Reversible PulpitisNCT05878249
Role Of Wound Lavage in Direct Pulp Capping Of Permanent Teeth With Carious Exposure
A study testing wound lavage with normal saline, wound lavage with sodium hypochlorite and wound lavage with Ethylenediaminetetraacetic acid(EDTA) in people with Reversible Pulpitis, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
the purpose of the study is to investigate the outcome of wound lavage agents Sodium hypochlorite and Ethylenediaminetetraacetic acid (EDTA) in direct pulp capping of mature permanent teeth with carious exposure. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Reversible Pulpitis
- What is being tested?
- wound lavage with normal saline, wound lavage with sodium hypochlorite and wound lavage with Ethylenediaminetetraacetic acid(EDTA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteIndia
- Study dates
- 1 Nov 2022to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient willing to participate in the study.
- Age group- 18-50 years.
- Mature permanent mandibular posterior teeth (molars or premolars) with reversible pulpitis.
- Teeth with extremely deep caries (Caries penetrating entire thickness of dentine) responding within normal limits to the cold test and Electric pulp test.
- Teeth with normal apical tissues(not showing any rarefaction on the intraoral periapical radiograph)
Who cannot join
- Primary teeth.
- Teeth with irreversible pulpitis (spontaneous pain) or pulp necrosis, chronic periodontitis, cracked tooth, internal or external resorption, calcified canals, associated with sinus tract, and furcation or apical radiolucency.
- Immuno-compromised, diabetic, pregnant and hypertensive patients.
- Positive history of antibiotic within past one month and analgesic since one week use of the treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role Of Wound Lavage in Direct Pulp Capping Of Permanent Teeth With Carious Exposure: A Randomized Controlled Trial
the purpose of the study is to investigate the outcome of wound lavage agents Sodium hypochlorite and Ethylenediaminetetraacetic acid (EDTA) in direct pulp capping of mature permanent teeth with carious exposure.
Read the detailed description
With the growth of advanced pulp biology and bioactive materials today, management of deep carious lesions has come to a more conservative approach. Vital pulp therapy (VPT), comprising direct pulp capping, partial pulpotomy, and coronal pulpotomy, has been proposed as an alternative treatment to the traditional root canal treatment. Although there seems to be an agreement on the appropriate pulp dressing materials, the recommended irrigant for VPT in permanent teeth is less studied. Dentin matrix is a reservoir of bioactive molecules that are sequestered during dentinogenesis.The releasable growth factors from dentine provide source of cell signaling molecules for initiating repair and regeneration. Evidence shows that EDTA has ability to release growth factors from dentine matrix and it also promotes cell survival,attachment,growth and differentiation. Sodium hypochlorite has high efficacy against biofilms and its semi selective tissue dissolving properties on necrotic rather than vital soft tissue makes it ideal for dentin/pulp wound lavage.In direct pulp capping ,wound lavage with sodium hypochlorite has shown to reduce postoperative pain and early painful failures. However there is a lack of well designed clinical trials on pulp wound lavage.
The aim of this study is to investigate the outcome of wound lavage agents Sodium hypochlorite and EDTA in direct pulp capping of mature permanent posterior teeth with carious exposure Study will be conducted in Post Graduate Institute of Dental Sciences, Rohtak in department of Conservative Dentistry \& Endodontics.Time Frame of the study will be 18 months and Patients of age 18-50 years will be enrolled in this study.
After caries excavation, patients will be randomly allocated into four groups- Group I-normal saline, Group II-sodium hypochlorite, Group III-EDTA, Group IV-Sodium hypochlorite followed by EDTA. Washing of the pulp wound will be done with respective allocated solution and then tooth in both groups will be restored according to standard protocol.
Primary outcome variables recorded will be clinical and radiographic success rates after 6 and 12 months from the treatment.
Secondary outcome measure will be reduction in post operative pain after 7days of the treatment.
- Conditions
- Reversible Pulpitis
- Being tested
- wound lavage with normal saline, wound lavage with sodium hypochlorite, wound lavage with Ethylenediaminetetraacetic acid(EDTA), wound lavage with sodium hypochlorite followed by Ethylenediaminetetraacetic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wound lavage with normal salineProcedure or surgery
After removing caries and achieving hemostasis after removing caries and achieving hemostasis, wound lavage of the exposed pulp will be done with 5 ml of Normal saline for 30 seconds
wound lavage with sodium hypochloriteProcedure or surgery
after removing caries and achieving hemostasis wound lavage of the exposed pulp will be done with 5 ml of 2.5% sodium hypochlorite (NaOCl) for 30 seconds,Subsequently the cavity will be flushed with saline for 10 s and blotted dry using sterile cotton pellets
wound lavage with Ethylenediaminetetraacetic acid(EDTA)Procedure or surgery
after removing caries and achieving hemostasis wound lavage of the exposed pulp will be done with 12% Ethylenediaminetetraacetic acid for 5minutes ,Subsequently, the cavity will be flushed with saline for 10 s and blotted dry using sterile cotton pellets.
