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Completed

NCT Number: NCT06201949

Articaine Infiltration in Anesthetizing Mandibular Second Primary Molars

Background: Articaine hydrochloride has steadily grown in popularity, and studies have shown that articaine hydrochloride performs better than lidocaine due to an enhanced anes-thetic efficacy. The most common technique to anesthetize mandibular primary teeth is in-ferior alveolar nerve block (IANB) which induces a relatively sustained anesthesia and in turn may potentially traumatize soft-tissues. Therefore, the need of having an alternative technique of anesthesia with a shorter term but the same efficacy is reasonable.

Aim: Evaluating The effectiveness of Articaine infiltration versus conventional inferior al-veolar nerve block in anesthetizing the second primary mandibular molars during pulpoto-my procedure.

Materials and Methods: The study will be two-arm randomized controlled clinical trial, parallel design and it will be setup and reported according the CONSORT guidelines. A total of 52 healthy children aged 5-6 years, will be selected from Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Alexandria University, Egypt. Children will be selected with scores 3 or 4 according to Frankl behavioral rating scale. Each child selected will have at least one mandibular second primary molar that is indicat-ed for pulpotomy. Written informed consent will be obtained from guardian. Participants will be randomly and equally allocated to one of the two arms into two groups according to the technique of anesthesia that will be used.

Group I (Experimental group n =26) assigned to articaine infiltration anesthesia, while group II (Control group n = 26) assigned to the conventional IANB injection articaine.

Pain will be assessed by three diferent methods: physiological method using the Heart rate as vital parameter of pain, and will be recorded at base line, during injection, pulpotomy and stainless steel crown (SSC) preparation. Objective method using Sensory, Eye, Motor (SEM) scale, and subjective method where the pain will be evaluated by asking the child to express his experience using a modified face scale from the Maunuksela scale

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Key information

Conditions

Anesthesia, Local

Age range

5 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alexandria Faculty of Dentistry

Alexandria, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Positive or definitely positive behavior during preoperative assessments according to the Frankl's behavior ratings III and IV.
  • Patients whose mandibular second primary molars are indicated for pulpotomy according to the AAPD.
  • Patients whose parents will give their consent to participate

Exclusion criteria

  • Children with any systemic disease or special health care.
  • History of allergy to local anesthesia.
  • Radiographic evidence of periapical or inter-radicular radiolucency
  • Patients with previous negative dental experience.
  • Presence of soft tissue lesions at the site of injection.

Treatment and study plan

Articaine infiltration technique

Other

infiltration will be performed with articaine and epinephrine 1/100 000 (Artinibsa, Inibsa, Barcelona, Spain) for all patients on their second pri-mary molar. The needle tip was placed in the buccal vestibule and then directed to the apex of the tooth and about one-third to one-fourth of the cartridge will be slowly discharged

Articaine nerve block technique

Other

this technique will be performed with articaine and epinephrine 1/100 000 for all patients on their second primary molar with conventional technique inferior alveolar nerve block. The thumb will be placed on the occlusal surface of intended side and protruded toward the inner oblique ridge of ramus and then placed in touch with retromolar pad. The syringe will be directed between the two mandibular primary molars of opposite side and the needle will be pushed forward until hitting the bone, then the injection will be slowly done. After three to five minutes, treatment will be started, after numbness in the lower lip is achieved

Primary outcomes

  1. change in heart rate

    Time frame: During procedure

    Heart rate (HR) is a physiological sign of pain.(30) It will be measured using a pulse oximeter.

  2. change in pain level

    Time frame: During procedure

    Sound, Eye, Motor (SEM) Scale(31) (Appendix III), will used as an ob-jective method for pain assessment during LA administration, pulpo-tomy and SSC. It comprises the following parameters: (1) Sound, (2) Eye, (3) Motor. For each child, the sounds, eye symptoms and body movements will be evaluated independently by a blind impartial ob-server using the recorded video tapes. The slightest manifestation of the sound, eyes, or motion of the patient is graded in four levels: com-fort, mild, moderate, and severe discomfort, and subsequently given grades 1, 2, 3, 4, respectively. SEM score will be calculated by sum-ming the three grades of the parameters.

Secondary outcomes

  1. Adevrse events

    Time frame: After 24 hours

    The presence of any adverse events including infection, oral/tooth pain, patients will be seen after 24 hours to detect any lip/cheek biting and parasethia

Sponsors and collaborators

Lead sponsor

Hams Hamed Abdelrahman

Other

Registry information

Official study title

Efficacy of Articaine Infiltration in Anesthetizing Mandibular Second Primary Molars During Pulpotomy Procedure (Randomized Clinical Trial)

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 11, 2024
Registry last updated
Jan 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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