Root Canal InfectionNCT05681221
Clinical and Radiographic Evaluation of the Synergistic Effect of Nano Silver Particles and Calcium Hydroxide Versus Triple Antibiotic Paste as Antibacterial Agents for Lesion Sterilization and Tissue Repair (LSTR) in Necrotic Primary Molars
A study testing Nano silver particles and calcium hydroxide and TAP in people with Root Canal Infection, run by Cairo University.
Trial summary
Could the clinical and radiographic success of Nano Silver Particles and Calcium Hydroxide be comparable to that of Triple Antibiotic Paste as antibacterial agents for Lesion Sterilization and Tissue Repair (LSTR) in necrotic second 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
- Root Canal Infection
- What is being tested?
- Nano silver particles and calcium hydroxide and TAP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 20 Feb 2023to 1 Jun 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
- Children aged between 4 years and 7 years.
- Restorable necrotic mandibular second primary molars
- Mandibular lower second primary molar with signs of radiolucency in periapical or furcation area.
- Mandibular lower second primary molar with widening of PDL space or loss of lamina dura continuity.
- Mandibular lower second primary molar with evidence of internal/external pathologic root resorption.
- Signs of radiolucency in periapical or furcation area.
Show all 9Show fewer
- Widening of PDL space or loss of lamina dura continuity.
- Evidence of internal/external pathologic root resorption.
- External root resorption from 1% to 50%.
Who cannot join
- Children that are not apparently healthy.
- Lack of informed consent by the child patient's parent.
- Patients allergic to any antibiotic used in the preparation of the TAP.
- Unable to attend follow-up visits.
- Refusal of participation.
- External root resorption above 50%.
Trial locations and contacts
No sites are listed yet.
Reem M. Wahby, PhD contact
About this study
Official title: Clinical and Radiographic Evaluation of the Synergistic Effect of Nano Silver Particles and Calcium Hydroxide Versus Triple Antibiotic Paste as Antibacterial Agents for Lesion Sterilization and Tissue Repair (LSTR) in Necrotic Primary Molars: Randomized Clinical Trial
Could the clinical and radiographic success of Nano Silver Particles and Calcium Hydroxide be comparable to that of Triple Antibiotic Paste as antibacterial agents for Lesion Sterilization and Tissue Repair (LSTR) in necrotic second primary molars?
Read the detailed description
The major aim of pediatric dentistry is to maintain the integrity of the primary dentition until physiologic exfoliation. Premature loss of primary teeth may lead to several complications, like disturbance in eruption sequence, ectopic eruption and space loss. Hence, the conservation of primary tooth structure is essential, provided that it can be restored to function and remain free from disease.Pulp therapy in primary teeth at times become contraindicated or compromised due to excessive root resorption, inadequate bone and periodontal support, a child with pre-cooperative age group, etc.
In the current era, a new perspective which is less invasive and less time consuming procedure could be a spark of hope for pedodontists. The Lesion Sterilization and Tissue Repair (LSTR) claims its significance in such clinical situation. The concept of LSTR was developed at the Cariology Research Unit of Niigata University School of Dentistry. The LSTR is an endodontic treatment procedure that involves non instrumentation or minimal instrumentation followed by placement of antibiotic mixture to disinfect root canal systems, and periapical lesions. The basic concept of LSTR is "do not remove or touch and leave it.". The principle behind LSTR is repair by natural defense mechanisms of host; Sterilizing the root canals and pulp chamber by medicaments can decrease the bacterial load. If the procedure is successful tissue repair can be expected.
However, because it is impossible to eradicate all microorganisms from the root canal system throughout the treatment, endodontic materials must contain specific components that release antibacterial substances. The most likely cause for this is the complex anatomy of the root canal system, which allows bacteria to colonize in inaccessible places to antimicrobial agents. Despite cleaning, and administration of highly effective antimicrobial agents, clinical trials have shown that bacteria remain within the root canal system because bacteria can form biofilms, infiltrate dentinal tubules, and cause monoinfection.
Among the intra canal medicaments, calcium hydroxide is most frequently used because of its wide antimicrobial spectrum. Calcium hydroxide Ca(OH)2 is commonly employed as an intra canal medicament. It releases hydroxyl ions which causes high alkalinity. Nevertheless, the ability of calcium hydroxide in elimination of bacteria from the root canal has been questioned. Antibacterial ability of calcium hydroxide in aqueous environment is linked to the discharge of hydroxyl ions. It can cause damage to the cytoplasmic membrane, bacterial DNA as well as can cause protein denaturation.