wound lavage with sodium hypochlorite followed by Ethylenediaminetetraacetic acidProcedure or surgery
fter removing caries and achieving hemostasis wound lavage of the exposed pulp will be done with 5 ml of 2.5%sodium hypochlorite (NaOCl) for 30 seconds followed by 12%Ethylenediaminetetraacetic acid(EDTA) for 5 minutes.Subsequently, the cavity will be flushed with saline for 10 s and blotted dry using sterile cotton pellets.
| Study group | Role | What they receive |
|---|---|---|
| wound lavage with normal saline | Experimental | after removing caries and achieving hemostasis wound lavage of the exposed pulp will be done with 5 ml of Normal saline for 30 seconds Receives: Procedure: wound lavage with normal saline |
| wound lavage with sodium hypochlorite | Experimental | after removing caries and achieving hemostasis wound lavage of the exposed pulp will be done with 5 ml of 2.5% sodium hypochlorite (NaOCl) for 30 seconds Receives: Procedure: wound lavage with sodium hypochlorite |
| wound lavage with Ethylenediaminetetraacetic acid(EDTA) | Experimental | after removing caries and achieving hemostasis wound lavage of the exposed pulp will be done with 12%Ethylenediaminetetraacetic acid(EDTA) for 5 minutes Receives: Procedure: wound lavage with Ethylenediaminetetraacetic acid(EDTA) |
| wound lavage with sodium hypochlorite followed by Ethylenediaminetetraacetic acid | Experimental | after removing caries and achieving hemostasis wound lavage of the exposed pulp will be done with 5 ml of 2.5%sodium hypochlorite (NaOCl) for 30 seconds followed by 12%Ethylenediaminetetraacetic acid(EDTA) for 5 minutes Receives: Procedure: wound lavage with sodium hypochlorite followed by Ethylenediaminetetraacetic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical and radiographic success at 6 and 12 months.
Clinical success criteria-
- Positive response on cold testing
- Absence of sign and symptoms of spontaneous pain or pain on stimulus and discomfort.
- No tenderness to palpation or percussion and the tooth is functional.
- Normal tooth mobility and no periodontal probing pocket depth.
- Soft tissues around tooth are normal with no swelling or sinus tract.
Radiographic success criteria-
- Absence of any periapical or interradicular radiolucency
- Absence of internal or external root resorption
- Periapical Index score < 2 according to Orstavik et al.
Measured: 12 months
Secondary outcomes (1)
To assess postoperative pain .
To assess incidence and intensity of pain postoperatively at every 24 hours till 7 days using Visual analogue Scale of 0 to 10 centimeter line. Score 0 means no pain and Score 10 means maximum pain
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start1 Nov 2022
- Primary completion30 Apr 2024 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reversible PulpitisStudies of the same condition, open and under way.
- More trials run by Postgraduate Institute of Dental Sciences RohtakThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ANSHU SINGH, MDS, Principal investigator, PGIDS ROHTAK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05878249
- Sponsor's protocol ID
- ANSHU SINGH
- Status last verified
- May 2023
- First submitted
- 5 May 2023
- Last updated
- 8 Dec 2023
- 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 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role Of Wound Lavage in Direct Pulp Capping Of Permanent Teeth With Carious Exposure: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05878249
- Acronym / sponsor ID
- ANSHU SINGH
- Conditions
- Reversible Pulpitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 26 May 2023 (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.
the purpose of the study is to investigate the outcome of wound lavage agents Sodium hypochlorite and Ethylenediaminetetraacetic acid (EDTA) in direct pulp capping of mature permanent teeth with carious exposure.
Detailed description
With the growth of advanced pulp biology and bioactive materials today, management of deep carious lesions has come to a more conservative approach. Vital pulp therapy (VPT), comprising direct pulp capping, partial pulpotomy, and coronal pulpotomy, has been proposed as an alternative treatment to the traditional root canal treatment. Although there seems to be an agreement on the appropriate pulp dressing materials, the recommended irrigant for VPT in permanent teeth is less studied. Dentin matrix is a reservoir of bioactive molecules that are sequestered during dentinogenesis.The releasable growth factors from dentine provide source of cell signaling molecules for initiating repair and regeneration. Evidence shows that EDTA has ability to release growth factors from dentine matrix and it also promotes cell survival,attachment,growth and differentiation. Sodium hypochlorite has high efficacy against biofilms and its semi selective tissue dissolving properties on necrotic rather than vital soft tissue makes it ideal for dentin/pulp wound lavage.In direct pulp capping ,wound lavage with sodium hypochlorite has shown to reduce postoperative pain and early painful failures. However there is a lack of well designed clinical trials on pulp wound lavage.
The aim of this study is to investigate the outcome of wound lavage agents Sodium hypochlorite and EDTA in direct pulp capping of mature permanent posterior teeth with carious exposure Study will be conducted in Post Graduate Institute of Dental Sciences, Rohtak in department of Conservative Dentistry \& Endodontics.Time Frame of the study will be 18 months and Patients of age 18-50 years will be enrolled in this study.
After caries excavation, patients will be randomly allocated into four groups- Group I-normal saline, Group II-sodium hypochlorite, Group III-EDTA, Group IV-Sodium hypochlorite followed by EDTA. Washing of the pulp wound will be done with respective allocated solution and then tooth in both groups will be restored according to standard protocol.
