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Acute PulpitisPhase 4NCT06784622

Evaluatıon of the Effect of Pulpotomy Treatments wıth dıfferent bıomaterıals on postoperatıve paın ın Permanent Molars

A Phase 4 study testing Treatment as usual in people with Acute Pulpitis, run by TC Erciyes 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

The aim of this study was to evaluate the results of partial and total pulpotomy with mineral trioxide aggregate (BIO MTA+) and bioceramic sealer (Well Root PT) in terms of pain and vitality in permanent molars with exposed pulp due to caries. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Acute Pulpitis
What is being tested?
Treatment as usual
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jan 2025to 1 Sep 2025
Phase
Phase 4
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 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patients over 18 years of age with no significant health problems.
  • Restorable and periodontally healthy teeth.
  • Teeth with complete root development.
  • Teeth with cold sensitivity and positive response to electric pulp testing.
  • Lower jaw first and second molars with deep/extremely deep caries detected on periapical radiographs.

Who cannot join

  • Patients with systemic diseases or allergic reactions
  • Teeth with open apex
  • Carious teeth that do not respond to pulp sensitivity tests
  • Teeth without signs of bleeding after opening the pulp chamber.
  • Detection of periodontal pockets with a depth greater than 4 mm.
  • Teeth with suspected cracks or crown fractures.
  • Severely damaged teeth
  • Teeth whose bleeding cannot be controlledTeeth with open apex

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Erciyes University Faculty of Dentistry

    Kayseri, Melikgazi, 38039

Other trials in Turkey (Türkiye)

About this study

The aim of this study was to evaluate the results of partial and total pulpotomy with mineral trioxide aggregate (BIO MTA+) and bioceramic sealer (Well Root PT) in terms of pain and vitality in permanent molars with exposed pulp due to caries.

Read the detailed description

Dental caries, an infectious disease, is the most common cause of pulp inflammation. However, the dentin-pulp complex has several physiological defence mechanisms against caries. Preserving pulp viability is the primary goal of biologically based, minimally invasive treatments. Therefore, vital pulp treatments such as partial and total pulpotomies have become increasingly common. Vital pulp therapy is a series of conservative procedures that rely on the natural repair mechanisms of the dentin-pulp complex. This treatment is based on the placement of an appropriate medicamentous and sealed coronal restoration to create a biologically suitable environment for the pulp tissue to heal and protect against bacterial contamination. Root canal treatment is also commonly performed on teeth with deep caries. However, despite the high success rate of 89%, problems such as transpotation, apical zipper formation, instrument breakage during mechanical preparation, failure to reach all canals and inadequate or excessive root filling can lead to treatment failure. Unlike root canal treatment, which involves the removal of all pulp tissue, vital pulp treatment preserves the immune defence and regenerative potential of the pulp and allows root development to continue in immature teeth. Many studies show that the carious pulp of mature teeth is capable of regeneration and that vital pulp therapy is successful in symptomatic and permanent teeth . In recent years, calcium silicate-based cements (MTA, biodentin and bioceramic cements) have become the standard biomaterials for vital pulp treatment due to their biocompatibility and bioactivity . In vivo studies have shown predictable histological results in pulp healing with pulpotomy treatments using MTA . However, as MTA is manufactured in powder/liquid form, it requires a mixing procedure prior to application. As it is difficult to achieve the appropriate consistency of the powder/liquid ratio during the mixing process , changes in the mechanical or chemical properties of the materials may occur. A previous in vitro study found that changes in the powder/liquid ratio affected the radiopacity, setting time, solubility and calcium ion release of MTA. Well-Root PT (Vericom Co., Chuncheon, Korea), a premixed cement, has recently been introduced to the market. Well-Root PT is clinically used in many areas such as pulp capping, perforation and resorption repair, root tip filling and apexification. As Well-Root PT is available in pre-mixed capsule form, it can provide a consistent and adequate consistency and clinical convenience. Well-Root PT can be applied directly into the oral cavity by placing the capsule in a syringe. In addition, Well-Root PT has a shorter setting time than MTA (approximately 5 minutes for initial setting and 45 minutes for final setting) . Despite these advantages, there is no study in the literature on the effect of Well-Root PT on postoperative pain and tooth vitality after pulpotomy in mature permanent molars. Therefore, the aim of this study was to evaluate the effect of Well-Root PT on postoperative pain and tooth vitality in vivo in comparison with MTA (BIO MTA+).

Conditions
Acute Pulpitis
Being tested
Treatment as usual

What participants receive

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

  • Treatment as usualDrug

    Well-Root PT is clinically used in many areas such as pulp capping, perforation and resorption repair, root tip filling and apexification. As Well-Root PT is available in pre-mixed capsule form, it can provide a consistent and adequate consistency and clinical convenience. Well-Root PT can be applied directly into the oral cavity by placing the capsule in a syringe. In addition, Well-Root PT has a shorter setting time than MTA.Despite these advantages, there is no study in the literature on the effect of Well-Root PT on postoperative pain and tooth vitality after pulpotomy in mature permanent molars

Study groups in NCT06784622
Study groupRoleWhat they receive
BİO MTA+ (CERKAMED, Poland) groupExperimentalPartial pulpotomy will be performed using bio mta+ (CERKAMED, Poland)
Well-Root PT (Vericom Co., Chuncheon, Kore) groupExperimentalPartial pulpotomy will be performed using Well-Root PT

What is being measured

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

  1. assessment of postoperative pain with questionnaires

    Visual Analogue Scala (VAS) will be used . 0: no pain 100: Worst pain

    Measured: 12 month

Timeline

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

  1. First posted20 Jan 2025
  2. Study start1 Jan 2025
  3. Primary completion1 Sep 2025
  4. Study completion1 Sep 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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06784622
Sponsor's protocol ID
01
Status last verified
Jan 2026
First submitted
14 Jan 2025
Last updated
11 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Treatment as usual in people with Acute Pulpitis, run by TC Erciyes 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 5 inclusion and 8 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 11 Sep 2026. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

assessment of postoperative pain with questionnaires (time frame: 12 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 11 Sep 2026.

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