NCT03585751

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 13, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

July 13, 2018

Status Verified

June 1, 2018

Enrollment Period

1 year

First QC Date

June 8, 2018

Last Update Submit

June 30, 2018

Conditions

Tooth, Deciduous

Keywords

non vitaldeciduous3mixstatinsimvastatintriple antibiotic mix3 mix

Outcome Measures

Primary Outcomes (1)

  • Over All Success Rate ( as a percentage)

    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.

    12 months

Secondary Outcomes (1)

  • Bone density changes in Region of Interest ROI

    12 months

Study Arms (3)

Triple antibiotic paste

ACTIVE COMPARATOR

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

3mixstatin

EXPERIMENTAL

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

simvastatin

EXPERIMENTAL

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

Interventions

Pulpectomy for primary molars + triple antibiotic mixPROCEDURE

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

Triple antibiotic paste
Pulpectomy for primary molars + 3mixstatinPROCEDURE

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

3mixstatin
Pulpectomy for primary molars + simvastatinPROCEDURE

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

simvastatin

Eligibility Criteria

Age5 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Patients:
  • Young cooperative patients with no history of systemic disease that may contraindicate pulp therapy
  • Age range 4-6 years.
  • Patient has at least one restorable primary molar that exhibits signs and symptoms of odontogenic infection with inflammatory root resorption and require pulpectomy,
  • 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):
  • Spontaneous pain
  • Intraoral Abscess
  • Extra oral Abscess
  • Tender to percussion
  • Presence of abnormal mobility other than that associated with exfoliation
  • Radiographic Criteria include:
  • \. 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • Aminabadi NA, Huang B, Samiei M, Agheli S, Jamali Z, Shirazi S. A Randomized Trial Using 3Mixtatin Compared to MTA in Primary Molars with Inflammatory Root Resorption: A Novel Endodontic Biomaterial. J Clin Pediatr Dent. 2016;40(2):95-102. doi: 10.17796/1053-4628-40.2.95.

    PMID: 26950808BACKGROUND

  • Takushige T, Cruz EV, Asgor Moral A, Hoshino E. Endodontic treatment of primary teeth using a combination of antibacterial drugs. Int Endod J. 2004 Feb;37(2):132-8. doi: 10.1111/j.0143-2885.2004.00771.x.

    PMID: 14871180BACKGROUND

  • Asl Aminabadi N, Maljaei E, Erfanparast L, Ala Aghbali A, Hamishehkar H, Najafpour E. Simvastatin versus Calcium Hydroxide Direct Pulp Capping of Human Primary Molars: A Randomized Clinical Trial. J Dent Res Dent Clin Dent Prospects. 2013 Winter;7(1):8-14. doi: 10.5681/joddd.2013.002. Epub 2013 Feb 21.

    PMID: 23487477BACKGROUND

  • Doneria D, Thakur S, Singhal P, Chauhan D, Keshav K, Uppal A. In Search of a Novel Substitute: Clinical and Radiological Success of Lesion Sterilization and Tissue Repair with Modified 3Mix-MP Antibiotic Paste and Conventional Pulpectomy for Primary Molars with Pulp Involvement with 18 Months Follow-up. Contemp Clin Dent. 2017 Oct-Dec;8(4):514-521. doi: 10.4103/ccd.ccd_47_17.

    PMID: 29326499BACKGROUND

  • Nakornchai S, Banditsing P, Visetratana N. Clinical evaluation of 3Mix and Vitapex as treatment options for pulpally involved primary molars. Int J Paediatr Dent. 2010 May;20(3):214-21. doi: 10.1111/j.1365-263X.2010.01044.x.

    PMID: 20409203BACKGROUND

  • Okamoto Y, Sonoyama W, Ono M, Akiyama K, Fujisawa T, Oshima M, Tsuchimoto Y, Matsuka Y, Yasuda T, Shi S, Kuboki T. Simvastatin induces the odontogenic differentiation of human dental pulp stem cells in vitro and in vivo. J Endod. 2009 Mar;35(3):367-72. doi: 10.1016/j.joen.2008.11.024.

    PMID: 19249597BACKGROUND

  • Seto H, Ohba H, Tokunaga K, Hama H, Horibe M, Nagata T. Topical administration of simvastatin recovers alveolar bone loss in rats. J Periodontal Res. 2008 Jun;43(3):261-7. doi: 10.1111/j.1600-0765.2007.01024.x.

    PMID: 18447852BACKGROUND

  • Chen S, Yang JY, Zhang SY, Feng L, Ren J. Effects of simvastatin gel on bone regeneration in alveolar defects in miniature pigs. Chin Med J (Engl). 2011 Dec;124(23):3953-8.

    PMID: 22340324BACKGROUND

  • Sakoda K, Yamamoto M, Negishi Y, Liao JK, Node K, Izumi Y. Simvastatin decreases IL-6 and IL-8 production in epithelial cells. J Dent Res. 2006 Jun;85(6):520-3. doi: 10.1177/154405910608500608.

    PMID: 16723648BACKGROUND

MeSH Terms

Interventions

PulpectomySimvastatin

Intervention Hierarchy (Ancestors)

EndodonticsDentistryLovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Sherif B El Tawil, DDS

    Cairo University

    STUDY CHAIR

  • Dina El Beshlawy

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

Dina y El Kharadly, Msc

CONTACT

+201222189574d.elkharadly@gmail.com

Rania N Abdalla, DDs

CONTACT

00201005037367nasrania05@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

June 8, 2018

First Posted

July 13, 2018

Study Start

September 1, 2018

Primary Completion

September 1, 2019

Study Completion

January 1, 2020

Last Updated

July 13, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share