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Evaluation of Three Irrigants, Sodium Hypochlorite, Chlorhexidine and Combination of CHX+H2O2 in Endodontic Treatment.

Primary Purpose

Periapical Periodontitis

Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Sodium hypochlorite
Chlorhexidine
Chlorhexidine + Hydrogen peroxide
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 Periapical Periodontitis focused on measuring Sodium hypochlorite, Chlorhexidine, Hydrogen peroxide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • All patients over 18 years of age.
  • Mature permanent mandibular molars.
  • A radiographic evidence of periapical radiolucency (minimum size > 2mm×2mm) and a diagnosis of pulpal necrosis, as confirmed by the negative response to cold and electrical tests; and absence of bleeding on entering the pulp chamber.

Exclusion Criteria

  • Diabetics, immunocompromised patients, pregnant females, any systemic disease.
  • Patients with a history of analgesic intake within the past 3 days and antibiotics in the last month.
  • Patients with pockets ≥ 4mm or having marginal or furcal bone loss due to periodontitis.
  • Non-restorable tooth, fractured, perforated roots and inflammatory root resorption.
  • Teeth those are not suitable for rubber dam isolation.
  • Primary teeth.

Sites / Locations

  • PGIDS, RohtakRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

Sodium hypochlorite

Chlorhexidine

Chlorhexidine + Hydrogen peroxide

Arm Description

Procedure/Surgery: Thirty mandibular molars treated with root canal treatment by using Sodium hypochlorite during biomechanical preparation.

Procedure/Surgery: Thirty mandibular molars treated with root canal treatment by using Chlorhexidine during biomechanical preparation.

Procedure/Surgery: Thirty mandibular molars treated with root canal treatment by using a combination of Chlorhexidine + Hydrogen peroxide during biomechanical preparation.

Outcomes

Primary Outcome Measures

Clinical success
Absence of signs and symptoms Absence of tenderness to percussion Tooth mobility of grade 1 or less Absence of associated soft tissue swelling or tenderness to palpation Attachment loss of less than 5mm . Two experienced observers with no knowledge of the treatment protocol will independently examine the immediate post obturation and follow up radiographs, mounted side by side, under controlled conditions. The treatment is considered successful only when both clinical and radiographic criteria are met. The worst outcome of an individual root decide the overall outcome for the tooth. In the event of disagreement, the two observers will meet to discuss their findings and came to an agreement.

Secondary Outcome Measures

Radiographic success
Absence of periapical alterations (radiolucency at furcal or periapical region) Scoring of each tooth will be done according to the following five point scale (PAI) Score Description Normal Periapical structure Small changes in bone structure Changes in bone structure with some mineral loss Periodontitis with well defined radiolucent area Severe periodontitis with exacerbating features
Pain assessment
Assess the incidence and intensity of pain postoperatively at every 6 hours to 1 day till 7d ays using Visual Analogue scale.Pain intensity will be noted as no pain (0-4mm), mild pain (5-44), moderate pain (45-74mm) and severe pain (75-100mm) on the scale of 0-100mm

Full Information

First Posted
April 22, 2020
Last Updated
April 29, 2020
Sponsor
Postgraduate Institute of Dental Sciences Rohtak
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1. Study Identification

Unique Protocol Identification Number
NCT04373018
Brief Title
Evaluation of Three Irrigants, Sodium Hypochlorite, Chlorhexidine and Combination of CHX+H2O2 in Endodontic Treatment.
Official Title
Comparative Evaluation of Clinical and Radiographic Outcome by Using Three Different Irrigants, Sodium Hypochlorite (NaOCl), Chlorhexidine (CHX) and Combination of CHX+H2O2 in Primary Endodontic Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
April 2021 (Anticipated)
Study Completion Date
April 2021 (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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will evaluate the synergistic effect of CHX + H2O2 when used as an irrigant during biomechanical preparation.in root canal treatment on periapical healing and compared with Chlorhexidine( CHX) and Sodium Hypochlorite (NaOCl).
Detailed Description
After a thorough history, clinical and radiographic examination with all eligibility confirmation, written informed consent will be taken from the patient after explaining the procedure and its associated risks and benefits. Patients randomly allocated to one of the three study groups Sodium hypochlorite (NaOCl), Chlorhexidine (CHX) and combination of (CHX+H2O2). All three irrigants will be used according to standard protocol during biomechanical preparation. Pain analysis will be carried out preoperatively and postoperatively at every 6 hours for 1 day and then every 24 hours till 7 days after the intervention. All the subjects will be followed up for evaluation of clinical and radiographic success at 3, 6 months and 1year.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periapical Periodontitis
Keywords
Sodium hypochlorite, Chlorhexidine, Hydrogen peroxide

