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

Primary Purpose

Reversible Pulpitis

Status
Active
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
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
Sponsored by
Postgraduate Institute of Dental Sciences Rohtak
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Reversible Pulpitis

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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) Exclusion Criteria: 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

Sites / Locations

  • PGIDS

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

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

Arm Description

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

after removing caries and achieving hemostasis wound lavage of the exposed pulp will be done with 12%Ethylenediaminetetraacetic acid(EDTA) for 5 minutes

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
May 5, 2023
Last Updated
May 17, 2023
Sponsor
Postgraduate Institute of Dental Sciences Rohtak
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1. Study Identification

Unique Protocol Identification Number
NCT05878249
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
May 31, 2023 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Postgraduate Institute of Dental Sciences Rohtak

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Reversible Pulpitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
wound lavage with normal saline
Arm Type
Experimental
Arm Description
after removing caries and achieving hemostasis wound lavage of the exposed pulp will be done with 5 ml of Normal saline for 30 seconds
Arm Title
wound lavage with sodium hypochlorite
Arm Type
Experimental
Arm Description
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
Arm Title
wound lavage with Ethylenediaminetetraacetic acid(EDTA)
Arm Type
Experimental
Arm Description
after removing caries and achieving hemostasis wound lavage of the exposed pulp will be done with 12%Ethylenediaminetetraacetic acid(EDTA) for 5 minutes
Arm Title
wound lavage with sodium hypochlorite followed by Ethylenediaminetetraacetic acid
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
wound lavage with normal saline
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
wound lavage with sodium hypochlorite
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
wound lavage with Ethylenediaminetetraacetic acid(EDTA)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
wound lavage with sodium hypochlorite followed by Ethylenediaminetetraacetic acid
Intervention Description
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.
Primary Outcome Measure Information:
Title
clinical and radiographic success at 6 and 12 months.
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
To assess postoperative pain .
Description
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
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ANSHU SINGH, MDS
Organizational Affiliation
PGIDS ROHTAK
Official's Role
Principal Investigator
Facility Information:
Facility Name
PGIDS
City
Rohtak
State/Province
Haryana
ZIP/Postal Code
124001
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No

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

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