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Octenidine and Sodium Hypochlorite for Pulp Irrigation in Direct Pulp Capping

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06946719
Enrollment
88
Registered
2025-04-27
Start date
2024-06-01
Completion date
2025-06-01
Last updated
2025-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulp Exposure, Dental

Keywords

pulp exposure, calcium silicate cement

Brief 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.

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.

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

Sponsors

Aydin Adnan Menderes University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Post operative pain24 hoursUse of the Visual Analog Scale (VAS) following the procedure

Secondary

MeasureTime frameDescription
Pulp vitality-ct6 monthsEvaluation through cold testing
Pulp vitality-ept6 monthsEvaluation through electric pulp testing
Pulp vitality-pr6 monthsEvaluation through periapical radiographic examinations

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026