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

The Effect of Different Hemostatic Agents Used in Partial Pulpotomy on Pulp Survival and Postoperative Pain: A Randomized Clinical Trial

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

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain; Partial Pulpotomy; Efficacy of Hemostatic Agents
• Intervention / Treatment: Drug: Sodium Hypochlorite 2,5%; Drug: Chlorhexidine; Drug: Cold Saline

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Sarıçam
    • Adana, Sarıçam, Turkey (Türkiye), 01250
      • Recruiting
      • Çukurova Üniversitesi Diş Hekimliği Fakültesi
      • Contact: Yaren Coşğun, Dr.; Phone Number: +90 544 745 8633; Email: yarenncoskun@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; 2.5% NaOCl applied for 1 min after pulp exposure.	Drug: Sodium Hypochlorite 2,5%; 2.5% NaOCl applied for 1 min to exposed pulp for hemostasis, followed by standard pulp capping
Experimental: Arm 2; 2% CHX applied for 1 min	Drug: Chlorhexidine; 2% CHX applied for 1 min to achieve hemostasis, with identical subsequent steps to NaOCl group
Experimental: Arm 3; Hemostasis achieved with 4°C saline for 1 min.	Drug: Cold Saline; Hemostasis via 4°C saline (1 Min), then standardized pulp capping

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulp Survival Rate	The pulp is expected to be vital, without percussion tenderness and without spontaneous pain	12 months
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Success	Maintaining the integrity of the restoration No need for endodontics treatments	12 months

Collaborators and Investigators

• Sponsor: Cukurova University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2025
• Primary Completion (Actual): November 1, 2025
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: June 19, 2025
• First Submitted That Met QC Criteria: June 30, 2025
• First Posted (Actual): July 10, 2025

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Organic Chemicals; Biguanides; Guanidines; Amidines; Chlorhexidine
• Other Study ID Numbers: PP-HemoRCT-2025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No