Assessment of Postoperative Pain After Using Two Formulations of Calcium Hydroxide Intracanal Medication .
Primary Purpose
Necrotic Pulp With Symptomatic Apical Periodontitis
Status
Recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Calcium hydroxide intracanal medication application
Sponsored by
About this trial
This is an interventional treatment trial for Necrotic Pulp With Symptomatic Apical Periodontitis focused on measuring pulp necrosis, symptomatic apical periodontitis, calcium hydroxide intracanal medication, postoperative pain, calcium hydroxide with iodoform, calcium hydroxide without iodoform
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.
Sites / Locations
- Endodontic Clinic At Faculty of Dentistry ,Suez Canal UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
Active Comparator
Arm Label
Group A
Group B
Group C
Arm Description
control group will not receive any intracanal medication
Calcium hydroxide intracanal medication without iodoform (Metapaste )
Calcium hydroxide intracanal medication with iodoform (Metapex)
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05021809
Brief Title
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
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 25, 2021 (Actual)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
November 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Suez Canal University
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Blind allocation will be followed in the study .
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).
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
No Intervention
Arm Description
control group will not receive any intracanal medication
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Calcium hydroxide intracanal medication without iodoform (Metapaste )
Arm Title
Group C
Arm Type
Active Comparator
Arm Description
Calcium hydroxide intracanal medication with iodoform (Metapex)
Intervention Type
Drug
Intervention Name(s)
Calcium hydroxide intracanal medication application
Intervention Description
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 .
Primary Outcome Measure Information:
Title
Measuring the severity of postoperative pain in both groups.
Description
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.
Time Frame
The pain score will be recorded at 4 hours .
Title
Measuring the severity of postoperative pain in both groups.
Description
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.
Time Frame
The pain score will be recorded at 6 hours.
Title
Measuring the severity of postoperative pain in both groups.
Description
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.
Time Frame
The pain score will be recorded at 12 hours .
Title
Measuring the severity of postoperative pain in both groups.
Description
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.
Time Frame
The pain score will be recorded at 24 hours .
Title
Measuring the severity of postoperative pain in both groups.
Description
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.
Time Frame
The pain score will be recorded at 48 hours .
Title
Measuring the severity of postoperative pain in both groups.
Description
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.
Time Frame
The pain score will be recorded at 72 hours .
Title
Measuring the severity of postoperative pain in both groups.
Description
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.
Time Frame
The pain score will be recorded after one week.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah ad elabyad, bachelors
Phone
01008922535
Ext
+2
Email
dr.saraelabyad@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nelly mo abdelsalam, PHD
Phone
01006623416
Ext
+2
Email
nelly_mohamed@dent.suez.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
marwa es sharaan, PHD
Organizational Affiliation
faculty of dentistry suez canal university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Endodontic Clinic At Faculty of Dentistry ,Suez Canal University
City
Ismailia
ZIP/Postal Code
41511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
sarah ad elabyad, bachelors
Phone
01008922535
Ext
+2
Email
dr.saraelabyad@gmail.com
First Name & Middle Initial & Last Name & Degree
nelly mo abdelsalam, phd
Phone
01006623416
Ext
+2
Email
nelly_mohamed@dent.suez.edu.eg
First Name & Middle Initial & Last Name & Degree
sarah ad elabyad, bachelors
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
undecided yet
Citations:
PubMed Identifier
14606782
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.
Results Reference
background
PubMed Identifier
26806591
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.
Results Reference
background
PubMed Identifier
28674723
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.
Results Reference
background
Learn more about this trial
Assessment of Postoperative Pain After Using Two Formulations of Calcium Hydroxide Intracanal Medication .
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