Assessment of Postoperative Pain After Using Two Formulations of Calcium Hydroxide Intracanal Medication .
NCT ID: NCT05021809
Last Updated: 2022-03-22
Study Results
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Basic Information
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UNKNOWN
PHASE4
60 participants
INTERVENTIONAL
2021-07-25
2022-11-30
Brief Summary
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Aim:
The aim of the study to compare between postoperative pain after using two formulations of calcium hydroxide intracanal medication with and without iodoform .
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Detailed Description
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The majority of patients with symptomatic necrotic teeth had significant postoperative pain and required analgesic medication to manage this pain.
There is a correlation between the intensity of preoperative pain and postoperative pain ,The preoperative pain has a significant influence on postoperative pain.
Several strategies are suggested to manage or prevent post instrumentation pain. One of them is insertion of intracanal medicament.
The interappointment intracanal medicaments are suggested for disinfection of the infected root canal system in multi-visit endodontic treatment. Calcium hydroxide (Ca(OH)2) is considered as a universal intracanal medicament for this purpose.
Additionally, calcium hydroxide is hypothesized to exert a pain-preventing effect indirectly through its antimicrobial and tissue modifying properties .
Significantly high healing rates have been shown with short term use of calcium hydroxide Ca(OH)2 in teeth with apical periodontitis. As a temporary root filling, it has been shown to be an effective antimicrobial agent when applied for a minimum of 1 week.
Calcium hydroxide is a suitable material of choice as an inter-appointment dressing for teeth diagnosed with pulpal necrosis and apical periodontitis.
Calcium hydroxide reduced pain risk than no intracanal medication within the 1-14 days interval as well as triple-antibiotic paste within the first day and was similar to corticosteroid/antibiotics combination.
Iodoform has bacteriostatic property by releasing free iodine.Thereby, iodine eliminates the infection of root canal and periapical tissue by precipitating protein and oxidizes essential enzymes.
The use of calcium hydroxide-iodoform-silicon-oil paste as nonsurgical approach for treatment of periapical lesions showed a high success rate.
As clinicians , one of the most important goals to achieve is reducing the pain of the patient. Up to our knowledge, none of the previous studies investigated the postoperative pain incidence after application of Ca(OH)2 with iodoform as an intracanal medication .
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
* Group A: will not receive any intracanal medication.(control group)
* Group B :will recieve calcium hydroxide intracanal medication without iodoform (Metapaste)
* Group c: will receive calcium hydroxide intracanal medication with iodoform (Metapex).
Study Groups
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Group A
control group will not receive any intracanal medication
No interventions assigned to this group
Group B
Calcium hydroxide intracanal medication without iodoform (Metapaste )
Calcium hydroxide intracanal medication application
The patient will be anaesthized with Articaine hydrochloride 40 mg/ml + 1/100000 Epinephrine bitartrate solution . Then the rubber dam isolation will be conducted, the access will be opened and then cleaning and shaping will be done by using Protaper Next rotary file system and irrigation by sodium hypochlorite 2.5% by side vented needle, EDTA 17%, sodium hypochlorite and the final rinse by saline where the canal will be dried by absorbent paper point. The application of calcium hydroxide intracanal medication will be done according to the manufacturer instructions then temporization by glass ionomer will be applied .
Group C
Calcium hydroxide intracanal medication with iodoform (Metapex)
Calcium hydroxide intracanal medication application
The patient will be anaesthized with Articaine hydrochloride 40 mg/ml + 1/100000 Epinephrine bitartrate solution . Then the rubber dam isolation will be conducted, the access will be opened and then cleaning and shaping will be done by using Protaper Next rotary file system and irrigation by sodium hypochlorite 2.5% by side vented needle, EDTA 17%, sodium hypochlorite and the final rinse by saline where the canal will be dried by absorbent paper point. The application of calcium hydroxide intracanal medication will be done according to the manufacturer instructions then temporization by glass ionomer will be applied .
Interventions
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Calcium hydroxide intracanal medication application
The patient will be anaesthized with Articaine hydrochloride 40 mg/ml + 1/100000 Epinephrine bitartrate solution . Then the rubber dam isolation will be conducted, the access will be opened and then cleaning and shaping will be done by using Protaper Next rotary file system and irrigation by sodium hypochlorite 2.5% by side vented needle, EDTA 17%, sodium hypochlorite and the final rinse by saline where the canal will be dried by absorbent paper point. The application of calcium hydroxide intracanal medication will be done according to the manufacturer instructions then temporization by glass ionomer will be applied .
Eligibility Criteria
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Inclusion Criteria
* Clinical signs of apical periodontitis.
* Teeth with sufficient coronal tooth structure for adequate rubber dam isolation were selected .
* Patients who are over 18 years old .
Exclusion Criteria
* Presence of non-restorable teeth
* Presence of large carious lesions approaching the root.
* Presence of calcification or resorption .
* Patients who had received antibiotics during the last 3 months .
* Teeth with periodontal probing depth \> 4 ml.
* Teeth with previous root canal treatment .
* Teeth with fluctuant facial swelling .
* Pregnant females.
18 Years
ALL
No
Sponsors
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Suez Canal University
OTHER
Responsible Party
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Sarah Alaa El Din Mohamed Hamed El Abyad
demonstrator at endodontic department
Principal Investigators
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marwa es sharaan, PHD
Role: PRINCIPAL_INVESTIGATOR
Suez Canal University
Locations
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Endodontic Clinic At Faculty of Dentistry ,Suez Canal University
Ismailia, , Egypt
Countries
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Central Contacts
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Facility Contacts
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References
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Walton RE, Holton IF Jr, Michelich R. Calcium hydroxide as an intracanal medication: effect on posttreatment pain. J Endod. 2003 Oct;29(10):627-9. doi: 10.1097/00004770-200310000-00003.
Sebastian R, Drum M, Reader A, Nusstein J, Fowler S, Beck M. What is the Effect of No Endodontic Debridement on Postoperative Pain for Symptomatic Teeth with Pulpal Necrosis? J Endod. 2016 Mar;42(3):378-82. doi: 10.1016/j.joen.2015.12.001. Epub 2016 Jan 20.
Madarati AA, Zafar MS, Sammani AMN, Mandorah AO, Bani-Younes HA. Preference and usage of intracanal medications during endodontic treatment. Saudi Med J. 2017 Jul;38(7):755-763. doi: 10.15537/smj.2017.7.18345.
Other Identifiers
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360/2021
Identifier Type: -
Identifier Source: org_study_id
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