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Root Canal SealersNCT06798467

Evaluation of Post Obturation Pain Associated With Calcium Hydroxide-based Root Canal Sealers and Resin-based Root Canal Sealer: a Single Visit Root Canal Treatment

A study testing Endodontic sealer and post obturation pain in people with Root Canal Sealers and Post Operative Pain, run by Jinnah Sindh Medical University at 1 site in Pakistan.

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

The objective of this study is to evaluate the post obturation pain associated with calcium hydroxide-based root canal sealer and resin-based root canal sealer after single visit root canal treatment following endodontic treatment by means of Visual Analog Scale. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Endodontic sealer and post obturation pain
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 sitePakistan
Study dates
1 Oct 2024to 30 Mar 2025
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • • Patients presenting with signs and symptoms of irreversible pulpitis in maxillary or mandibular teeth
  • ≥18 years of age.

Who cannot join

  • • Patients with any systemic diseases
  • Retreatment cases
  • Teeth with calcified canals.
  • Medically compromised patient (with immunosuppressive/ systemic diseases, patient on medication)
  • Patients on analgesics or sedative medication prior to root canal therapy.
  • Patients in whom single visit endodontic treatment will not be possible

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Sindh Institute of Oral Health Sciences Jinnah Sindh Medical University Karachi

    Karcahi, Sindh, 75510

Other trials in Pakistan

About this study

Official title: An in Vivo "Evaluation of Post Obturation Pain Associated With Calcium Hydroxide-based Root Canal Sealers and Resin-based Root Canal Sealer: a Single Visit Root Canal Treatment

The objective of this study is to evaluate the post obturation pain associated with calcium hydroxide-based root canal sealer and resin-based root canal sealer after single visit root canal treatment following endodontic treatment by means of Visual Analog Scale.

Methods: This study was designed as single blind, randomized control trial. Sixty patients with irreversible pulpitis requiring endodontic canal treatment were recruited by probability random sampling into two groups based on root canal sealer used during endodontic treatment: calcium hydroxide-based root canal sealer and resin-based root canal sealer . The post-operative pain of patients was recorded via a telephone call at 6 hours, 24 hours, and at 48hours on the visual analogue scale (VAS).

Read the detailed description

Modern endodontics offers advancements in technologies, procedures and materials. Post-obturation pain is defined as pain of any degree that occurs after initiation of root canal treatment1 and its occurrence was noted to vary between 3 and 58%.2 3 The causes of postoperative pain is related to post obturation pain and can be classified as mechanical, chemical and/or microbiological injuries to the peri-radicular tissues.Factors identified that contribute to post-operative pain after single- visit root canal treatment consist of the following: age, sex, tooth type or location. Intraoperative factors include the physical properties of endodontic instruments used in the initial treatment, features of irrigation protocol like chemical solutions and concentrations, microbiological stability and resistance, histopathological state of the tissues surrounding the tooth, etc.6 During the obturation phase of root canal therapy, the endodontic sealer makes direct and local contact with the reshaped periapical tissues through the apical foramen and any supplementary lateral canals. By understanding the factors that contribute to postoperative pain, dental practitioners may better choose procedures and supplies that have been shown to reduce the occurrence of this symptom.7 Pain perception is mainly a subjective and variable experience that depends on many psychological and physical factors. The visual analog scale (VAS) is usually used as a measure of pain intensity in clinical researches due to its simplicity. The VAS intensity rating consisted of a 100-mm length line with two end points as no pain and worst pain. 8 An ideal root canal sealer should be capable of creating an effective bond to the GP and root canal walls to prevent microleakage at the interface.9 Biocompatibility and bioactivity are essential properties for root canal sealers, as these materials are in close proximation with the surrounding tissues and affect the repair.10 If the sealers are biocompatible and soluble in tissue fluid, minimal extrusions could be tolerated by the peri-radicular tissues.11 Sealers placed in the root canals interfere with periodontal tissues through the apical foramina, lateral canals, or leaching and can potentially affect the healing process in the periodontium Thus, the local inflammation caused by root canal obturation materials may result in postoperative pain. The intensity of inflammatory reactions depends on a number of different factors, including the composition of the sealer. 12 Therefore, root canal sealers may have a role in the discomfort felt after having a root canal. Pain sensations and flare-ups may be triggered by root canal sealers due to the stimulation of trigeminal nociceptors in vitro and the accompanying immunologic response, as proposed by Ruparel et al13 The un-polymerized residues remain due to formation of oxygen inhibition layer in the mixture of AH Plus sealer, which is responsible for maintaining its toxic effect.14 Sealapex is one of calcium hydroxide based root canal sealer having cytotoxic potential. After setting Sealapex becomes unstable and disintegrates.15 Khatri S1 in his study stated that AH Plus was associated with the highest pain intensity post 12 hours evaluation 5.00±1.124. This signifies the increased toxic effect of AH Plus sealer then Sealapex. AH Plus contains both epoxy resins and amines which have toxic effect. A randomized controlled clinical investigation by Ates et al16 including both vital and non-vital mandibular premolars and molars found a 68% and 59% prevalence of patients experiencing discomfort in teeth filled with AH Plus sealer.

