Apical Patency and Postoperative Pain.
Influence of Maintaining Apical Patency on Postoperative Pain in Posterior Teeth With Necrotic Pulp and Apical Periodontitis: A Randomized Controlled Trial.
1 other identifier
interventional
320
1 country
1
Brief Summary
The purpose of this study is to determine whether maintaining an apical patency causes postoperative pain in posterior 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
1 active site
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
CompletedFirst Submitted
Initial submission to the registry
May 5, 2016
CompletedFirst Posted
Study publicly available on registry
May 11, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 17, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 7, 2017
CompletedOctober 25, 2017
January 1, 2016
1.5 years
May 5, 2016
October 23, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
100-mm Visual Analog Scale (VAS).
Pain severity was evaluated as no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm) and severe pain (75-100 mm).
7 days.
Secondary Outcomes (1)
The number of patients taking an analgesic following the endodontic treatment.
7 days.
Study Arms (2)
Intervention
EXPERIMENTALEndodontic treatment was performed in posterior teeth with necrotic pulp and periapical periodontitis using a reciprocating single-file system (Reciproc). Local anesthesia was provided (2% Novocaine with 1:80,000 epinephrine), isolation with rubber dam and standard access cavity preparation was done.Using 2.5 % sodium hypochlorite, canal negotiation was done \& apical patency was achieved with #10 K-files in patency group after determining working length. Coronal flaring with # 2 and #3 Gates-Glidden drills was done. The canals were obturated with gutta-percha and epoxy resin sealer. The treatments were carried out in one-visit.
Control
NO INTERVENTIONIn the control group, apical patency did not maintained.
Interventions
After determining the working length, a small and flexible size 10 K-file was inserted 1 mm beyond the WL.
Eligibility Criteria
You may qualify if:
- Mature permanent teeth having plural 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
Study Sites (1)
Isparta Military Hospital
Isparta, 32010, Turkey (Türkiye)
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
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 5, 2016
First Posted
May 11, 2016
Study Start
January 1, 2016
Primary Completion
July 17, 2017
Study Completion
August 7, 2017
Last Updated
October 25, 2017
Record last verified: 2016-01
Data Sharing
- IPD Sharing
- Will share