Occlusal Reduction Effect on Postendodontic Pain

Study Overview
=================
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.

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

Conditions
-----------------
Symptomatic Irreversible Pulpitis

Intervention / Treatment
-----------------
* Procedure: Occlusal reduction
* Procedure: Sham occlusal reduction


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

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 |