NCT04186897

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
308

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2014

Typical duration for not_applicable

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

November 28, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 5, 2019

Completed
Last Updated

December 6, 2019

Status Verified

December 1, 2019

Enrollment Period

2.3 years

First QC Date

November 28, 2019

Last Update Submit

December 4, 2019

Conditions

Symptomatic Irreversible Pulpitis

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (2)

  • Sham analgesic intake incidence

    7 days

  • Analgesic intake incidence

    7 days

Study Arms (2)

Occlusal reduction

EXPERIMENTAL

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

Procedure: Occlusal reduction

No occlusal reduction

SHAM COMPARATOR

Occlusal surfaces kept intact. No actual occlusal reduction..

Procedure: Sham occlusal reduction

Interventions

Occlusal reductionPROCEDURE

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

Occlusal reduction
Sham occlusal reductionPROCEDURE

The occlusal surface left intact. No actual occlusal reduction.

No occlusal reduction

Eligibility Criteria

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

You may qualify if:

  • Healthy adults 18-65 years old.
  • The diagnosis of symptomatic irreversible pulpitis with sensitivity to percussion.
  • Posterior mandibular teeth.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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

  • 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.

    PMID: 27129585BACKGROUND

Study Officials

  • Randa El Boghdadi, PhD

    Cairo University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 28, 2019

First Posted

December 5, 2019

Study Start

September 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

December 6, 2019

Record last verified: 2019-12