Clinical trial NCT05677945: 3Mixtatin Versus Modified 3Mix-MP in Lesion Sterilization and Tissue Repair for Treatment of Necrotic Primary Molars
Official title: 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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Necrotic Primary Molars
Keywords: 3MIX-MP
3Mixtatin
LSTR
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-01-10
Enrollment: 24
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized clinical study aims to assess the clinical and radiographic success rate of the 3Mixtatin versus the 3Mix in LSTR in necrotic primary molars.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Absence of pathological mobility measured by (Miller's grades)
timeFrame: baseline
measure: Absence of pathological mobility measured by (Miller's grades)
timeFrame: at 3 months post operative
measure: Absence of pathological mobility measured by (Miller's grades)
timeFrame: at 6 months post operative
measure: Absence of pathological mobility measured by (Miller's grades)
timeFrame: at 12 months post operative
measure: Absence of post-operative pain (binary)
timeFrame: baseline
measure: Absence of post-operative pain (binary)
timeFrame: at 3 months post operative
measure: Absence of post-operative pain (binary)
timeFrame: at 6 months post operative
measure: Absence of post-operative pain (binary)
timeFrame: at 12 months post operative
measure: Absence of soft tissue pathologies (binary)
timeFrame: baseline
measure: Absence of soft tissue pathologies (binary)
timeFrame: at 3 months post operative
measure: Absence of soft tissue pathologies (binary)
timeFrame: at 6 months post operative
measure: Absence of soft tissue pathologies (binary)
timeFrame: at 12 months post operative
measure: Absence of pain on percussion (binary)
timeFrame: baseline
measure: Absence of pain on percussion (binary)
timeFrame: at 3 months post operative
measure: Absence of pain on percussion (binary)
timeFrame: at 6 months post operative
measure: Absence of pain on percussion (binary)
timeFrame: at 12 months post operative
Secondary outcomes:
measure: Status of radiolucency if present at the periapical or at furcation area
timeFrame: baseline
measure: Status of radiolucency if present at the periapical or at furcation area
timeFrame: at 6 months post operative
measure: Status of radiolucency if present at the periapical or at furcation area
timeFrame: at 12 months post operative
measure: Absence of external or internal root resorption
timeFrame: baseline , 6 ,12 months
Other outcomes:
Locations:
Study officials:
affiliation: Professor of pediatric dentistry
name: Rania Nasr, Professor
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.