Back to results

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

Primary Purpose

Postoperative Pain, Pain, Dental

Status

Unknown status

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

calcium hydroxide chlorhexidine combination

calcium hydroxide intra-canal medicament

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring intra-canal medications

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Univeristy of Cairo

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

calcium hydroxide chlorhexidine

calcium hydroxide

Arm Description

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

intervention: calcium hydroxide an intra-canal medicament composed of calcium hydroxide paste for decreasing postoperative symptoms and signs .

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03064191

First Posted

February 16, 2017

Last Updated

September 9, 2017

Sponsor

rayan rabie dahab

Collaborators

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT03064191

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Unknown status

Study Start Date

September 2017 (Anticipated)

Primary Completion Date

March 13, 2018 (Anticipated)

Study Completion Date

April 13, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

rayan rabie dahab

Collaborators

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pain, Pain, Dental

Keywords

intra-canal medications

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

calcium hydroxide chlorhexidine

Arm Type

Active Comparator

Arm Description

Arm Title

calcium hydroxide

Arm Type

Active Comparator

Arm Description

intervention: calcium hydroxide an intra-canal medicament composed of calcium hydroxide paste for decreasing postoperative symptoms and signs .

Intervention Type

Combination Product

Intervention Name(s)

calcium hydroxide chlorhexidine combination

Other Intervention Name(s)

intra-canal medicament combination

Intervention Description

Endodontic intra-canal medicament used for decreasing postoperative signs ans symptoms

Intervention Type

Other

Intervention Name(s)

calcium hydroxide intra-canal medicament

Other Intervention Name(s)

calcium hydroxide, gold standard intra-canal medicament

Intervention Description

Endodontic intra-canal medicament used for decreasing postoperative signs and symptoms.

Primary Outcome Measure Information:

Title

measuring patients postoperative pain and swelling following endodontic re-treatment sessions using Categorical (4 points) unit using questionnaire.

Description

Time Frame

7 days between the 2 visits ( one week)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

associate professor

Phone

00201226322227

Geraldine.ahmed@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

clinical instructor

Phone

00201202277368

dr.nehalnabil@yahoo.com

Facility Information:

Facility Name

Univeristy of Cairo

City

Cairo

Country

Egypt

Facility Contact:

First Name & Middle Initial & Last Name & Degree

rayan ra dahab, master

Phone

00201068775688

rayanrabiedahab@gmail.com

First Name & Middle Initial & Last Name & Degree

hisham na hassan, master

Phone

00201068778033

dr_hishamnabeel@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs