Occlusal Reduction and Postoperative Pain

NCT03117062 | Completed

• 1 other identifier: CEBC-CU-2015-15-166
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this randomized clinical study was to evaluate the impact of occlusal reduction on the incidences of post-instrumentation and post-obturation pain. Forty four patients were included in this study. Inclusion criteria were posterior mandibular teeth having symptomatic irreversible pulpitis and symptomatic apical periodontitis. Patients were randomized into two equal groups. In the intervention group the functional and nonfunctional cusps were reduced until absence of contact was confirmed, while in the control group the occlusal surfaces were left intact. Standard endodontic treatment was performed in two visits using rotary nickel titanium files for shaping, 2.5% sodium hypochlorite for cleaning and lateral condensation technique with resin sealer for obturation. Pain was assessed preoperatively, then after 6, 12, 24 and 48 hours following instrumentation, then after 6 and 12 hours following obturation. Visual Analogue Scale (VAS) was used as the primary outcome measure. Patients were given a placebo to be administrated in case of severe pain and ibuprofen 400mg was prescribed in case of persistent pain.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (2)

• postinstrumentation pain

  postoperative pain was measured using visual analogue scale (VAS) following root canal instrumentation

  up to 48 hours following instrumentation

• postobturation pain

  postoperative pain was measured using visual analogue scale (VAS) following root canal obturation

  upto 24 hours following obturation

Secondary Outcomes (1)

• incidence of placebo and analgesic intake

  up to 48 hours following each visit

Study Arms (2)

Occlusal Reduction

EXPERIMENTAL

performing occlusal reduction on functional cusps until abscence of contact was confirmed

Other: occlusal reduction

non-occlusal reduction

NO INTERVENTION

occlusal surface left intact

Interventions

occlusal reduction OTHER

relief of occlusion following endodontic treatment

Also known as: occlusal relief

Occlusal Reduction

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy adults of 18-50 years. The diagnosis of symptomatic irreversible pulpitis with symptomatic apical periodontitis in a posterior mandibular tooth was confirmed by history of chief complaint of moderate to severe lingering sharp throbbing pain with pain on biting, clinical examination revealing positive response to an electrical pulp tester and tenderness to percussion on tapping the tooth with the end of a mirror handle, and radiographic examination showing posterior tooth with no apical radiolucency or slight widening of lamina dura.

You may not qualify if:

• pregnant women, patients who reported bruxism or clenching, or patients who have administrated analgesics preoperatively during the past 12 hours that might alter their pain perception. Teeth that had no occlusal contact, no sensitivity to percussion, association with swelling or fistulous tract, greater than grade I mobility, or no possible restorability were also excluded.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Radwa S Emara, Masters

  Cairo University

  PRINCIPAL INVESTIGATOR

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: assisstant lecturer

Study Record Dates

• First Submitted: April 6, 2017
• First Posted: April 17, 2017
• Study Start: September 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: April 17, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share