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Young patients' perceptions of intra bony local anesthetics and their usefulness in treating lower molars with pulp therapy and crowns

Pain-related behavior, perception, and effectiveness of intraosseous local anesthesia (Quicksleeper 5®) in pulpotomies and stainless steel crowns of mandibular primary molars: a randomized controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN14600773
Enrollment
53
Registered
2023-10-02
Start date
2023-02-01
Completion date
Unknown
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intraosseous local anesthesia and its effectiveness in treating lower molars for pulp therapy and crowns Oral Health

Interventions

Current interventions as of 22/11/2024: part1 This study will include a total of 33 patients who fulfilled the inclusion criteria. Each patient will receive either intraosseous (IO) anesthesia using

Sponsors

King Saud University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 22/11/2024: 1. Aged 4-9 years 2. Physically and mentally healthy 3. Positive or definitely positive behavior, assessed by taking the history of the patient; if the patient has no previous dental treatment, a treatment will be provided to the patient to assess the behavior 3. No contraindication for the use of local anesthesia 4. Not taking any analgesic before the appointment for at least 48 hours 5. No infection or inflammation on either side of the lower arch 6. Two lower second primary molars indicated for pulpotomy and SSC, i.e.: 6.1. No history of spontaneous or persistent pain 6.2. No pathological mobility 6.3. No tenderness to percussion 6.4. No swelling or sinus tract 6.5. No widening of the periodontal ligament space 6.6. Restorable tooth _____ Previous inclusion criteria: 1. Aged 5-9 years 2. Physically and mentally healthy 3. Positive or definitely positive behavior, assessed by taking the history of the patient; if the patient has no previous dental treatment, a treatment will be provided to the patient to assess the behavior 3. No contraindication for the use of local anesthesia 4. Not taking any analgesic before the appointment for at least 48 hours 5. No infection or inflammation on either side of the lower arch 6. Two lower second primary molars indicated for pulpotomy and SSC, i.e.: 6.1. No history of spontaneous or persistent pain 6.2. No pathological mobility 6.3. No tenderness to percussion 6.4. No swelling or sinus tract 6.5. No widening of the periodontal ligament space 6.6. Restorable tooth

Exclusion criteria

Exclusion criteria: 1. Physical or mental illness 2. Definitely negative or negative behavior 3. Presence of contraindication for using local anesthesia 4. Presence of infection or inflammation on either side of the lower arch 5. History of spontaneous or persistent pain 6. Pathological mobility 7. Tenderness to percussion 8. Swelling or sinus tract 9. Widening of the periodontal ligament space 10. Nonrestorable tooth

Design outcomes

Primary

MeasureTime frame
1. Pain-related behavior: 5 different behaviors (present or absent) measured every 15 seconds 2. Pain perception: Wong baker Scale. The patient will be asked once after giving the LA. (added 22/11/2024) 3. The effectiveness of LA: (sound, Eye, Motor Scale). The blinded evaluators will evaluate the scores in 7 steps during the procedure, then the mean score will be taken

Secondary

MeasureTime frame
Current secondary outcome measures as of 22/11/2024: 1. Complications of intraosseous local anesthesia: patient's parents will be contacted after 2 - 4 hours after the procedure and will be asked standard questions Eligibility _____ Previous secondary outcome measures: 1. The effectiveness of LA: (sound, Eye, Motor Scale). The blinded evaluators will evaluate the scores in 7 steps during the procedure, then the mean score will be taken 2. Complications of intraosseous local anesthesia: patient's parents will be contacted after 2 - 4 hours after the procedure and will be asked standard questions

Countries

Saudi Arabia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026