Effect of Occlusal Reduction on Post-operative Pain

Effect of Occlusal Reduction on Post-operative Pain in Patients With Irreversible Pulpitis and Symptomatic Apical Periodontitis Treated in a Single-visit: A Randomized Clinical Trial

effect of occlusal reduction on post-operative pain is evaluated after single visit root canal treatment in upper and lower molar teeth in patients with sypmtomatic irreversible pulpitis and apical periondontis

Study Overview

• Status: Unknown
• Conditions: Evaluate Occlusal Reduction on Post-operative Pain; Teeth With Symptomatic Irreversible Pulpitis; Apical Periodontitis
• Intervention / Treatment: Procedure: occlusal surface reduction

• Study Type: Interventional
• Enrollment (Anticipated): 52
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patient's age between 20-50 years with no sex predilection.
2. Medically free patients.

3. Patients suffering from symptomatic irreversible pulpitis with symptomatic apical periodontitis in maxillary and mandibular molars with:

   • Preoperative pain.
   • Vital pulp.
   • Sensitivity to percussion.
   • Occlusal contact with the opposing teeth.
   • Normal periapical radiographic appearance or slight widening in the periodontal membrane space.

Exclusion Criteria:

1. Pregnant females.
2. Patients having a significant systemic disorder.
3. Patients who had administered analgesics or antibiotics during the last 12 hours preoperatively.
4. Patients having bruxism or clenching.

5. Teeth having :

   • No occlusal contact.
   • No sensitivity to percussion.
   • Association with swelling or fistulous tract.
   • Acute or chronic peri-apical abscess.
   • Greater than grade I mobility.
   • Pocket depth greater than 5mm.
   • No possible restorability.
   • Previous endodontic treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: occlusal surface reduction; occlusal surface reduction after single visit root canal treatment	Procedure: occlusal surface reduction; occlusal surface reduction after single visit root canal treatment
Placebo Comparator: no occlusal surface reduction; No occlusal surface reduction after single visit root canal treatment	Procedure: occlusal surface reduction; occlusal surface reduction after single visit root canal treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pre-operative pain before single visit root canal treatment by NRS (numerical rating scale)	Primary outcome will be assessed by NRS (numerical rating scale), the unit of measurement is categorical.The scale is from (0-10) (1-3) Mild pain (4-6) Moderate pain (7-10) Severe pain	Baseline
post-operative pain after single visit root canal treatment by NRS (numerical rating scale)	Primary outcome will be assessed by NRS (numerical rating scale), the unit of measurement is categorical.The scale is from (0-10) (1-3) Mild pain (4-6) Moderate pain (7-10) Severe pain	after treatment by 6 hours
post-operative pain after single visit root canal treatment by NRS (numerical rating scale)	Primary outcome will be assessed by NRS (numerical rating scale), the unit of measurement is categorical.The scale is from (0-10) (1-3) Mild pain (4-6) Moderate pain (7-10) Severe pain	after treatment by 12 hours
post-operative pain after single visit root canal treatment by NRS (numerical rating scale)	Primary outcome will be assessed by NRS (numerical rating scale), the unit of measurement is categorical.The scale is from (0-10) (1-3) Mild pain (4-6) Moderate pain (7-10) Severe pain	after treatment by 24 hours
post-operative pain after single visit root canal treatment by NRS (numerical rating scale)	Primary outcome will be assessed by NRS (numerical rating scale), the unit of measurement is categorical.The scale is from (0-10) (1-3) Mild pain (4-6) Moderate pain (7-10) Severe pain	after treatment by 48 hours

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): June 27, 2017
• Primary Completion (Anticipated): July 1, 2018
• Study Completion (Anticipated): July 30, 2018

Study Registration Dates

• First Submitted: June 9, 2017
• First Submitted That Met QC Criteria: June 15, 2017
• First Posted (Actual): June 16, 2017

Study Record Updates

• Last Update Posted (Actual): June 16, 2017
• Last Update Submitted That Met QC Criteria: June 15, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Diseases; Jaw Diseases; Dental Pulp Diseases; Periapical Diseases; Pain, Postoperative; Periodontitis; Pulpitis; Periapical Periodontitis; Anti-Infective Agents; Dermatologic Agents; Antifungal Agents; Keratolytic Agents; Salicylic Acid
• Other Study ID Numbers: evidence comittee

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No