Outcome Following Endodontic Treatment Using Traditional Access Versus Conservative Access

  • STATUS
    Recruiting
  • End date
    Sep 16, 2023
  • participants needed
    92
  • sponsor
    Postgraduate Institute of Dental Sciences Rohtak
Updated on 16 June 2022
Accepts healthy volunteers

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

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.

Details
Condition Pulpitis - Irreversible
Treatment Endodontic treatment using traditional access, Endodontic treatment using conservative access
Clinical Study IdentifierNCT05402098
SponsorPostgraduate Institute of Dental Sciences Rohtak
Last Modified on16 June 2022

Eligibility

Yes No Not Sure

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
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  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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