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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03064191
• Other study ID #: CEBD-CU-2017-02-11
• Status: Not yet recruiting
• Phase: N/A
• First received: February 16, 2017
• Last updated: September 9, 2017
• Start date: September 2017
• Est. completion date: April 13, 2018

Study information

• Verified date: September 2017
• Source: Cairo University
• Contact: associate professor
• Phone: 00201226322227
• Email: Geraldine.ahmed[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: April 13, 2018
• Est. primary completion date: March 13, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Dental
• Pain, Postoperative
• Postoperative Pain

Intervention

Combination Product:
• calcium hydroxide chlorhexidine combination
Endodontic intra-canal medicament used for decreasing postoperative signs ans symptoms

Other:
• calcium hydroxide intra-canal medicament
Endodontic intra-canal medicament used for decreasing postoperative signs and symptoms.

Locations

Country	Name	City	State
Egypt	Univeristy of Cairo	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
rayan rabie dahab	Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)