Protocol summary
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Study aim
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Assessment and comparison of pain relief effect of three intracanal medicament after cleaning and shaping of tooth root canal.
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Design
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Three blinded randomized trial (randomized by random number table) which will conduct to compare pain relieving effect of three root canal medicaments.
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Settings and conduct
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Patients referring to office of the conductor dentist of the study are the target group. Patient, dentist and statistical analyzer will be blinded and drugs will be prepared and given to the dentist by the dental assistant
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Participants/Inclusion and exclusion criteria
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inclusion criteria: without any systemic diseases, molar or premolar tooth with necrotic pulp, permanent and closed apex tooth, tooth shouldn't have any kind of resorption and patient should not use any NSAIDS in last three hours before treatment.
exclusion criteria: patient won't come for the following treatment appointment, patient doesn't prefer to collaborate and don't complete the pain in the charts by the patient.
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Intervention groups
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this study includes three case groups: treatment will done by mixture of "calcium hydroxide and %0/9 normal saline", "calcium hydroxide and %2 Chlorhexidine" and "calcium hydroxide and dexamethasone (8mg/2cc)". after cleaning and shaping one of these mentioned medicament will apply in root canal for comparison of their pain relieving effect.
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Main outcome variables
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inter appointments pain.
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180521039766N1
Registration date:
2018-06-25, 1397/04/04
Registration timing:
registered_while_recruiting
Last update:
2023-01-29, 1401/11/09
Update count:
1
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Registration date
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2018-06-25, 1397/04/04
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-06-22, 1397/04/01
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Expected recruitment end date
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2018-09-23, 1397/07/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Study of the Efficacy of Intracanal Medicaments on Tooth Root Canal Treatment Pain Management
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Public title
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Intracanal Medicaments and Root Canal Treatment Pain
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
without any systemic diseases
molar or premolar tooth with necrotic pulp
permanent and closed apex tooth
tooth shouldn't have any kind of resorption
patient should not use any NSAIDS in last three hours before treatment
Exclusion criteria:
patient won't come for the following treatment appointment
patient doesn't prefer to collaborate
don't complete the pain in the charts by the patient
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Age
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No age limit
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
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Sample size
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Target sample size:
90
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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patient will be select by random number table.
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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Patient, dentist and statistical analyzer will be blinded and drugs will be prepared and given to the dentist by the dental assistant.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-06-03, 1397/03/13
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Ethics committee reference number
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IR.AJAUMS.REC.1397.005
Health conditions studied
1
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Description of health condition studied
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inter appointments pain after cleaning and shaping of root canal
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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inter appointments pain after cleaning and shaping of tooth root canal
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Timepoint
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4 hours after treatment, the first day, the second day, the third day and the fourth day.
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Method of measurement
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Visual Analog Scale
Intervention groups
1
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Description
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Intervention group: treated by mixture of calcium hydroxide and %0/9 normal saline.
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Category
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Treatment - Drugs
2
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Description
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Intervention group: treated by mixture of calcium hydroxide and %2 Chlorhexidine.
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Category
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Treatment - Drugs
3
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Description
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Intervention group: treated by mixture of calcium hydroxide and dexamethasone (8mg/2cc).
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Artesh University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
Trial results
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Please tick if results have been published
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Yes
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Summary result posting date
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2023-01-29, 1401/11/09
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Table of baseline comparison
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Participant flow diagram
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Table of variable outcomes' results
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Table of adverse events
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First publication date
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2019-01-20, 1397/10/30
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Abstract of published paper
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Abstract
Introduction: After treating the tooth root canal, pain is one of the problems that many patients are facing. In order to reduce pain, and regarding the advice of treating necrotic teeth during several sessions, intra-canal medicaments can be used between sessions. The purpose of this study is to compare pain relieving effect of calcium hydroxide combined with three solutions of normal saline, chlorhexidine 2% and dexamethasone. Materials and methods: This triple blind randomized clinical trial was performed on 90 necrotic molars and premolars. The patients were classified in three medicaments' groups including mixture of calcium hydroxide and normal saline (G1), chlorhexidine 2% (G2) or dexamethasone (G3) that were placed in the canal during the first treatment session. The patients were provided with a Heft-Parker Visual Analog Scale form to record their pain in different intervals of 4, 24, 48, 72 and 96 h after cleaning and shaping the root canal. Data analysis was carried out using the Chi-Square, one-way ANOVA and Repeated Measure tests. Results: No significant difference was observed in the mean pain of the groups after 4 h (P>0.05). However, a significant difference was found between G1 and G3 in the mean pain from day 1 to 72 h after treatment. The mean pain was less in dexamethasone (G3) group (P<0.05), but the difference was not statistically significant at 96 h after treatment (P>0.05). No significant difference was found between "G2-G1" and "G2-G3" groups at different time intervals (P>0.05). Conclusion: The mixture of calcium hydroxide and dexamethasone compared to calcium hydroxide and normal saline in short and medium time had a significant effect on reducing pain after cleaning and shaping the root canal. It seems that the mixture of calcium hydroxide and dexamethasone can be considered as an effective medicament on reducing pain during root canal treatment sessions.