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Irriversible PulpitisPO-PainNCT07608939

Postoperative Pain After Root Canal Treatment Using Different Root Canal Sealers

A study testing AH Plus Root Canal Sealer, ProRoot Bio Sealer and BC Sealer ion+ Sealer in people with Irriversible Pulpitis, run by European University of Lefke at 1 site in Cyprus.

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Trial summary

This prospective randomized clinical trial aims to compare the effects of three different root canal sealers-AH Plus, ProRoot Bio Sealer, and BC Sealer ion+-on postoperative pain following root canal treatment in patients diagnosed with asymptomatic irreversible pulpitis. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Irriversible Pulpitis
What is being tested?
AH Plus Root Canal Sealer, ProRoot Bio Sealer and BC Sealer ion+ Sealer
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
135 participants
Where
1 siteCyprus
Study dates
16 May 2026to 31 Dec 2026
Phase
Interventional

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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Asymptomatic teeth showing delayed positive responses to thermal testing (EndoIce; Coltene/Whaledent Inc.) and electric pulp testing (Parkell)
  • Teeth with extensive pulp exposure during caries excavation
  • Inflamed pulp tissue in which bleeding cannot be controlled within 5 minutes
  • Periodontally healthy, mature mandibular first or second molars Exclusion Criteria
  • Patients presenting with the following conditions will be excluded from the study:
  • Diabetes mellitus, immunocompromised conditions, or pregnancy
Show all 14Show fewer
  • Use of antibiotics within the last month or requirement for antibiotic prophylaxis
  • Use of analgesics within 7 days prior to treatment
  • Allergy to any material used during root canal treatment
  • Teeth suitable for vital pulp therapy in which bleeding can be controlled within 5 minutes
  • Non-vital or symptomatic teeth
  • Presence of radiographically detectable periapical lesions
  • Teeth requiring post-core restorations or prosthetic support
  • Calcified root canals, root resorption, or immature teeth

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Cyprus1 site, 1 recruiting
  • European University of Lefke

    Lefka

    Mohamad Abduljalil, DDS, PhD, +905338600604, mohamad_abduljalil@hotmail.com

    Recruiting

Other trials in Cyprus

About this study

Official title: Comparison of Postoperative Pain Following Root Canal Treatment Using AH Plus, ProRoot Bio Sealer, and BC Sealer Ion+: A Randomized Clinical Trial

This prospective randomized clinical trial aims to compare the effects of three different root canal sealers-AH Plus, ProRoot Bio Sealer, and BC Sealer ion+-on postoperative pain following root canal treatment in patients diagnosed with asymptomatic irreversible pulpitis.

Postoperative pain is a common complication after endodontic treatment and may be influenced by microbial, chemical, and mechanical factors. The type and composition of root canal sealer may also affect tissue response, inflammation, and pain levels. AH Plus is an epoxy resin-based sealer known for its sealing ability and dimensional stability, whereas ProRoot Bio Sealer and BC Sealer ion+ are bioceramic sealers with enhanced bioactive properties. BC Sealer ion+ additionally releases both calcium and magnesium ions, which may improve tissue healing and biological performance.

Read more

The study will include patients aged 18-60 years presenting with asymptomatic irreversible pulpitis in mandibular first or second molars. Following ethical approval from the European University of Lefke Ethics Committee, approximately 135 patients will be enrolled and randomly assigned into three equal groups according to the root canal sealer used. Sample size calculation was performed using G*Power software with 80% statistical power and a significance level of 0.05.

All treatments will be completed in a single visit by the same experienced clinician under standardized clinical conditions. Root canal preparation will be performed using the ProTaper Universal rotary system with standardized irrigation protocols including sodium hypochlorite, EDTA, chlorhexidine, and sonic activation. Obturation will be completed using a modified single-cone technique with the assigned root canal sealer.

Patients and the outcome assessor will be blinded to group allocation. Postoperative pain will be assessed using the Numeric Rating Scale (NRS) at 6, 12, 24, 48, and 72 hours, as well as on day 7 after treatment. Secondary outcomes will include analgesic consumption and flare-up incidence. All patients will be prescribed ibuprofen to use only if necessary, and analgesic intake will be recorded.

The primary objective of this study is to determine whether different root canal sealers significantly influence postoperative pain levels after root canal treatment. The null hypothesis states that there will be no statistically significant difference among AH Plus, ProRoot Bio Sealer, and BC Sealer ion+ regarding postoperative pain outcomes. Data will be analyzed using appropriate statistical methods, with a significance level set at P < 0.05.

Read the detailed description

Postoperative pain following root canal treatment remains one of the most important factors affecting patient comfort and perceived treatment success in endodontics. The occurrence and intensity of postoperative pain may be influenced by several factors, including instrumentation techniques, irrigation protocols, extrusion of debris or filling materials into periapical tissues, and the physicochemical properties of root canal sealers. Bioceramic sealers have gained increasing popularity because of their bioactivity, biocompatibility, antibacterial properties, and potential to enhance periapical healing. However, limited clinical evidence is available regarding their influence on postoperative pain when compared with conventional epoxy resin-based sealers.

This prospective randomized clinical trial is designed to evaluate and compare postoperative pain levels after root canal treatment performed using three different root canal sealers: AH Plus, ProRoot Bio Sealer, and BC Sealer ion+. The study will include adult patients diagnosed with asymptomatic irreversible pulpitis in mandibular first or second molars requiring primary root canal treatment. All clinical procedures will be performed in a standardized manner by a single experienced clinician to minimize operator-related variability.

