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Effectiveness of Buccal Infiltration During Vital Pulpotomy After Administering Two Analgesic Premedications

Effect of Preoperative Oral Administration of Ibuprofen and Acetaminophen on the Anesthetic Efficacy of Buccal Infiltration During Vital Pulpotomy of Mandibular Primary Molars: A Prospective, Double-blinded, Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03423329
Enrollment
60
Registered
2018-02-06
Start date
2018-01-20
Completion date
2018-04-25
Last updated
2018-11-15

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

Conditions

Anesthesia, Local

Brief summary

This Randomized study was designed to assess and compare the effect of two analgesic premedications (Ibuprofen BP 100 mg/5 ml and Paracetamol 200 mg/5ml.) on the anesthetic efficacy of buccal infiltration in vital pulpotomy of primary mandibular molars in children . A multivitamin with the same color as the twp tested medications will be administered to children in the control group. Parents of eligible children will be informed about the nature of the procedure, the purpose of the study, any possible discomfort or risks and a signed informed consent will be obtained from them prior to enrollment.

Detailed description

A total of 60 healthy children will be recruited from the outpatient clinic of the Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Ain Shams University. Inclusion Criteria include: age group 7-9 years Without systemic or mental disorders. Who could be categorized as cooperative according to Wright's classification for child behavior Ability of child to understand the use of pain scales; Having at least one lower second primary molar with deep caries indicated for pulpotomy; Absence of any periapical or furcation radiolucency on radiographs, Absence of any signs of internal or external resorption on radiographs, A vital coronal pulp on access opening. . Patients who had taken analgesics within 12 hours before administration of the study drugs or those having active pain, pulpitis or abscess related to the designated mandibular molar will not be included. To ensure randomization and allocation concealment, children will be randomly assigned to the three groups using computer-generated numbers. One operator will do pulpotomy for all participants and to ensure blinding, another author ( will give the premedication to children.Pain during pulpotomy will be assessed using Wong Baker FACES pain assessment tool.

Interventions

DRUGBrufen

Brufen Syrup

DRUGCital

Cital Cyrup

DRUGPlacebo for Brufen

Sansovit Syrup

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
7 Years to 9 Years
Healthy volunteers
Yes

Inclusion criteria

1. age group 7-9 years 2. Patients medically free. 3. Patients who can be categorized as cooperative or potentially cooperative according to Wright's classification for child behavior 4. Patients able to understand the use of pain scales; 5. Having at least one lower second primary molar with deep caries indicated for pulpotomy; 6. A vital coronal pulp on access opening of designated molar.

Exclusion criteria

1. Patients with allergic reactions, sensitivity, or contraindications to any tested drugs 2. Patients who had taken analgesics within 12 hours before administration of the study drugs 3. Patients having active pain, pulpitis or abscess related to the designated mandibular molar. 4. Children with special health care needs or any systemic problems 5. Presence of periapical or furcation radiolucency on radiographs in relation to designated molar 6. Presence of of any signs of internal or external resorption on radiographs in relation to designated molar

Design outcomes

Primary

MeasureTime frameDescription
Pain/discomfort felt during vital pulpotomy of mandibular second primary molars75 minutes after drug administrationUsing Wong Baker FACES pain assessment tool Children will be asked to rate any pain felt during coronal access

Other

MeasureTime frameDescription
Pain /discomfort in carious mandibular primary second molarJust before drug administrationUsing Wong Baker FACES pain assessment tool Children will be asked to rate any pain felt in designated molar before treatment

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026