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Active, not recruitingNCT06946719Updated Apr 27, 2025

Octenidine and Sodium Hypochlorite for Pulp Irrigation in Direct Pulp Capping

An interventional study of pulp lavage Octenidine and pulp lavage NaOCl in Pulp Exposure, Dental, sponsored by Aydin Adnan Menderes University. Active, not recruiting at 1 site in Turkey. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-27.

Sponsored by Aydin Adnan Menderes University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Jun 2024, registered Apr 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
88
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Pulp Exposure, Dental

Browse trials for

Keywords

  • pulp exposure
  • calcium silicate cement
03

In context

Dental Pulp Exposure

29 studies on the registry are indexed under Dental Pulp Exposure; 5 are open to participants now.

This study's planned enrollment of 88 is above the median of 53 across 27 interventional studies indexed under Dental Pulp Exposure.

Browse Dental Pulp Exposure studies →

Lead sponsor

Aydin Adnan Menderes University is the lead sponsor of 236 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
88 participants (estimated)

Study arms

  • Experimental
    Octenidine

    A cotton pellet soaked in 0.1% Octenidine will be applied to the exposed pulp area

    Other: pulp lavage Octenidine

  • Experimental
    NaOCl

    A cotton pellet soaked in 2.5% NaOCl will be applied to the exposed pulp area

    Other: pulp lavage NaOCl

Interventions

  • Otherpulp lavage Octenidine

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

  • Otherpulp lavage NaOCl

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

06

What researchers measure

Primary outcomes

  1. Post operative pain

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

    Time frame: 24 hours

  2. Post operative pain

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

    Time frame: 48 hours

  3. Post operative pain

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

    Time frame: 72 hours

Secondary outcomes

  1. Pulp vitality-ct

    Evaluation through cold testing

    Time frame: 6 months

  2. Pulp vitality-ept

    Evaluation through electric pulp testing

    Time frame: 6 months

  3. Pulp vitality-pr

    Evaluation through periapical radiographic examinations

    Time frame: 6 months

07

Study locations

1 site
  • Cemre Koç
    Aydın, Efeler 09100, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06946719
Lead sponsor
Aydin Adnan Menderes University
Responsible party
cemre koç (Dr., Aydin Adnan Menderes University) — Principal investigator
First posted
Apr 27, 2025
Start date
Jun 1, 2024
Primary completion
Dec 1, 2024
Completion
Jun 1, 2025 (estimated)
Last update
Apr 27, 2025

Study contacts

Cemre Koç
principal investigator · Aydın Adnan Menderes University, Faculty of Dentistry

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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