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Occlusal Reduction Effect on Postendodontic Pain

NCT ID: NCT04186897

Last Updated: 2019-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

308 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-12-31

Brief Summary

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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

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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.

Conditions

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Symptomatic Irreversible Pulpitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Occlusal reduction

Occlusal contacts on the functional and non-functional cusps were reduced.

Group Type EXPERIMENTAL

Occlusal reduction

Intervention Type PROCEDURE

Occlusal contacts on the functional and non-functional cusps were reduced.

No occlusal reduction

Occlusal surfaces kept intact. No actual occlusal reduction..

Group Type SHAM_COMPARATOR

Sham occlusal reduction

Intervention Type PROCEDURE

The occlusal surface left intact. No actual occlusal reduction.

Interventions

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Occlusal reduction

Occlusal contacts on the functional and non-functional cusps were reduced.

Intervention Type PROCEDURE

Sham occlusal reduction

The occlusal surface left intact. No actual occlusal reduction.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Suzan AW Amin

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Randa El Boghdadi, PhD

Role: STUDY_CHAIR

Cairo University

References

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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.

Reference Type BACKGROUND
PMID: 9693578 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27129585 (View on PubMed)

Other Identifiers

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ENDO-CU-2013-12-10

Identifier Type: -

Identifier Source: org_study_id