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Endodontically Treated TeethNCT05052814

The Effect of Root-canal Medicaments on Post-operative Pain in Re-treatment Cases

A study testing root canal medicament-calcium hydroxide, root canal medicament-chlorhexidine gel and root canal medicament-calcuim hyroxide &chlorhexidine ge in people with Endodontically Treated Teeth, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This randomized clinical trial compares the effects of intracanal medicaments on the incidence of postoperative pain and flare-up in asymptomatic retreatment cases. Read more about this study

Who is it for?
Ages 20 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Endodontically Treated Teeth
What is being tested?
root canal medicament-calcium hydroxide, root canal medicament-chlorhexidine gel and root canal medicament-calcuim hyroxide &chlorhexidine ge
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteTurkey (Türkiye)
Study dates
23 Mar 2019to 23 Aug 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patients between 20 - 65 years of ages
  • Patients who agree to participate this study
  • Not taking analgesic or antibiotics in the last week
  • Single root and single-canal incisor, canine, premolar teeth that have been treated only once before
  • Teeth with previous endodontic treatment but with insufficient root canal filling on radiographic examination
  • Teeth with periapical lesions and at least 2 years since the previous treatment, although root canal filling seems sufficient
Show all 9Show fewer
  • Periapical radiolucency, teeth with increased or unchanged according to pre-treatment radiography (if available)
  • Teeth are asymptomatic
  • Patients who had good oral hygiene

Who cannot join

  • Pregnant patients and patients in lactation period
  • Having used corticosteroids in the last 6 months
  • Individuals with systemic diseases (endocarditis, immune system diseases,etc.) requiring antibiotic prophylaxis
  • Having received immunosuppressive therapy within the last week
  • Patients who had systemic or allergic sensitivty for the NSAIDs and local ananesthetics
  • The presence of advanced periodontal disease (probing depth > 4 mm)
Show all 12Show fewer
  • The presence of a foreign body in the root canal that prevents entry (broken file, post, etc.)
  • Fracture or crack in the root
  • Teeth that cannot reach the working length due to calcification in the root canal and step formation
  • Teeth that cannot be restored due to excessive loss of material in the coronal structure
  • The presence of more than one adjacent tooth requiring endodontic treatment that may cause reflected pain in the same patient.
  • Teeth that develop any complications ( breakage of endodontic file, perforation, inability to determine the working length with the apex finder) during the removal of the canal filling material.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Hicran Dönmez Özkan

    Merkez, Aydın

Other trials in Turkey (Türkiye)

About this study

Official title: Comparative Evaluation of the Effect of Three Different Root-canal Medicaments on Post-operative Pain in Re-treatment Cases: a Randomized Clinical Trial

This randomized clinical trial compares the effects of intracanal medicaments on the incidence of postoperative pain and flare-up in asymptomatic retreatment cases.

Read the detailed description

Introduction: The aim of this study was to compare the effects of intracanal medicaments on the incidence of postoperative pain and flare-up in asymptomatic retreatment cases.

Methods: One hundred twenty patients with asymptomatic teeth with single-root, single-canal without spontaneous pain or swelling were included in the present study. All patients were previously undergone endodontic treatment but still had periapical radiolucencies. Patients were randomly and equally divided into three groups in which stratified randomization was performed based on the gender and the age of the patients. Intracanal medicaments were placed into the root canals following the removal of previous root canal fillings and re-instrumentation. Calcium hydroxide (Ca(OH)2), chlorhexidine gel (CHX), calcium hydroxide, and chlorhexidine gel combinations were used as intracanal medicaments in the present study. Postoperative pain scores were recorded at 6 and 12 hours and at 1, 2, 3, 4, 5, 6, and 7 days using a visual analog scale (VAS). Sensitivity on percussion, spontaneous pain, swelling, and antibiotic and analgesic requirements of the patients were evaluated during clinical examinations performed postoperatively after 2 and 7 days.

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Being tested
root canal medicament-calcium hydroxide, root canal medicament-chlorhexidine gel, root canal medicament-calcuim hyroxide &chlorhexidine ge
Keywords
retreatment
Medical subject headings
Tooth, Nonvital

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • root canal medicament-calcium hydroxideOther

    Two different root canal medicaments and their combination were placed into the root canals following the removal of previous root canal fillings and re-instrumentation. Afterward, postoperative pain scores were recorded at 6 and 12 hours and at 1, 2, 3, 4, 5, 6, and 7 days using the visual analog scale (VAS). Sensitivity on percussion, spontaneous pain, swelling, and antibiotic and analgesic requirements of the patients were married during clinical examinations performed postoperatively after 2 and 7 days.

