- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03415724
Comparison of Anesthetic Efficacy of Dexmedetomidine and Epinephrine With Lidocaine in Irreversible Pulpitis
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 Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: shreya singh
- Phone Number: 9896326782
- Email: shreya.redhu@gmail.com
Study Contact Backup
- Name: shweta mittal
- Phone Number: 9255596960
- Email: shwetagoelendo@gmail.com
Study Locations
-
-
Haryana
-
Rohtak, Haryana, India, 124001
- Post Graduate Institute of Dental Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: 1.8 ml Lignocaine plus adrenaline
The study subjects will receive conventional inferior alveolar nerve block with 1.8 ml of 2% inj lignocaine with adrenaline 1:80000.
|
Inferior alveolar nerve block will be given to patients having irreversible pulpitis in mandibular molars
|
ACTIVE_COMPARATOR: 3.6 ml Lignocaine plus adrenaline
The study subjects will receive conventional inferior alveolar nerve block with 3.6 ml of 2% inj lignocaine with adrenaline 1:80000.
|
Inferior alveolar nerve block will be given to patients having irreversible pulpitis in mandibular molars
|
ACTIVE_COMPARATOR: 1.8 ml Lignocaine plus dexmedetomidine
conventional inferior alveolar nerve block with1.8
ml of injection lignocaine plus injection dexmedetomidiene 1micromol/ ml.
|
Inferior alveolar nerve block will be given to patients having irreversible pulpitis in mandibular molars
|
ACTIVE_COMPARATOR: 3.6 ml Lignocaine plus dexmedetomidine
conventional inferior alveolar nerve block with3.6 ml of injection lignocaine plus injection dexmedetomidiene 1micromol/ ml.
|
Inferior alveolar nerve block will be given to patients having irreversible pulpitis in mandibular molars
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pain intensity
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
|
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
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Shreya singh
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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