Back to resultsFE in Anterior Teeth
Primary Purpose
Pain, Postoperative, Apical Periodontitis
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Foraminal enlargement
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative focused on measuring Apical patency, Endodontics
Eligibility Criteria
Inclusion Criteria:
Mature permenent maxillary anterior teeth having pulpal necrosis and apical periodontitis.
Exclusion Criteria:
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.
Sites / Locations
- Isparta Military HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
Endodontic treatment will be performed in maxillary anterior 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 rotary 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.
In the control group, no foraminal enlargement will be performed.
Outcomes
Primary Outcome Measures
100-mm Visual Analog Scale (VAS).
The severity of pain in 12 h, 24 h, and 2, 3, 4, and 5 days according to the VAS: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm)
Secondary Outcome Measures
The number of patients taking an analgesic following the endodontics treatment.
The patients were asked to take an analgesic in the 5 days of time frame.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03527602
Brief Title
FE in Anterior Teeth
Official Title
Enlargement of Apical Foramen in Anterior Teeth With Apical Periodontitis and Postoperative Pain and Flare-up Rate.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 5, 2017 (Actual)
Primary Completion Date
August 1, 2018 (Anticipated)
Study Completion Date
August 5, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isparta Military Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether enlarging the apical foramen causes postoperative pain in maxillary anterior teeth with apical periodontitis.
Detailed Description
Foraminal enlargement (FE) is an intentional procedure that enlarges the cement canal. However, some RCTs indicate that enlarging the FE causes postoperative pain, flare-up, and destroy the apical constriction, whilst some RCTs pointed out there is no difference in terms of pain when a FE has been performed in maxillary anterior teeth with apical periodontitis. We will assess the risk of postoperative pain as risk ratio (RR). The binary (dichotomous) data: 0-44 mm: Mild or no pain; 45-100 mm: Moderate to severe pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Apical Periodontitis
Keywords
Apical patency, Endodontics
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Single-blind. (Participants)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Endodontic treatment will be performed in maxillary anterior 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 rotary 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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
In the control group, no foraminal enlargement will be performed.
Intervention Type
Procedure
Intervention Name(s)
Foraminal enlargement
Intervention Description
After determining the working length, a rotary file will be inserted 1 mm beyond the WL and the apical foramen will be enlarged.
Primary Outcome Measure Information:
Title
100-mm Visual Analog Scale (VAS).
Description
The severity of pain in 12 h, 24 h, and 2, 3, 4, and 5 days according to the VAS: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm)
Time Frame
5 days
Secondary Outcome Measure Information:
Title
The number of patients taking an analgesic following the endodontics treatment.
Description
The patients were asked to take an analgesic in the 5 days of time frame.
Time Frame
5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Mature permenent maxillary anterior teeth having pulpal necrosis and apical periodontitis.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ibrahim Ethem Yaylali, PhD
Phone
05378707924
Email
ibotenring@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
ibrahim E Yaylali, PhD
Phone
05378707924
Email
ibotenring@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ibrahim ethem yaylali
Organizational Affiliation
Military Hospital, Isparta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Isparta Military Hospital
City
Isparta
ZIP/Postal Code
32010
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ibrahim E YAYLALI, Ph.D.
Email
ibotenring@yahoo.com
12. IPD Sharing Statement
Learn more about this trial
FE in Anterior Teeth
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