Influence of Calcium Hydroxide Chlorhexidine Combination vs. Calcium Hydroxide as an Intra Canal Medicaments in Retreatment Cases

Study Overview
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Brief Summary
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Influence of Calcium hydroxide Chlorhexidine Combination vs. Calcium Hydroxide as an Intra canal Medicamentson Postoperative flare -up following two-Visit Endodontic Retreatment cases

Detailed Description
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Each patient will be anesthetized with the same solution, 40 mg articaine hydrochloride + 0.006 mg/mL epinephrine hydrochloride (Ultracaine DS; Aventis Pharma, Istanbul, Turkey). The standard procedure for each group at the first appointment included rubber dam isolation,removing of previous coronal restorations, and root canal filling materials. The removal of previous root canal fillings will be performed with one of these: Gates Glidden drills, hand files, heated pluggers, and Ni-Ti rotary instruments. After the removal of previous root canal fillings, the working lengths were determined by apex locator and periapical radiographs 1 mm from the apexes. Chemo-mechanical preparation of root canals will be made with the master apical files ranged from #25 to #70 depending on the initial diameter or preparation of the root canals. Irrigation was performed with 2.5% NaOCl after each instrument in all cases. At the end of instrumentation, the final irrigation was made by saline, and the root canals were dried with paper points. In the 1st group the root canals will be medicated with a calcium hydroxide paste for 7 days.(calcium hydroxide injectable paste Metapex , 2.2g paste in a 1 syringe). In the 2nd group the root canals will be medicated with a calcium hydroxidechlorhexidine paste for 7 days. The paste consists of 1.2 g Ca(OH)2 powder per 1 mL 0.2% chlorhexidine in water. The teeth in both groups will be closed with a sterile dry cotton pellet and a minimum of 3 mm of temporary restorative material. In the next appointment, the tooth was reopened, the intra-canal paste will be removed and a patency file (size 08 Flexofile; Dentsply-Maillefer) was pushed through the foramen. Master apical file will be checked again and then master cones will be placed and radiographed. Obturation will be done using lateral compaction technique with AD seal resin sealer using spreader for placement of auxiliary cones.

Official Title
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Influence of Calcium Hydroxide Chlorhexidine Combination vs. Calcium Hydroxide as an Intra Canal Medicamentson Postoperative Flare -up Following Two-Visit Endodontic Retreatment Cases

Conditions
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Postoperative Flare up

Intervention / Treatment
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* Drug: combination of calcium hydroxide and chlorhexidine
* Drug: Calcium Hydroxide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Complicating systemic disease Having severe pain and/or acute apical abscesses Being under 18 years of age Using antibiotics or corticosteroids

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Intracanal medication
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: calcium hydroxide and chlorhexidine<br>Removal of old root canal filling and placing calcium hydroxide and chlorehexidine as intracanal medication | Drug: combination of calcium hydroxide and chlorhexidine<br>* placement of calcium hydroxide and chlorhexidine as intracanal medicament after removal of old filling and mechanical preparation of root canal<br>|
| Active Comparator: calcium hydroxide<br>Removal of old root canal filling and placing calcium hydroxide as intracanal medication | Drug: Calcium Hydroxide<br>* placement of calcium hydroxide as intracanal medicament after removal of old filling and mechanical preparation of root canal<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative flare up (pain and swelling ) will be measured as below after 7 days from first visit postoperative pain | categorical ( 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 |