Primary outcome variables recorded will be clinical and radiographic success rates after 6 and 12 months from the treatment.
Secondary outcome measure will be reduction in post operative pain after 7days of the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| wound lavage with normal saline | Experimental | Procedure: wound lavage with normal salineafter removing caries and achieving hemostasis wound lavage of the exposed pulp will be done with 5 ml of Normal saline for 30 seconds |
| wound lavage with sodium hypochlorite | Experimental | Procedure: wound lavage with sodium hypochloriteafter removing caries and achieving hemostasis wound lavage of the exposed pulp will be done with 5 ml of 2.5% sodium hypochlorite (NaOCl) for 30 seconds |
| wound lavage with Ethylenediaminetetraacetic acid(EDTA) | Experimental | Procedure: wound lavage with Ethylenediaminetetraacetic acid(EDTA)after removing caries and achieving hemostasis wound lavage of the exposed pulp will be done with 12%Ethylenediaminetetraacetic acid(EDTA) for 5 minutes |
| wound lavage with sodium hypochlorite followed by Ethylenediaminetetraacetic acid | Experimental | Procedure: wound lavage with sodium hypochlorite followed by Ethylenediaminetetraacetic acidafter removing caries and achieving hemostasis wound lavage of the exposed pulp will be done with 5 ml of 2.5%sodium hypochlorite (NaOCl) for 30 seconds followed by 12%Ethylenediaminetetraacetic acid(EDTA) for 5 minutes |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patient willing to participate in the study.
- Age group- 18-50 years.
- Mature permanent mandibular posterior teeth (molars or premolars) with reversible pulpitis.
- Teeth with extremely deep caries (Caries penetrating entire thickness of dentine) responding within normal limits to the cold test and Electric pulp test.
- Teeth with normal apical tissues(not showing any rarefaction on the intraoral periapical radiograph)
Key exclusion criteria (4 listed)
- Primary teeth.
- Teeth with irreversible pulpitis (spontaneous pain) or pulp necrosis, chronic periodontitis, cracked tooth, internal or external resorption, calcified canals, associated with sinus tract, and furcation or apical radiolucency.
- Immuno-compromised, diabetic, pregnant and hypertensive patients.
- Positive history of antibiotic within past one month and analgesic since one week use of the treatment
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 |
|---|---|---|
| wound lavage with normal salineAfter removing caries and achieving hemostasis after removing caries and achieving hemostasis, wound lavage of the exposed pulp will be done with 5 ml of Normal saline for 30 seconds | Procedure or surgery | wound lavage with normal saline |
| wound lavage with sodium hypochloriteafter removing caries and achieving hemostasis wound lavage of the exposed pulp will be done with 5 ml of 2.5% sodium hypochlorite (NaOCl) for 30 seconds,Subsequently the cavity will be flushed with saline for 10 s and blotted dry using sterile cotton pellets | Procedure or surgery | wound lavage with sodium hypochlorite |
| wound lavage with Ethylenediaminetetraacetic acid(EDTA)after removing caries and achieving hemostasis wound lavage of the exposed pulp will be done with 12% Ethylenediaminetetraacetic acid for 5minutes ,Subsequently, the cavity will be flushed with saline for 10 s and blotted dry using sterile cotton pellets. | Procedure or surgery | wound lavage with Ethylenediaminetetraacetic acid(EDTA) |
| wound lavage with sodium hypochlorite followed by Ethylenediaminetetraacetic acidfter removing caries and achieving hemostasis wound lavage of the exposed pulp will be done with 5 ml of 2.5%sodium hypochlorite (NaOCl) for 30 seconds followed by 12%Ethylenediaminetetraacetic acid(EDTA) for 5 minutes.Subsequently, the cavity will be flushed with saline for 10 s and blotted dry using sterile cotton pellets. | Procedure or surgery | wound lavage with sodium hypochlorite followed by Ethylenediaminetetraacetic acid |
Primary outcome
clinical and radiographic success at 6 and 12 months.
Time frame: 12 months
Clinical success criteria- * Positive response on cold testing * Absence of sign and symptoms of spontaneous pain or pain on stimulus and discomfort. * No tenderness to palpation or percussion and the tooth is functional. * Normal tooth mobility and no periodontal probing pocket depth. * Soft tissues around tooth are normal with no swelling or sinus tract. Radiographic success criteria- * Absence of any periapical or interradicular radiolucency * Absence of internal or external root resorption * Periapical Index score < 2 according to Orstavik et al.
1 secondary outcome
To assess postoperative pain .
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
- Individual participant dataSharing planned: No
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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.
ANSHU SINGH, MDS principal investigator
PGIDS ROHTAK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing wound lavage with normal saline, wound lavage with sodium hypochlorite and wound lavage with Ethylenediaminetetraacetic acid(EDTA) in people with Reversible Pulpitis, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 8 Dec 2023. 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 India. 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?
Results are not available in the source record.
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?
clinical and radiographic success at 6 and 12 months. (time frame: 12 months). 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 8 Dec 2023.