Postoperative Pain Endodontic Retreatment
Primary Purpose
Endodontically Treated Teeth
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Non-surgical endodontic retreatment in single visit
Sponsored by
About this trial
This is an interventional treatment trial for Endodontically Treated Teeth
Eligibility Criteria
Inclusion Criteria:
- Clinically asymptomatic.
- Previously treated teeth in need of retreatment due to leakage and/or improper filling.
- No periapical radiolucency.
- No percussion pains.
- Age 20 - 45.
- Premolar teeth.
- Male & female.
Exclusion Criteria:
- Complicating compromised patient.
- Tenderness to percussion and acute apical abscess.
- Presence of an associated sinus tract.
- Presence of swelling in adjacent soft tissue.
- Teeth with periodontal pathologies or mobility.
- Teeth representing root fracture.
- Pregnant women.
- If analgesics or antibiotics have been administrated by the patient during the past 24 hours.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
group 1 Non-surgical endodontic retreatment in single visit
group 2 Non-surgical endodontic retreatment in Two-visit
Arm Description
Single visit treatments have gained more popularity. Completing the treatment in a single appointment has many advantages including reduction in treatment time and cost, lower risk of micro leakage and recontamination of root canals between appointments
Two-visit endodontic treatment with intra-canal medication was traditionally found to be effective in decreasing the number of flare-up in all retreatment cases and in reducing postoperative pain of previously symptomatic teeth
Outcomes
Primary Outcome Measures
Incidence and intensity of postoperative
Evaluate incidence and intensity of postoperative pain at 6,12,24, 48hours , and one week using numerical visual scale (NRS) after each visit endodontic retreatment
Secondary Outcome Measures
Number of analgesic tablets
Number of analgesic tablets taken by the patient after endodontic retreatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04580862
Brief Title
Postoperative Pain Endodontic Retreatment
Official Title
Incidence Postoperative Pain After Single Visit Versus Two Visit Nonsurgical Endodontic Retreatment
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2020 (Anticipated)
Primary Completion Date
May 2021 (Anticipated)
Study Completion Date
June 2021 (Anticipated)
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
To compare the incidence of post-operative pain after single-visit versus two-visit non-surgical endodontic retreatment.
Detailed Description
Post treatment failure could be treated by two options including orthograde retreatment and apical surgery . In a previous study, orthograde retreatments presented a success rate of 81 % classified as healed and 93 % as no symptoms and fully functional. In a systematic review, it has also been concluded that endodontic surgery offers more favorable initial success but orthograde retreatment yields to a better long-term outcome . Although early results of single-visit treatments are contradictory ; Completing the treatment in a single appointment reduces the treatment time and cost, decreases micro leakage risk and avoids recontamination of root canals between appointments in multiple-visit treatments . Again, reviewing the literature concerning primary treatment showed that, no significant differences were observed in healing of periapical radiolucency between teeth treated in single-visit and those treated in two-visits. Even, after using calcium hydroxide for four weeks . The presence of a positive bacterial culture at the time of filling did not influence the outcome of treatment .
Thorough online search revealed that, few studies are found concerning post- operative pain after single visit retreatment . The present study is designed to compare the effects of single-visit and two-visit root canal treatments on postoperative pain in retreatment cases. The primary outcome measure of this study is proposed to be whether single-visit root canal retreatment influenced the occurrence of postoperative pain as compared to two-visit treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endodontically Treated Teeth
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
62 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group 1 Non-surgical endodontic retreatment in single visit
Arm Type
Experimental
Arm Description
Single visit treatments have gained more popularity. Completing the treatment in a single appointment has many advantages including reduction in treatment time and cost, lower risk of micro leakage and recontamination of root canals between appointments
Arm Title
group 2 Non-surgical endodontic retreatment in Two-visit
Arm Type
Active Comparator
Arm Description
Two-visit endodontic treatment with intra-canal medication was traditionally found to be effective in decreasing the number of flare-up in all retreatment cases and in reducing postoperative pain of previously symptomatic teeth
Intervention Type
Other
Intervention Name(s)
Non-surgical endodontic retreatment in single visit
Other Intervention Name(s)
Non-surgical endodontic retreatment in Two-visit
Intervention Description
Full medical and dental history using a schematic dental chart, will be obtained from all patients treated during this study.
Primary Outcome Measure Information:
Title
Incidence and intensity of postoperative
Description
Evaluate incidence and intensity of postoperative pain at 6,12,24, 48hours , and one week using numerical visual scale (NRS) after each visit endodontic retreatment
Time Frame
At one week after each visit
Secondary Outcome Measure Information:
Title
Number of analgesic tablets
Description
Number of analgesic tablets taken by the patient after endodontic retreatment
Time Frame
baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Clinically asymptomatic.
Previously treated teeth in need of retreatment due to leakage and/or improper filling.
No periapical radiolucency.
No percussion pains.
Age 20 - 45.
Premolar teeth.
Male & female.
Exclusion Criteria:
Complicating compromised patient.
Tenderness to percussion and acute apical abscess.
Presence of an associated sinus tract.
Presence of swelling in adjacent soft tissue.
Teeth with periodontal pathologies or mobility.
Teeth representing root fracture.
Pregnant women.
If analgesics or antibiotics have been administrated by the patient during the past 24 hours.
12. IPD Sharing Statement
Citations:
PubMed Identifier
30054099
Citation
Erdem Hepsenoglu Y, Eyuboglu TF, Ozcan M. Postoperative Pain Intensity after Single- versus Two-visit Nonsurgical Endodontic Retreatment: A Randomized Clinical Trial. J Endod. 2018 Sep;44(9):1339-1346. doi: 10.1016/j.joen.2018.05.017. Epub 2018 Jul 24.
Results Reference
background
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Postoperative Pain Endodontic Retreatment
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