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Endodontically Treated TeethNCT05399303

Bioceramics Pain Control

A study testing obturation in people with Endodontically Treated Teeth and Post Operative Pain, run by Misr International University at 1 site in Egypt.

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

Postoperative pain in endodontic retreatment cases presents a challenge to any endodontist. Tricalcium silicate materials as mineral trioxide aggregate (MTA) and bioceramics have shown favorable periapical tissue reactions and healing when used as part of the root canal filling material. Read more about this study

Who is it for?
Ages 20 to 50 yearsHealthy volunteers can take part
What is being tested?
obturation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteEgypt
Study dates
1 Jan 2022to 3 May 2022
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 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • • Mandibular molars with fully formed roots that need retreatment.
  • Age range 20 - 50 years.
  • Teeth having a baseline periapical lesion (PAI score ≥2) in the affected root.

Who cannot join

  • • Patients with separated files that need to be retrieved or bypassed.
  • Pregnant females.
  • Patients suffering from a systemic disease.
  • Teeth with lesions connected to adjacent teeth.
  • Teeth with root fractures or perforations.
  • Teeth with lesions communicating with the alveolar crest.
Show all 9Show fewer
  • Patients with generalized chronic periodontitis or teeth that need periodontal surgery prior to coronal restorations due to marginal deficiency
  • Teeth with damaged or resorbed peri- apex
  • Teeth that were treated with a fiber post and teeth with canal curvature more than 30 degrees.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • MIU

    Cairo, 11341

Other trials in Egypt

About this study

Official title: Pain Evaluation After Single Visit Nonsurgical Retreatment Using a Bio Ceramic Sealer

Postoperative pain in endodontic retreatment cases presents a challenge to any endodontist. Tricalcium silicate materials as mineral trioxide aggregate (MTA) and bioceramics have shown favorable periapical tissue reactions and healing when used as part of the root canal filling material. This study was conducted to compare the difference in the postoperative pain when resin cements are used versus bioceramic cements in the obturation of root canals.

Read the detailed description

The Faculty of Dentistry Ain Shams University's Research Ethics Committee reviewed the current proposal for ethical approval. One hundred patients with permanent molar teeth requiring endodontic non-surgical retreatment were treated in this study. Teeth with fractured instruments were excluded. Patient ages ranged from twenty to fifty years, both men and women were treated in the current study. Infants, children, people unable to take decisions, university students, orphans, mentally or physically disabled patients were excluded from the current study.

Preoperative assessment of the degree of the patient's pain was done using the visual analog scale. Fifty teeth were obturated with gutta percha using the epoxy resin-based sealer (AH Plus) as the control group, and in the other fifty bioceramic based cement (Endosequence) was used. All teeth were prepared by the protaper next rotary files (Dentsply Sirona) under copious irrigation with 30ml of 2.6 % sodium hypochlorite throughout the procedure. Ethylamine diamine tetracetic acid (EDTA) 17% was used to remove the smear layer before the obturation commenced. Obturation was done using the cold lateral compaction technique in the resin group and single cone technique in the bioceramic group. Postoperative pain assessment was done for each patient after six hours, twenty-four hours, four days and one week.

Being tested
obturation
Keywords
bio-ceramic postoperative pain sealer
Medical subject headings
Tooth, Nonvital, Pain, Postoperative

What participants receive

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

  • obturationProcedure or surgery

    obturation using different types of sealers

Study groups in NCT05399303
Study groupRoleWhat they receive
bioceramic sealer obturationExperimentalNot described
Receives: Procedure: obturation
resin sealerExperimentalNot described
Receives: Procedure: obturation

What is being measured

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

  1. Visual analogue scale (VAS)

    Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."

