis - IrreversibleNCT05402098
Outcome Following Endodontic Treatment Using Traditional Access Versus Conservative Access
A study testing Endodontic treatment using traditional access and Endodontic treatment using conservative access in people with Pulpitis - Irreversible, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
This study will compare the outcome of endodontic treatment using conservative or traditional access design in permanent molars with clinical signs indicative of irreversible pulpitis Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulpitis - Irreversible
- What is being tested?
- Endodontic treatment using traditional access and Endodontic treatment using conservative access
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteIndia
- Study dates
- 12 May 2022to Sep 2023
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The patient should be ≥18 years of age.
- Restorable mandibular molars with extremely deep caries involving occlusal surface only
- Clinical diagnosis of symptomatic irreversible pulpitis with PAI score ≤2.
- Tooth should give positive response to pulp sensibility testing.
- Tooth with probing pocket depth and mobility are within normal limits.
- Non-contributory medical history.
Who cannot join
- Teeth with immature roots.
- No pulp exposure even after caries excavation.
- Teeth with signs of pulpal necrosis including sinus tract or swelling.
- Teeth with percussion sensitivity
- Positive history of antibiotic use in the past 1 month or requiring antibiotic prophylaxis
- Had taken analgesic in past 3 days
Show all 10Show fewer
- Teeth with pathologic changes such as internal or external resorption
- Teeth with morphological variation
- Teeth with root canal calcification
- Teeth with fixed full coverage prosthesis
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Dr. Ankita Ramani
Rohtak, Haryana, 124001
DR. ANKITA RAMANI, MDS, 09582841539, ramaniankita95@gmail.com
About this study
Official title: Comparative Evaluation of Outcome Following Endodontic Treatment Using Traditional Versus Conservative Access in Mandibular Molars With Symptomatic Irreversible Pulpitis: a Randomized Controlled Trial
This study will compare the outcome of endodontic treatment using conservative or traditional access design in permanent molars with clinical signs indicative of irreversible pulpitis
Read the detailed description
After thorough history and clinical and radio graphic examination, and confirmation of eligibility for the study, written informed consent will be obtained after explaining the procedure and its associated risks and benefits.
Clinical diagnosis of symptomatic irreversible pulpitis will be established based on a history of spontaneous pain or pain exacerbated by cold stimuli and lasting for a few seconds to several hours (lingering pain) compared to control teeth and which is reproducible using cold testing.
Once included, study subjects will be randomly allocated to either traditional access or conservative access group. Subsequently biomechanical preparation will be carried out using standard protocol with the use of rotary NiTi file system followed by root canal filling using gutta percha and zinc oxide eugenol sealer. Teeth will be restored using composite resin in the same appointment.
Pain analysis will be carried out preoperatively and postoperatively at every 24 hours till 7 days after intervention. All the subjects will be followed up for evaluation of success at 6 and 12 months from baseline.
- Conditions
- Pulpitis - Irreversible
- Being tested
- Endodontic treatment using traditional access, Endodontic treatment using conservative access
- Keywords
- Irreversible pulpitis, Endodontic treatment, Traditional access, Conservative access, Contracted endodontic cavities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endodontic treatment using traditional accessProcedure or surgery
Endodontic treatment will be carried out following complete removal of pulp chamber roof and achieving straight line access
Endodontic treatment using conservative accessProcedure or surgery
Endodontic treatment will be carried out following partial removal of pulp chamber roof, extended only to the extent which helps to locate all the orifices with no efforts will be made to achieve straight line access
| Study group | Role | What they receive |
|---|---|---|
| Endodontic treatment using traditional access | Active comparator | Straight line access will be achieved following complete removal of pulp chamber roof Receives: Procedure: Endodontic treatment using traditional access |
| Endodontic treatment using conservative access | Experimental | Part of pulp chamber roof will be preserved and no efforts will be directed to achieve straight line access Receives: Procedure: Endodontic treatment using conservative access |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical and radiographic success
CLINICAL SUCCESS CRITERIA:
Absence of spontaneous pain, discomfort, swelling, sinus tract or tenderness to palpation or percussion.
RADIOGRAPHIC SUCCESS CRITERIA:
No pathosis evident on the radiograph such as root resorption, furcal pathosis or new periapical pathosis.
Periapical Index score 1 or 2 according to Orstavic et al. Evaluation of both clinical and radiographic outcome is must for analyzing the actual success of therapeutic technique.
Number of participants fulfilling both clinical as well as radiographic success criteria will be considered in success category.
