Clinical trial NCT06946719: Octenidine and Sodium Hypochlorite for Pulp Irrigation in Direct Pulp Capping
Official title: Comparison of Octenidine and Sodium Hypochlorite for Pulp Irrigation in Direct Pulp Capping
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pulp Exposure, Dental
Keywords: pulp exposure
calcium silicate cement
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2025-04-27
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Post operative pain
timeFrame: 24 hours
measure: Post operative pain
timeFrame: 48 hours
measure: Post operative pain
timeFrame: 72 hours
Secondary outcomes:
measure: Pulp vitality-ct
timeFrame: 6 months
measure: Pulp vitality-ept
timeFrame: 6 months
measure: Pulp vitality-pr
timeFrame: 6 months
Other outcomes:
Locations:
city: Aydın
country: Turkey
facility: Cemre Koç
state: Efeler
Study officials:
affiliation: Aydın Adnan Menderes University, Faculty of Dentistry
name: Cemre Koç
role: PRINCIPAL_INVESTIGATOR
References: