- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06953856
Analyzing the Impact of Occlusal Reduction on the Pain Following Root Canal Therapy in Molar Teeth With and Without Pain in Turkish Patients.
Effect of Occlusal Reduction on Post-operative Pain of Symptomatic and Asymptomatic Molar Teeth
Introduction: This study aimed to compare the intensity of postoperative pain after single-visit root canal treatment of symptomatic or asymptomatic teeth following occlusal reduction.
Methods: A total of 140 symptomatic or asymptomatic patients in need of root canal therapy were registered in this prospective, single-center, single-blind, randomized clinical trial.
For all patients, root canal treatment was carried out in a single visit, and the teeth were restored using composite resin. The teeth were randomly allocated into two equal groups according to whether occlusal reduction was done or not. The patients' pain were assessed using a 0-3 verbal rate scale 1, 3, and 7 days following root canal treatment. The pain incidence and intensity were compared using the chi-square and Fisher's exact tests.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Sakarya, Turkey, 54050
- Sakarya University Facultry of Dentistry
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healty patients
- Maxillary and mandibulary first and second molars
- Irriversible pulpitis cases with or without prior discomfort
Exclusion Criteria:
- Patients under 18 years old,
- Patients older 65 years old,
- Teeth with previously undergone root canal treatment,
- Complicating systemic diseases,
- Allergies o local anesthetic agents,
- Presence of acute apical apsesses,
- History of trauma,
- Analgesic, antibiotic or antiinflamatory intake 7 days before treatment,
- Periodontal pockets deeper than 4 mm,
- Multiple teeth that require endodontic treatment,
- Pregnancy,
- Teeth that can not be restored,
- Patients who needed emergency treatment,
- Grade 2 or 3 mobility,
- Patients with bruxism
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Occlusal reduction,
one of the group received occlusal reduction after root canal treatment while other did not.
|
Occlusal reduction is a procedure that applied patients for different aims.
One of these aims is pain relief after endodontic treatment and there are some studies about this topic however, there is no consensus about it.
This discrepency could be related to differences of the inclusion criteria for this reason this study aimed to get a reliable result.
Other Names:
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No Intervention: no occlusal reduction
this group did not receive any occlusal reduction after root canal treatment.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effect of occlusal reduction on pain relief
Time Frame: from enrollment to the end each patient called for a week to understand their pain levels and each of them called after 1st, 3th, 7th days treatment.
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This study was primarily aim to understand the effect of occlusal reduction on pain relief after root canal treatment of irriversible pulpitis. After root canal treatment patients were called to estimate their pain levels. A 0-3 rate verbal rating scale was used for this aim. 0: no discomfort or pain
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from enrollment to the end each patient called for a week to understand their pain levels and each of them called after 1st, 3th, 7th days treatment.
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Collaborators and Investigators
Sponsor
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.
- Sathorn C, Parashos P, Messer H. The prevalence of postoperative pain and flare-up in single- and multiple-visit endodontic treatment: a systematic review. Int Endod J. 2008 Feb;41(2):91-9. doi: 10.1111/j.1365-2591.2007.01316.x. Epub 2007 Oct 23.
- Parirokh M, Rekabi AR, Ashouri R, Nakhaee N, Abbott PV, Gorjestani H. Effect of occlusal reduction on postoperative pain in teeth with irreversible pulpitis and mild tenderness to percussion. J Endod. 2013 Jan;39(1):1-5. doi: 10.1016/j.joen.2012.08.008. Epub 2012 Sep 29.
- Ahmed YE, Emara RS, Sarhan SM, El Boghdadi RM, El-Bayoumi MAA, El-Far HMM, Sabet NE, Abou El-Nasr HM, Gawdat SI, Amin SAW. Post-treatment endodontic pain following occlusal reduction in mandibular posterior teeth with symptomatic irreversible pulpitis and sensitivity to percussion: a single-centre randomized controlled trial. Int Endod J. 2020 Sep;53(9):1170-1180. doi: 10.1111/iej.13328. Epub 2020 Jun 15.
- Emara RS, Abou El Nasr HM, El Boghdadi RM. Evaluation of postoperative pain intensity following occlusal reduction in teeth associated with symptomatic irreversible pulpitis and symptomatic apical periodontitis: a randomized clinical study. Int Endod J. 2019 Mar;52(3):288-296. doi: 10.1111/iej.13012. Epub 2018 Sep 28.
- Nguyen-Nhon D, Nagendrababu V, Pulikkotil SJ, Rossi-Fedele G. Effect of occlusal reduction on postendodontic pain: A systematic review and meta-analysis of randomised clinical trials. Aust Endod J. 2020 Aug;46(2):282-294. doi: 10.1111/aej.12380. Epub 2019 Oct 22.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-71522473-050.01.04-39802-329
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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