Pulpal anesthetic efficacy of a combination of supplementary intraseptal and buccal infiltration in young permanent mandibular molars with deep caries: a superiority randomized controlled trial

Not Applicable

• Conditions: Vital deep carious mandibular molars which response positive to cold test.The molars are diagnosed as normal pulp, initial, mild, moderate or severe pulpitis.Radiographically, the caries extended; Anesthesia, Dental; Dental Pulp Diseases; Articaine; Nerve block

• Registration Number: TCTR20200609003
• Lead Sponsor: Faculty of Dentistry, Chiang Mai University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-09
• Study Completion: 2021-08-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 204

Inclusion Criteria

1)healthy children (ASA-I, ASA-II) aged between 6-18 years with minimum weight at 20 kg,
2)the children are not allergic to Articaine or other component of the anesthetic agent used in this study
3)the children’s behavior are rated as positive (3, +) or definitely positive (4, ++) according to the Frankl behavior rating scale
4)the children do not take any analgesic drugs or non-steroidal anti-inflammatory drugs prior to treatment on the day of treatment
5)Vital permanent molars of the included children have deep caries with a depth at least ¾ of dentin thickness
6)the molars are judged to be vital due to respond positively to cold test
7)the molars are restorable
8)the molars have normal surrounding periodontal tissue including their mesial and distal interdental papilla
9)the molars have no abnormal tooth mobility
10)radiographically, the molars should have normal root and periapical region, however, the molars can have early periapical lesions such as widening PDL space, condensing osteitis

Exclusion Criteria

1)children who have diseases which are contraindicated for vital pulp therapy
2)children who report positive to sham test
3)children who do not want to, or their parents do not agree to, participate in the study
4)Failed inferior alveolar nerve block pre-operatively, as shown by no lips or tongue numbness occur at 15 minutes after injection
5)The molars have no vital pulp tissue, as shown when enter into the pulp intra-operatively

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
intra-operatively pulpal anethetic efficacy caries removal, pulp exposure, pulp removal, pulp dressing material placement, restoring the tooth Wong Baker Faces Pain Scale

Secondary Outcome Measures

Name	Time	Method
Pre-operatively pulpal anethetic efficacy after inferior alvelolar nerve block and after supplemental injections Cold test,Pre-operatively pulpal anethetic efficacy after inferior alvelolar nerve block and after supplemental injections Cold test