Clinical trial NCT05878249: Role Of Wound Lavage in Direct Pulp Capping Of Permanent Teeth With Carious Exposure
Official title: Role Of Wound Lavage in Direct Pulp Capping Of Permanent Teeth With Carious Exposure: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Reversible Pulpitis
Lead sponsor: Postgraduate Institute of Dental Sciences Rohtak
Sponsor class: OTHER
First posted: 2023-05-26
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Patient willing to participate in the study.
2. Age group- 18-50 years.
3. Mature permanent mandibular posterior teeth (molars or premolars) with reversible pulpitis.
4. Teeth with extremely deep caries (Caries penetrating entire thickness of dentine) responding within normal limits to the cold test and Electric pulp test.
5. Teeth with normal apical tissues(not showing any rarefaction on the intraoral periapical radiograph)

Exclusion Criteria:

1. Primary teeth.
2. 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.
3. Immuno-compromised, diabetic, pregnant and hypertensive patients.
4. Positive history of antibiotic within past one month and analgesic since one week use of the treatment

Primary outcomes:
measure: clinical and radiographic success at 6 and 12 months.
timeFrame: 12 months
Secondary outcomes:
measure: To assess postoperative pain .
timeFrame: 7 days
Other outcomes:
Locations:
city: Rohtak
country: India
facility: PGIDS
state: Haryana
Study officials:
affiliation: PGIDS ROHTAK
name: ANSHU SINGH, MDS
role: PRINCIPAL_INVESTIGATOR
References: