Postoperative Pain and Quality of Life Following Root Canal Treatment With Two Different Sealers

NCT07884799 | Completed

• 1 other identifier: 25-AKD-201
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

This study compares two different root canal sealers, AH Plus and BioRoot Flow, to determine whether the type of sealer used during root canal treatment affects pain after treatment and oral health-related quality of life. Root canal treatment is performed to treat infection inside a tooth. Some patients may experience pain or discomfort after treatment, which can affect their daily activities and well-being. The study includes adults with asymptomatic apical periodontitis in a permanent tooth with one root and one root canal. Participants are randomly assigned to receive root canal treatment using either AH Plus, a resin-based sealer, or BioRoot Flow, a bioceramic-based sealer. All participants receive treatment in a single visit. Pain after treatment is assessed using a visual analog scale at 6 and 12 hours and on days 1, 2, 3, 5, 7, and 30. Oral health-related quality of life is assessed using the 14-item Oral Health Impact Profile (OHIP-14) questionnaire on day 7. The study also evaluates pain medication use and swelling after treatment. The findings may help clinicians better understand patients' experiences following root canal treatment with these two sealers.

Conditions

Asymptomatic Apical Periodontitis

Outcome Measures

Primary Outcomes (2)

• Postoperative Pain Intensity Assessed Using the Visual Analog Scale (VAS)

  Postoperative pain intensity was assessed using a 100-mm visual analog scale (VAS), ranging from 0 (no pain) to 100 (worst imaginable pain). Participants recorded their pain intensity at eight postoperative time points. Higher scores indicated greater pain intensity. VAS scores were compared between the AH Plus and BioRoot Flow groups.

  6 and 12 hours and 1, 2, 3, 5, 7, and 30 days after root canal treatment

• Oral Health-Related Quality of Life Assessed Using the OHIP-14

  Oral health-related quality of life was assessed using the Turkish version of the 14-item Oral Health Impact Profile (OHIP-14-TR) questionnaire. The questionnaire consists of 14 items across seven domains, with each item scored from 0 (never) to 4 (very often). Total scores range from 0 to 56, with higher scores indicating poorer oral health-related quality of life. OHIP-14 total scores were compared between the AH Plus and BioRoot Flow groups.

  7 days after root canal treatment

Study Arms (2)

AH Plus

ACTIVE COMPARATOR

Participants received single-visit root canal treatment using AH Plus, an epoxy resin-based root canal sealer, with the cold lateral condensation technique.

Device: AH Plus

BioRoot Flow

EXPERIMENTAL

Participants received single-visit root canal treatment using BioRoot Flow, a bioceramic-based root canal sealer, with the cold lateral condensation technique.

Device: BioRoot Flow

Interventions

AH Plus DEVICE

AH Plus, an epoxy resin-based root canal sealer, was used for root canal obturation in the control group. Root canal treatment was completed in a single visit, and obturation was performed using the cold lateral condensation technique with gutta-percha and AH Plus sealer

AH Plus

BioRoot Flow DEVICE

BioRoot Flow, a premixed calcium silicate-based bioceramic root canal sealer, was used for root canal obturation in the experimental group. Root canal treatment was completed in a single visit, and obturation was performed using the cold lateral condensation technique with gutta-percha and BioRoot Flow sealer.

BioRoot Flow

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals without systemic diseases (ASA physical status I or II).
• Individuals with single-rooted, single-canal permanent teeth requiring endodontic treatment.
• Individuals with teeth diagnosed with asymptomatic apical periodontitis (2 ≤ PAI ≤ 4).

You may not qualify if:

• Individuals with immature permanent teeth.
• Individuals with previously root canal-treated teeth.
• Individuals with systemic diseases.
• Individuals with teeth exhibiting internal or external root resorption or a history of dental trauma.
• Individuals who had taken analgesics within 24 hours before treatment.
• Individuals with calcified root canals.
• Individuals with symptomatic teeth.
• Individuals with advanced periodontal disease.
• Pregnant or breastfeeding individuals.

Sponsors & Collaborators

• Karadeniz Technical University: lead

Study Sites (1)

Karadeniz Technical University Faculty of Dentistry

Trabzon, Ortahisar, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants were unaware of which root canal sealer (AH Plus or BioRoot Flow) was used during their treatment. The clinician performing the treatment was aware of the group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSİSTANT PROFESSOR

Model Details: Participants were randomly assigned to one of two parallel groups. Both groups received single-visit root canal treatment using the cold lateral condensation technique. The only difference between the groups was the root canal sealer used: AH Plus (epoxy resin-based) or BioRoot Flow (bioceramic-based).

Study Record Dates

• First Submitted: October 13, 2026
• First Posted: October 21, 2026
• Study Start: April 1, 2026
• Primary Completion: June 1, 2026
• Study Completion: June 1, 2026
• Last Updated: October 21, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)