Outcome Following Endodontic Treatment Using Traditional Access Versus Conservative Access

Not Applicable

• Conditions: Pulpitis - Irreversible
• Interventions: Procedure: Endodontic treatment using traditional access; Procedure: Endodontic treatment using conservative access

• Registration Number: NCT05402098
• Lead Sponsor: Postgraduate Institute of Dental Sciences Rohtak

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.

Study Timeline

• Status Verified: 2022-05
• Study Start: 2022-05-12
• Study First Submitted: 2022-05-29
• Study First Submitted QC: 2022-05-29
• Last Update Submitted: 2022-05-29
• Study First Posted: 2022-06-02
• Last Update Posted: 2022-06-02
• Primary Completion: 2023-09
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 92

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endodontic treatment using traditional access	Endodontic treatment using traditional access	Straight line access will be achieved following complete removal of pulp chamber roof
Endodontic treatment using conservative access	Endodontic treatment using conservative access	Part of pulp chamber roof will be preserved and no efforts will be directed to achieve straight line access

Primary Outcome Measures

Name	Time	Method
Clinical and radiographic success	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.

Secondary Outcome Measures

Name	Time	Method
Pain analysis	Baseline to 7 days	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.

Trial Locations

Locations (1)

Dr. Ankita Ramani; 🇮🇳 Rohtak, Haryana, India