NCT06953856

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 3, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2021

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2021

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

April 5, 2025

Completed
26 days until next milestone

First Posted

Study publicly available on registry

May 1, 2025

Completed
Last Updated

May 1, 2025

Status Verified

April 1, 2025

Enrollment Period

6 months

First QC Date

April 5, 2025

Last Update Submit

April 29, 2025

Conditions

Keywords

AnalgesicsOcclusal reductionPostoperative painSingle-visit endodontic treatment

Outcome Measures

Primary Outcomes (1)

  • Effect of occlusal reduction on pain relief

    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 1. mild pain (not requiring analgesic medication) 2. moderate pain (requiring analgesic medication) 3. severe pain (interfering with physical activity and minimally responsive to analgesics)

    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.

Study Arms (2)

Occlusal reduction,

OTHER

one of the group received occlusal reduction after root canal treatment while other did not.

Other: occlusal reduction

no occlusal reduction

NO INTERVENTION

this group did not receive any occlusal reduction after root canal treatment.

Interventions

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.

Also known as: occlusal reduction procedure
Occlusal reduction,

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healty patients
  • Maxillary and mandibulary first and second molars
  • Irriversible pulpitis cases with or without prior discomfort

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sakarya University Facultry of Dentistry

Adapazarı, Sakarya, 54050, Turkey (Türkiye)

Location

Related Publications (6)

  • 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.

    PMID: 23228248BACKGROUND
  • 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.

    PMID: 32418236BACKGROUND
  • 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.

    PMID: 30171777BACKGROUND
  • 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.

    PMID: 9693578BACKGROUND
  • 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.

    PMID: 31638301BACKGROUND
  • 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.

    PMID: 17956561BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 5, 2025

First Posted

May 1, 2025

Study Start

August 3, 2020

Primary Completion

January 29, 2021

Study Completion

February 5, 2021

Last Updated

May 1, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

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