Pulp Exposure, DentalNCT06946719
Octenidine and Sodium Hypochlorite for Pulp Irrigation in Direct Pulp Capping
A study testing pulp lavage Octenidine and pulp lavage NaOCl in people with Pulp Exposure, Dental, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulp Exposure, Dental
- What is being tested?
- pulp lavage Octenidine and pulp lavage NaOCl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2024to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Octenidine and Sodium Hypochlorite for Pulp Irrigation in Direct Pulp Capping
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.
Read the 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
- Pulp Exposure, Dental
- Being tested
- pulp lavage Octenidine, pulp lavage NaOCl
- Keywords
- pulp exposure, calcium silicate cement
- Medical subject headings
- Dental Pulp Exposure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulp lavage OctenidineOther
Use of Octenidine as a pulp irrigation solution in pulp capping for mature permanent teeth
pulp lavage NaOClOther
Use of NaOCl as a pulp irrigation solution in pulp capping for mature permanent teeth
| Study group | Role | What they receive |
|---|---|---|
| Octenidine | Experimental | A cotton pellet soaked in 0.1% Octenidine will be applied to the exposed pulp area Receives: Other: pulp lavage Octenidine |
| NaOCl | Experimental | A cotton pellet soaked in 2.5% NaOCl will be applied to the exposed pulp area Receives: Other: pulp lavage NaOCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative pain
Use of the Visual Analog Scale (VAS) following the procedure
Measured: 24 hours
Post operative pain
Use of the Visual Analog Scale (VAS) following the procedure
Measured: 48 hours
Post operative pain
Use of the Visual Analog Scale (VAS) following the procedure
Measured: 72 hours
Secondary outcomes (3)
Pulp vitality-ct
Evaluation through cold testing
Measured: 6 months
Pulp vitality-ept
Evaluation through electric pulp testing
Measured: 6 months
Pulp vitality-pr
Evaluation through periapical radiographic examinations
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start1 Jun 2024
- Primary completion1 Dec 2024
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulp Exposure, DentalStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, cemre koç, Aydin Adnan Menderes University
- Investigators
- Cemre Koç, Principal investigator, Aydın Adnan Menderes University, Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06946719
- Sponsor's protocol ID
- 2023/04
- Status last verified
- Apr 2025
- First submitted
- 21 Apr 2025
- Last updated
- 27 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Octenidine and Sodium Hypochlorite for Pulp Irrigation in Direct Pulp Capping
- ClinicalTrials.gov ID
- NCT06946719
- Acronym / sponsor ID
- 2023/04
- Conditions
- Pulp Exposure, Dental
- Keywords
- pulp exposure, calcium silicate cement
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 27 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Octenidine | Experimental | Other: pulp lavage OctenidineA cotton pellet soaked in 0.1% Octenidine will be applied to the exposed pulp area |
| NaOCl | Experimental | Other: pulp lavage NaOClA cotton pellet soaked in 2.5% NaOCl will be applied to the exposed pulp area |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pulp lavage OctenidineUse of Octenidine as a pulp irrigation solution in pulp capping for mature permanent teeth | Other | Octenidine |
| pulp lavage NaOClUse of NaOCl as a pulp irrigation solution in pulp capping for mature permanent teeth | Other | NaOCl |
Primary outcome
Post operative pain
Time frame: 24 hours
Use of the Visual Analog Scale (VAS) following the procedure
Post operative pain
Time frame: 48 hours
Use of the Visual Analog Scale (VAS) following the procedure
Post operative pain
Time frame: 72 hours
Use of the Visual Analog Scale (VAS) following the procedure
3 secondary outcomes
Pulp vitality-ct
Time frame: 6 months
Pulp vitality-ept
Time frame: 6 months
Pulp vitality-pr
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Individual participant dataSharing planned: No
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Oxymetazoline Versus Sodium Hypochlorite as Hemostatic Agents in MTA Pulpotomy of Primary Molars
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Comparative Evaluation of Clinical and Radiographic Outcomes of Mustard Gel (Brassica Nigra) and Mineral Trioxide Aggregate (MTA) as Pulpotomy Agents in Deciduous Molars- A Randomized Controlled Trial
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Effects of Total and Selective Caries Removal - Requiring or Avoiding Vital Pulp Therapy - on Pulp Vitality and Postoperative Pain in Deep Carious Mature Permanent Teeth: A Split-Mouth Clinical Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cemre Koç principal investigator
Aydın Adnan Menderes University, Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pulp lavage Octenidine and pulp lavage NaOCl in people with Pulp Exposure, Dental, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post operative pain (time frame: 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025; AzTrials last refreshed its copy on 6 Nov 2026.