Effect of cold saline solution on the outcome of pulpotomy in cariously exposed and painful permanent mandibular molar teeth

Effect of cryotherapy on the treatment outcome of full pulpotomy performed on mature permanent mandibular molar teeth with symptomatic irreversible pulpitis-a randomized clinical trial.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/06/034350

Enrollment

Registered

2021-06-23

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: K040- Pulpitis

Interventions

Intervention1: Full pulpotomy: Full pulpotomy with 2.5 degree normal saline cryotherapy as hemostatic agent Control Intervention1: Full pulpotomy: Full pulpotomy with 2.5% NaOCl as hemostatic agent

Eligibility

Inclusion criteria

Inclusion criteria: 1. Healthy patients of either gender between 15-35 years of age with mature mandibular 1st & 2nd molar teeth with established clinical diagnosis of symptomatic irreversible pulpitis without periapical rarefaction. 2. Positive response to cold test. 3. Teeth with restorable carious lesion

Exclusion criteria

Exclusion criteria: 1. Teeth with cracks, cusp fractures, sub gingival caries and poor periodontal health 2. Patients with systemic conditions which could compromise the healing. 3. Patients not willing to participate in the study. 4.Hemostasis after pulpotomy cannot be achieved within 10 minutes 5. Clinical diagnosis changes to pulp necrosis

Design outcomes

Primary

Measure	Time frame
SUCCESS â?¢Patient is asymptomatic â?¢Absence of swelling,sinus tract â?¢Negative response to palpation and percussion test â?¢Normal periradicular architecture â?¢Absence of root resorption â?¢Absence of pulp canal obliteration. FAILURES Patient symptomatic â?¢Presence of swelling, sinus tract â?¢Positive response to palpation and percussion test â?¢Widening of periodontal ligament space â?¢Presence of apical or furcal radiolucency â?¢Presence of pulp canal obliterations Timepoint: 6 months and 1 year	—

Measure

Time frame

SUCCESS â?¢Patient is asymptomatic â?¢Absence of swelling,sinus tract â?¢Negative response to palpation and percussion test â?¢Normal periradicular architecture â?¢Absence of root resorption â?¢Absence of pulp canal obliteration. FAILURES Patient symptomatic â?¢Presence of swelling, sinus tract â?¢Positive response to palpation and percussion test â?¢Widening of periodontal ligament space â?¢Presence of apical or furcal radiolucency â?¢Presence of pulp canal obliterations Timepoint: 6 months and 1 year

—

Secondary

Measure	Time frame
â?¢Absence of root resorption â?¢Absence of pulp canal obliteration. Timepoint: 6 months and 1 year	—

Countries

India

Contacts

Public ContactAKHIL V S

ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI

kumarvijay29@gmail.com9540055001

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026