Measured: Baseline to 12 Months
Secondary outcomes (1)
Pain analysis
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 to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start12 May 2022
- Primary completionSep 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulpitis - IrreversibleStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- DR. ANKITA RAMANI, MDS, Principal investigator, PGIDS, ROHTAK, HARYANA, INDIA-124001
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05402098
- Sponsor's protocol ID
- A Ramani
- Status last verified
- May 2022
- First submitted
- 29 May 2022
- Last updated
- 2 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Outcome Following Endodontic Treatment Using Traditional Versus Conservative Access in Mandibular Molars With Symptomatic Irreversible Pulpitis: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05402098
- Acronym / sponsor ID
- A Ramani
- Conditions
- Pulpitis - Irreversible
- Keywords
- Irreversible pulpitis, Endodontic treatment, Traditional access, Conservative access, Contracted endodontic cavities
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 12 May 2022 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 2 Jun 2022 (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 study will compare the outcome of endodontic treatment using conservative or traditional access design in permanent molars with clinical signs indicative of irreversible pulpitis
Detailed description
After thorough history and clinical and radio graphic examination, and confirmation of eligibility for the study, written informed consent will be obtained after explaining the procedure and its associated risks and benefits.
Clinical diagnosis of symptomatic irreversible pulpitis will be established based on a history of spontaneous pain or pain exacerbated by cold stimuli and lasting for a few seconds to several hours (lingering pain) compared to control teeth and which is reproducible using cold testing.
Once included, study subjects will be randomly allocated to either traditional access or conservative access group. Subsequently biomechanical preparation will be carried out using standard protocol with the use of rotary NiTi file system followed by root canal filling using gutta percha and zinc oxide eugenol sealer. Teeth will be restored using composite resin in the same appointment.
Pain analysis will be carried out preoperatively and postoperatively at every 24 hours till 7 days after intervention. All the subjects will be followed up for evaluation of success at 6 and 12 months from baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endodontic treatment using traditional access | Active comparator | Procedure: Endodontic treatment using traditional accessStraight line access will be achieved following complete removal of pulp chamber roof |
| Endodontic treatment using conservative access | Experimental | Procedure: Endodontic treatment using conservative accessPart of pulp chamber roof will be preserved and no efforts will be directed to achieve straight line access |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- The patient should be ≥18 years of age.
- Restorable mandibular molars with extremely deep caries involving occlusal surface only
- Clinical diagnosis of symptomatic irreversible pulpitis with PAI score ≤2.
- Tooth should give positive response to pulp sensibility testing.
- Tooth with probing pocket depth and mobility are within normal limits.
Key exclusion criteria (10 listed)
- Teeth with immature roots.
- No pulp exposure even after caries excavation.
- Teeth with signs of pulpal necrosis including sinus tract or swelling.
- Teeth with percussion sensitivity
- Positive history of antibiotic use in the past 1 month or requiring antibiotic 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 |
|---|---|---|
| Endodontic treatment using traditional accessEndodontic treatment will be carried out following complete removal of pulp chamber roof and achieving straight line access | Procedure or surgery | Endodontic treatment using traditional access |
| Endodontic treatment using conservative accessEndodontic treatment will be carried out following partial removal of pulp chamber roof, extended only to the extent which helps to locate all the orifices with no efforts will be made to achieve straight line access | Procedure or surgery | Endodontic treatment using conservative access |
Primary outcome
Clinical and radiographic success
Time frame: Baseline to 12 Months
CLINICAL SUCCESS CRITERIA: Absence of spontaneous pain, discomfort, swelling, sinus tract or tenderness to palpation or percussion. RADIOGRAPHIC SUCCESS CRITERIA: No pathosis evident on the radiograph such as root resorption, furcal pathosis or new periapical pathosis. Periapical Index score 1 or 2 according to Orstavic et al. Evaluation of both clinical and radiographic outcome is must for analyzing the actual success of therapeutic technique. Number of participants fulfilling both clinical as well as radiographic success criteria will be considered in success category.
1 secondary outcome
Pain analysis
Time frame: Baseline to 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
- 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.
DR. ANKITA RAMANI, MDS principal investigator
PGIDS, ROHTAK, HARYANA, INDIA-124001
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endodontic treatment using traditional access and Endodontic treatment using conservative access in people with Pulpitis - Irreversible, 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 6 inclusion and 10 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 2 Jun 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact DR. ANKITA RAMANI, MDS (+919582841539, ramaniankita95@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical and radiographic success (time frame: Baseline to 12 Months). 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 2 Jun 2022.