However, calcium hydroxide is not as much effective when used for canal disinfection having established Enterococcus faecalis (E.faecalis) biofilm. Recently, numerous studies have introduced silver nanoparticles as an antimicrobial agent. Silver nanoparticles have antimicrobial activity and are biocompatible, silver ions can cause damage to the bacterial cell wall. These are productive against many microorganisms including E.faecalis. Nanoparticles have /polyanionic polycationic properties with a high surface area and positive charge density, which increases their antibacterial activity. The particle size was also related to antimicrobial activity; the smaller particles give more bactericidal effects compared to larger particles. Calcium hydroxide do not always eradicate E.faecalis biofilm from root canals. Hence, it is essential to introduce advanced endodontic intra-canal medicament approaches that are successful in eradicating biofilm bacteria inside the root canals.
- Conditions
- Root Canal Infection
- Being tested
- Nano silver particles and calcium hydroxide, TAP
- Keywords
- primary teeth, LSTR, necrotic
- Medical subject headings
- Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nano silver particles and calcium hydroxideOther
Combination of two materials that can possibly eradicate the mixed odontogenic infection in the periapical area and dentinal tubules in necrotic primary second molars.
TAPOther
Triple antibiotic paste (TAP) is considered the gold standard in LSTR. It is a combination of ciprofloxacin, metronidazole and minocycline. Many anaerobic bacteria are resistant to ciprofloxacin. Hence, it is often used with metronidazole in treating mixed infections to compensate for its limited scope. Therefore, TAP can affect gram-negative, gram-positive, and anaerobic bacteria, and this combination can be effective against odontogenic microorganisms.
| Study group | Role | What they receive |
|---|---|---|
| LSTR in necrotic primary second molar using TAP | Active comparator | Triple antibiotic paste (TAP) is considered the gold standard in LSTR. It is a combination of ciprofloxacin, metronidazole and minocycline. Many anaerobic bacteria are resistant to ciprofloxacin. Hence, it is often used with metronidazole in treating mixed infections to compensate for its limited scope. Therefore, TAP can affect gram-negative, gram-positive, and anaerobic bacteria, and this combination can be effective against odontogenic microorganisms. Receives: Other: TAP |
| LSTR in necrotic primary second molar using nano silver particles and calcium hydroxide | Experimental | Nano silver particles have a strong anti-bacterial properties due to its ability to target the bacteria on different cellular levels. Calcium hydroxide has been used for so long as an intra canal medication in odontogenic infections due to its strong alkalinity that gives it its anti bacterial properties. This combination might be a future alternative to antibiotics, in an attempt to decrease the bacterial antibiotic resistance and antibiotics use. Receives: Other: Nano silver particles and calcium hydroxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological mobility
presence/ absence. Mobility test by applying pressure using the handle of dental mirrors
Measured: 1 year.
Post-operative pain
presence/ absence. Verbal question to patient/ parent.
Measured: 1 year.
Soft tissue pathology
presence/ absence. Visual clinical examination
Measured: 1 year.
Pain to percussion
presence/ absence. Percussion test by the handle of the dental mirror
Measured: 1 year.
Secondary outcomes (2)
Absence of furcation or periapical radiolucency
Intra-oral digital peri-apical x-ray
Measured: 1 year.
Absence of external or internal root resorption
Intra-oral digital peri-apical x-ray
Measured: 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start20 Feb 2023 (estimated)
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Root Canal InfectionStudies 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
- Model description
- TAP is an efficient antibacterial for the disinfection of the periapical area in the necrotic primary second molars as well as the infected dentinal tubules. It is effective against the persistent odontogenic infections.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sohair Magdy Abdel Fattah Aly, Cairo University
- Investigators
- Rania A. Nasr, PhD, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05681221
- Sponsor's protocol ID
- LSTR
- Status last verified
- Dec 2022
- First submitted
- 13 Dec 2022
- Last updated
- 12 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shetty A, Geethanjali G, Hegde A. Lesion sterilization and tissue repair in primary teeth. SRM Journal of Research in Dental Sciences. 2020;11(2):99. doi:10.4103/srmjrds.srmjrds_87_19
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.
