Postoperative Pain After Root Canal Treatment Using Different Root Canal Sealers

NCT07608939 | Not Yet Recruiting

• 1 other identifier: BAYEK061.21
• Study Type: interventional
• Target: 135
• Locations: 0 countries
• Sites: N/A

Brief 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. 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. 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.

Conditions

Irriversible Pulpitis

Keywords

postoperative-pain; root canal sealer; bioceramic; root canal treatment

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (1)

• Analgesic Consumption

  From completion of treatment until 7 days postoperatively

Study Arms (3)

AH Plus Sealer Group

EXPERIMENTAL

Participants 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.

Device: AH Plus Root Canal Sealer

ProRoot Bio Sealer Group

EXPERIMENTAL

Participants 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.

Device: ProRoot Bio Sealer

BC Sealer ion+ Group

EXPERIMENTAL

Participants 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.

Device: BC Sealer ion+ Sealer

Interventions

AH Plus Root Canal Sealer DEVICE

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.

AH Plus Sealer Group

ProRoot Bio Sealer DEVICE

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.

ProRoot Bio Sealer Group

BC Sealer ion+ Sealer DEVICE

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.

BC Sealer ion+ Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Patients presenting with the following conditions will be excluded from the study:
• Diabetes mellitus, immunocompromised conditions, or pregnancy
• 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

Sponsors & Collaborators

• European University of Lefke: lead

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof. Dr.

Model Details: 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.

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: May 27, 2026
• Study Start: May 16, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 29, 2026

Record last verified: 2026-05