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UnknownNCT05878249

Role Of Wound Lavage in Direct Pulp Capping Of Permanent Teeth With Carious Exposure

Role Of Wound Lavage in Direct Pulp Capping Of Permanent Teeth With Carious Exposure: A Randomized Controlled Trial

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
140 (estimated)
Sponsor
Postgraduate Institute of Dental Sciences Rohtak · Academic / Other
Sex
All
Age
18 Years – 50 Years
Healthy volunteers
Accepted

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.

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

Interventions

TypeNameDescription
PROCEDUREwound 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
PROCEDUREwound 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
PROCEDUREwound 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.
PROCEDUREwound 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.

Timeline

Start date
2022-11-01
Primary completion
2024-04-30
Completion
2024-05-31
First posted
2023-05-26
Last updated
2023-12-08

Locations

1 site across 1 country: India

Source: ClinicalTrials.gov record NCT05878249. Inclusion in this directory is not an endorsement.