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3Mixstatin ,Tri-Antibiotic Mix & Simvastatin in the Treatment of Primary Molars

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ClinicalTrials.gov Identifier: NCT03585751
Recruitment Status : Not yet recruiting
First Posted : July 13, 2018
Last Update Posted : July 13, 2018
Sponsor:
Information provided by (Responsible Party):
Dina El Kharadly, October 6 University

Brief Summary:
The aim of this study is to determine whether the success rate of pulp therapy undergone on primary molars with signs and symptoms of odontogenic infection that may render them indicated for extraction will improve with the use of the Simvastatin alone, the Tri-Antibiotic Mix alone or when in combination together 3Mixstatin as a component in the root filling material.

Condition or disease Intervention/treatment Phase
Tooth, Deciduous Procedure: Pulpectomy for primary molars + triple antibiotic mix Procedure: Pulpectomy for primary molars + 3mixstatin Procedure: Pulpectomy for primary molars + simvastatin Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Every participant will grasp an opaque sealed envelop from a box after diagnosis of the case. Being opaque and sealed ensures allocation concealment. Envelopes have been assigned to RN who is not involved in neither the diagnosis nor the treatment phases of the cases.
Primary Purpose: Treatment
Official Title: A Comparative Clinical and Radiographic Study of 3Mixstatin vs Tri-Antibiotic Mix and Simvastatin in the Treatment of Primary Molars With Inflammatory Root Resorption A Randomized Clinical Trial
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics
Drug Information available for: Simvastatin

Arm Intervention/treatment
Active Comparator: Triple antibiotic paste
Pulpectomy for primary molars, triple antibiotic mix is used as obturating material mixed with Macrogol and Polyethylene glycol & small amount of Zinc oxide powder to obtain workable , radio opaque mix
Procedure: Pulpectomy for primary molars + triple antibiotic mix
complete extirpation of infected pulp from primary molars. Following instrumentation and copious irrigation ,the root canals are filled with one of .Following instrumentation and copious irrigation ,the root canals are filled with a triple antibiotic mix mixed with a Carrier ( MP) as an obturating material

Experimental: 3mixstatin
Pulpectomy for primary molars, 3 Mixstatin ( mix of simvastatin and triple antibiotic mix ) is used as obturating material mixed with Macrogol and Polyethylene glycol & small amount of Zinc oxide powder to obtain workable , radio opaque mix
Procedure: Pulpectomy for primary molars + 3mixstatin
complete extirpation of infected pulp from primary molars. Following instrumentation and copious irrigation ,the root canals are filled with one of .Following instrumentation and copious irrigation ,the root canals are filled with 3mixstatin (triple antibiotic mix + simvastatin) as an obturating material mixed with a Carrier ( MP) as an obturating material

Experimental: simvastatin
Pulpectomy for primary molars, simvastatin is used as obturating material mixed with Macrogol and Polyethylene glycol & small amount of Zinc oxide powder to obtain workable , radio opaque mix
Procedure: Pulpectomy for primary molars + simvastatin
complete extirpation of infected pulp from primary molars. Following instrumentation and copious irrigation ,the root canals are filled with simvastatin as mixed with a Carrier ( MP) as an obturating material




Primary Outcome Measures :
  1. Over All Success Rate ( as a percentage) [ Time Frame: 12 months ]

    For each group

    Number of cases exhibiting success criterion at 12 months / Total number of cases x 100

    At the end of the follow up period, the cases are considered successful if they exhibited ALL the following criteria:

    • Absence of tenderness to percussion
    • No abnormal mobility
    • Absence of swelling and fistula
    • Absence or decrease of furcation radiolucency
    • Absence or decrease of radicular radiolucency
    • Absence of Internal/external root resorption or other pathological changes

    The cases were considered as total (overall) failures if they failed clinically at the 3, 6 or 12 months; or when they failed radiographically at the 12 months follow-up.

    Otherwise they will be considered as a success.



Secondary Outcome Measures :
  1. Bone density changes in Region of Interest ROI [ Time Frame: 12 months ]
    measured by :Digora image analysis software i.e. Digora for windows software DFW Measuring Unit :Relative pixel values using an 8-bit scale from full black (0) to full white (255)



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Patients:

  1. Young cooperative patients with no history of systemic disease that may contraindicate pulp therapy
  2. Age range 4-6 years.
  3. Patient has at least one restorable primary molar that exhibits signs and symptoms of odontogenic infection with inflammatory root resorption and require pulpectomy,
  4. Patient's parents are willing to participate in this study and will be able to follow up Clinical & Radiographic Criteria for Case Selection Signs and symptoms of irreversible pulpitis as well as inter-radicular, or periapical root resorption as a result of infective or inflammatory conditions that may render the tooth hopeless and indicated for extraction

Clinical Criteria (include):

  1. Spontaneous pain
  2. Intraoral Abscess
  3. Extra oral Abscess
  4. Tender to percussion
  5. Presence of abnormal mobility other than that associated with exfoliation

Radiographic Criteria include:

1. Radiolucency in furcation area 2. Periapical root resorption or excessive bone destruction and/or perforation in coronal third of roots as a result of infective or inflammatory conditions.

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Exclusion Criteria:

  • Patients with systemic disease 2. Patients who cannot attend follow up. 3. Primary molars that are unrestorable 4. Primary molars exhibiting pathology of permanent tooth follicle

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03585751


Contacts
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Contact: Dina y El Kharadly, Msc +201222189574 d.elkharadly@gmail.com
Contact: Rania N Abdalla, DDs 00201005037367 nasrania05@yahoo.com

Sponsors and Collaborators
Cairo University
Investigators
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Study Chair: Sherif B El Tawil, DDS Cairo University
Study Director: Dina El Beshlawy Cairo University

Additional Information:
Publications:

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Responsible Party: Dina El Kharadly, Assistant lecturer, October 6 University
ClinicalTrials.gov Identifier: NCT03585751     History of Changes
Other Study ID Numbers: 3Mixstatin
First Posted: July 13, 2018    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Dina El Kharadly, October 6 University:
non vital
deciduous
3mixstatin
simvastatin
triple antibiotic mix
3 mix
Additional relevant MeSH terms:
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Anti-Bacterial Agents
Bacitracin
Neomycin
Polymyxin B
Antibiotics, Antitubercular
Simvastatin
Anti-Infective Agents
Antitubercular Agents
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Anti-Infective Agents, Local
Protein Synthesis Inhibitors