Assessment of Postoperative Pain After Using Two Formulations of Calcium Hydroxide Intracanal Medication .

Assessment of Postoperative Pain After Using Two Formulations of Calcium Hydroxide Intracanal Medication : A Randomized Clinical Trial.

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 .

Study Overview

• Status: Recruiting
• Conditions: Necrotic Pulp With Symptomatic Apical Periodontitis
• Intervention / Treatment: Drug: Calcium hydroxide intracanal medication application

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 .

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: sarah ad elabyad, bachelors; Phone Number: +2 01008922535; Email: dr.saraelabyad@gmail.com
• Study Contact Backup: Name: nelly mo abdelsalam, phd; Phone Number: +2 01006623416; Email: nelly_mohamed@dent.suez.edu.eg

Study Locations

• Egypt
  • Ismailia, Egypt, 41511
    • Recruiting
    • Endodontic Clinic At Faculty of Dentistry ,Suez Canal University
    • Contact: sarah ad elabyad, bachelors; Phone Number: +2 01008922535; Email: dr.saraelabyad@gmail.com
    • Contact: nelly mo abdelsalam, phd; Phone Number: +2 01006623416; Email: nelly_mohamed@dent.suez.edu.eg
    • Principal Investigator: sarah ad elabyad, bachelors

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Group A; control group will not receive any intracanal medication
Active Comparator: Group B; Calcium hydroxide intracanal medication without iodoform (Metapaste )	Drug: 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 .
Active Comparator: Group C; Calcium hydroxide intracanal medication with iodoform (Metapex)	Drug: 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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measuring the severity of postoperative pain in both groups.	Measuring the severity of postoperative pain in both groups. The patients will be informed to record their pain scores in visual analogue scale (VAS) as used by Habib et al. (1990) .The degree of the pain will have numerical value 0= no pain, 1-3= mild pain, 4-6= moderate pain , 7-9= severe pain . The pain score will be recorded at 4 hours . No medication will be prescribed for the patients . They will be instructed to take only Ibuprofen if they experienced pain and it will be recorded in the chart.	The pain score will be recorded at 4 hours .
Measuring the severity of postoperative pain in both groups.	Measuring the severity of postoperative pain in both groups. The patients will be informed to record their pain scores in visual analogue scale (VAS) as used by Habib et al. (1990) .The degree of the pain will have numerical value 0= no pain, 1-3= mild pain, 4-6= moderate pain , 7-9= severe pain . The pain score will be recorded at 6 hours . No medication will be prescribed for the patients . They will be instructed to take only Ibuprofen if they experienced pain and it will be recorded in the chart.	The pain score will be recorded at 6 hours.
Measuring the severity of postoperative pain in both groups.	Measuring the severity of postoperative pain in both groups. The patients will be informed to record their pain scores in visual analogue scale (VAS) as used by Habib et al. (1990) .The degree of the pain will have numerical value 0= no pain, 1-3= mild pain, 4-6= moderate pain , 7-9= severe pain . The pain score will be recorded at 12 hours . No medication will be prescribed for the patients . They will be instructed to take only Ibuprofen if they experienced pain and it will be recorded in the chart.	The pain score will be recorded at 12 hours .
Measuring the severity of postoperative pain in both groups.	Measuring the severity of postoperative pain in both groups. The patients will be informed to record their pain scores in visual analogue scale (VAS) as used by Habib et al. (1990) .The degree of the pain will have numerical value 0= no pain, 1-3= mild pain, 4-6= moderate pain , 7-9= severe pain . The pain score will be recorded at 24 hours . No medication will be prescribed for the patients . They will be instructed to take only Ibuprofen if they experienced pain and it will be recorded in the chart.	The pain score will be recorded at 24 hours .
Measuring the severity of postoperative pain in both groups.	Measuring the severity of postoperative pain in both groups. The patients will be informed to record their pain scores in visual analogue scale (VAS) as used by Habib et al. (1990) .The degree of the pain will have numerical value 0= no pain, 1-3= mild pain, 4-6= moderate pain , 7-9= severe pain . The pain score will be recorded at 48 hours . No medication will be prescribed for the patients . They will be instructed to take only Ibuprofen if they experienced pain and it will be recorded in the chart.	The pain score will be recorded at 48 hours .
Measuring the severity of postoperative pain in both groups.	Measuring the severity of postoperative pain in both groups. The patients will be informed to record their pain scores in visual analogue scale (VAS) as used by Habib et al. (1990) .The degree of the pain will have numerical value 0= no pain, 1-3= mild pain, 4-6= moderate pain , 7-9= severe pain . The pain score will be recorded at 72 hours . No medication will be prescribed for the patients . They will be instructed to take only Ibuprofen if they experienced pain and it will be recorded in the chart.	The pain score will be recorded at 72 hours .
Measuring the severity of postoperative pain in both groups.	Measuring the severity of postoperative pain in both groups. The patients will be informed to record their pain scores in visual analogue scale (VAS) as used by Habib et al. (1990) .The degree of the pain will have numerical value 0= no pain, 1-3= mild pain, 4-6= moderate pain , 7-9= severe pain . The pain score will be recorded after one week . No medication will be prescribed for the patients . They will be instructed to take only Ibuprofen if they experienced pain and it will be recorded in the chart.	The pain score will be recorded after one week.

Collaborators and Investigators

• Sponsor: Suez Canal University
• Investigators: Principal Investigator: marwa es sharaan, PHD, Faculty of Dentistry Suez Canal University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2021
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): November 1, 2022

Study Registration Dates

• First Submitted: August 16, 2021
• First Submitted That Met QC Criteria: August 21, 2021
• First Posted (Actual): August 26, 2021

Study Record Updates

• Last Update Posted (Actual): March 22, 2022
• Last Update Submitted That Met QC Criteria: March 20, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: postoperative pain; pulp necrosis; symptomatic apical periodontitis; calcium hydroxide intracanal medication; calcium hydroxide with iodoform; calcium hydroxide without iodoform
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Postoperative Complications; Pain; Neurologic Manifestations; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Diseases; Jaw Diseases; Dental Pulp Diseases; Periapical Diseases; Pain, Postoperative; Periodontitis; Periapical Periodontitis; Dental Pulp Necrosis; Physiological Effects of Drugs; Calcium-Regulating Hormones and Agents; Calcium
• Other Study ID Numbers: 360/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: undecided yet

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No