Injection pain and anesthetic efficacy between buccal infiltration and either palatal infiltration or intraseptal injection in young permanent maxillary molar with deep caries in children: a non-inferiority randomized controlled trial

Phase 2

Recruiting

• Conditions: Deep carious lesion with pulpitis

• Registration Number: TCTR20201002008
• Lead Sponsor: Faculty of Dentistry, Chiang Mai University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-02
• Study Completion: 2021-10-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

Patient inclusion criteria
1.Patients aged between 6â€18 years old with the American Society of Anesthesiologists I or II (ASA I or II)
2.Patients with no history of allergy to articaine or other anesthetic compounds such as epinephrine
3.Patients do not take any drugs that affect pain perception on the day of treatment 4 hours prior, such as analgesic drugs, non-steroidal anti-inflammatory drugs (NSAIDs).
4.Cooperative pediatric patients (Frankl behavior rating scale 3 and 4) and can communicate
5.Patients and parents agree to participate in the study.

Tooth inclusion criteria
Pre-operative clinical inclusion criteria
1. Permanent maxillary first molar with deep carious lesion
2. Tooth responds positively to the sensibility test by cold test and diagnosed with normal pulp, initial pulpitis, mild pulpitis, moderate pulpitis or severe pulpitis.
3. Tooth has no signs of pulp necrosis such as clinical swelling, pus exudate, or fistula of soft and periodontal tissues
4. Tooth has no abnormal tooth mobility

Intra-operative clinical inclusion criteria
1. Both exposed and non-exposed teeth after non-selective caries removal are included.
2. In the case of pulpal exposed teeth, the pulp tissues must be vital judging by its bleeding and pulp tissue appearance
3. Pulpal bleeding must be controlled within 10 minutes.

Radiographic inclusion criteria
1. From bitewing radiographs, the carious lesion must be deeper than 3/4 of the dentin thickness.
2. From paralleled periapical radiographs, there are no prominent radiolucency at the furcation or periapical regions, internal root resorption, or pathologic external root resorption, and absence of calcification or pulp canal obliteration.

Exclusion Criteria

Patient exclusion criteria
1. Patients with underlying diseases that are contraindicated for vital pulp therapy
2. Patients with history of allergy to articaine or other anesthetic compounds such as epinephrine
3. Patients take any drugs that affect pain perception on the day of treatment 4 hours prior
4. Patients who cannot distinguish the sensation of pulpal tissue proved by sham test
5. Uncooperative pediatric patients (Frankl behavior rating scale 1 and 2)
6. Patients and parents deny participation in the study.

Tooth exclusion criteria
Pre-operative clinical inclusion criteria
1. Tooth with clinically diagnosis of pulp necrosis
2. Tooth has no respond to the sensibility test by cold test
3. Tooth cannot be restored by a resin composite restoration or stainless-steel crown
4. Tooth with history of clinical swelling, pus exudate, or fistula of soft and periodontal tissues
5. Tooth that does not have soft or pulp tissue? anesthesia after 10 minutes following buccal infiltration
Intra-operative clinical inclusion criteria
6. Uncontrollable bleeding from exposure site for more than 10 minutes
7. Pale color of pulp tissue or absence of bleeding suggesting pulp necrosis
8. Pulpal bleeding with dark colored blood suggesting high pulpal inflammation rate

Radiographic exclusion criteria
1. Bitewing radiographs, the carious lesion is less than 3/4 of the dentin thickness.
2. Paralleled periapical radiograph, there are prominent radiolucency at the furcation or periapical regions, internal root resorption, pathologic external root resorption, calcification, or pulp canal obliteration.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Injection pain Immediately after injection Wong-Baker FACES® Pain Rating Scale

Secondary Outcome Measures

Name	Time	Method
Preoperative pulpal anesthesia 3, 6 minute after palatal or intraseptal injection Cold test,Intraoperative pulpal anesthesia during treatment Wong-Baker FACES® Pain Rating Scale