- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05677945
3Mixtatin Versus Modified 3Mix-MP in Lesion Sterilization and Tissue Repair for Treatment of Necrotic Primary Molars (LSTR)
A Randomized Controlled Trial Comparing the Clinical and Radiographic Success of 3Mixtatin Versus Modified 3Mix in Lesion Sterilization and Tissue Repair (LSTR) for The Treatment of Necrotic Primary Molars
Study Overview
Status
Conditions
Detailed Description
Research question:
In necrotic primary molars with peri-radicular lesions and/or external root, resorption does adding Simvastatin to the triple antibiotic mix have higher clinical and radiographic success than the triple antibiotic paste solely?
Statement of the problem:
Primary teeth with necrotic pulp and extensive root resorption and/or furcal radiolucency are not uncommon scenarios that pediatric dentists are exposed to. Such clinical and radiographic presentations contraindicate the application of conventional pulpectomy treatment. Lesion Sterilization and Tissue Repair (LSTR) is an approach that has shown promising results in maintaining such teeth for up to 12 months. Primary teeth serve as a natural space maintainer, enable normal and healthy functioning of the child, and eliminate the chances for malocclusion and growth pattern disruptions. LSTR offers practitioners a promising option to save those teeth when all other treatment options seem impossible.
The Rationale for Conducting the Research:
In accordance to the popularity that LSTR has recently been gaining in the field of Pediatric dentistry, an abundance of studies have been conducted in the recent years. Researchers are striving to explore the plethora of possibilities and variances in the LSTR technique that could help clinicians practice better and achieve more for their patients. Amongst the alternatives is the recent and common detour towards regenerative dentistry.
Simvastatin, one of the materials, remains of high interest to the field due to its healing powers. However, to our knowledge insufficient studies are available on the direct comparison of the clinical and radiographic success including bone regeneration using the 3Mixtatin versus 3Mix alone. Furthermore, studies conducted warrant the need for further studies directly comparing 3Mixtatin with 3mix. Therefore, this study aims to come to a conclusion on whether the 3mix with the host's body defense and repair mechanism are sufficient to save a necrotic primary tooth or is some help in bone regeneration and healing promotion needed.
The LSTR technique involves non-instrumentation or minimal instrumentation followed by sterilization of the infected pulpal space by the placement of a triple antibiotic mixture in a propylene glycol vehicle to disinfect the microbial flora inhabiting the infected root canal systems and peri-apical lesions. The latter step achieves disinfection while tissue repair is then allowed to take place by the host's natural body defense mechanisms
The triple antibiotic paste (TAP/3mix), is an intracanal medicament that has continuously proven its efficacy and superiority for years against the microflora inhabiting necrotic canals predominantly Enterococcus Faecalis, the most prevalent organism in infected root canals. Metronidazole, ciprofloxacin, and minocycline, the oldest and most common combination suggested by Takushige et al., has been subjected to many studies and changes due to the discoloration caused by minocycline. As a result of, modified triple antibiotic paste (Modified-3mix) was introduced to replace minocycline with clindamycin.
Statins are antihyperlipidemic drugs, with a bio inductive feature that includes inhibition of bone resorption and promotion of osteoblast proliferation and differentiation as well as stimulating angiogenesis all of which aid in the healing process. In a clinical trial mixing modified 3mix with statins in, namely, Simvastatin; resulted in excellent clinical and radiographic success rates. Hence, modifying the LSTR technique to include regenerative materials such as statin is an extremely promising area of research.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dalia Magdy Al Shamy, BSC
- Phone Number: 002 01023363613
- Email: dalia.elshamy@dentistry.cu.edu.eg
Study Contact Backup
- Name: Maii Mohamed, lecturer
- Phone Number: 002 01012632608
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Pediatric patients aged 4-7 years.
- Positive parental informed consent.
- Restorable necrotic mandibular second primary molars with peri-radicular/furcal involvement and/or pathologic root resorption (external or internal).
- Presence of chronic apical abscess or sinus tract or furcation radiolucency. (Thakur et al., 2021)
Exclusion Criteria:
- Medically compromised children.
- Children with known allergy to any of the components being utilized.
- Molars near exfoliation.
- Molars with severely resorbed roots more than two thirds indicated for extraction
- Molars with insufficient coronal structure disabling proper coronal seal.
