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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT03225326
Date of registration:	17/07/2017
Prospective Registration:	No
Primary sponsor:	University of Belgrade
Public title:	Effects of Articaine Computer-controlled and Conventional Delivery for Anterior and Middle Superior Alveolar Nerve Block for Tooth Extraction
Scientific title:	Efficacy of Anterior and Middle Superior Alveolar (AMSA) Nerve Block Anesthesia Obtained by Articaine Computer-controlled and Conventional Delivery
Date of first enrolment:	December 2016
Target sample size:	0
Recruitment status:	Withdrawn
URL:	https://clinicaltrials.gov/show/NCT03225326
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
Phase:	Phase 4

Countries of recruitment
Serbia

Contacts

Name:	Vladimir Biocanin, Assistant Professor
Address:
Telephone:
Email:
Affiliation:	Faculty of Pharmacy and Health, University of Travnik, Bosnia and Herzegovina

Name:	Marija Milic, Research Associate
Address:
Telephone:
Email:
Affiliation:	School of Dental Medicine, University of Belgrade

Key inclusion & exclusion criteria

Inclusion Criteria:

- ASA 1

- maxillary incisors canines or premolars indicated for extraction due to periapical
pathology, root fracture or orthodontic treatment

Exclusion Criteria:

- allergies to local anesthetic solution ingredients, food and drugs

- alcohol and drugs abuse

- heavy tobacco smoking

Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Local Anesthesia

Intervention(s)

Drug: Conventional 4% articaine delivery by carpule syringe

Drug: Computer controlled 4% articaine delivery by Anaeject

Primary Outcome(s)

Success of Pulpal Anesthesia for Lateral Incisive [Time Frame: after 1 hour]

Success of Pulpal Anesthesia for First Premolar [Time Frame: after 1 hour]

Success of Pulpal Anesthesia for Canine [Time Frame: after 1 hour]

Success of Pulpal Anesthesia for Central Incisive [Time Frame: after 1 hour]

Success of Pulpal Anesthesia for Second Premolar [Time Frame: after 1 hour]

Secondary Outcome(s)

Diastolic blood pressure at 30th minute [Time Frame: 30th minute]

Heart rate at 5th minute [Time Frame: 5th minute]

Diastolic blood pressure at 15th minute [Time Frame: 15th minute]

Onset Canine [Time Frame: up to 8 minutes]

Duration Canine [Time Frame: up to 60 minutes]

Systolic blood pressure at 30th minute [Time Frame: 30th minute]

Onset First Premolar [Time Frame: up to 8 minutes]

Diastolic blood pressure at 10th minute [Time Frame: 10th minute]

Duration Central Incisive [Time Frame: up to 60 minutes]

Onset Central Incisive [Time Frame: up to 8 minutes]

Onset Lateral Incisive [Time Frame: up to 8 minutes]

Onset Second Premolar [Time Frame: up to 8 minutes]

Systolic blood pressure [Time Frame: baseline]

Duration First Premolar [Time Frame: up to 60 minutes]

Duration Lateral Incisive [Time Frame: up to 60 minutes]

Heart rate at 10th minute [Time Frame: 10th minute]

Diastolic blood pressure [Time Frame: baseline]

Diastolic blood pressure at 5th minute [Time Frame: 5th minute]

Heart rate at 15th minute [Time Frame: 15th minute]

Heart rate at 30th minute [Time Frame: 30th minute]

Duration Second Premolar [Time Frame: up to 60 minutes]

Heart rate [Time Frame: baseline]

Systolic blood pressure at 10th minute [Time Frame: 10th minute]

Systolic blood pressure at 15th minute [Time Frame: 15th minute]

Systolic blood pressure at 5th minute [Time Frame: 5th minute]

Secondary ID(s)

UBelgrade 784/2

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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