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Octenidine and Sodium Hypochlorite for Pulp Irrigation in Direct Pulp Capping

A

Aydin Adnan Menderes University

Status

Active, not recruiting

Conditions

Pulp Exposure, Dental

Treatments

Other: pulp lavage Octenidine
Other: pulp lavage NaOCl

Study type

Interventional

Funder types

Other

Identifiers

NCT06946719
2023/04

Details and patient eligibility

About

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.

Full 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.

Enrollment

88 estimated patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

88 participants in 2 patient groups

Octenidine
Experimental group
Description:
A cotton pellet soaked in 0.1% Octenidine will be applied to the exposed pulp area
Treatment:
Other: pulp lavage Octenidine
NaOCl
Experimental group
Description:
A cotton pellet soaked in 2.5% NaOCl will be applied to the exposed pulp area
Treatment:
Other: pulp lavage NaOCl

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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