Clinical trial NCT05402098: Outcome Following Endodontic Treatment Using Traditional Access Versus Conservative Access
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulpitis - Irreversible
Keywords: Irreversible pulpitis
Endodontic treatment
Traditional access
Conservative access
Contracted endodontic cavities
Lead sponsor: Postgraduate Institute of Dental Sciences Rohtak
Sponsor class: OTHER
First posted: 2022-06-02
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical and radiographic success
timeFrame: Baseline to 12 Months
Secondary outcomes:
measure: Pain analysis
timeFrame: Baseline to 7 days
Other outcomes:
Locations:
city: Rohtak
country: India
facility: Dr. Ankita Ramani
state: Haryana
Study officials:
affiliation: PGIDS, ROHTAK, HARYANA, INDIA-124001
name: DR. ANKITA RAMANI, MDS
role: PRINCIPAL_INVESTIGATOR
References: