Necrotic Primary MolarsLSTRNCT05677945
3Mixtatin Versus Modified 3Mix-MP in Lesion Sterilization and Tissue Repair for Treatment of Necrotic Primary Molars
A study testing 3Mixtatin paste: Simvastatin mixed with modified triple antibiotic and 3Mix: Modified triple antibiotic mix in propylene glycol in people with Necrotic Primary Molars, run by Cairo University.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Necrotic Primary Molars
- What is being tested?
- 3Mixtatin paste: Simvastatin mixed with modified triple antibiotic and 3Mix: Modified triple antibiotic mix in propylene glycol
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Mar 2023to Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet.
Maii Mohamed, lecturer contact
About this study
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
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.
Read the 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.
- Conditions
- Necrotic Primary Molars
- Being tested
- 3Mixtatin paste: Simvastatin mixed with modified triple antibiotic, 3Mix: Modified triple antibiotic mix in propylene glycol
- Keywords
- 3MIX-MP, 3Mixtatin, LSTR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3Mixtatin paste: Simvastatin mixed with modified triple antibioticDrug
- Drying the mucosa with gauze,topical anesthesia will be applied.
- Administration of local anesthesia with vasoconstrictor.
- Rubber dam isolation.
- Caries removal \& access cavity using a round bur mounted on a high-speed contra with coolant.
- Removal of necrotic pulp tissue in coronal portion of the tooth using sharp excavator.
- Radicular section will be kept untouched,no instrumentation.
- Using disposable syringe Irrigation of the pulp chamber with 2.5% NaOCl.
- In case of hemorrhage moist cotton immersed in 1% NaOCL will be placed to achieve hemostasis.
- Drying the access cavity with sterile cotton pellets.
- Freshly mixed 3Mix-MP or 3Mixtatin paste (according to group of intervention) will be transferred to the floor of the pulp chamber using an amalgam carrier \& condensed over orifices using a moist cotton pellet.
- Cavity sealing with RMGI capsules.
- Same visit placement with preformed Stainless-steel crown(3M® ESPE)cemented with glass ionomer cement.
3Mix: Modified triple antibiotic mix in propylene glycolDrug
- Drying the mucosa with gauze,topical anesthesia will be applied.
- Administration of local anesthesia with vasoconstrictor.
- Rubber dam isolation.
- Caries removal \& access cavity using a round bur mounted on a high-speed contra with coolant.
- Removal of necrotic pulp tissue in coronal portion of the tooth using sharp excavator.
- Radicular section will be kept untouched,no instrumentation.
- Using disposable syringe Irrigation of the pulp chamber with 2.5% NaOCl.
- In case of hemorrhage moist cotton immersed in 1% NaOCL will be placed to achieve hemostasis.
- Drying the access cavity with sterile cotton pellets.
- Freshly mixed 3Mix-MP or 3Mixtatin paste (according to group of intervention) will be transferred to the floor of the pulp chamber using an amalgam carrier \& condensed over orifices using a moist cotton pellet.
- Cavity sealing with RMGI capsules.
- Same visit placement with preformed Stainless-steel crown(3M® ESPE)cemented with glass ionomer cement.
| Study group | Role | What they receive |
|---|---|---|
| (Group I Experimental Group):Simvastatin mixed with modified triple antibiotic (3Mixtatin) | Experimental | 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:
* 2mg of pure Simvastatin powder will be added to the 1:1:1 3Mix powder and will be stored together in an air tight porcelain container to avoid the exposure to moisture and light.
* Upon clinical application the 3Mixtatin powder will be mixed with normal saline to form a paste and is then applied in the same manner as the Modified 3Mix-MP paste. Receives: Drug: 3Mixtatin paste: Simvastatin mixed with modified triple antibiotic |
| Group II Control group Modified triple antibiotic mix in propylene glycol (3Mix) | Active comparator | * Removal of enteric coating/capsule of the three antibiotic tablets using a surgical blade.
* 500 mg Metronidazole tab
* 500 mg Ciprofloxacin tab
* 200 mg Cefixime caps
* Pulverization of each of the drug, will be done using a pestle \& mortar, stored in an air tight porcelain container to avoid the exposure to moisture \& light.
* Pulverized powders will be stored at a temperature of 16°C.Powder should be allowed to be cooled to the room temperature before initiating the preparation of 3Mix-MP paste.
* Powders will be mixed in the proportion of: 1:1:1 by volume (Hoshino et al., 1988).
* Vehicle that will be used is Systane eye drops (Kharadly et al., 2022) it contains the two main components propylene Glycol (Macrogol) \& polyethylene glycol.
* The prepared antibiotic powder is mixed with the prepared vehicle in the ratio of 7:1 by volume. The two steps above are done after access cavity preparation to obtain a fresh mix. Receives: Drug: 3Mix: Modified triple antibiotic mix in propylene glycol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence of pathological mobility measured by (Miller's grades)
Miller's Classification
- Grade I: first distinguishable sign of movement
- Grade II: movement of tooth which allows crown to deviate 1mm of its normal position
- Grade III shows noticeable and increased movement of tooth more than 1mm in any direction or the tooth can be depressed into the socket.
A reduction in grade of mobility from preoperative baseline will be considered as success while increased mobility will be recorded as failure
Measured: baseline
Absence of pathological mobility measured by (Miller's grades)
Miller's Classification
- Grade I: first distinguishable sign of movement
- Grade II: movement of tooth which allows crown to deviate 1mm of its normal position
- Grade III shows noticeable and increased movement of tooth more than 1mm in any direction or the tooth can be depressed into the socket.
A reduction in grade of mobility from preoperative baseline will be considered as success while increased mobility will be recorded as failure
Measured: at 3 months post operative
Absence of pathological mobility measured by (Miller's grades)
Miller's Classification
- Grade I: first distinguishable sign of movement
- Grade II: movement of tooth which allows crown to deviate 1mm of its normal position
- Grade III shows noticeable and increased movement of tooth more than 1mm in any direction or the tooth can be depressed into the socket.
A reduction in grade of mobility from preoperative baseline will be considered as success while increased mobility will be recorded as failure
Measured: at 6 months post operative
Absence of pathological mobility measured by (Miller's grades)
Miller's Classification
- Grade I: first distinguishable sign of movement
- Grade II: movement of tooth which allows crown to deviate 1mm of its normal position
- Grade III shows noticeable and increased movement of tooth more than 1mm in any direction or the tooth can be depressed into the socket.
A reduction in grade of mobility from preoperative baseline will be considered as success while increased mobility will be recorded as failure
Measured: at 12 months post operative
Absence of post-operative pain (binary)
Measured by asking the patient to identify presence or absence of pain
Measured: baseline
Absence of post-operative pain (binary)
Measured by asking the patient to identify presence or absence of pain
Measured: at 3 months post operative
Absence of post-operative pain (binary)
Measured by asking the patient to identify presence or absence of pain
Measured: at 6 months post operative
Absence of post-operative pain (binary)
Measured by asking the patient to identify presence or absence of pain
Measured: at 12 months post operative
Absence of soft tissue pathologies (binary)
Binary outcome measured visually by intraoral/extraoral examination
Measured: baseline
Absence of soft tissue pathologies (binary)
Binary outcome measured visually by intraoral/extraoral examination
Measured: at 3 months post operative
Absence of soft tissue pathologies (binary)
Binary outcome measured visually by intraoral/extraoral examination
Measured: at 6 months post operative
Absence of soft tissue pathologies (binary)
Binary outcome measured visually by intraoral/extraoral examination
Measured: at 12 months post operative
Absence of pain on percussion (binary)
Binary outcome measured by gentle tapping using the back of the mirror on the tooth
Measured: baseline
Absence of pain on percussion (binary)
Binary outcome measured by gentle tapping using the back of the mirror on the tooth
Measured: at 3 months post operative
Absence of pain on percussion (binary)
Binary outcome measured by gentle tapping using the back of the mirror on the tooth
Measured: at 6 months post operative
Absence of pain on percussion (binary)
Binary outcome measured by gentle tapping using the back of the mirror on the tooth
Measured: at 12 months post operative
Secondary outcomes (4)
Status of radiolucency if present at the periapical or at furcation area
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.
Measured: baseline
Status of radiolucency if present at the periapical or at furcation area
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.
Measured: at 6 months post operative
Status of radiolucency if present at the periapical or at furcation area
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.
Measured: at 12 months post operative
Absence of external or internal root resorption
Binary outcome measured by comparing pre-operative x-ray with baseline and follow up x-rays. using customized stent
Measured: baseline , 6 ,12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study startMar 2023 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Necrotic Primary MolarsStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalia Magdy Abdel Azeem Al Shamy, Cairo University
- Investigators
- Rania Nasr, Professor, Study director, Professor of pediatric dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05677945
- Sponsor's protocol ID
- LSTR in necrotic primary teeth
- Acronym
- LSTR
- Status last verified
- Dec 2022
- First submitted
- 15 Dec 2022
- Last updated
- 10 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35645497Hoshino 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.
PubMed 9206436Hoshino 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.
PubMed 3052845Aminabadi 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.
PubMed 26950808Sain 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.
PubMed 30787561Takushige 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.
PubMed 14871180Thakur 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.
PubMed 35003558
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05677945
- Acronym / sponsor ID
- LSTR / LSTR in necrotic primary teeth
- Conditions
- Necrotic Primary Molars
- Keywords
- 3MIX-MP, 3Mixtatin, LSTR
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Mar 2023 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 10 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| (Group I Experimental Group):Simvastatin mixed with modified triple antibiotic (3Mixtatin) | Experimental | Drug: 3Mixtatin paste: Simvastatin mixed with modified triple antibioticPatients 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: * 2mg of pure Simvastatin powder will be added to the 1:1:1 3Mix powder and will be stored together in an air tight porcelain container to avoid the exposure to moisture and light. * Upon clinical application the 3Mixtatin powder will be mixed with normal saline to form a paste and is then applied in the same manner as the Modified 3Mix-MP paste. |
| Group II Control group Modified triple antibiotic mix in propylene glycol (3Mix) | Active comparator | Drug: 3Mix: Modified triple antibiotic mix in propylene glycol* Removal of enteric coating/capsule of the three antibiotic tablets using a surgical blade. * 500 mg Metronidazole tab * 500 mg Ciprofloxacin tab * 200 mg Cefixime caps * Pulverization of each of the drug, will be done using a pestle \& mortar, stored in an air tight porcelain container to avoid the exposure to moisture \& light. * Pulverized powders will be stored at a temperature of 16°C.Powder should be allowed to be cooled to the room temperature before initiating the preparation of 3Mix-MP paste. * Powders will be mixed in the proportion of: 1:1:1 by volume (Hoshino et al., 1988). * Vehicle that will be used is Systane eye drops (Kharadly et al., 2022) it contains the two main components propylene Glycol (Macrogol) \& polyethylene glycol. * The prepared antibiotic powder is mixed with the prepared vehicle in the ratio of 7:1 by volume. The two steps above are done after access cavity preparation to obtain a fresh mix. |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3Mixtatin paste: Simvastatin mixed with modified triple antibiotic* Drying the mucosa with gauze,topical anesthesia will be applied. * Administration of local anesthesia with vasoconstrictor. * Rubber dam isolation. * Caries removal \& access cavity using a round bur mounted on a high-speed contra with coolant. * Removal of necrotic pulp tissue in coronal portion of the tooth using sharp excavator. * Radicular section will be kept untouched,no instrumentation. * Using disposable syringe Irrigation of the pulp chamber with 2.5% NaOCl. * In case of hemorrhage moist cotton immersed in 1% NaOCL will be placed to achieve hemostasis. * Drying the access cavity with sterile cotton pellets. * Freshly mixed 3Mix-MP or 3Mixtatin paste (according to group of intervention) will be transferred to the floor of the pulp chamber using an amalgam carrier \& condensed over orifices using a moist cotton pellet. * Cavity sealing with RMGI capsules. * Same visit placement with preformed Stainless-steel crown(3M® ESPE)cemented with glass ionomer cement. | Drug | (Group I Experimental Group):Simvastatin mixed with modified triple antibiotic (3Mixtatin) |
| 3Mix: Modified triple antibiotic mix in propylene glycol* Drying the mucosa with gauze,topical anesthesia will be applied. * Administration of local anesthesia with vasoconstrictor. * Rubber dam isolation. * Caries removal \& access cavity using a round bur mounted on a high-speed contra with coolant. * Removal of necrotic pulp tissue in coronal portion of the tooth using sharp excavator. * Radicular section will be kept untouched,no instrumentation. * Using disposable syringe Irrigation of the pulp chamber with 2.5% NaOCl. * In case of hemorrhage moist cotton immersed in 1% NaOCL will be placed to achieve hemostasis. * Drying the access cavity with sterile cotton pellets. * Freshly mixed 3Mix-MP or 3Mixtatin paste (according to group of intervention) will be transferred to the floor of the pulp chamber using an amalgam carrier \& condensed over orifices using a moist cotton pellet. * Cavity sealing with RMGI capsules. * Same visit placement with preformed Stainless-steel crown(3M® ESPE)cemented with glass ionomer cement. | Drug | Group II Control group Modified triple antibiotic mix in propylene glycol (3Mix) |
Primary outcome
Absence of pathological mobility measured by (Miller's grades)
Time frame: baseline
Miller's Classification * Grade I: first distinguishable sign of movement * Grade II: movement of tooth which allows crown to deviate 1mm of its normal position * Grade III shows noticeable and increased movement of tooth more than 1mm in any direction or the tooth can be depressed into the socket. A reduction in grade of mobility from preoperative baseline will be considered as success while increased mobility will be recorded as failure
Absence of pathological mobility measured by (Miller's grades)
Time frame: at 3 months post operative
Miller's Classification * Grade I: first distinguishable sign of movement * Grade II: movement of tooth which allows crown to deviate 1mm of its normal position * Grade III shows noticeable and increased movement of tooth more than 1mm in any direction or the tooth can be depressed into the socket. A reduction in grade of mobility from preoperative baseline will be considered as success while increased mobility will be recorded as failure
Absence of pathological mobility measured by (Miller's grades)
Time frame: at 6 months post operative
Miller's Classification * Grade I: first distinguishable sign of movement * Grade II: movement of tooth which allows crown to deviate 1mm of its normal position * Grade III shows noticeable and increased movement of tooth more than 1mm in any direction or the tooth can be depressed into the socket. A reduction in grade of mobility from preoperative baseline will be considered as success while increased mobility will be recorded as failure
Absence of pathological mobility measured by (Miller's grades)
Time frame: at 12 months post operative
Miller's Classification * Grade I: first distinguishable sign of movement * Grade II: movement of tooth which allows crown to deviate 1mm of its normal position * Grade III shows noticeable and increased movement of tooth more than 1mm in any direction or the tooth can be depressed into the socket. A reduction in grade of mobility from preoperative baseline will be considered as success while increased mobility will be recorded as failure
Absence of post-operative pain (binary)
Time frame: baseline
Measured by asking the patient to identify presence or absence of pain
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
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
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
Absence of soft tissue pathologies (binary)
Time frame: baseline
Binary outcome measured visually by intraoral/extraoral examination
Absence of soft tissue pathologies (binary)
Time frame: at 3 months post operative
Binary outcome measured visually by intraoral/extraoral examination
Absence of soft tissue pathologies (binary)
Time frame: at 6 months post operative
Binary outcome measured visually by intraoral/extraoral examination
Absence of soft tissue pathologies (binary)
Time frame: at 12 months post operative
Binary outcome measured visually by intraoral/extraoral examination
Absence of pain on percussion (binary)
Time frame: baseline
Binary outcome measured by gentle tapping using the back of the mirror on the tooth
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
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
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
4 secondary outcomes
Status of radiolucency if present at the periapical or at furcation area
Time frame: baseline
Status of radiolucency if present at the periapical or at furcation area
Time frame: at 6 months post operative
Status of radiolucency if present at the periapical or at furcation area
Time frame: at 12 months post operative
Absence of external or internal root resorption
Time frame: baseline , 6 ,12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
- Background: PubMed 35645497Chak 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.
- Background: PubMed 9206436Hoshino 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.
- Background: PubMed 3052845Hoshino 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.
- Background: PubMed 26950808Aminabadi 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.
- Background: PubMed 30787561Sain 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.
- Background: PubMed 14871180Takushige 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.
- Background: PubMed 35003558Thakur 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.
- Individual participant dataSharing planned: No
Related trials for Necrotic Primary Molars
Active, not recruitingObservational study
Lesion Sterilization Tissue Repair and Conventional Pulpectomy in Primary Molars
Pulpitis - Irreversible, Pulp Necroses
Enrolling by invitation
Evaluation of Different Medicaments in the Management of Necrotic Primary Molars by Lesion Sterilization and Tissue Repair
Pain, Postoperative, Root Resorption
Not yet recruiting
Clinical and Radiographic Success of Calcium Hydroxide-Iodoform Paste Versus Modified Triple Antibiotic Paste for Necrotic Primary Molars in Children
Dental Pulp Necrosis, Periapical Diseases
Not yet recruitingEarly Phase 1
Chloramphenicol, Tetracycline, Zinc Oxide and Eugenol Paste (CTZ Paste) for Emergency Dental Treatment in Public Health Settings: A Randomized Trial
Pulp Disease, Dental, Pulp Necrosis
Not yet recruitingPhase 1/2
Lesion Sterilization and Tissue Repair Antibiotic Paste Versus Zinc Oxide and Eugenol Pulpectomy for Treatment of Primary Molars With Pulp Necrosis
Pulp Necrosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maii Mohamed, lecturer contact
Rania Nasr, Professor study director
Professor of pediatric dentistry
Questions about this trial
What is this clinical trial studying?
A study testing 3Mixtatin paste: Simvastatin mixed with modified triple antibiotic and 3Mix: Modified triple antibiotic mix in propylene glycol in people with Necrotic Primary Molars, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dalia Magdy Al Shamy, BSC (01023363613 ext. 002, dalia.elshamy@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absence of pathological mobility measured by (Miller's grades) (time frame: baseline). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05677945, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2023.