Octenidine and Sodium Hypochlorite for Pulp Irrigation in Direct Pulp Capping

NCT06946719 — Not applicable, Active not recruiting, 88 participants, Aydin Adnan Menderes University

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

RegistryNCT06946719
StatusActive not recruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: triple, treatment
Enrollment88 (Estimated)
SponsorAydin Adnan Menderes University (Other)
ConditionsPulp Exposure, Dental
Interventionspulp lavage Octenidine, pulp lavage NaOCl (Other)
Datesstart 2024-06-01, primary completion 2024-12-01, completion 2025-06-01 (estimated), first posted 2025-04-27, last updated 2025-04-27
Locations1 site in Turkey (Türkiye)

Related Papers Related Patents Related Grants Related Experts
All trials for Pulp Exposure, Dental All trials of pulp lavage Octenidine All trials of pulp lavage NaOCl

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
OctenidineExperimentalOther: pulp lavage OctenidineA cotton pellet soaked in 0.1% Octenidine will be applied to the exposed pulp area
NaOClExperimentalOther: pulp lavage NaOClA cotton pellet soaked in 2.5% NaOCl will be applied to the exposed pulp area
  • pulp lavage Octenidine (Other): Use of Octenidine as a pulp irrigation solution in pulp capping for mature permanent teeth
  • pulp lavage NaOCl (Other): Use of NaOCl as a pulp irrigation solution in pulp capping for mature permanent teeth

+Outcome measures

Primary outcomes

  • Post operative pain [24 hours]: Use of the Visual Analog Scale (VAS) following the procedure
  • Post operative pain [48 hours]: Use of the Visual Analog Scale (VAS) following the procedure
  • Post operative pain [72 hours]: Use of the Visual Analog Scale (VAS) following the procedure

Secondary outcomes

  • Pulp vitality-ct [6 months]: Evaluation through cold testing
  • Pulp vitality-ept [6 months]: Evaluation through electric pulp testing
  • Pulp vitality-pr [6 months]: Evaluation through periapical radiographic examinations

+Eligibility

Sex: All, ages: 18 Years to 45 Years, 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

+Locations (1)

FacilityCityCountryStatus
Cemre KoçAydin, EfelerTurkey (Türkiye)

+Investigators

  • Cemre Koç, Principal investigator, Aydın Adnan Menderes University, Faculty of Dentistry