Octenidine and Sodium Hypochlorite for Pulp Irrigation in Direct Pulp Capping

Comparison of Octenidine and Sodium Hypochlorite for Pulp Irrigation in Direct Pulp Capping

In the included patients, after complete removal of caries from the entire cavity, the exposed pulp will be treated with either a 2.5% NaOCl or 0.1% Octenidine solution. Subsequently, the cavity will be restored using calcium silicate cement, glass ionomer cement, and composite resin. Postoperatively, the patient's pain level will be assessed using the Visual Analogue Scale (VAS) at 24 and 72 hours, as well as on the 7th day. Responses to pulp sensitivity tests and periapical radiographs will be evaluated at 6 months.

Study Overview

• Status: Active, not recruiting
• Conditions: Pulp Exposure, Dental
• Intervention / Treatment: Other: pulp lavage Octenidine; Other: pulp lavage NaOCl

Detailed Description

After obtaining a detailed pain history from the patients and conducting clinical and radiographic examinations, if a case is deemed suitable for the study, patients will be informed about the possibility of participating in this research project and the procedures involved. The risks and benefits associated with the study will be explained to the patients. Once a patient is considered a potential candidate for the study and expresses interest in participation, informed consent will be obtained.

Before the caries removal procedure, local anesthesia will be administered, and the teeth will be isolated using a rubber dam. Cavities will be prepared using a diamond bur under continuous water cooling. Caries will be completely removed from the entire cavity with the help of steel round burs and excavators, continuing until hard dentin is reached. Bleeding from the exposed pulp will be controlled by pressing a cotton pellet soaked in sterile physiological saline onto the exposure site for one minute. At this point, a researcher not involved in this study will provide the treating clinician with a glass dish containing either a 2.5% NaOCl or 0.1% Octenidine solution. A cotton pellet soaked in the test or control solution will be applied to the exposed pulp, and the cavity will be gently wiped. The cavity will be restored using calcium silicate cement, glass ionomer cement, and composite resin. Postoperatively, the patient's pain levels will be assessed using the Visual Analogue Scale (VAS) at 24 and 72 hours, as well as on the 7th day. Pulp sensitivity tests and periapical radiographs will be conducted at 6 months to evaluate the outcome.

• Study Type: Interventional
• Enrollment (Estimated): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Efeler
    • Aydın, Efeler, Turkey, 09100
      • Cemre Koç

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Asymptomatic posterior tooth (premolar or molar) with deep caries
• A healthy periodontal status, normal probing depth, and restorable.
• Negative responses to percussion and palpation tests while responding positively to cold testing and electric pulp testing

Exclusion Criteria:

• Participants will be excluded if they had any systemic diseases
• A negative response to cold testing and electric pulp testing.
• Presence of a sinus tract, absence of pulp exposure following complete caries removal, or necrotic or partially necrotic pulp tissue

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Octenidine; A cotton pellet soaked in 0.1% Octenidine will be applied to the exposed pulp area	Other: pulp lavage Octenidine; Use of Octenidine as a pulp irrigation solution in pulp capping for mature permanent teeth
Experimental: NaOCl; A cotton pellet soaked in 2.5% NaOCl will be applied to the exposed pulp area	Other: pulp lavage NaOCl; Use of NaOCl as a pulp irrigation solution in pulp capping for mature permanent teeth

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post operative pain	Use of the Visual Analog Scale (VAS) following the procedure	24 hours
Post operative pain	Use of the Visual Analog Scale (VAS) following the procedure	48 hours
Post operative pain	Use of the Visual Analog Scale (VAS) following the procedure	72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulp vitality-ct	Evaluation through cold testing	6 months
Pulp vitality-ept	Evaluation through electric pulp testing	6 months
Pulp vitality-pr	Evaluation through periapical radiographic examinations	6 months

Collaborators and Investigators

• Sponsor: Aydin Adnan Menderes University
• Investigators: Principal Investigator: Cemre Koç, Aydın Adnan Menderes University, Faculty of Dentistry

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Actual): December 1, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: April 21, 2025
• First Submitted That Met QC Criteria: April 21, 2025
• First Posted (Actual): April 27, 2025

Study Record Updates

• Last Update Posted (Actual): April 27, 2025
• Last Update Submitted That Met QC Criteria: April 21, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: pulp exposure; calcium silicate cement
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Dental Pulp Diseases; Tooth Diseases; Dental Pulp Exposure; Anti-Infective Agents; Anti-Infective Agents, Local; Octenidine
• Other Study ID Numbers: 2023/04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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