PubMed 14871180Motiwala MA, Habib S, Ghafoor R, Irfan S. Comparison of antimicrobial efficacy of Calcipex and Metapex in endodontic treatment of chronic apical periodontitis: a randomised controlled trial study protocol. BMJ Open. 2021 Jul 21;11(7):e048947. doi: 10.1136/bmjopen-2021-048947.
PubMed 34290069Mohammadi Z, Shalavi S, Yazdizadeh M. Antimicrobial activity of calcium hydroxide in endodontics: a review. Chonnam Med J. 2012 Dec;48(3):133-40. doi: 10.4068/cmj.2012.48.3.133. Epub 2012 Dec 21.
PubMed 23323217Afkhami F, Pourhashemi SJ, Sadegh M, Salehi Y, Fard MJ. Antibiofilm efficacy of silver nanoparticles as a vehicle for calcium hydroxide medicament against Enterococcus faecalis. J Dent. 2015 Dec;43(12):1573-9. doi: 10.1016/j.jdent.2015.08.012. Epub 2015 Aug 29.
PubMed 26327612Zapór L. Effects of silver nanoparticles of different sizes on cytotoxicity and oxygen metabolism disorders in both reproductive and respiratory system cells. Archives of Environmental Protection. 2016;42(4):32-47. doi:10.1515/aep-2016-0038
Riaz Z, Raza M, Hanif A, Haider B, Akram S, Safdar S. Antibacterial efficacy of silver nanoparticles impregnated calcium hydroxide: An in vitro study. J Pak Dent Assoc 2022;31(1):1-4
Deepak BM, Prabhakar AR, Karuna YM, Sugandhan S, Zahoor N, Mahendrapa Shagale A. Evaluation of the Antibacterial Activity of Triclosan-incorporated Root Canal Filling Materials for Primary Teeth against Enterococcus faecalis. Int J Clin Pediatr Dent. 2021 May-Jun;14(3):393-397. doi: 10.5005/jp-journals-10005-1960.
PubMed 34720513
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of the Synergistic Effect of Nano Silver Particles and Calcium Hydroxide Versus Triple Antibiotic Paste as Antibacterial Agents for Lesion Sterilization and Tissue Repair (LSTR) in Necrotic Primary Molars: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05681221
- Acronym / sponsor ID
- LSTR
- Conditions
- Root Canal Infection
- Keywords
- primary teeth, LSTR, necrotic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Feb 2023 (estimated)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 12 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.
Could the clinical and radiographic success of Nano Silver Particles and Calcium Hydroxide be comparable to that of Triple Antibiotic Paste as antibacterial agents for Lesion Sterilization and Tissue Repair (LSTR) in necrotic second primary molars?
Detailed description
The major aim of pediatric dentistry is to maintain the integrity of the primary dentition until physiologic exfoliation. Premature loss of primary teeth may lead to several complications, like disturbance in eruption sequence, ectopic eruption and space loss. Hence, the conservation of primary tooth structure is essential, provided that it can be restored to function and remain free from disease.Pulp therapy in primary teeth at times become contraindicated or compromised due to excessive root resorption, inadequate bone and periodontal support, a child with pre-cooperative age group, etc.
In the current era, a new perspective which is less invasive and less time consuming procedure could be a spark of hope for pedodontists. The Lesion Sterilization and Tissue Repair (LSTR) claims its significance in such clinical situation. The concept of LSTR was developed at the Cariology Research Unit of Niigata University School of Dentistry. The LSTR is an endodontic treatment procedure that involves non instrumentation or minimal instrumentation followed by placement of antibiotic mixture to disinfect root canal systems, and periapical lesions. The basic concept of LSTR is "do not remove or touch and leave it.". The principle behind LSTR is repair by natural defense mechanisms of host; Sterilizing the root canals and pulp chamber by medicaments can decrease the bacterial load. If the procedure is successful tissue repair can be expected.
However, because it is impossible to eradicate all microorganisms from the root canal system throughout the treatment, endodontic materials must contain specific components that release antibacterial substances. The most likely cause for this is the complex anatomy of the root canal system, which allows bacteria to colonize in inaccessible places to antimicrobial agents. Despite cleaning, and administration of highly effective antimicrobial agents, clinical trials have shown that bacteria remain within the root canal system because bacteria can form biofilms, infiltrate dentinal tubules, and cause monoinfection.
