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Completed

NCT Number: NCT04186897

Occlusal Reduction Effect on Postendodontic Pain

The aim of this study, thus, was to assess the effect of occlusal reduction on postendodontic pain after the first (post-instrumentation) and the second (post-obturation) visit in mandibular posterior teeth with symptomatic irreversible pulpitis and sensitivity to percussion treated in two visits.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The purpose of this randomized clinical trial was to evaluate the effect of occlusal reduction on post-instrumentation and post-obturation pain in mandibular posterior teeth with symptomatic irreversible pulpitis and sensitivity to percussion treated in two visits. Three hundred and eight patients were included in this study. Inclusion criteria were posterior mandibular teeth having symptomatic irreversible pulpitis with sensitivity to percussion. Patients were randomized into two equal groups. In the intervention group, occlusal reduction was done, while, in the control group, the occlusal surfaces were left intact. Conventional endodontic treatment was performed in two visits using a rotary nickel-titanium system followed by the lateral-condensation obturation technique. Post-instrumentation pain was assessed after 6, 12, 24 and 48 hours following the first visit, and post-obturation pain after 6 and 12 hours following the second visit. Each patient received a pain diary to record their pain levels and rescue medication intake.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy adults 18-65 years old.
  • The diagnosis of symptomatic irreversible pulpitis with sensitivity to percussion.
  • Posterior mandibular teeth.

Exclusion criteria

  • Pregnant women.
  • Patients who reported bruxism or clenching.
  • Patients who took analgesics during the last 12 hours before treatment start.
  • Teeth with no occlusal contact.
  • Unrestorable teeth.

Treatment and study plan

Occlusal reduction

Procedure

Occlusal contacts on the functional and non-functional cusps were reduced.

Sham occlusal reduction

Procedure

The occlusal surface left intact. No actual occlusal reduction.

Primary outcomes

  1. Post-instrumentation pain using a pain-measuring scale

    Time frame: 6 hours

    Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured.

  2. Post-instrumentation pain using a pain-measuring scale

    Time frame: 12 hours

    Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured.

  3. Post-instrumentation pain using a pain-measuring scale

    Time frame: 24 hours

    Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured.

  4. Post-instrumentation pain using a pain-measuring scale

    Time frame: 48 hours

    Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured.

  5. Post-obturation pain using a pain-measuring scale

    Time frame: 6 hours

    Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured.

  6. Post-obturation pain using a pain-measuring scale

    Time frame: 12 hours

    Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured.

Secondary outcomes

  1. Sham analgesic intake incidence

    Time frame: 7 days

    Sham medication intake incidence (Yes/No) taken as an initial rescue medication in case of postoperative pain.

  2. Analgesic intake incidence

    Time frame: 7 days

    Analgesic intake incidence (Yes/No) as a rescue medication in case postoperative pain persisted after the sham analgesic intake.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Postendodontic Pain Following Occlusal Reduction in Mandibular Posterior Teeth: a Single-centre Randomized Controlled Trial

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 5, 2019
Registry last updated
Dec 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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