Tooth, DeciduousNCT03585751
3Mixstatin ,Tri-Antibiotic Mix & Simvastatin in the Treatment of Primary Molars
A study testing Pulpectomy for primary molars + triple antibiotic mix, Pulpectomy for primary molars + 3mixstatin and Pulpectomy for primary molars + simvastatin in people with Tooth, Deciduous, run by Cairo University.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth, Deciduous
- What is being tested?
- Pulpectomy for primary molars + triple antibiotic mix, Pulpectomy for primary molars + 3mixstatin and Pulpectomy for primary molars + simvastatin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Sep 2018to Jan 2020
- 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 5 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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):
Show all 14Show fewer
- Spontaneous pain
- Intraoral Abscess
- Extra oral Abscess
- Tender to percussion
- 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.
- -
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the detailed description
A clinical situation will often present itself where primary teeth under radiographic examination show inter-radicular or periapical root resorption, perforation of coronal third of roots and/or loss of bone support as a result of infective or inflammatory conditions. Pathologic root resorption is the most common cause of premature tooth loss in primary dentition. The reason for that may be the high content of undifferentiated mesenchymal cells, which may give rise to odontoclastic cells in response to either the caries process or the pulp-capping materials, resulting in the exaggerated inflammatory response and consequently internal resorption in primary teeth. It would make sense to utilize the rich supply of undifferentiated mesenchymal cells towards regeneration of remaining dental tissues.
Antibiotic Mix as an intracanal medicament
In recent years, the Cariology Research Unit of Niigata University School of Dentistry has developed the concept of lesion sterilization and tissue repair (LSTR) therapy that employed a mixture of antibacterial drugs for disinfection. Repair of damaged tissues can be expected if lesions are disinfected. This procedure uses a mixture of three antibacterial drugs (3Mix MP) as a root canal medicament to eliminate the remaining bacteria in endodontic lesions. The medicament consists of metronidazole, ciprofloxacin and minocycline - with macrogol (M) as the ointment base and propylene glycol (P) as the carrier Alone, none of these drugs resulted in complete elimination of the bacteria. However, in combination, these drugs were able to consistently sterilize all samples.
Although a local antibiotic medication in endodontics offers many advantages, this mode has some drawbacks, including development of bacterial resistant strains. That is a major concern and may lead to the transfer of resistance genes from antibiotic-resistant to antibiotic-susceptible microorganisms. Other drawbacks include allergic reactions inhibition of angiogenesis , and tooth staining or discoloration particularly with Minocycline. More importantly is that although the concept of Lesion sterilization and tissue repair (LSTR) therapy is that it provides an efficient and predictable disinfection, through 3 Mix on a local level and providing the suitable environment for tissues to heal, it does not in itself have any anti-inflammatory nor regenerative potential. Statins may provide these two benefit.
Choice of comparator Statins are structural analogs of HMG-CoA (3hydroxy-3-methylglutaryl-coenzyme A). These drugs are the first-line for hyperlipidemia and it has been recognized to be a safe and low-priced drug as a result of its worldwide longtime usage. Moreover, statins have multiple functions including anti-inflammation, induction of angiogenesis and improvement of the vascular endothelial cell function. Another interesting and important function of statin is its effect on bone formation. It has been reported that several statins such as simvastatin and lovastatin have anabolic effects on bone metabolism at in vitro and in vivo studies. They promote mineralization in non-mineralizing osteoblasts through induction of BMP-2 and osteocalcin. Local application of simvastatin gel has shown to stimulate the regeneration of alveolar bone defects Statins have an anti-inflammatory effect. They act by decreasing the production of interleukin-6 and interleukin-8 and may also improve the function of odontoblasts, thus dentin formation.
3 Mixstatin as an intracanal medicament
Often, different chemicals or drugs are combination in a cocktail in an attempt to elicit variety of effects with a single application.
Aminabadi et al combined the above-mentioned techniques by adding simvastatin powder to the tri-antibiotic mix (3Mix) and proposed the term "3Mixtatin", (an acronym of 3Mix and simvastatin) with the aims of suppressing bacteria, preventing pulp inflammation, and inducing hard tissue formation. His study population involved poor prognosis primary molars with advanced root resorption and/or pulpal floor perforation.
When compared with MTA, radio graphic and clinical healing occurred more successfully following 3Mixtatin treatment within a 24-month study period 96.8% success rate both clinically and radiographically. 3Mixstatin, a previously unstudied combination was applied, lead to preservation of the primary teeth that were otherwise indicated for extraction according to current guidelines. It may lead to a paradigm shift in the treatment of primary teeth in the future.
- Conditions
- Tooth, Deciduous
- Being tested
- Pulpectomy for primary molars + triple antibiotic mix, Pulpectomy for primary molars + 3mixstatin, Pulpectomy for primary molars + simvastatin
- Keywords
- non vital, deciduous, 3mixstatin, simvastatin, triple antibiotic mix, 3 mix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulpectomy for primary molars + triple antibiotic mixProcedure or surgery
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
Pulpectomy for primary molars + 3mixstatinProcedure or surgery
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
Pulpectomy for primary molars + simvastatinProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Procedure: Pulpectomy for primary molars + simvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (1)
Bone density changes in Region of Interest ROI
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)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2018
- Study startSep 2018 (estimated)
- Primary completionSep 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Tooth, DeciduousStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina El Kharadly, October 6 University
- Investigators
- Sherif B El Tawil, DDS, Study chair, Cairo UniversityDina El Beshlawy, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03585751
- Sponsor's protocol ID
- 3Mixstatin
- Status last verified
- Jun 2018
- First submitted
- 8 Jun 2018
- Last updated
- 13 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 26950808Takushige 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 14871180Asl 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.
PubMed 23487477Doneria 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.
PubMed 29326499Nakornchai 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.
PubMed 20409203Okamoto 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.
PubMed 19249597Seto 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.
PubMed 18447852Chen 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.
PubMed 22340324Sakoda 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.
PubMed 16723648
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03585751
- Acronym / sponsor ID
- 3Mixstatin
- Conditions
- Tooth, Deciduous
- Keywords
- non vital, deciduous, 3mixstatin, simvastatin, triple antibiotic mix, 3 mix
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Sep 2018 (estimated)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 13 Jul 2018 (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.
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.
Detailed description
A clinical situation will often present itself where primary teeth under radiographic examination show inter-radicular or periapical root resorption, perforation of coronal third of roots and/or loss of bone support as a result of infective or inflammatory conditions. Pathologic root resorption is the most common cause of premature tooth loss in primary dentition. The reason for that may be the high content of undifferentiated mesenchymal cells, which may give rise to odontoclastic cells in response to either the caries process or the pulp-capping materials, resulting in the exaggerated inflammatory response and consequently internal resorption in primary teeth. It would make sense to utilize the rich supply of undifferentiated mesenchymal cells towards regeneration of remaining dental tissues.
Antibiotic Mix as an intracanal medicament
In recent years, the Cariology Research Unit of Niigata University School of Dentistry has developed the concept of lesion sterilization and tissue repair (LSTR) therapy that employed a mixture of antibacterial drugs for disinfection. Repair of damaged tissues can be expected if lesions are disinfected. This procedure uses a mixture of three antibacterial drugs (3Mix MP) as a root canal medicament to eliminate the remaining bacteria in endodontic lesions. The medicament consists of metronidazole, ciprofloxacin and minocycline - with macrogol (M) as the ointment base and propylene glycol (P) as the carrier Alone, none of these drugs resulted in complete elimination of the bacteria. However, in combination, these drugs were able to consistently sterilize all samples.
Although a local antibiotic medication in endodontics offers many advantages, this mode has some drawbacks, including development of bacterial resistant strains. That is a major concern and may lead to the transfer of resistance genes from antibiotic-resistant to antibiotic-susceptible microorganisms. Other drawbacks include allergic reactions inhibition of angiogenesis , and tooth staining or discoloration particularly with Minocycline. More importantly is that although the concept of Lesion sterilization and tissue repair (LSTR) therapy is that it provides an efficient and predictable disinfection, through 3 Mix on a local level and providing the suitable environment for tissues to heal, it does not in itself have any anti-inflammatory nor regenerative potential. Statins may provide these two benefit.
Choice of comparator Statins are structural analogs of HMG-CoA (3hydroxy-3-methylglutaryl-coenzyme A). These drugs are the first-line for hyperlipidemia and it has been recognized to be a safe and low-priced drug as a result of its worldwide longtime usage. Moreover, statins have multiple functions including anti-inflammation, induction of angiogenesis and improvement of the vascular endothelial cell function. Another interesting and important function of statin is its effect on bone formation. It has been reported that several statins such as simvastatin and lovastatin have anabolic effects on bone metabolism at in vitro and in vivo studies. They promote mineralization in non-mineralizing osteoblasts through induction of BMP-2 and osteocalcin. Local application of simvastatin gel has shown to stimulate the regeneration of alveolar bone defects Statins have an anti-inflammatory effect. They act by decreasing the production of interleukin-6 and interleukin-8 and may also improve the function of odontoblasts, thus dentin formation.
3 Mixstatin as an intracanal medicament
Often, different chemicals or drugs are combination in a cocktail in an attempt to elicit variety of effects with a single application.
Aminabadi et al combined the above-mentioned techniques by adding simvastatin powder to the tri-antibiotic mix (3Mix) and proposed the term "3Mixtatin", (an acronym of 3Mix and simvastatin) with the aims of suppressing bacteria, preventing pulp inflammation, and inducing hard tissue formation. His study population involved poor prognosis primary molars with advanced root resorption and/or pulpal floor perforation.
When compared with MTA, radio graphic and clinical healing occurred more successfully following 3Mixtatin treatment within a 24-month study period 96.8% success rate both clinically and radiographically. 3Mixstatin, a previously unstudied combination was applied, lead to preservation of the primary teeth that were otherwise indicated for extraction according to current guidelines. It may lead to a paradigm shift in the treatment of primary teeth in the future.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Triple antibiotic paste | Active comparator | Procedure: Pulpectomy for primary molars + triple antibiotic mixPulpectomy 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 |
| 3mixstatin | Experimental | Procedure: Pulpectomy for primary molars + 3mixstatinPulpectomy 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 |
| simvastatin | Experimental | Procedure: Pulpectomy for primary molars + simvastatinPulpectomy 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 |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (14 listed)
- 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
- Spontaneous pain
Key exclusion criteria (1 listed)
- 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
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 |
|---|---|---|
| Pulpectomy for primary molars + triple antibiotic mixcomplete 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 | Procedure or surgery | Triple antibiotic paste |
| Pulpectomy for primary molars + 3mixstatincomplete 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 | Procedure or surgery | 3mixstatin |
| Pulpectomy for primary molars + simvastatincomplete 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 | Procedure or surgery | simvastatin |
Primary outcome
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.
1 secondary outcome
Bone density changes in Region of Interest ROI
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2018.
- 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 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 23487477Asl 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.
- Background: PubMed 29326499Doneria 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.
- Background: PubMed 20409203Nakornchai 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.
- Background: PubMed 19249597Okamoto 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.
- Background: PubMed 18447852Seto 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.
- Background: PubMed 22340324Chen 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.
- Background: PubMed 16723648Sakoda 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.
- Individual participant dataSharing planned: No
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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.
Sherif B El Tawil, DDS study chair
Cairo University
Dina El Beshlawy study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Pulpectomy for primary molars + triple antibiotic mix, Pulpectomy for primary molars + 3mixstatin and Pulpectomy for primary molars + simvastatin in people with Tooth, Deciduous, 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 14 inclusion and 1 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 13 Jul 2018. 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 Dina y El Kharadly, Msc (+201222189574, d.elkharadly@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Over All Success Rate ( as a percentage) (time frame: 12 months). 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 NCT03585751, which also lists 9 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 13 Jul 2018.