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Recruiting Not applicable

Laser-Assisted vs Conventional Total Pulpotomy in Symptomatic Irreversible Pulpitis

NCT07850258 · tracked via the Priya Life Science Turkey tracker
Sponsor
meliksahgunduz
Phase
Not applicable
Started
2026-05-01
Last updated
2026-09-30

Condition(s) studied

Symptomatic Irreversible Pulpitis and Post Operative Pain

Investigational drug(s) / intervention(s)

Conventional Total PulpotomyLaser-Assisted Total Pulpotomy

Conventional Total Pulpotomy: Following removal of the coronal pulp tissue to the level of the canal orifices, initial bleeding control will be performed using a saline-moistened cotton pellet. Hemostasis will then be achieved using a cotton pellet moistened with 2.5% sodium hypochlorite for 2 minutes and repeated if necessary, without exceeding a total application time of 5 minutes. After hemostasis, approximately 2 mm of Biodentine will be placed over the remaining pulp tissue, followed by a glass ionomer base and composite resin restoration.

Laser-Assisted Total Pulpotomy: Following removal of the coronal pulp tissue to the level of the canal orifices, initial bleeding control will be performed using a saline-moistened cotton pellet. Hemostasis will then be achieved using an Er:YAG laser (2940 nm) with an H14 handpiece in SP mode at 20 mJ, 15 Hz, and 0.3 W. The laser will be applied approximately 1 mm from the pulp surface using a sweeping motion for 15 seconds and repeated until complete hemostasis is achieved. After hemostasis, approximately 2 mm of Biodentine will be placed over the remaining pulp tissue, followed by a glass ionomer base and composite resin restoration.

Study summary

his randomized controlled clinical trial will compare laser-assisted total pulpotomy with conventional total pulpotomy in permanent molar teeth diagnosed with symptomatic irreversible pulpitis. Participants will be randomly assigned to one of two treatment groups. In the conventional group, bleeding control will be achieved using sodium hypochlorite, whereas in the laser-assisted group, an Er:YAG laser will be used for hemostasis. In both groups, Biodentine will be placed over the remaining pulp tissue and the tooth will be permanently restored.

Postoperative pain will be assessed using a visual analog scale at 6, 12, and 24 hours and on days 3, 5, and 7 after treatment. Clinical and radiographic outcomes will also be evaluated during follow-up to determine treatment success. The study aims to determine whether laser-assisted total pulpotomy differs from conventional total pulpotomy in terms of postoperative pain and clinical and radiographic outcomes.

Eligibility

Sex
ALL
Min age
12 Years
Max age
40 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Participants aged 12-40 years * Systemically healthy individuals classified as ASA I or ASA II * Permanent molar teeth * Teeth suitable for rubber dam isolation * Diagnosis of symptomatic irreversible pulpitis * Presence of spontaneous pain and/or prolonged response to thermal stimuli * Pain persisting for more than 10 seconds after cold testing * Positive pulp sensibility, supported by electric pulp testing * Normal or minimally altered periapical status with a Periapical Index (PAI) score ≤2 * Final diagnosis confirmed based on combined clinical and radiographic findings Exclusion Criteria: * Presence of sinus tract, abscess, or swelling * Internal or external root resorption * Pathological tooth mobility * Periodontally compromised teeth, including probing depth ≥4 mm and/or -clinical attachment loss * Pulp necrosis or negative pulp sensibility tests * Absence of bleeding after pulp exposure * More than one carious tooth in the same region * Anterior or premolar teeth * Antibiotic use within the previous 1 week * Immunosuppressed patients * Patients unable to provide consent * Patients younger than 12 years

Primary outcome measure(s)

  • Postoperative Pain Intensity — 6, 12, and 24 hours and 3, 5, and 7 days after treatment
    Postoperative pain intensity will be assessed using a 0-10 visual analog scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity. Participants will record their pain scores using the provided follow-up forms.

Trial sites (1)

FacilityCityRegionStatus
Kutahya health sciences university faculty of dentistry Kütahya Merkez Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07850258 on ClinicalTrials.gov ↗ ← All trials in Turkey