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

NCT05021809 | Unknown Phase 4 DMC

• 1 other identifier: 360/2021
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 .

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

Outcome Measures

Primary Outcomes (7)

• 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.

Study Arms (3)

Group A

NO INTERVENTION

control group will not receive any intracanal medication

Group B

ACTIVE COMPARATOR

Calcium hydroxide intracanal medication without iodoform (Metapaste )

Drug: Calcium hydroxide intracanal medication application

Group C

ACTIVE COMPARATOR

Calcium hydroxide intracanal medication with iodoform (Metapex)

Drug: Calcium hydroxide intracanal medication application

Interventions

Calcium hydroxide intracanal medication application DRUG

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 B; Group C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Endodontic Clinic At Faculty of Dentistry ,Suez Canal University

Ismailia, 41511, Egypt

RECRUITING

Related Publications (3)

• 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.

  PMID: 14606782 BACKGROUND

• 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.

  PMID: 26806591 BACKGROUND

• 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.

  PMID: 28674723 BACKGROUND

MeSH Terms

Conditions

Dental Pulp Necrosis; Pain, Postoperative

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• marwa es sharaan, PHD

  Suez Canal University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah ad elabyad, bachelors

CONTACT

01008922535; dr.saraelabyad@gmail.com

Nelly mo abdelsalam, PHD

CONTACT

01006623416; nelly_mohamed@dent.suez.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: demonstrator at endodontic department

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: August 26, 2021
• Study Start: July 25, 2021
• Primary Completion: September 1, 2022
• Study Completion: November 1, 2022
• Last Updated: March 22, 2022

Record last verified: 2022-02

Locations

EG (1)