- Presence of periapical or interradicular radiolucent area which could compromise the permanent tooth bud. (Shetty et al., 2020)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: (Group I Experimental Group):Simvastatin mixed with modified triple antibiotic (3Mixtatin)
Patients will then be allocated into either one of the groups alternatively after access cavity preparation depending on the mix to be used as follows: for this group:
|
|
Active Comparator: Group II Control group Modified triple antibiotic mix in propylene glycol (3Mix)
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Absence of pathological mobility measured by (Miller's grades)
Time Frame: baseline
|
Miller's Classification
A reduction in grade of mobility from preoperative baseline will be considered as success while increased mobility will be recorded as failure |
baseline
|
Absence of pathological mobility measured by (Miller's grades)
Time Frame: at 3 months post operative
|
Miller's Classification
A reduction in grade of mobility from preoperative baseline will be considered as success while increased mobility will be recorded as failure |
at 3 months post operative
|
Absence of pathological mobility measured by (Miller's grades)
Time Frame: at 6 months post operative
|
Miller's Classification
A reduction in grade of mobility from preoperative baseline will be considered as success while increased mobility will be recorded as failure |
at 6 months post operative
|
Absence of pathological mobility measured by (Miller's grades)
Time Frame: at 12 months post operative
|
Miller's Classification
A reduction in grade of mobility from preoperative baseline will be considered as success while increased mobility will be recorded as failure |
at 12 months post operative
|
Absence of post-operative pain (binary)
Time Frame: baseline
|
Measured by asking the patient to identify presence or absence of pain
|
baseline
|
Absence of post-operative pain (binary)
Time Frame: at 3 months post operative
|
Measured by asking the patient to identify presence or absence of pain
|
at 3 months post operative
|
Absence of post-operative pain (binary)
Time Frame: at 6 months post operative
|
Measured by asking the patient to identify presence or absence of pain
|
at 6 months post operative
|
Absence of post-operative pain (binary)
Time Frame: at 12 months post operative
|
Measured by asking the patient to identify presence or absence of pain
|
at 12 months post operative
|
Absence of soft tissue pathologies (binary)
Time Frame: baseline
|
Binary outcome measured visually by intraoral/extraoral examination
|
baseline
|
Absence of soft tissue pathologies (binary)
Time Frame: at 3 months post operative
|
Binary outcome measured visually by intraoral/extraoral examination
|
at 3 months post operative
|
Absence of soft tissue pathologies (binary)
Time Frame: at 6 months post operative
|
Binary outcome measured visually by intraoral/extraoral examination
|
at 6 months post operative
|
Absence of soft tissue pathologies (binary)
Time Frame: at 12 months post operative
|
Binary outcome measured visually by intraoral/extraoral examination
|
at 12 months post operative
|
Absence of pain on percussion (binary)
Time Frame: baseline
|
Binary outcome measured by gentle tapping using the back of the mirror on the tooth
|
baseline
|
Absence of pain on percussion (binary)
Time Frame: at 3 months post operative
|
Binary outcome measured by gentle tapping using the back of the mirror on the tooth
|
at 3 months post operative
|
Absence of pain on percussion (binary)
Time Frame: at 6 months post operative
|
Binary outcome measured by gentle tapping using the back of the mirror on the tooth
|
at 6 months post operative
|
Absence of pain on percussion (binary)
Time Frame: at 12 months post operative
|
Binary outcome measured by gentle tapping using the back of the mirror on the tooth
|
at 12 months post operative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Status of radiolucency if present at the periapical or at furcation area
Time Frame: baseline
|
Comparison between pre-operative radiolucency and at follow up periods post-operatively to asses bone regeneration.
Results will be recorded as Static-Increased-Decreased using customized stent for xray and Digora software for measurements.
|
baseline
|
Status of radiolucency if present at the periapical or at furcation area
Time Frame: at 6 months post operative
|
Comparison between pre-operative radiolucency and at follow up periods post-operatively to asses bone regeneration.
Results will be recorded as Static-Increased-Decreased using customized stent for xray and Digora software for measurements.
|
at 6 months post operative
|
Status of radiolucency if present at the periapical or at furcation area
Time Frame: at 12 months post operative
|
Comparison between pre-operative radiolucency and at follow up periods post-operatively to asses bone regeneration.
Results will be recorded as Static-Increased-Decreased using customized stent for xray and Digora software for measurements.
|
at 12 months post operative
|
Absence of external or internal root resorption
Time Frame: baseline , 6 ,12 months
|
Binary outcome measured by comparing pre-operative x-ray with baseline and follow up x-rays.
using customized stent
|
baseline , 6 ,12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Rania Nasr, Professor, Professor of Pediatric Dentistry
Publications and helpful links
General Publications
- 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.
- 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.
- Chak RK, Singh RK, Mutyala J, Killi NK. Clinical Radiographic Evaluation of 3Mixtatin and MTA in Primary Teeth Pulpotomies: A Randomized Controlled. Int J Clin Pediatr Dent. 2022;15(Suppl 1):S80-S86. doi: 10.5005/jp-journals-10005-2216.
- Hoshino E, Kurihara-Ando N, Sato I, Uematsu H, Sato M, Kota K, Iwaku M. In-vitro antibacterial susceptibility of bacteria taken from infected root dentine to a mixture of ciprofloxacin, metronidazole and minocycline. Int Endod J. 1996 Mar;29(2):125-30. doi: 10.1111/j.1365-2591.1996.tb01173.x.
- Hoshino E, Kota K, Sato M, Iwaku M. Bactericidal efficacy of metronidazole against bacteria of human carious dentin in vitro. Caries Res. 1988;22(5):280-2. doi: 10.1159/000261121.
- Sain S, J R, S A, George S, S Issac J, A John S. Lesion Sterilization and Tissue Repair-Current Concepts and Practices. Int J Clin Pediatr Dent. 2018 Sep-Oct;11(5):446-450. doi: 10.5005/jp-journals-10005-1555. Epub 2018 Oct 1.
- Thakur S, Deep A, Singhal P, Chauhan D. A randomized control trial comparing the efficacy of 3Mixtatin and Modified 3Mix-MP paste using lesion sterilization and tissue repair technique to conventional root canal treatment in primary molars of children aged 4-8 years: An in vivo study. Dent Res J (Isfahan). 2021 Nov 22;18:93. doi: 10.4103/1735-3327.330874. eCollection 2021.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Necrosis
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Antitubercular Agents
- Anti-Bacterial Agents
- Antibiotics, Antitubercular
- Simvastatin
Other Study ID Numbers
- LSTR in necrotic primary teeth
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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