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Outcome Following Endodontic Treatment Using Traditional Access Versus Conservative Access

P

Postgraduate Institute of Dental Sciences Rohtak

Status

Unknown

Conditions

Pulpitis - Irreversible

Treatments

Procedure: Endodontic treatment using conservative access
Procedure: Endodontic treatment using traditional access

Study type

Interventional

Funder types

Other

Identifiers

NCT05402098
A Ramani

Details and patient eligibility

About

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

Full 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.

Enrollment

92 estimated patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

92 participants in 2 patient groups

Endodontic treatment using traditional access
Active Comparator group
Description:
Straight line access will be achieved following complete removal of pulp chamber roof
Treatment:
Procedure: Endodontic treatment using traditional access
Endodontic treatment using conservative access
Experimental group
Description:
Part of pulp chamber roof will be preserved and no efforts will be directed to achieve straight line access
Treatment:
Procedure: Endodontic treatment using conservative access

Trial contacts and locations

1

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Central trial contact

DR. PANKAJ SANGWAN, MDS; DR. ANKITA RAMANI, MDS

Data sourced from clinicaltrials.gov

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