Clinical trial NCT04186897: Occlusal Reduction Effect on Postendodontic Pain
Official title: Postendodontic Pain Following Occlusal Reduction in Mandibular Posterior Teeth: a Single-centre Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Symptomatic Irreversible Pulpitis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-12-05
Enrollment: 308
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Post-instrumentation pain using a pain-measuring scale
timeFrame: 6 hours
measure: Post-instrumentation pain using a pain-measuring scale
timeFrame: 12 hours
measure: Post-instrumentation pain using a pain-measuring scale
timeFrame: 24 hours
measure: Post-instrumentation pain using a pain-measuring scale
timeFrame: 48 hours
measure: Post-obturation pain using a pain-measuring scale
timeFrame: 6 hours
measure: Post-obturation pain using a pain-measuring scale
timeFrame: 12 hours
Secondary outcomes:
measure: Sham analgesic intake incidence
timeFrame: 7 days
measure: Analgesic intake incidence
timeFrame: 7 days
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Randa El Boghdadi, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.