Foraminal Enlargement and Postoperative Pain.
Influence of Foraminal Enlargement on Postoperative Pain in Teeth With Necrotic Pulp and Apical Periodontitis: A Randomized Controlled Trial.
1 other identifier
interventional
80
0 countries
N/A
Brief Summary
The purpose of this study is to determine whether enlarging the apical foramen causes postoperative pain in teeth with necrotic pulp and apical periodontitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2016
Shorter than P25 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 11, 2016
CompletedFirst Posted
Study publicly available on registry
May 12, 2016
CompletedOctober 31, 2016
May 1, 2016
1 month
May 11, 2016
October 28, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
4-step pain intensity measures using a Visual Analog Scale (VAS).
The severity of pain in 1-7 days according to the VAS: 0-3 mild pain, 4-7 moderate pain, and 8-10 severe pain.
7 days.
Secondary Outcomes (1)
The number of patients taking an analgesic following the endodontics treatment.
7 days.
Study Arms (2)
Intervention
EXPERIMENTALEndodontic treatment will be performed in teeth with necrotic pulp and periapical periodontitis. Local anaesthesia will be provided (2% Novocaine with 1:80,000 epinephrine), isolation with rubber dam and standard access cavity preparation will be done.Using 2.5 % sodium hypochlorite, canal negotiation will be done. Foraminal enlargement will be achieved with #35 K-files in foraminal enlargement group after determining working length. Coronal flaring with # 2 and #3 Gates-Glidden drills will be done. The canals will be obturated with gutta-percha and epoxy resin sealer. The treatments will be carried out in single-visit.
Control
ACTIVE COMPARATORIn the control group, no foraminal enlargement will be performed.
Interventions
After determining the working length, a flexible size 30 K-file will be inserted 1 mm beyond the WL and the apical foramen will be enlarged.
Eligibility Criteria
You may qualify if:
- Mature permenent teeth having pulpal necrosis and apical periodontitis.
You may not qualify if:
- Systemic disorders
- Diabetes
- Pregnancy
- Less than 18 years of age
- Immunocompromised
- Patients who had taken antibiotics in the past 1 month
- Patients who had a positive history of analgesic use within the past 3 days
- Previously accessed teeth
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ibrahim E YAYLALI, Ph.D.
Isparta Military Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Dentistry
Study Record Dates
First Submitted
May 11, 2016
First Posted
May 12, 2016
Study Start
January 1, 2016
Primary Completion
February 1, 2016
Study Completion
May 1, 2016
Last Updated
October 31, 2016
Record last verified: 2016-05
Data Sharing
- IPD Sharing
- Will share