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sodium hypochlorite
Arm Type
Active Comparator
Arm Description
Procedure/Surgery: Thirty mandibular molars treated with root canal treatment by using Sodium hypochlorite during biomechanical preparation.
Arm Title
Chlorhexidine
Arm Type
Active Comparator
Arm Description
Procedure/Surgery: Thirty mandibular molars treated with root canal treatment by using Chlorhexidine during biomechanical preparation.
Arm Title
Chlorhexidine + Hydrogen peroxide
Arm Type
Experimental
Arm Description
Procedure/Surgery: Thirty mandibular molars treated with root canal treatment by using a combination of Chlorhexidine + Hydrogen peroxide during biomechanical preparation.
Intervention Type
Procedure
Intervention Name(s)
Sodium hypochlorite
Intervention Description
Sodium hypochlorite irrigant will be used during biomechanical preparation.
Intervention Type
Procedure
Intervention Name(s)
Chlorhexidine
Intervention Description
Chlorhexidine irrigant will be used during biomechanical preparation.
Intervention Type
Procedure
Intervention Name(s)
Chlorhexidine + Hydrogen peroxide
Intervention Description
Chlorhexidine + Hydrogen peroxide irrigant will be used during biomechanical preparation.
Primary Outcome Measure Information:
Title
Clinical success
Description
Absence of signs and symptoms Absence of tenderness to percussion Tooth mobility of grade 1 or less Absence of associated soft tissue swelling or tenderness to palpation Attachment loss of less than 5mm . Two experienced observers with no knowledge of the treatment protocol will independently examine the immediate post obturation and follow up radiographs, mounted side by side, under controlled conditions. The treatment is considered successful only when both clinical and radiographic criteria are met. The worst outcome of an individual root decide the overall outcome for the tooth. In the event of disagreement, the two observers will meet to discuss their findings and came to an agreement.
Time Frame
Base line to 1 year.
Secondary Outcome Measure Information:
Title
Radiographic success
Description
Absence of periapical alterations (radiolucency at furcal or periapical region) Scoring of each tooth will be done according to the following five point scale (PAI) Score Description Normal Periapical structure Small changes in bone structure Changes in bone structure with some mineral loss Periodontitis with well defined radiolucent area Severe periodontitis with exacerbating features
Time Frame
Baseline to 1 year
Title
Pain assessment
Description
Assess the incidence and intensity of pain postoperatively at every 6 hours to 1 day till 7d ays using Visual Analogue scale.Pain intensity will be noted as no pain (0-4mm), mild pain (5-44), moderate pain (45-74mm) and severe pain (75-100mm) on the scale of 0-100mm
Time Frame
Baseline to 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All patients over 18 years of age. Mature permanent mandibular molars. A radiographic evidence of periapical radiolucency (minimum size > 2mm×2mm) and a diagnosis of pulpal necrosis, as confirmed by the negative response to cold and electrical tests; and absence of bleeding on entering the pulp chamber. Exclusion Criteria Diabetics, immunocompromised patients, pregnant females, any systemic disease. Patients with a history of analgesic intake within the past 3 days and antibiotics in the last month. Patients with pockets ≥ 4mm or having marginal or furcal bone loss due to periodontitis. Non-restorable tooth, fractured, perforated roots and inflammatory root resorption. Teeth those are not suitable for rubber dam isolation. Primary teeth.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anshu Yadav
Phone
9050522830
Email
anshuyadav99@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dr Vinay Kumar
Phone
8901149107
Email
29vinaykr@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anshu Yadav
Organizational Affiliation
PGIDS, Rohtak
Official's Role
Principal Investigator
Facility Information:
Facility Name
PGIDS, Rohtak
City
Rohtak
State/Province
Haryana
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Vinay Kumar
Phone
8901149107
Email
29vinaykr@gmail.com
First Name & Middle Initial & Last Name & Degree
Anshu Yadav
Phone
9050522830
Email
anshuyadav99@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Three Irrigants, Sodium Hypochlorite, Chlorhexidine and Combination of CHX+H2O2 in Endodontic Treatment.

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