Influence of Moment of Restoration in Pain After a Root Canal Treatment
Post-treatment Pain After Cementing an Indirect Restoration at the End of a Root Canal Treatment: Clinical Trial
1 other identifier
interventional
60
1 country
2
Brief Summary
The goal of this randomized clinical trial is to compare immediate placement of an overlay after root canal treatment with delayed placement of the overlay leaving the tooth one week in infra occlusion. The main question it aims to answer are: type of study: clinical trial participant population/health conditions: patients more that 18 years old who need a root canal treatment in posterior teeth with antagonist teeth. question 1: postoperative pain after 6 hours question 2: postoperative pain after 12 hours question 3: postoperative pain after 24 hours question 4: postoperative pain after 48 hours question 4: postoperative pain after 72 hours If there is a comparison group: Researchers will compare immediate overlay placement and delayed (1 week) overlay placement after root canal treatment to see if there is more pain in one group than in the other.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2023
Shorter than P25 for not_applicable
2 active sites
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
November 14, 2023
CompletedFirst Submitted
Initial submission to the registry
November 15, 2023
CompletedFirst Posted
Study publicly available on registry
November 22, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2024
CompletedJanuary 31, 2024
September 1, 2023
5 months
November 15, 2023
January 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
postoperative pain
Pain assessed by the visual analog scale. A 10 cm line with the words "extreme pain" and "no pain" will be used
6, 12, 24, 48, 72 hours
Study Arms (2)
immediate overlay placement
EXPERIMENTALImmediately after root canal treatment an overlay is cemented, and the patient is asked to record the pain after 6, 12, 24, 48 and 72 hours after treatment
delayed overlay placement
ACTIVE COMPARATORAfter root canal treatment the tooth is left in infraoclussion and the patient is asked to record the pain after 6, 12, 24, 48 and 72 hours
Interventions
The root canal completedwill be completed. Then randomly it will be decided if the planned and milled overlay is placed the same day or delayed one week
Eligibility Criteria
You may qualify if:
- Need of a root canal treatment in a posterior tooth
You may not qualify if:
- Preoperative pain requiring pain killers
- Absence of antagonist teeth
- cannot afford and overlay
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Clinica Universitaria d'Odontologia
Sant Cugat Del Vallés, Barcelona, 08195, Spain
Clinica Lluch
Barcelona, 08006, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MARC GARCIA, DDS, PhD
Universitat Internacional de Catalunya
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 15, 2023
First Posted
November 22, 2023
Study Start
November 14, 2023
Primary Completion
March 30, 2024
Study Completion
April 30, 2024
Last Updated
January 31, 2024
Record last verified: 2023-09