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

NCT03423329 | Completed

• 1 other identifier: FDASU-REC R 071607
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia, Local

Outcome Measures

Primary Outcomes (1)

• Pain/discomfort felt during vital pulpotomy of mandibular second primary molars

  Using Wong Baker FACES pain assessment tool Children will be asked to rate any pain felt during coronal access

  75 minutes after drug administration

Other Outcomes (1)

• Pain /discomfort in carious mandibular primary second molar

  Just before drug administration

Study Arms (3)

Group A

EXPERIMENTAL

Intervention:Drug: Brufen \& Placebo Brufen syrup 10 ml, once, 1 hour before local anesthesia

Drug: Brufen; Drug: Placebo for Brufen

Group B

EXPERIMENTAL

Intervention: Drug: Cital and Placebo Cital Syrup 10 ml, once 1 hour before Local anesthesia

Drug: Cital; Drug: Placebo for Brufen

Group C

PLACEBO COMPARATOR

Intervention: Drug: Placebo Other names: (Placebo for Brufen) (Placebo for Cital) Sansovit Iron Multivitamin syrup, an orange-coloured, orange-flavoured

Drug: Brufen; Drug: Cital; Drug: Placebo for Brufen

Interventions

Brufen DRUG

Brufen Syrup

Also known as: Advil, Nurfen

Group A; Group C

Cital DRUG

Cital Cyrup

Also known as: Paramol

Group B; Group C

Placebo for Brufen DRUG

Sansovit Syrup

Also known as: Placebo for Cital

Group A; Group B; Group C

Eligibility Criteria

• Age: 7 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Dentistry Ain Shams University

Cairo, Other, 11341, Egypt

Location

MeSH Terms

Interventions

Ibuprofen; Acetaminophen

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Study Officials

• Reham Abou El Fadl, DDS

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 28, 2017
• First Posted: February 6, 2018
• Study Start: January 20, 2018
• Primary Completion: April 25, 2018
• Study Completion: April 25, 2018
• Last Updated: November 15, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Within one month after study completion

Locations

EG (1)