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Comparison of Anesthetic Efficacy of Dexmedetomidine and Epinephrine With Lidocaine in Irreversible Pulpitis

Primary Purpose

Irreversible Pulpitis

Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Inferior alveolar nerve block
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 Irreversible Pulpitis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18-50 years of age.
  • Patient willing to participate in the study.
  • Mature permanent mandibular first and second molars exhibiting signs of symptomatic irreversible pulpitis as assessed by history, cold and electric pulp tests.
  • Absence of periapical lesions on radiographic examination.

Exclusion Criteria:

  • Patient not ready to participate in the study voluntarily
  • Clinical history or electrocardiographic evidence of heart block, Ischaemic heart disease
  • Asthma, Sleep apnoea syndrome.
  • Impaired liver, renal or mental function.
  • Alcohol consumption in excess of 28 units per week.
  • Chronic sedative and analgesic user and those having known allergy to study drugs
  • Patients with severe periodontal disease.
  • Patients unable to return for recall appointments
  • Signs or symptoms of external /internal resorption, furcation or periapical radiolucency, swelling, or sinus tract.
  • Negative response to cold and electric pulp tests.
  • Antibiotic or analgesic intake within past 24 hours before treatment

Sites / Locations

  • Post Graduate Institute of Dental Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

1.8 ml Lignocaine plus adrenaline

3.6 ml Lignocaine plus adrenaline

1.8 ml Lignocaine plus dexmedetomidine

3.6 ml Lignocaine plus dexmedetomidine

Arm Description

The study subjects will receive conventional inferior alveolar nerve block with 1.8 ml of 2% inj lignocaine with adrenaline 1:80000.

The study subjects will receive conventional inferior alveolar nerve block with 3.6 ml of 2% inj lignocaine with adrenaline 1:80000.

conventional inferior alveolar nerve block with1.8 ml of injection lignocaine plus injection dexmedetomidiene 1micromol/ ml.

conventional inferior alveolar nerve block with3.6 ml of injection lignocaine plus injection dexmedetomidiene 1micromol/ ml.

Outcomes

Primary Outcome Measures

pain intensity
After giving inferior alveolar nerve block as per the standard protocol, conventional access opening will be initiated after isolation with a rubber dam. Patients will be instructed to raise their hand if any pain felt during the procedure and rate the pain on heft parker VAS scale.

Secondary Outcome Measures

Full Information

First Posted
December 29, 2017
Last Updated
January 31, 2018
Sponsor
Postgraduate Institute of Dental Sciences Rohtak
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1. Study Identification

Unique Protocol Identification Number
NCT03415724
Brief Title
Comparison of Anesthetic Efficacy of Dexmedetomidine and Epinephrine With Lidocaine in Irreversible Pulpitis
Official Title
Comparison of Anesthetic Efficacy of Dexmedetomidine and Epinephrine in Combination With 2% Lidocaine for Inferior Alveolar Nerve Block in Patients With Irreversible Pulpitis: A Prospective, Double Blinded, Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2018 (Anticipated)
Primary Completion Date
April 30, 2018 (Anticipated)
Study Completion Date
April 30, 2018 (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
No

