Clinical trial NCT05021809: Assessment of Postoperative Pain After Using Two Formulations of Calcium Hydroxide Intracanal Medication .
Official title: Assessment of Postoperative Pain After Using Two Formulations of Calcium Hydroxide Intracanal Medication : A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Necrotic Pulp With Symptomatic Apical Periodontitis
Keywords: pulp necrosis
symptomatic apical periodontitis
calcium hydroxide intracanal medication
postoperative pain
calcium hydroxide with iodoform
calcium hydroxide without iodoform
Lead sponsor: Suez Canal University
Sponsor class: OTHER
First posted: 2021-08-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Calcium hydroxide is advocated as an intracanal medication for various purposes, including prevention of post-treatment symptoms. Calcium hydroxide has a pain-controlling effect at different times when compared to non-intracanal medication .

Aim:

The aim of the study to compare between postoperative pain after using two formulations of calcium hydroxide intracanal medication with and without iodoform .

Detailed description: The most persuasive factor for a patient to visit a dental health care professional is the existence of odontalgia. Accordingly, the pain after a dental therapy results in demotivation of the patient. Unfortunately, mild to severe pain following a tooth-preserving therapy such as root canal treatment is reported to be experienced by 40% of the patients.

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 .

Eligibility criteria: Inclusion Criteria:

* .single-rooted teeth with pulpal necrosis and symptomatic apical periodontitis with visible radiographic disturbance of periapical lamina dura. The diagnosis of pulp necrosis was confirmed by negative response to cold test, electric pulp tester and clinically by absence of blood upon access cavity .
* 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 open apices
* 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.

Primary outcomes:
measure: Measuring the severity of postoperative pain in both groups.
timeFrame: The pain score will be recorded at 4 hours .
measure: Measuring the severity of postoperative pain in both groups.
timeFrame: The pain score will be recorded at 6 hours.
measure: Measuring the severity of postoperative pain in both groups.
timeFrame: The pain score will be recorded at 12 hours .
measure: Measuring the severity of postoperative pain in both groups.
timeFrame: The pain score will be recorded at 24 hours .
measure: Measuring the severity of postoperative pain in both groups.
timeFrame: The pain score will be recorded at 48 hours .
measure: Measuring the severity of postoperative pain in both groups.
timeFrame: The pain score will be recorded at 72 hours .
measure: Measuring the severity of postoperative pain in both groups.
timeFrame: The pain score will be recorded after one week.
Secondary outcomes:
Other outcomes:
Locations:
city: Ismailia
country: Egypt
facility: Endodontic Clinic At Faculty of Dentistry ,Suez Canal University
Study officials:
affiliation: Suez Canal University
name: marwa es sharaan, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.