The aim of this in-vivo study is to compare and evaluate the effect of AH Plus and Sealapex sealers on postoperative pain. Given the conflicting findings and lack of data in the endodontic literature on this issue, we decided to investigate the connection between endodontic sealers and postoperative discomfort. The purpose of this randomized clinical trial was to evaluate the effectiveness of two root canal sealer AH Plus and sealapex in reducing postoperative pain and the need for analgesics following root canal treatment.

Being tested
Endodontic sealer, post obturation pain
Keywords
root canal sealers, post operative pain, symptomatic periapical periodontitis, calcium hydroxide sealer, resin-based root canal sealer, visual analogue scale
Medical subject headings
Pain, Postoperative

What participants receive

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

  • Endodontic sealerOther

    endodontic sealer is a material used in root canal therapy to fill the microscopic spaces between the root canal filling material (typically gutta-percha) and the walls of the root canal. Its primary function is to create a tight seal that prevents the ingress of bacteria and fluids into the root canal system, helping to prevent reinfection and promoting the healing of periapical tissues. Endodontic sealers also help to ensure that the root canal filling reaches all parts of the canal, especially in complex or irregularly shaped anatomies.

  • post obturation painOther

    Unpleasant sensation of any degree of pain after root canal treatment.

Study groups in NCT06798467
Study groupRoleWhat they receive
post obturation painActive comparatorUnpleasant sensation of any degree of pain after root canal treatment.
Receives: Other: Endodontic sealer
endodontic sealerActive comparatorendodontic sealer is a material used in root canal therapy to fill the microscopic spaces between the root canal filling material (typically gutta-percha) and the walls of the root canal. Its primary function is to create a tight seal that prevents the ingress of bacteria and fluids into the root canal system, helping to prevent reinfection and promoting the healing of periapical tissues. Endodontic sealers also help to ensure that the root canal filling reaches all parts of the canal, especially in complex or irregularly shaped anatomies.
Receives: Other: post obturation pain

What is being measured

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

  1. Evaluation of post obturation pain associated with calcium hydroxide-based root canal sealers and resin-based root canal sealer: a single visit root canal treatment.

    Introduction: Modern endodontics offers advancements in technologies, procedures and materials. Post-obturation pain is defined as pain of any degree that occurs after initiation of root canal treatment and its occurrence was noted to vary between 3 and 58%. The objective is to evaluate the post obturation pain associated with calcium hydroxide-based root canal sealer and resin-based root canal sealer after single visit root canal treatment following endodontic treatment by means of Visual Analog Scale.

    Methods: This study was designed as single blind, randomized control trial .Sixty patients with irreversible pulpitis requiring endodontic canal treatment were recruited by probability random sampling into two groups based on irrigation protocols used during endodontic treatment: calcium hydroxide-based rootand resin-based root canal sealer . The post-operative pain of patients was recorded via a telephone call at 6 hours, 24 hours, and at 48 hours on the visual analogue scale (VAS).

    Measured: 6 hours, 24 hours and 48 hours

Timeline

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

  1. First posted29 Jan 2025
  2. Study start1 Oct 2024
  3. Primary completion30 Mar 2025
  4. Study completion30 Mar 2025

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
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06798467
Sponsor's protocol ID
JSMU/IRB/2024/971
Status last verified
Jan 2025
First submitted
15 Jan 2025
Last updated
30 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Khatri S, Parvez S, Agarwal MK, Goyal D, Binawra KK, Jain A, et al. Comparative Evaluation of Effect of Resinbased, Calcium Hydroxide-Based and Bioceramic-Based Root Canal Sealers on Postoperative Pain. List of Articles Pages No.2022;11(1) :54-61

Questions about this trial

What is this clinical trial studying?

A study testing Endodontic sealer and post obturation pain in people with Root Canal Sealers and Post Operative Pain, run by Jinnah Sindh Medical University at 1 site in Pakistan.

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 2 inclusion and 6 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 30 Apr 2025. 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 Pakistan. 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?

Evaluation of post obturation pain associated with calcium hydroxide-based root canal sealers and resin-based root canal sealer: a single visit root canal treatment. (time frame: 6 hours, 24 hours and 48 hours). 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 NCT06798467, which also lists 1 linked publication.

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 30 Apr 2025.

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