Occlusal Reduction and Postoperative Pain
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
occlusal reduction
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Pain
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Occlusal Reduction
non-occlusal reduction
Arm Description
performing occlusal reduction on functional cusps until abscence of contact was confirmed
occlusal surface left intact
Outcomes
Primary Outcome Measures
postinstrumentation pain
postoperative pain was measured using visual analogue scale (VAS) following root canal instrumentation
postobturation pain
postoperative pain was measured using visual analogue scale (VAS) following root canal obturation
Secondary Outcome Measures
incidence of placebo and analgesic intake
The incidence of placebo intake and number of analgesic tablets taken were recorded by the patients.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03117062
Brief Title
Occlusal Reduction and Postoperative Pain
Official Title
Evaluation of Postoperative Pain Intensity Following Occlusal Reduction in Teeth Associated With Symptomatic Irreversible Pulpitis and Symptomatic Apical Periodontitis: A Randomized Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
September 2014 (Actual)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed Description
Recruitment of the study participants was done from the outpatient clinic of the Endodontic Department of the Faculty of Oral and Dental Medicine, Cairo University.
Randomization was done to assign participants to the study groups by chance and not choice. 44 numbers were generated and randomly allocated to either intervention or control group on a table using Microsoft Office Excel 2010. Each participant was given a number from 1 to 44 according to his turn in enrollment in the study.
Root canal treatment was completed in two visits. Before treatment, each patient was given pain scale chart and was asked to record their pain level. The tooth was anesthetized using inferior alveolar nerve block technique by local anesthesia of 1.8 - 3.6 ml of 2% Mepivacaine HCl. The access cavity preparation was performed using round carbide bur and Endo-z bur. After access cavity in the intervention group, all occlusal contacts on the functional and non-functional cusps as well as on the marginal ridges were reduced using a wheel diamond bur. Absence of contact was confirmed using an articulating paper. In the control group, all occlusal contacts were left intact. The tooth was then properly isolated with rubber dam. The patency of the root canals was confirmed using stainless steel hand K-files size #10 and #15. Working length was determined using an electronic apex locator and confirmed radiographically to be 1 mm shorter than radiographic apex. Mechanical preparation was done by crown-down technique using rotary Revo-S instruments and Ethylene Diamine Tetra Aceticacid gel as a lubricant. The canals were thoroughly irrigated using 3ml of 2.5% sodium hypochlorite following each instrument. After dryness of the canals using paper points, a cotton pellet was placed in the pulp chamber and the access cavity was sealed with a temporary filling. After 7 days, the root canals were obturated with lateral condensation technique using 0.04 taper gutta-percha and AdSeal resin-based root canal sealer.
Degree of postoperative pain was measured using visual analogue scale (VAS) after 6, 12, 24 and 48 hours after instrumentation then at 6 and 12 hours after obturation. The VAS consists of a 10-cm line anchored by two extremes "No pain" and "pain as bad as could be". The patients were asked to choose the mark that represents their level of pain. Pain level was assigned to one of four categorical scores: 1, None(0); 2,Mild(1-3); 3,Moderate(4-6); 4,Severe(7-10) 10.
In case of moderate to severe postoperative pain, the patients were instructed to take a capsule of placebo given to him/her at the end of each visit. In case of persistent pain, patients were allowed to take Ibuprofen 400mg. The incidence of placebo intake and number of analgesic tablets taken were recorded by the patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Occlusal Reduction
Arm Type
Experimental
Arm Description
performing occlusal reduction on functional cusps until abscence of contact was confirmed
Arm Title
non-occlusal reduction
Arm Type
No Intervention
Arm Description
occlusal surface left intact
Intervention Type
Other
Intervention Name(s)
occlusal reduction
Other Intervention Name(s)
occlusal relief
Intervention Description
relief of occlusion following endodontic treatment
Primary Outcome Measure Information:
Title
postinstrumentation pain
Description
postoperative pain was measured using visual analogue scale (VAS) following root canal instrumentation
Time Frame
up to 48 hours following instrumentation
Title
postobturation pain
Description
postoperative pain was measured using visual analogue scale (VAS) following root canal obturation
Time Frame
upto 24 hours following obturation
Secondary Outcome Measure Information:
Title
incidence of placebo and analgesic intake
Description
The incidence of placebo intake and number of analgesic tablets taken were recorded by the patients.
Time Frame
up to 48 hours following each visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Radwa S Emara, Masters
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
IPD data are confidential and secured. Only accessed by principal investigator and supervisors
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Occlusal Reduction and Postoperative Pain
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