Occlusal Reduction Effect on Postendodontic Pain

Not Applicable

Completed

• Conditions: Symptomatic Irreversible Pulpitis
• Interventions: Procedure: Occlusal reduction; Procedure: Sham occlusal reduction

• Registration Number: NCT04186897
• Lead Sponsor: Cairo University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2014-09
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Study First Submitted: 2019-11-28
• Status Verified: 2019-12
• Study First Submitted QC: 2019-12-02
• Last Update Submitted: 2019-12-04
• Study First Posted: 2019-12-05
• Last Update Posted: 2019-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 308

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Occlusal reduction	Occlusal reduction	Occlusal contacts on the functional and non-functional cusps were reduced.
No occlusal reduction	Sham occlusal reduction	Occlusal surfaces kept intact. No actual occlusal reduction..

Primary Outcome Measures

Name	Time	Method
Post-obturation pain using a pain-measuring scale	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.
Post-instrumentation pain using a pain-measuring scale	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.

Secondary Outcome Measures

Name	Time	Method
Sham analgesic intake incidence	7 days	Sham medication intake incidence (Yes/No) taken as an initial rescue medication in case of postoperative pain.
Analgesic intake incidence	7 days	Analgesic intake incidence (Yes/No) as a rescue medication in case postoperative pain persisted after the sham analgesic intake.