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

NCT ID: NCT03209115

Last Updated: 2017-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-08

Study Completion Date

2018-07-08

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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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.

Conditions

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Postoperative Flare up

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Intracanal medication
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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calcium hydroxide and chlorhexidine

Removal of old root canal filling and placing calcium hydroxide and chlorehexidine as intracanal medication

Group Type ACTIVE_COMPARATOR

combination of calcium hydroxide and chlorhexidine

Intervention Type DRUG

placement of calcium hydroxide and chlorhexidine as intracanal medicament after removal of old filling and mechanical preparation of root canal

calcium hydroxide

Removal of old root canal filling and placing calcium hydroxide as intracanal medication

Group Type ACTIVE_COMPARATOR

Calcium Hydroxide

Intervention Type DRUG

placement of calcium hydroxide as intracanal medicament after removal of old filling and mechanical preparation of root canal

Interventions

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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

Intervention Type DRUG

Calcium Hydroxide

placement of calcium hydroxide as intracanal medicament after removal of old filling and mechanical preparation of root canal

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Hind Midhat AbdulGader Hussein

principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Geraldine M Ahmed, Assistant professor

Role: STUDY_DIRECTOR

Cairo University

Central Contacts

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Hind Midhat Abdul Gader, bachelor

Role: CONTACT

01146912244 ext. 2009

Hanaa Midhat Abdul Gader, bachelor

Role: CONTACT

01223867011 ext. 2010

Other Identifiers

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Hind

Identifier Type: -

Identifier Source: org_study_id

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