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

Study Overview
=================
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.

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

Conditions
-----------------
Pain, Dental, Postoperative Pain

Intervention / Treatment
-----------------
* Combination Product: calcium hydroxide chlorhexidine combination
* Other: calcium hydroxide intra-canal medicament


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: calcium hydroxide chlorhexidine<br>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<br>* Endodontic intra-canal medicament used for decreasing postoperative signs ans symptoms<br>* Other names: intra-canal medicament combination;|
| Active Comparator: calcium hydroxide<br>intervention: calcium hydroxide an intra-canal medicament composed of calcium hydroxide paste for decreasing postoperative symptoms and signs . | Other: calcium hydroxide intra-canal medicament<br>* Endodontic intra-canal medicament used for decreasing postoperative signs and symptoms.<br>* 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intra-canal medications