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

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

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

Study Overview

• Status: Unknown
• Conditions: Postoperative Flare up
• Intervention / Treatment: Drug: combination of calcium hydroxide and chlorhexidine; Drug: Calcium Hydroxide

Detailed Description

1. 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).
2. 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.
3. After the removal of previous root canal fillings, the working lengths were determined by apex locator and periapical radiographs 1 mm from the apexes.

4. 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.

5. 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.

6. 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.

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Early Phase 1

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: calcium hydroxide and chlorhexidine; Removal of old root canal filling and placing calcium hydroxide and chlorehexidine as intracanal medication	Drug: combination of calcium hydroxide and chlorhexidine; placement of calcium hydroxide and chlorhexidine as intracanal medicament after removal of old filling and mechanical preparation of root canal
ACTIVE_COMPARATOR: calcium hydroxide; Removal of old root canal filling and placing calcium hydroxide as intracanal medication	Drug: Calcium Hydroxide; placement of calcium hydroxide as intracanal medicament after removal of old filling and mechanical preparation of root canal

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Geraldine M Ahmed, Assistant professor, Cairo University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 8, 2017
• Primary Completion (ANTICIPATED): September 8, 2017
• Study Completion (ANTICIPATED): July 8, 2018

Study Registration Dates

• First Submitted: July 3, 2017
• First Submitted That Met QC Criteria: July 5, 2017
• First Posted (ACTUAL): July 6, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 6, 2017
• Last Update Submitted That Met QC Criteria: July 5, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: 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: Hind

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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