    Measured: one week

Timeline

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

  1. First posted1 Jun 2022
  2. Study start1 Jan 2022
  3. Primary completion15 Mar 2022
  4. Study completion3 May 2022

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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05399303
Sponsor's protocol ID
END 10 231
Status last verified
Jun 2022
First submitted
26 May 2022
Last updated
3 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data other than personal data will be shared

Publications

  • Yoldas O, Topuz A, Isci AS, Oztunc H. Postoperative pain after endodontic retreatment: single- versus two-visit treatment. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2004 Oct;98(4):483-7. doi: 10.1016/j.tripleo.2004.03.009.

    PubMed 15472665

  • Comparin D, Moreira EJL, Souza EM, De-Deus G, Arias A, Silva EJNL. Postoperative Pain after Endodontic Retreatment Using Rotary or Reciprocating Instruments: A Randomized Clinical Trial. J Endod. 2017 Jul;43(7):1084-1088. doi: 10.1016/j.joen.2017.02.010. Epub 2017 May 3.

    PubMed 28477995

  • Seltzer S, Naidorf IJ. Flare-ups in endodontics: I. Etiological factors. 1985. J Endod. 2004 Jul;30(7):476-81; discussion 475. doi: 10.1097/00004770-200407000-00005.

    PubMed 15220641

  • Trope M. Flare-up rate of single-visit endodontics. Int Endod J. 1991 Jan;24(1):24-6. doi: 10.1111/j.1365-2591.1991.tb00866.x.

    PubMed 1917085

  • Mattscheck DJ, Law AS, Noblett WC. Retreatment versus initial root canal treatment: factors affecting posttreatment pain. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2001 Sep;92(3):321-4. doi: 10.1067/moe.2001.115135.

    PubMed 11552152

  • Atav Ates A, Dumani A, Yoldas O, Unal I. Post-obturation pain following the use of carrier-based system with AH Plus or iRoot SP sealers: a randomized controlled clinical trial. Clin Oral Investig. 2019 Jul;23(7):3053-3061. doi: 10.1007/s00784-018-2721-6. Epub 2018 Nov 5.

    PubMed 30397735

  • Graunaite I, Skucaite N, Lodiene G, Agentiene I, Machiulskiene V. Effect of Resin-based and Bioceramic Root Canal Sealers on Postoperative Pain: A Split-mouth Randomized Controlled Trial. J Endod. 2018 May;44(5):689-693. doi: 10.1016/j.joen.2018.02.010. Epub 2018 Mar 20.

    PubMed 29571915

  • Drumond JPSC, Maeda W, Nascimento WM, Campos DL, Prado MC, de-Jesus-Soares A, Frozoni M. Comparison of Postobturation Pain Experience after Apical Extrusion of Calcium Silicate- and Resin-Based Root Canal Sealers. J Endod. 2021 Aug;47(8):1278-1284. doi: 10.1016/j.joen.2021.05.008. Epub 2021 May 29.

    PubMed 34058249

  • Materials used for root canal obturation: technical, biological and clinical testingORSTAVIK DEndodontic Topics (2005) 12(1)

  • DiRenzo A, Gresla T, Johnson BR, Rogers M, Tucker D, BeGole EA. Postoperative pain after 1- and 2-visit root canal therapy. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2002 May;93(5):605-10. doi: 10.1067/moe.2002.121900.

    PubMed 12075212

  • Toia CC, Khoury RD, Corazza BJM, Orozco EIF, Valera MC. Effectiveness of 1-Visit and 2-Visit Endodontic Retreatment of Teeth with Persistent/Secondary Endodontic Infection: A Randomized Clinical Trial with 18 Months of Follow-up. J Endod. 2022 Jan;48(1):4-14. doi: 10.1016/j.joen.2021.09.004. Epub 2021 Sep 20.

    PubMed 34555421

Questions about this trial

What is this clinical trial studying?

A study testing obturation in people with Endodontically Treated Teeth and Post Operative Pain, run by Misr International University at 1 site in Egypt.

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 3 inclusion and 9 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 3 Jun 2022. 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 Egypt. 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?

Visual analogue scale (VAS) (time frame: one week). 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 NCT05399303, which also lists 11 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 3 Jun 2022.

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