  • root canal medicament-chlorhexidine gelOther

    Two different root canal medicaments and their combination were placed into the root canals following the removal of previous root canal fillings and re-instrumentation. Afterward, postoperative pain scores were recorded at 6 and 12 hours and at 1, 2, 3, 4, 5, 6, and 7 days using the visual analog scale (VAS). Sensitivity on percussion, spontaneous pain, swelling, and antibiotic and analgesic requirements of the patients were married during clinical examinations performed postoperatively after 2 and 7 days.

  • root canal medicament-calcuim hyroxide &chlorhexidine geOther

    Two different root canal medicaments and their combination were placed into the root canals following the removal of previous root canal fillings and re-instrumentation. Afterward, postoperative pain scores were recorded at 6 and 12 hours and at 1, 2, 3, 4, 5, 6, and 7 days using the visual analog scale (VAS). Sensitivity on percussion, spontaneous pain, swelling, and antibiotic and analgesic requirements of the patients were married during clinical examinations performed postoperatively after 2 and 7 days.

Study groups in NCT05052814
Study groupRoleWhat they receive
Calcium hydroxide ( Ca(OH)2 )ExperimentalRoot canal medicament which was placed into root canals with a lentulo spiral.
Receives: Other: root canal medicament-calcium hydroxide
Chlorhexidine gel (CHX gel)ExperimentalRoot canal medicament which was placed into root canals with a lentulo spiral.
Receives: Other: root canal medicament-chlorhexidine gel
Calcium hydroxide+ CHX gelExperimentalRoot canal medicament which was placed into root canals with a lentulo spiral.
Receives: Other: root canal medicament-calcuim hyroxide &chlorhexidine ge

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain level comparison after the application of three different root canal medicaments in root canal : VAS (Visual Analogue Scale) at 6th hours.

    Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.

    Measured: 6 th hours

  2. Pain level comparison after the application of three different root canal medicaments in root canal : VAS (Visual Analogue Scale) at 12 th hours.

    Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.

    Measured: 12 th hour

  3. Pain level comparison after the application of three different root canal medicaments in root canal : VAS (Visual Analogue Scale) at 24th hours.

    Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.

    Measured: 24 th hour

  4. Pain level comparison after the application of three different root canal medicaments in root canal : VAS (Visual Analogue Scale) at 2nd days.

    Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.

    Measured: 2nd days

  5. Pain level comparison after the application of three different root canal medicaments in root canal : VAS (Visual Analogue Scale) at 3th days.

    Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.

    Measured: 3th days

  6. Pain level comparison after the application of three different root canal medicaments in root canal : VAS (Visual Analogue Scale) at 4th days.

    Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.

    Measured: 4th days

  7. Pain level comparison after the application of three different root canal medicaments in root canal : VAS (Visual Analogue Scale) at 5th days.

    Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.

    Measured: 5th days

  8. Pain level comparison after the application of three different root canal medicaments in root canal : VAS (Visual Analogue Scale) at 6th days.

    Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.

    Measured: 6th days

  9. Pain level comparison after the application of three different root canal medicaments in root canal : VAS (Visual Analogue Scale) at 7th days.

    Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.

    Measured: 7th days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2021
  2. Study start23 Mar 2019
  3. Primary completion23 Jun 2020
  4. Study completion23 Aug 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05052814
Sponsor's protocol ID
2019/079
Status last verified
Sep 2021
First submitted
8 Sep 2021
Last updated
22 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Erdem Hepsenoglu Y, Eyuboglu TF, Ozcan M. Postoperative Pain Intensity after Single- versus Two-visit Nonsurgical Endodontic Retreatment: A Randomized Clinical Trial. J Endod. 2018 Sep;44(9):1339-1346. doi: 10.1016/j.joen.2018.05.017. Epub 2018 Jul 24.

    PubMed 30054099
  • Gondim E Jr, Setzer FC, Dos Carmo CB, Kim S. Postoperative pain after the application of two different irrigation devices in a prospective randomized clinical trial. J Endod. 2010 Aug;36(8):1295-301. doi: 10.1016/j.joen.2010.04.012. Epub 2010 Jun 19.

    PubMed 20647083

Questions about this trial

What is this clinical trial studying?

A study testing root canal medicament-calcium hydroxide, root canal medicament-chlorhexidine gel and root canal medicament-calcuim hyroxide &chlorhexidine ge in people with Endodontically Treated Teeth, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain level comparison after the application of three different root canal medicaments in root canal : VAS (Visual Analogue Scale) at 6th hours. (time frame: 6 th hours). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05052814, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2021.

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