Comparison of Anesthetic Efficacy of Dexmedetomidine and Epinephrine With Lidocaine in Irreversible Pulpitis
1 other identifier
interventional
100
1 country
1
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.
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 Feb 2018
Shorter than P25 for not_applicable
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
First Submitted
Initial submission to the registry
December 29, 2017
CompletedFirst Posted
Study publicly available on registry
January 30, 2018
CompletedStudy Start
First participant enrolled
February 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2018
CompletedFebruary 1, 2018
January 1, 2018
3 months
December 29, 2017
January 31, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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.
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
Study Arms (4)
1.8 ml Lignocaine plus adrenaline
ACTIVE COMPARATORThe study subjects will receive conventional inferior alveolar nerve block with 1.8 ml of 2% inj lignocaine with adrenaline 1:80000.
3.6 ml Lignocaine plus adrenaline
ACTIVE COMPARATORThe study subjects will receive conventional inferior alveolar nerve block with 3.6 ml of 2% inj lignocaine with adrenaline 1:80000.
1.8 ml Lignocaine plus dexmedetomidine
ACTIVE COMPARATORconventional inferior alveolar nerve block with1.8 ml of injection lignocaine plus injection dexmedetomidiene 1micromol/ ml.
3.6 ml Lignocaine plus dexmedetomidine
ACTIVE COMPARATORconventional inferior alveolar nerve block with3.6 ml of injection lignocaine plus injection dexmedetomidiene 1micromol/ ml.
Interventions
Inferior alveolar nerve block will be given to patients having irreversible pulpitis in mandibular molars
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Post Graduate Institute of Dental Sciences
Rohtak, Haryana, 124001, India
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 29, 2017
First Posted
January 30, 2018
Study Start
February 1, 2018
Primary Completion
April 30, 2018
Study Completion
April 30, 2018
Last Updated
February 1, 2018
Record last verified: 2018-01
Data Sharing
- IPD Sharing
- Will not share