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Active, Not Recruiting

NCT Number: NCT06946719

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cemre Koç

Aydin, Efeler, 09100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pulp lavage Octenidine

Other

Use of Octenidine as a pulp irrigation solution in pulp capping for mature permanent teeth

pulp lavage NaOCl

Other

Use of NaOCl as a pulp irrigation solution in pulp capping for mature permanent teeth

Primary outcomes

  1. Post operative pain

    Time frame: 24 hours

    Use of the Visual Analog Scale (VAS) following the procedure

  2. Post operative pain

    Time frame: 48 hours

    Use of the Visual Analog Scale (VAS) following the procedure

  3. Post operative pain

    Time frame: 72 hours

    Use of the Visual Analog Scale (VAS) following the procedure

Secondary outcomes

  1. Pulp vitality-ct

    Time frame: 6 months

    Evaluation through cold testing

  2. Pulp vitality-ept

    Time frame: 6 months

    Evaluation through electric pulp testing

  3. Pulp vitality-pr

    Time frame: 6 months

    Evaluation through periapical radiographic examinations

Sponsors and collaborators

Lead sponsor

Aydin Adnan Menderes University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Apr 27, 2025
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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