Irreversible PulpitisNCT03415724
Comparison of Anesthetic Efficacy of Dexmedetomidine and Epinephrine With Lidocaine in Irreversible Pulpitis
A study testing Inferior alveolar nerve block in people with Irreversible Pulpitis, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Irreversible Pulpitis
- What is being tested?
- Inferior alveolar nerve block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- 1 Feb 2018to 30 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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
- Conditions
- Irreversible Pulpitis
- Being tested
- Inferior alveolar nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inferior alveolar nerve blockProcedure or surgery
Inferior alveolar nerve block will be given to patients having irreversible pulpitis in mandibular molars
| Study group | Role | What they receive |
|---|---|---|
| 1.8 ml Lignocaine plus adrenaline | Active comparator | The study subjects will receive conventional inferior alveolar nerve block with 1.8 ml of 2% inj lignocaine with adrenaline 1:80000. Receives: Procedure: Inferior alveolar nerve block |
| 3.6 ml Lignocaine plus adrenaline | Active comparator | The study subjects will receive conventional inferior alveolar nerve block with 3.6 ml of 2% inj lignocaine with adrenaline 1:80000. Receives: Procedure: Inferior alveolar nerve block |
| 1.8 ml Lignocaine plus dexmedetomidine | Active comparator | conventional inferior alveolar nerve block with1.8 ml of injection lignocaine plus injection dexmedetomidiene 1micromol/ ml. Receives: Procedure: Inferior alveolar nerve block |
| 3.6 ml Lignocaine plus dexmedetomidine | Active comparator | conventional inferior alveolar nerve block with3.6 ml of injection lignocaine plus injection dexmedetomidiene 1micromol/ ml. Receives: Procedure: Inferior alveolar nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2018
- Study start1 Feb 2018 (estimated)
- Primary completion30 Apr 2018 (estimated)
- Study completion30 Apr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irreversible PulpitisStudies of the same condition, open and under way.
- More trials run by Postgraduate Institute of Dental Sciences RohtakThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03415724
- Sponsor's protocol ID
- Shreya singh
- Status last verified
- Jan 2018
- First submitted
- 29 Dec 2017
- Last updated
- 1 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03415724
- Acronym / sponsor ID
- Shreya singh
- Conditions
- Irreversible Pulpitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 1 Feb 2018 (estimated)
- Primary completion
- 30 Apr 2018 (estimated)
- Study completion
- 30 Apr 2018 (estimated)
- First posted
- 30 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1.8 ml Lignocaine plus adrenaline | Active comparator | Procedure: Inferior alveolar nerve blockThe 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 comparator | Procedure: Inferior alveolar nerve blockThe 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 comparator | Procedure: Inferior alveolar nerve blockconventional inferior alveolar nerve block with1.8 ml of injection lignocaine plus injection dexmedetomidiene 1micromol/ ml. |
| 3.6 ml Lignocaine plus dexmedetomidine | Active comparator | Procedure: Inferior alveolar nerve blockconventional inferior alveolar nerve block with3.6 ml of injection lignocaine plus injection dexmedetomidiene 1micromol/ ml. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inferior alveolar nerve blockInferior alveolar nerve block will be given to patients having irreversible pulpitis in mandibular molars | Procedure or surgery | 1.8 ml Lignocaine plus adrenaline, 1.8 ml Lignocaine plus dexmedetomidine, 3.6 ml Lignocaine plus adrenaline, 3.6 ml Lignocaine plus dexmedetomidine |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inferior alveolar nerve block in people with Irreversible Pulpitis, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact shreya singh (9896326782, shreya.redhu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2018.