Influence of Intra Canal Medications on Postoperative Flare-up in Endodontic Re-treatment Cases

Influence of Calcium Hydroxide Chlorhexidine Combination vs. Calcium Hydroxide as an Intra Canal Medicaments on Postoperative Flare -up Following Two-Visits Endodontic Retreatment Cases: Single Blinded Randomized Clinical Trial

Is to evaluate the influence of the calcium hydroxide / chlorhexidine combination and calcium hydroxide alone as an intra-canal medication in postoperative flare-up in two visits endodontic retreatment cases

Study Overview

• Status: Unknown
• Conditions: Postoperative Pain; Pain, Dental
• Intervention / Treatment: Combination product: calcium hydroxide chlorhexidine combination; Other: calcium hydroxide intra-canal medicament

Detailed Description

Problem: patient needs retreatment Intervention: calcium hydroxide chlorhexidine combination as an intra-canal medicament Control: calcium hydroxide alone as an intra-canal medicament Outcome: postoperative flare-up (pain and swelling) Time: after 7 days from 1st visit. population will be examined:

1. Patients' needs retreatment.
2. Patients in good health with no systemic disease (American Society of Anesthesiologists Class II)
3. Age range is between 20 and 50 years.
4. Patients who can understand the categorical tool (points)for measurement
5. Patients able to sign informed consent.

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Univeristy of Cairo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 1. Patients' needs retreatment.
• 2. Patients in good health with no systemic disease (American Society of Anesthesiologists Class II)
• 3. Age range is between 20 and 50 years.
• 4. Patients who can understand the categorical tool (points)for measurement
• 5. Patients able to sign informed consent.

Exclusion Criteria:

• 1) Complicating systemic disease
• 2) Having severe pain and/or acute apical abscesses
• 3) Being under 18 years of age
• 4) Using antibiotics or corticosteroids,
• 5) having multiple teeth that required retreatment to eliminate the possibility of pain referral
• 6) Having root canals that could not be treated well with initial root canal treatment.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: calcium hydroxide chlorhexidine; intervention: calcium hydroxide chlorhexidine combination an intra-canal medication composed of calcium hydroxide powder and chlorhexidine solution as a combination to be administered as intra-canal paste for decreasing postoperative symptoms	Combination product: calcium hydroxide chlorhexidine combination; Endodontic intra-canal medicament used for decreasing postoperative signs ans symptoms; Other Names: intra-canal medicament combination
Active Comparator: calcium hydroxide; intervention: calcium hydroxide an intra-canal medicament composed of calcium hydroxide paste for decreasing postoperative symptoms and signs .	Other: calcium hydroxide intra-canal medicament; Endodontic intra-canal medicament used for decreasing postoperative signs and symptoms.; Other Names: calcium hydroxide, gold standard intra-canal medicament

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
measuring patients postoperative pain and swelling following endodontic re-treatment sessions using Categorical (4 points) unit using questionnaire.	postoperative pain and swelling will be measured by:Categorical (4 points). The incidence of postoperative discomfort was recorded and expressed as numbers and percentages Subjectively into 4 points: no pain; Mild pain: recognizable but not discomforting pain that required no analgesics.; Moderate pain: discomforting but bearable pain(analgesics if used were effective in relieving pain); Severe pain: difficult to bear (analgesics were effective in relieving pain). Patients with severe postoperative pain and/or occurrence of swelling were classified as flare-ups.3 Objectively : percussion test	7 days between the 2 visits ( one week)

Collaborators and Investigators

• Sponsor: rayan rabie dahab
• Collaborators: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2017
• Primary Completion (Anticipated): March 13, 2018
• Study Completion (Anticipated): April 13, 2018

Study Registration Dates

• First Submitted: February 16, 2017
• First Submitted That Met QC Criteria: February 21, 2017
• First Posted (Actual): February 24, 2017

Study Record Updates

• Last Update Posted (Actual): September 12, 2017
• Last Update Submitted That Met QC Criteria: September 9, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: intra-canal medications
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Disinfectants; Calcium; Chlorhexidine; Calcium, Dietary
• Other Study ID Numbers: CEBD-CU-2017-02-11

Plan for Individual participant data (IPD)

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

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