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Active Not RecruitingNCT06946719

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
Phase
N/A
Study type
Interventional
Enrollment
88 (estimated)
Sponsor
Aydin Adnan Menderes University · Academic / Other
Sex
All
Age
18 Years – 45 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERpulp lavage OctenidineUse of Octenidine as a pulp irrigation solution in pulp capping for mature permanent teeth
OTHERpulp lavage NaOClUse of NaOCl as a pulp irrigation solution in pulp capping for mature permanent teeth

Timeline

Start date
2024-06-01
Primary completion
2024-12-01
Completion
2025-06-01
First posted
2025-04-27
Last updated
2025-04-27

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT06946719. Inclusion in this directory is not an endorsement.