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Impact of Sodium Hypochlorite Irrigation at Different Concentrations, With and Without Cryotherapy, on Post Operative Pain in Permanent Mandibular Molar Teeth.

Impact of Sodium Hypochlorite Irrigation at Different Concentrations, With and Without Cryotherapy, on Post Operative Pain in Permanent Mandibular Molar Teeth "Randomized Controlled Trial"

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07771816
Acronym
VPT-RCT-MTA
Enrollment
3
Registered
2026-08-18
Start date
2026-09-01
Completion date
2027-03-01
Last updated
2026-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain, Vital Pulp Therapies

Keywords

cryotherapy, pulpotomy

Brief summary

The aim of the present study will compare the impact of sodium hypochlorite irrigation at different concentrations with and without cryotherapy on post operative pain in permanent mandibular molar teeth. Will cryotherapy combined with sodium hypochlorite irrigation at different concentrations reduce postoperative pain in compared to conventional sodium hypochlorite irrigation during pulpotomy of mandibular molar teeth with symptomatic irreversible pulpitis?

Detailed description

Sodium hypochlorite (NaOCl) is among the most commonly recommended irrigants due to its broad-spectrum antimicrobial effect, ability to dissolve organic tissue, and efficacy in eliminating biofilm(6). However, most of the evidence supporting its use comes from studies in root canal therapy, not vital pulp therapy. NaOCl action in pulpotomy differs significantly because the material comes into direct contact with living, vascularized, sensitive pulp tissue, raising concerns about its potential cytotoxicity

Interventions

PROCEDUREvital pulp therapy

Endodontic procedure: The procedures will be performed under local anesthesia with Lidocaine 2% and adrenaline 1/100,000. Teeth will be isolated with rubber dam. Caries will be completely removed with a sterile diamond stone (size 2) under an operating surgical microscope. The access cavity will be prepared up to the level of pulp chamber floor using sterile round diamond bur size 2 in high-speed hand piece with coolant.Once the pulp has been reached, a sharp sterile spoon excavator should be used to remove the pulp tissue to the level of the radicular pulp. Hemostasis will be achieved by irrigating the prepared cavity with volume 3ml of irrigant for up to 6 minutes over the pulp stump. If hemostasis cannot be achieved after 6 mins, the tooth should undergo pulpectomy and Root Canal treatment as per the clinician's normal practice.

Sponsors

Future University in Egypt
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
15 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

Eligibility criteria: A- Inclusion criteria: * Tooth show positive response to sensitivity test. * Haemostasias can be achieved after total pulpotomy. * The tooth is restorable and free from advanced periodontal disease, cracks and splits. * Patients suffering from Symptomatic irreversible pulpitis in mature mandibular molars teeth only will be involved. * Patients of either gender aged from 15-40. * Patients should be free from any systemic disease that may affect normal healing and predictable outcome. * Patients who will agree to the consent and will commit to follow-up period. * Patients with mature root. * Patients with no internal or external resorption and no periapical lesions. * Soft tissues around the tooth are normal with no swelling or sinus tract. B-

Exclusion criteria

* Patients with immature roots. * Haemostasias after 10 minutes can not be controlled after total pulpotomy * Patients with any systemic disease that may affect normal healing. * Patients with periapical lesions or infections. * Pregnant females. * Patients who could/would not participate in a 6 months follow-up. * Patients with fistula or swelling * Patients with necrotic pulp. * Patients with old age.

Design outcomes

Primary

MeasureTime frameDescription
postoperative painPain will be assessed at baseline (preoperatively) and postoperatively at 6 hours, 12 hours , 24 hours , 72 hours and 1week after treatment.numerical rate scale (NRS), ranging from 0 (no pain) to 10 (worst pain), with higher scores indicating greater pain.

Secondary

MeasureTime frameDescription
overall success3 months, 6 months and 12 months after treatmentOverall treatment success assessed by clinical examination and digital periapical radiographs. Clinical success is defined as absence of spontaneous pain, tenderness to percussion, swelling, sinus tract, or other clinical signs of failure, with no new periapical pathology on radiographic examination.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 19, 2026