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Outcome Following Endodontic Treatment Using Traditional Access Versus Conservative Access

Comparative Evaluation of Outcome Following Endodontic Treatment Using Traditional Versus Conservative Access in Mandibular Molars With Symptomatic Irreversible Pulpitis: a Randomized Controlled Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05402098
Enrollment
92
Registered
2022-06-02
Start date
2022-05-12
Completion date
2023-09-30
Last updated
2022-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulpitis - Irreversible

Keywords

Irreversible pulpitis, Endodontic treatment, Traditional access, Conservative access, Contracted endodontic cavities

Brief 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

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.

Interventions

PROCEDUREEndodontic treatment using traditional access

Endodontic treatment will be carried out following complete removal of pulp chamber roof and achieving straight line access

PROCEDUREEndodontic treatment using conservative access

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

Sponsors

Postgraduate Institute of Dental Sciences Rohtak
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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 * 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

Design outcomes

Primary

MeasureTime frameDescription
Clinical and radiographic successBaseline to 12 MonthsCLINICAL 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.

Secondary

MeasureTime frameDescription
Pain analysisBaseline to 7 daysTo 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.

Countries

India

Contacts

Primary ContactDR. ANKITA RAMANI, MDS
ramaniankita95@gmail.com+919582841539
Backup ContactDR. PANKAJ SANGWAN, MDS
drps_1@yahoo.com9996112202

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026