Octenidine and Sodium Hypochlorite for Pulp Irrigation in Direct Pulp Capping

NCT06946719 | Active Not Recruiting

• 1 other identifier: 2023/04
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulp Exposure, Dental

Keywords

pulp exposure; calcium silicate cement

Outcome Measures

Primary Outcomes (3)

• Post operative pain

  Use of the Visual Analog Scale (VAS) following the procedure

  24 hours

• Post operative pain

  Use of the Visual Analog Scale (VAS) following the procedure

  48 hours

• Post operative pain

  Use of the Visual Analog Scale (VAS) following the procedure

  72 hours

Secondary Outcomes (3)

• Pulp vitality-ct

  6 months

• Pulp vitality-ept

  6 months

• Pulp vitality-pr

  6 months

Study Arms (2)

Octenidine

EXPERIMENTAL

A cotton pellet soaked in 0.1% Octenidine will be applied to the exposed pulp area

Other: pulp lavage Octenidine

NaOCl

EXPERIMENTAL

A cotton pellet soaked in 2.5% NaOCl will be applied to the exposed pulp area

Other: pulp lavage NaOCl

Interventions

pulp lavage Octenidine OTHER

Use of Octenidine as a pulp irrigation solution in pulp capping for mature permanent teeth

Octenidine

pulp lavage NaOCl OTHER

Use of NaOCl as a pulp irrigation solution in pulp capping for mature permanent teeth

NaOCl

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Cemre Koç

Aydin, Efeler, 09100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dental Pulp Exposure

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Cemre Koç

  Aydın Adnan Menderes University, Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: April 21, 2025
• First Posted: April 27, 2025
• Study Start: June 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: June 1, 2025
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)