Occlusal Reduction Effect on Postendodontic Pain

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

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.

Study Overview

• Status: Completed
• Conditions: Symptomatic Irreversible Pulpitis
• Intervention / Treatment: Procedure: Occlusal reduction; Procedure: Sham occlusal reduction

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 Type: Interventional
• Enrollment (Actual): 308
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Occlusal reduction; Occlusal contacts on the functional and non-functional cusps were reduced.	Procedure: Occlusal reduction; Occlusal contacts on the functional and non-functional cusps were reduced.
Sham Comparator: No occlusal reduction; Occlusal surfaces kept intact. No actual occlusal reduction..	Procedure: Sham occlusal reduction; The occlusal surface left intact. No actual occlusal reduction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-instrumentation pain using a pain-measuring scale	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 hours
Post-instrumentation pain using a pain-measuring scale	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.	12 hours
Post-instrumentation pain using a pain-measuring scale	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.	24 hours
Post-instrumentation pain using a pain-measuring scale	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.	48 hours
Post-obturation pain using a pain-measuring scale	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 hours
Post-obturation pain using a pain-measuring scale	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.	12 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Randa El Boghdadi, PhD, Cairo University

Publications and helpful links

General Publications

• Rosenberg PA, Babick PJ, Schertzer L, Leung A. The effect of occlusal reduction on pain after endodontic instrumentation. J Endod. 1998 Jul;24(7):492-6. doi: 10.1016/S0099-2399(98)80054-X.
• Arslan H, Seckin F, Kurklu D, Karatas E, Yanikoglu N, Capar ID. The effect of various occlusal reduction levels on postoperative pain in teeth with symptomatic apical periodontitis using computerized analysis: a prospective, randomized, double-blind study. Clin Oral Investig. 2017 Apr;21(3):857-863. doi: 10.1007/s00784-016-1835-y. Epub 2016 Apr 30.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2014
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: November 28, 2019
• First Submitted That Met QC Criteria: December 2, 2019
• First Posted (Actual): December 5, 2019

Study Record Updates

• Last Update Posted (Actual): December 6, 2019
• Last Update Submitted That Met QC Criteria: December 4, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Pulpitis; Anti-Infective Agents; Dermatologic Agents; Antifungal Agents; Keratolytic Agents; Salicylic Acid
• Other Study ID Numbers: ENDO-CU-2013-12-10

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No