Root canal preparation will be completed using the ProTaper Universal rotary instrumentation system under standardized irrigation and disinfection protocols. Canal irrigation will include sodium hypochlorite, EDTA, chlorhexidine, and sonic activation procedures. Obturation will be carried out using a modified single-cone technique with gutta-percha cones corresponding to the final preparation size and the allocated root canal sealer. Randomization will be performed using computer-generated allocation, and allocation concealment will be ensured with sealed opaque envelopes. The study will follow a single-blind design in which participants and outcome assessors remain unaware of group assignment.

AH Plus is an epoxy resin-based sealer widely used because of its dimensional stability, sealing ability, and long-term clinical performance. ProRoot Bio Sealer is a calcium silicate-based bioceramic sealer with enhanced bioactive cement content and a flexible delivery system designed to improve handling and material placement. BC Sealer ion+ is an Akermanite-based premixed bioceramic sealer capable of releasing both calcium and magnesium ions, which may contribute to improved tissue healing, stem cell differentiation, and prolonged bioactivity. Structural differences between conventional calcium silicate materials and Akermanite-based formulations may influence ion release kinetics and tissue responses, potentially affecting postoperative symptoms.

Postoperative pain intensity will be recorded using the Numeric Rating Scale (NRS) at predetermined postoperative intervals. Analgesic intake and flare-up incidence will also be monitored throughout the follow-up period. Statistical analysis will be performed using appropriate parametric or non-parametric tests according to data distribution, with statistical significance established at P < 0.05. The findings of this study may contribute to a better understanding of the clinical performance of contemporary bioceramic sealers and their potential influence on postoperative pain management in endodontic treatment.

Being tested
AH Plus Root Canal Sealer, ProRoot Bio Sealer, BC Sealer ion+ Sealer
Keywords
postoperative-pain, root canal sealer, bioceramic, root canal treatment
Medical subject headings
Pain, Postoperative

What participants receive

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

  • AH Plus Root Canal SealerDevice

    AH Plus is an epoxy resin-based root canal sealer used during obturation with a modified single-cone technique. The material is characterized by high dimensional stability, good sealing ability, low solubility, and adhesion to dentin and gutta-percha. Root canal treatment procedures, instrumentation protocol, irrigation regimen, and obturation technique will be standardized for all participants.

  • ProRoot Bio SealerDevice

    ProRoot Bio Sealer is a calcium silicate-based bioceramic root canal sealer used during obturation with a modified single-cone technique. The material contains bioactive cement components designed to promote hydroxyapatite formation and maintain an alkaline environment. The study will use standardized instrumentation, irrigation, and obturation protocols identical to the other intervention groups.

  • BC Sealer ion+ SealerDevice

    BC Sealer ion+ is an Akermanite-based premixed bioceramic root canal sealer used during obturation with a modified single-cone technique. The material releases calcium and magnesium ions and is designed to enhance bioactivity and tissue healing potential. All other clinical procedures, including instrumentation, irrigation, and restoration protocols, will remain standardized across study groups.

Study groups in NCT07608939
Study groupRoleWhat they receive
AH Plus Sealer GroupExperimentalParticipants assigned to this group will undergo standardized single-visit root canal treatment using the ProTaper Universal rotary instrumentation system. Root canal obturation will be performed using gutta-percha cones and AH Plus epoxy resin-based root canal sealer with a modified single-cone obturation technique.
Receives: Device: AH Plus Root Canal Sealer
ProRoot Bio Sealer GroupExperimentalParticipants assigned to this group will undergo standardized single-visit root canal treatment using the ProTaper Universal rotary instrumentation system. Root canal obturation will be performed using gutta-percha cones and ProRoot Bio Sealer calcium silicate-based bioceramic sealer with a modified single-cone obturation technique.
Receives: Device: ProRoot Bio Sealer
BC Sealer ion+ GroupExperimentalParticipants assigned to this group will undergo standardized single-visit root canal treatment using the ProTaper Universal rotary instrumentation system. Root canal obturation will be performed using gutta-percha cones and BC Sealer ion+ Akermanite-based bioceramic root canal sealer with a modified single-cone obturation technique.
Receives: Device: BC Sealer ion+ Sealer

What is being measured

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

  1. Postoperative Pain Intensity

    Postoperative pain intensity following root canal treatment will be evaluated using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (unbearable pain). Pain scores will be recorded by participants at predetermined postoperative intervals.

    Measured: 6, 12, 24, 48, and 72 hours, and 7 days after treatment

Secondary outcomes (1)
  1. Analgesic Consumption

    The number and frequency of analgesic tablets used by participants after treatment will be recorded throughout the follow-up period.

    Measured: From completion of treatment until 7 days postoperatively

Timeline

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

  1. First posted27 May 2026
  2. Study start16 May 2026
  3. Primary completion15 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

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
Model description
Participants will be randomly assigned to one of three parallel groups according to the root canal sealer used during treatment. All participants will undergo standardized single-visit root canal treatment procedures performed by the same clinician under identical clinical conditions. The only variable differing among the groups will be the type of root canal sealer used for obturation: AH Plus sealer ProRoot Bio Sealer BC Sealer ion+ The study will follow a single-blind design in which participants and outcome assessors will remain unaware of group allocation. Postoperative pain levels, analgesic consumption, and flare-up incidence will be compared among the three groups during the follow-up period.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
135 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07608939
Sponsor's protocol ID
BAYEK061.21
Acronym
PO-Pain
Status last verified
Sep 2026
First submitted
20 May 2026
Last updated
11 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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