Evaluation of Post-operative Pain After Vital Pulpotomy in Primary Molars Using Allium Sativum Oil Versus MTA

NCT03908489 | Unknown

• 1 other identifier: 1441989
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

Preservation of the remaining vital portion of curiously exposed pulpal tissue in primary teeth, was one of the most frequent problems in pediatric dentistry. To solve this problem, pulpotomy therapy was introduced. Pulpotomy involves amputation of the coronal portion of affected or infected dental pulp, treatment of the remaining vital radicular pulp tissue surface should preserve the vitality and function of all or part of the remaining radicular portion of the pulp. Furthermore, it is an accepted procedure for treating both primary and permanent teeth with carious pulp exposures, several materials have been using for capping the radicular pulp after pulpotomy, these included formocresol, glutaraldehyde, ferric sulfate, and mineral trioxide aggregate. Allium sativum is one of the most extensively researched medical plants and its antibacterial activity depends on allicin produced by the enzymatic activity of allinase (a cysteine sulfoxide lyase). Allicin and other thiosulfinates are believed to be responsible for the range of therapeutic effects reported for garlic. Garlic extract has been reported to inhibit growth of various gram-positive and gram-negative bacteria. Previous studies showed that A. sativum oil is used as new pulp medications and it offers a good healing potential, leaving the remaining pulp tissue healthy and functioning. MTA is a unique material with various advantages. It has been used successfully by pediatric dentists in a variety of clinical applications. However, its drawbacks especially its high cost, discoloration potential, difficulty in handling, and long setting time.

Conditions

Deep Caries

Outcome Measures

Primary Outcomes (3)

• post- operative Pain ( Spontaneous or on biting):

  Pain ( Spontaneous or on biting) using visual analogue scale range from (0 -10) (0) No pain (10) the worst pain condition

  3 months

• post-operative pain (spontaneous or on bitting): visual analogue scale

  pain (spontaneous or on bitting) using visual analouge scale range from (0 -10) (0) No pain (10) the worst pain condition

  at 6 months

• post- operative Pain ( Spontaneous or on biting): visual analogue scale

  pain (spontaneous or on bitting) using visual analogue scale. range from (0 -10) (0) No pain (10) the worst pain condition

  at 9 months

Secondary Outcomes (21)

• periapical radiolucency

  3 months

• periapical radiolucency

  6 months

• periapical radiolucency

  at 9 months

• Pathologic internal or external root resorption

  3 months

• Pathologic internal or external root resorption

  6 months

Study Arms (2)

intervention we want to test vital pulpotomy using garlic oil

EXPERIMENTAL

interventional group as garlic oil pulpotomy dressed in zinc oxide powder

Procedure: vital pulpotomy primary molars using garlic oil

control or comparator as mta vital pulpotomy in primary molars

ACTIVE COMPARATOR

mta vital pulpotomy in primary molars

Procedure: vital pulpotomy using mta

Interventions

vital pulpotomy primary molars using garlic oil PROCEDURE

vital pulpotomy using garlic oil

Also known as: vital pulpotomy primary molars using Allium sativium oil

intervention we want to test vital pulpotomy using garlic oil

vital pulpotomy using mta PROCEDURE

mta vital pulpotomy

Also known as: mta vital pulpotomy

control or comparator as mta vital pulpotomy in primary molars

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy cooperative children with pair of contralateral deep carious mandibular primary molars indicated for vital pulpotomy.
• In age range from 4 to 8 years.
• Both sexes are included.
• Patients with provoked pain.
• Remaining radicular tissue is vital without suppuration or purulence.
• With no clinical or radiographic signs of pulp necrosis.
• Restorable teeth

You may not qualify if:

• Excessive haemorrhage that cannot stop by a damp cotton pellet after several minutes
• With congenital anomalies in teeth e.g., taurodontism, concrescence or fusion. 3- Patients who will show allergic reaction to any material will be used in this trial.
• Will not be able to stick to follow up protocol in the trial and refuse to give communication data.
• Patient's guardians refuse to sign up an informed consent before participating in this trial.

Sponsors & Collaborators

• Cairo University: lead

Study Officials

• cairo university

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elgebaly

CONTACT

00201060637928; nourhanelgebaly@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The statistician, clinical and radiographic outcomes assessors will be blinded in this study.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistnat lecturer in Pediatric Dentistry and Public Health Department Nahda University

Model Details: same patient will one molar indicated for vital pulpotomy on one side and on contralateral side

Study Record Dates

• First Submitted: April 5, 2019
• First Posted: April 9, 2019
• Study Start: September 1, 2019
• Primary Completion: September 1, 2020
• Study Completion: December 1, 2020
• Last Updated: April 25, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available within one and half year.
• Access Criteria: not yet