5. Study Description

Brief Summary
Aim of the study is to determine and compare the anaesthetic efficacy of dexmedetomidine and epinephrine in combination with 2% lidocaine for inferior nerve block in patients with irreversible pulpitis. Study will be conducted in Post Graduate Institute of Dental Sciences, Rohtak in department of Conservative Dentistry & Endodontics. Vital mature permanent mandibular molars with radiographically exposed dentinal caries and with signs of irreversible pulpitis will be included in the study. The patients will be randomly allocated into two control and two experimental groups and nerve block will be given according to standard protocol.
Detailed Description
AIMS AND OBJECTIVES: To evaluate the efficacy of conventional inferior alveolar nerve block in mandibular molars with symptomatic irreversible pulpitis with injection dexmedetomidine plus injection lignocaine and compare it with injection lignocaine plus adrenaline. MATERIALS AND METHODS - Study subjects will be recruited from OPD of Department of conservative dentistry and endodontics, PGIDS, Rohtak. METHODOLOGY- Prior to treatment, a thorough clinical and radiological examination will be carried out and a thorough history will be taken. Clinical procedure: Mature mandibular permanent molars exhibiting deep caries involving pulp radiographically will be chosen for the study. The teeth will be evaluated by periapical radiographs, periodontal probing, percussion test, and vitality assessment with thermal test and electric pulp test; teeth determined to have irreversible pulpitis will be included and with reversible pulpitis will be excluded. All periapical radiographs will be exposed by using constant kVP, mA, and exposure time (70 KVP, 8 mA, and 0.8 sec.) with a Rinn paralleling device. Study groups: The subjects will be randomly assigned to 2 EXPERIMENTAL AND 2 CONTROL groups. CONTROL GROUP 1 - The study subjects will receive conventional inferior alveolar nerve block with 1.8 ml of 2% inj lignocaine with adrenaline 1:80000. CONTROL GROUP 2 - The study subjects will receive conventional inferior alveolar nerve block with 3.6 ml of 2% inj lignocaine with adrenaline 1:80000. EXPERIMENTAL GROUP 1 - conventional inferior alveolar nerve block with1.8 ml of injection lignocaine plus injection dexmedetomidine 1micromol/ ml. EXPERIMENTAL GROUP 2 - conventional inferior alveolar nerve block with3.6 ml of injection lignocaine plus injection dexmedetomidine 1micromol/ ml. Patients will be explained the treatment procedure and use of pain scales. Patients will mark their pretreatment pain on a 170-mm HP VAS The area of injection will be dried by using sterile gauze, and topical anesthesia of 20% benzocaine (Mucopain; ICPA, Mumbai, India) will be applied by using sterile cotton-tip applicator for 60 seconds. The solution will be injected via a 5-mL disposable syringe (pricon, jodhpur, India) with a 24-gauge needle . The anterior border of the mandibular ramus will be palpated and coronoid notch located. The needle will be inserted on an imaginary line drawn from coronoid notch to the pterygomandibular raphe, 2 mm above the occlusal plane of mandibular molars. The barrel of the syringe will be in the opposite corner of the mouth, between the mandibular premolars. The needle will be inserted until bony resistance felt. After reaching the target area, aspiration will be performed, and the solution will be deposited with a rate of 1 ml/min. No anaesthetic solution will be deposited during needle insertion and placement. Heft-parker visual analogue scale (Heft & Parker 1984), with 170-millimetre line marked with various terms describing the levels of pain, will be used. The millimetre marks will be removed from the scale, and the scale will be divided into 4 categories: 'no pain' corresponding to 0 mm; 'faint, weak or mild' pain corresponding to 1-54 mm; 'moderate' pain corresponding to 55-114 mm; and severe pain corresponding above 114 mm and included 'strong, intense and maximum possible' pain. After 15 minutes, each patient will be asked whether his or her lip is numb. If profound lip numbness is not recorded, the block will be considered unsuccessful, and the patients will be excluded from the study. A conventional access opening will be initiated after isolation with a rubber dam. Patients will be instructed to raise their hand if any pain felt during the procedure. In case of pain during the treatment, the procedure will be stopped, and patients will be asked to rate the pain on HP VAS. The extent of access preparation and/or instrumentation will be recorded as within dentin, within pulpal space, and instrumentation of canals. • Success will be defined as no pain or weak/mild pain during endodontic access preparation and instrumentation

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1.8 ml Lignocaine plus adrenaline
Arm Type
Active Comparator
Arm Description
The study subjects will receive conventional inferior alveolar nerve block with 1.8 ml of 2% inj lignocaine with adrenaline 1:80000.
Arm Title
3.6 ml Lignocaine plus adrenaline
Arm Type
Active Comparator
Arm Description
The study subjects will receive conventional inferior alveolar nerve block with 3.6 ml of 2% inj lignocaine with adrenaline 1:80000.
Arm Title
1.8 ml Lignocaine plus dexmedetomidine
Arm Type
Active Comparator
Arm Description
conventional inferior alveolar nerve block with1.8 ml of injection lignocaine plus injection dexmedetomidiene 1micromol/ ml.
Arm Title
3.6 ml Lignocaine plus dexmedetomidine
Arm Type
Active Comparator
Arm Description
conventional inferior alveolar nerve block with3.6 ml of injection lignocaine plus injection dexmedetomidiene 1micromol/ ml.
Intervention Type
Procedure
Intervention Name(s)
Inferior alveolar nerve block
Intervention Description
Inferior alveolar nerve block will be given to patients having irreversible pulpitis in mandibular molars
Primary Outcome Measure Information:
Title
pain intensity
Description
After giving inferior alveolar nerve block as per the standard protocol, conventional access opening will be initiated after isolation with a rubber dam. Patients will be instructed to raise their hand if any pain felt during the procedure and rate the pain on heft parker VAS scale.
Time Frame
The root canal treatment will be completed in two sittings and the second sitting will be provided after 3-4 days.The time frame of the study is estimated to be about 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18-50 years of age. Patient willing to participate in the study. Mature permanent mandibular first and second molars exhibiting signs of symptomatic irreversible pulpitis as assessed by history, cold and electric pulp tests. Absence of periapical lesions on radiographic examination. Exclusion Criteria: Patient not ready to participate in the study voluntarily Clinical history or electrocardiographic evidence of heart block, Ischaemic heart disease Asthma, Sleep apnoea syndrome. Impaired liver, renal or mental function. Alcohol consumption in excess of 28 units per week. Chronic sedative and analgesic user and those having known allergy to study drugs Patients with severe periodontal disease. Patients unable to return for recall appointments Signs or symptoms of external /internal resorption, furcation or periapical radiolucency, swelling, or sinus tract. Negative response to cold and electric pulp tests. Antibiotic or analgesic intake within past 24 hours before treatment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
shreya singh
Phone
9896326782
Email
shreya.redhu@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
shweta mittal
Phone
9255596960
Email
shwetagoelendo@gmail.com
Facility Information:
Facility Name
Post Graduate Institute of Dental Sciences
City
Rohtak
State/Province
Haryana
ZIP/Postal Code
124001
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparison of Anesthetic Efficacy of Dexmedetomidine and Epinephrine With Lidocaine in Irreversible Pulpitis

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