Role Of Wound Lavage in Direct Pulp Capping Of Permanent Teeth With Carious Exposure
1 other identifier
interventional
140
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2022
CompletedFirst Submitted
Initial submission to the registry
May 5, 2023
CompletedFirst Posted
Study publicly available on registry
May 26, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2024
CompletedDecember 8, 2023
May 1, 2023
1.5 years
May 5, 2023
December 7, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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.
12 months
Secondary Outcomes (1)
To assess postoperative pain .
7 days
Study Arms (4)
wound lavage with normal saline
EXPERIMENTALafter 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
EXPERIMENTALafter 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)
EXPERIMENTALafter 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
EXPERIMENTALafter 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
Interventions
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
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
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.
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
PGIDS
Rohtak, Haryana, 124001, India
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
ANSHU SINGH, MDS
PGIDS ROHTAK
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 5, 2023
First Posted
May 26, 2023
Study Start
November 1, 2022
Primary Completion
April 30, 2024
Study Completion
May 31, 2024
Last Updated
December 8, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share