Occlusal Reduction Effect on Postendodontic Pain
Primary Purpose
Symptomatic Irreversible Pulpitis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Occlusal reduction
Sham occlusal reduction
Sponsored by
About this trial
This is an interventional prevention trial for Symptomatic Irreversible Pulpitis
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Occlusal reduction
No occlusal reduction
Arm Description
Occlusal contacts on the functional and non-functional cusps were reduced.
Occlusal surfaces kept intact. No actual occlusal reduction..
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
Sham analgesic intake incidence
Sham medication intake incidence (Yes/No) taken as an initial rescue medication in case of postoperative pain.
Analgesic intake incidence
Analgesic intake incidence (Yes/No) as a rescue medication in case postoperative pain persisted after the sham analgesic intake.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04186897
Brief Title
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
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
September 2014 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Symptomatic Irreversible Pulpitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
308 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Occlusal reduction
Arm Type
Experimental
Arm Description
Occlusal contacts on the functional and non-functional cusps were reduced.
Arm Title
No occlusal reduction
Arm Type
Sham Comparator
Arm Description
Occlusal surfaces kept intact. No actual occlusal reduction..
Intervention Type
Procedure
Intervention Name(s)
Occlusal reduction
Intervention Description
Occlusal contacts on the functional and non-functional cusps were reduced.
Intervention Type
Procedure
Intervention Name(s)
Sham occlusal reduction
Intervention Description
The occlusal surface left intact. No actual occlusal reduction.
Primary Outcome Measure Information:
Title
Post-instrumentation pain using a pain-measuring scale
Description
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.
Time Frame
6 hours
Title
Post-instrumentation pain using a pain-measuring scale
Description
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.
Time Frame
12 hours
Title
Post-instrumentation pain using a pain-measuring scale
Description
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.
Time Frame
24 hours
Title
Post-instrumentation pain using a pain-measuring scale
Description
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.
Time Frame
48 hours
Title
Post-obturation pain using a pain-measuring scale
Description
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.
Time Frame
6 hours
Title
Post-obturation pain using a pain-measuring scale
Description
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.
Time Frame
12 hours
Secondary Outcome Measure Information:
Title
Sham analgesic intake incidence
Description
Sham medication intake incidence (Yes/No) taken as an initial rescue medication in case of postoperative pain.
Time Frame
7 days
Title
Analgesic intake incidence
Description
Analgesic intake incidence (Yes/No) as a rescue medication in case postoperative pain persisted after the sham analgesic intake.
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randa El Boghdadi, PhD
Organizational Affiliation
Cairo University
Official's Role
Study Chair
12. IPD Sharing Statement
Citations:
PubMed Identifier
9693578
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.
Results Reference
background
PubMed Identifier
27129585
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.
Results Reference
background
Learn more about this trial
Occlusal Reduction Effect on Postendodontic Pain
We'll reach out to this number within 24 hrs