Different Hemostatic Agents Used in Partial Pulpotomy on Pulp Survival and Postoperative Pain

NCT07058727 | Recruiting

• 1 other identifier: PP-HemoRCT-2025
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized clinical trial evaluates the efficacy of sodium hypochlorite (NaOCl), chlorhexidine (CHX), and cold saline as hemostatic agents in partial pulpotomy. The study compares postoperative pain (via VAS scores) and pulp survival (via clinical/radiographic evaluation) at 1, 3, 7 days, 6 months, and 12 months

Conditions

Efficacy of Hemostatic Agents; Partial Pulpotomy; Postoperative Pain

Outcome Measures

Primary Outcomes (2)

• Postoperative Pain

  The patient will be asked to rate the pain on the 1st, 3rd and 7th day according to VAS. (The patient is asked to score their pain in this range, with 0 being the lowest and 10 being the highest.)

  1 week

• Pulp Survival Rate

  The pulp is expected to be vital, without percussion tenderness and without spontaneous pain

  12 months

Secondary Outcomes (1)

• Clinical Success

  12 months

Study Arms (3)

Arm 1

EXPERIMENTAL

2.5% NaOCl applied for 1 min after pulp exposure.

Drug: Sodium Hypochlorite 2,5%

Arm 2

EXPERIMENTAL

2% CHX applied for 1 min

Drug: Chlorhexidine

Arm 3

EXPERIMENTAL

Hemostasis achieved with 4°C saline for 1 min.

Drug: Cold Saline

Interventions

Chlorhexidine DRUG

2% CHX applied for 1 min to achieve hemostasis, with identical subsequent steps to NaOCl group

Arm 2

Sodium Hypochlorite 2,5% DRUG

2.5% NaOCl applied for 1 min to exposed pulp for hemostasis, followed by standard pulp capping

Arm 1

Cold Saline DRUG

Hemostasis via 4°C saline (1 Min), then standardized pulp capping

Arm 3

Eligibility Criteria

• Age: 15 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Permanent teeth with carious pulp exposure (no spontaneous pain).
• Positive vitality test (Endo-Ice).
• No periapical radiolucency.

You may not qualify if:

• Systemic diseases affecting healing.
• Pregnancy.
• Non-vital pulp/necrosis

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Çukurova Üniversitesi Diş Hekimliği Fakültesi

Adana, Sarıçam, 01250, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Chlorhexidine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

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: Principal Investigator

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: July 10, 2025
• Study Start: May 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: May 1, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

TU (1)