Postoperative Pain in Single-visit and Multiple-visit Retreatment Cases

NCT ID: NCT03042377

Last Updated: 2018-03-01

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-01

Study Completion Date

2015-08-30

Brief Summary

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The purpose of this randomized clinical trial was to evaluate the incidence of postoperative pain after retreatment using different techniques. Patients whom need retreatment were included. The presence of postoperative pain was assessed after retreatment cases at 1, 6, 12, 24 and 48 hrs.

Detailed Description

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The aim of this clinical study was to evaluate the intensity and duration of postoperative pain after single-visit and multiple-visit root canal retreatment procedures. Patients who have asymptomatic failed endodontically treated teeth were included in this study and routine channel treatment procedure will be applied to these teeth. All of the patients have been recruited from the Istanbul Medipol University Dental Clinics in Istanbul. Eighty asymptomatic teeth were randomly participated into four treatment groups in terms of intracanal medicament applied. The presence of postoperative pain was assessed after 1, 6, 12, 24 and 48 hrs. Postoperative pain was recorded by each patient by using visual analogue pain scale. Before the retreatments, the nature of the study, complications and associated risks were totally explained and written informed consent was obtained from all study participants. The patients were offered local anesthetic before the treatment start. The routine root canal retreatment procedure was applied. Different intracanal medicaments used between sessions in accordance to the manufacturers' instructions. At the end of retreatment, each patient was given an evaluation sheet, explained the treatment procedure and using of visual analogue pain scales, and informed to be returned during the following one week. After one week the teeth was examined according to for pain intensity, percussion \& palpation sensitivity, swelling, analgesic intake and clinical status.

Conditions

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Postoperative Pain Root Canal Infection Endodontic Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The patients were assigned to four medication groups randomly with an equal allocation rate between groups.The patients in the groups had same characteristics.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
The patients were unaware as to which study group they had been allocated.

Study Groups

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Single-Visit Retreatment

Root canal retreatment were performed according to the guidelines for single-visit endodontic treatments.

Group Type ACTIVE_COMPARATOR

Single-Visit Retreatment

Intervention Type OTHER

The teeth in this group were treated according to the guidelines for root canal retreatment in single-session. The filling was removed and cavity was opened. Then root canal filling was removed from the root canals completely using retreatment kit. After irrigation protocol, root canals were obturated with gutta percha and coronal restoration was made using composite and/or fully crown if necessary.

Multiple-Visit-"Calcium Hydroxide"

Root canal retreatment were performed according to the guidelines for multiple-visit endodontic treatments.

Group Type ACTIVE_COMPARATOR

Multiple-Visit-"Calcium Hydroxide"

Intervention Type DRUG

The teeth in this group were treated according to the guidelines for root canal retreatment in multiple-session. The filling was removed and cavity was opened. Then root canal filling was removed from the root canals completely using retreatment kit. After irrigation protocol, root canals were treated with calcium hydroxide and the cavity was filled with temporary restorative material.

Multiple-Visit-"Corticosteroid Paste"

Root canal retreatment were performed according to the guidelines for multiple-visit endodontic treatments.

Group Type ACTIVE_COMPARATOR

Multiple-Visit-"Corticosteroid Paste"

Intervention Type DRUG

The teeth in this group were treated according to the guidelines for root canal retreatment in multiple-session. The filling was removed and cavity was opened. Then root canal filling was removed from the root canals completely using retreatment kit. After irrigation protocol, root canals were treated with corticosteroid \& antibiotic paste and the cavity was filled with temporary restorative material.

Multiple-Visit-"Antibiotic Paste"

Root canal retreatment were performed according to the guidelines for multiple-visit endodontic treatments.

Group Type ACTIVE_COMPARATOR

Multiple-Visit-"Antibiotic Paste"

Intervention Type DRUG

The teeth in this group were treated according to the guidelines for root canal retreatment in multiple-session. The filling was removed and cavity was opened. Then root canal filling was removed from the root canals completely using retreatment kit. After irrigation protocol, root canals were treated with an antibiotic paste and the cavity was filled with temporary restorative material.

Interventions

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Single-Visit Retreatment

The teeth in this group were treated according to the guidelines for root canal retreatment in single-session. The filling was removed and cavity was opened. Then root canal filling was removed from the root canals completely using retreatment kit. After irrigation protocol, root canals were obturated with gutta percha and coronal restoration was made using composite and/or fully crown if necessary.

Intervention Type OTHER

Multiple-Visit-"Calcium Hydroxide"

The teeth in this group were treated according to the guidelines for root canal retreatment in multiple-session. The filling was removed and cavity was opened. Then root canal filling was removed from the root canals completely using retreatment kit. After irrigation protocol, root canals were treated with calcium hydroxide and the cavity was filled with temporary restorative material.

Intervention Type DRUG

Multiple-Visit-"Corticosteroid Paste"

The teeth in this group were treated according to the guidelines for root canal retreatment in multiple-session. The filling was removed and cavity was opened. Then root canal filling was removed from the root canals completely using retreatment kit. After irrigation protocol, root canals were treated with corticosteroid \& antibiotic paste and the cavity was filled with temporary restorative material.

Intervention Type DRUG

Multiple-Visit-"Antibiotic Paste"

The teeth in this group were treated according to the guidelines for root canal retreatment in multiple-session. The filling was removed and cavity was opened. Then root canal filling was removed from the root canals completely using retreatment kit. After irrigation protocol, root canals were treated with an antibiotic paste and the cavity was filled with temporary restorative material.

Intervention Type DRUG

Other Intervention Names

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Single-Visit Root Canal Therapy Calcium Hydroxide Ledermix Paste Triple Antibiotic Paste

Eligibility Criteria

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Inclusion Criteria

Patients who were not included the study who;

* were pregnant or breast feeding during the duration of the study,
* have systemic disease,
* have any pain and/or any facial swelling, abscess,
* were immunocompromised,
* were under 18 yrs. and over 65 yrs. age,
* were taking antibiotics or corticosteroids within previous three months,
* have multiple teeth that required retreatment at the same time period; for eliminating pain referral,
* have root canals that could not be well-treated with orthograde retreatment.

Exclusion Criteria

The patients who forgot to fill out the form and took antibiotics and/or analgesics right after the first appointment of the therapy were excluded from the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Istanbul Medipol University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Keziban Olcay

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Keziban Olcay, DDS. PhD.

Role: PRINCIPAL_INVESTIGATOR

Medipol University

Locations

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Istanbul Medipol University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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156

Identifier Type: -

Identifier Source: org_study_id

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