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

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

Study Overview

• Status: Recruiting
• Conditions: Pulpitis - Irreversible
• Intervention / Treatment: Procedure: Endodontic treatment using traditional access; Procedure: Endodontic treatment using conservative access

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 Type: Interventional
• Enrollment (Anticipated): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Haryana
    • Rohtak, Haryana, India, 124001
      • Recruiting
      • Dr. Ankita Ramani

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Endodontic treatment using traditional access; Straight line access will be achieved following complete removal of pulp chamber roof	Procedure: Endodontic treatment using traditional access; Endodontic treatment will be carried out following complete removal of pulp chamber roof and achieving straight line access
Experimental: Endodontic treatment using conservative access; Part of pulp chamber roof will be preserved and no efforts will be directed to achieve straight line access	Procedure: Endodontic 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to 12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to 7 days

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Dental Sciences Rohtak

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2022
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: May 29, 2022
• First Submitted That Met QC Criteria: May 29, 2022
• First Posted (Actual): June 2, 2022

Study Record Updates

• Last Update Posted (Actual): June 2, 2022
• Last Update Submitted That Met QC Criteria: May 29, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Irreversible pulpitis; Endodontic treatment; Traditional access; Conservative access; Contracted endodontic cavities
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Pulpitis
• Other Study ID Numbers: A Ramani

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No