Back to resultsPostoperative Pain and PTN and Reciproc
Primary Purpose
Apical Periodontitis, Dental Pulp Necrosis
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Reciprocating single-file system
Rotational multi-file system.
Sponsored by
About this trial
This is an interventional treatment trial for Apical Periodontitis
Eligibility Criteria
Inclusion Criteria:
Participants who have in their mandibular or maxillary molar teeth necrotic pulp and apical periodontitis.
Exclusion Criteria:
Pregnancy, drug hypersensitivity, cardiac problems, previously performed endodontics treatment.
Sites / Locations
- Isparta Military Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Reciproc
ProTaper Next
Arm Description
Endodontic 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. 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 this group, intervention will be carried out by the Reciproc motor (VDW, Germany) and Reciproc single-file system. The intervention is foraminal enlargement with the Reciproc single-file system.
The active comparator is foraminal enlargement with the ProTaper Next multi-file system. Endodontic treatment is identical to experimental group except file systems used. In this group, ProTaper Next multi-file system will be used in enlarging apical foramina.
Outcomes
Primary Outcome Measures
4-step pain intensity measures using a Visual Analog Scale (VAS).
The severity of pain in 1-7 days according to the VAS: 0 no pain, 1-3 mild pain, 4-7 moderate pain, 7-10 severe pain.
Secondary Outcome Measures
The number of patients taking an analgesic following the endodontics treatment.
The patients were asked to take an analgesic in the 7 days of time frame.
Full Information
NCT ID
NCT03380585
First Posted
December 15, 2017
Last Updated
March 9, 2018
Sponsor
Isparta Military Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03380585
Brief Title
Postoperative Pain and PTN and Reciproc
Official Title
Postoperative Pain Assessment After Foraminal Enlargement Using Protaper Next and Reciproc File Systems.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
March 1, 2018 (Actual)
Study Completion Date
March 2, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
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
Yes
5. Study Description
Brief Summary
In this clinical trial, the researchers will investigate the effect of single-file reciprocating file system (Reciproc) versus multi-file rotational file systems (ProTaper Next) on the postoperative pain in adult patients who have necrotic pulp and apical periodontitis. The participants will be assigned by chance to separate groups that compare 2 different treatments, reciprocating single-file system (Reciproc) and rotational multi-file system (ProTaper Next).
Detailed Description
The infected root canal treatments will be performed using one-visit approach with either a reciprocating single-file system or a continuous rotational multi-file system. Foraminal enlargement will be perfomed using either Reciproc or ProTaper Next file systems. The root canals will be completed in single-visit. The patients will record their postoperative pain during the follow-up period using a VAS scale.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apical Periodontitis, Dental Pulp Necrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Single-blinded (Participant)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Reciproc
Arm Type
Experimental
Arm Description
Endodontic 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. 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 this group, intervention will be carried out by the Reciproc motor (VDW, Germany) and Reciproc single-file system. The intervention is foraminal enlargement with the Reciproc single-file system.
Arm Title
ProTaper Next
Arm Type
Active Comparator
Arm Description
The active comparator is foraminal enlargement with the ProTaper Next multi-file system. Endodontic treatment is identical to experimental group except file systems used. In this group, ProTaper Next multi-file system will be used in enlarging apical foramina.
Intervention Type
Procedure
Intervention Name(s)
Reciprocating single-file system
Other Intervention Name(s)
Reciproc
Intervention Description
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.The device in the experimental group moves in CW and CCW direction with different angles. It is a single-file endodontic file system. The intervention is reciprocating single-file system. A Reciproc single-file will be used for enlarging apical foramen. In the active comparator group, a continuous rotational multi-file system, ProTaper Next, will be used in enlarging apical foramen.
Intervention Type
Procedure
Intervention Name(s)
Rotational multi-file system.
Other Intervention Name(s)
ProTaper Next
Intervention Description
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. In this group, a continuous rotational multi-file system, ProTaper Next, will be used in enlarging apical foramen.
Primary Outcome Measure Information:
Title
4-step pain intensity measures using a Visual Analog Scale (VAS).
Description
The severity of pain in 1-7 days according to the VAS: 0 no pain, 1-3 mild pain, 4-7 moderate pain, 7-10 severe pain.
Time Frame
7 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 7 days of time frame.
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Participants who have in their mandibular or maxillary molar teeth necrotic pulp and apical periodontitis.
Exclusion Criteria:
Pregnancy, drug hypersensitivity, cardiac problems, previously performed endodontics treatment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ibrahim E YAYLALI, PhD
Organizational Affiliation
Isparta Military Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Isparta Military Hospital
City
Isparta
ZIP/Postal Code
32010
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Postoperative Pain and PTN and Reciproc
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