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

NCT ID: NCT03423329

Last Updated: 2018-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-20
• Study Completion Date: 2018-04-25

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.

Conditions

Anesthesia, Local

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Group A

Intervention:Drug: Brufen & Placebo

Brufen syrup 10 ml, once, 1 hour before local anesthesia

Group Type: EXPERIMENTAL

Brufen

Intervention Type: DRUG

Brufen Syrup

Placebo for Brufen

Intervention Type: DRUG

Sansovit Syrup

Group B

Intervention: Drug: Cital and Placebo

Cital Syrup 10 ml, once 1 hour before Local anesthesia

Group Type: EXPERIMENTAL

Cital

Intervention Type: DRUG

Cital Cyrup

Placebo for Brufen

Intervention Type: DRUG

Sansovit Syrup

Group C

Intervention: Drug: Placebo

Other names:

(Placebo for Brufen) (Placebo for Cital)

Sansovit Iron Multivitamin syrup, an orange-coloured, orange-flavoured

Group Type: PLACEBO_COMPARATOR

Brufen

Intervention Type: DRUG

Brufen Syrup

Cital

Intervention Type: DRUG

Cital Cyrup

Placebo for Brufen

Intervention Type: DRUG

Sansovit Syrup

Interventions

Brufen

Brufen Syrup

Intervention Type: DRUG

Cital

Cital Cyrup

Intervention Type: DRUG

Placebo for Brufen

Sansovit Syrup

Intervention Type: DRUG

Other Intervention Names

Advil; Nurfen; Paramol; Placebo for Cital

Eligibility Criteria

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Reham Abou El Fadl

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Reham Abou El Fadl, DDS

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

Faculty of Dentistry Ain Shams University

Cairo, Other, Egypt

Countries

Egypt

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

FDASU-REC R 071607

Identifier Type: -

Identifier Source: org_study_id