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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
TCTR
Registry ID
TCTR20200609003
Enrollment
204
Registered
2020-06-09
Start date
2020-06-09
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Vital deep carious mandibular molars which response positive to cold test. The molars are diagnosed as normal pulp&#44

Interventions

inferior alveolar nerve block with 4% Articaine with 1:100&#44
000 epinephrine 3/4 cartridge supplemented by buccal infiltration alone with 4% Articaine with 1:100&#44
000 epinephrine 3/4 cartridge,inferior alveolar nerve block with 4% Articaine with 1:100&#44
000 epinephrine 1/4 cartridge and intraseptal injection with 4% Articaine with 1:100&#44
000 epinephrine 2/4 cartridge
Active Comparator Procedure/Surgery,Active Comparator Procedure/Surgery
supplementary buccal infiltration alone to inferior alveolar nerve block,a combination of supplementary intraseptal and buccal infiltration to inferior alveolar nerve block

Sponsors

Faculty of Dentistry, Chiang Mai University
Lead Sponsor
Faculty of Dentistry&#44
Collaborator
Chiang Mai University
Collaborator

Eligibility

Sex/Gender
All
Age
6 Years to 18 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
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

Countries

Thailand

Contacts

Public ContactChanika Manmontri

Faculty of Dentistry, Chiang Mai University

chanika.m@cmu.ac.th011-66-53-944460

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026