Among the intra canal medicaments, calcium hydroxide is most frequently used because of its wide antimicrobial spectrum. Calcium hydroxide Ca(OH)2 is commonly employed as an intra canal medicament. It releases hydroxyl ions which causes high alkalinity. Nevertheless, the ability of calcium hydroxide in elimination of bacteria from the root canal has been questioned. Antibacterial ability of calcium hydroxide in aqueous environment is linked to the discharge of hydroxyl ions. It can cause damage to the cytoplasmic membrane, bacterial DNA as well as can cause protein denaturation.
However, calcium hydroxide is not as much effective when used for canal disinfection having established Enterococcus faecalis (E.faecalis) biofilm. Recently, numerous studies have introduced silver nanoparticles as an antimicrobial agent. Silver nanoparticles have antimicrobial activity and are biocompatible, silver ions can cause damage to the bacterial cell wall. These are productive against many microorganisms including E.faecalis. Nanoparticles have /polyanionic polycationic properties with a high surface area and positive charge density, which increases their antibacterial activity. The particle size was also related to antimicrobial activity; the smaller particles give more bactericidal effects compared to larger particles. Calcium hydroxide do not always eradicate E.faecalis biofilm from root canals. Hence, it is essential to introduce advanced endodontic intra-canal medicament approaches that are successful in eradicating biofilm bacteria inside the root canals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- TAP is an efficient antibacterial for the disinfection of the periapical area in the necrotic primary second molars as well as the infected dentinal tubules. It is effective against the persistent odontogenic infections.
| Arm | Type | Receives |
|---|---|---|
| LSTR in necrotic primary second molar using TAP | Active comparator | Other: TAPTriple antibiotic paste (TAP) is considered the gold standard in LSTR. It is a combination of ciprofloxacin, metronidazole and minocycline. Many anaerobic bacteria are resistant to ciprofloxacin. Hence, it is often used with metronidazole in treating mixed infections to compensate for its limited scope. Therefore, TAP can affect gram-negative, gram-positive, and anaerobic bacteria, and this combination can be effective against odontogenic microorganisms. |
| LSTR in necrotic primary second molar using nano silver particles and calcium hydroxide | Experimental | Other: Nano silver particles and calcium hydroxideNano silver particles have a strong anti-bacterial properties due to its ability to target the bacteria on different cellular levels. Calcium hydroxide has been used for so long as an intra canal medication in odontogenic infections due to its strong alkalinity that gives it its anti bacterial properties. This combination might be a future alternative to antibiotics, in an attempt to decrease the bacterial antibiotic resistance and antibiotics use. |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Children aged between 4 years and 7 years.
- Restorable necrotic mandibular second primary molars
- Mandibular lower second primary molar with signs of radiolucency in periapical or furcation area.
- Mandibular lower second primary molar with widening of PDL space or loss of lamina dura continuity.
- Mandibular lower second primary molar with evidence of internal/external pathologic root resorption.
Key exclusion criteria (6 listed)
- Children that are not apparently healthy.
- Lack of informed consent by the child patient's parent.
- Patients allergic to any antibiotic used in the preparation of the TAP.
- Unable to attend follow-up visits.
- Refusal of participation.
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 |
|---|---|---|
| Nano silver particles and calcium hydroxideCombination of two materials that can possibly eradicate the mixed odontogenic infection in the periapical area and dentinal tubules in necrotic primary second molars. | Other | LSTR in necrotic primary second molar using nano silver particles and calcium hydroxide |
| TAPTriple antibiotic paste (TAP) is considered the gold standard in LSTR. It is a combination of ciprofloxacin, metronidazole and minocycline. Many anaerobic bacteria are resistant to ciprofloxacin. Hence, it is often used with metronidazole in treating mixed infections to compensate for its limited scope. Therefore, TAP can affect gram-negative, gram-positive, and anaerobic bacteria, and this combination can be effective against odontogenic microorganisms. | Other | LSTR in necrotic primary second molar using TAP |
Primary outcome
Pathological mobility
Time frame: 1 year.
presence/ absence. Mobility test by applying pressure using the handle of dental mirrors
Post-operative pain
Time frame: 1 year.
presence/ absence. Verbal question to patient/ parent.
Soft tissue pathology
Time frame: 1 year.
presence/ absence. Visual clinical examination
Pain to percussion
Time frame: 1 year.
presence/ absence. Percussion test by the handle of the dental mirror
2 secondary outcomes
Absence of furcation or periapical radiolucency
Time frame: 1 year.
Absence of external or internal root resorption
Time frame: 1 year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
- BackgroundShetty A, Geethanjali G, Hegde A. Lesion sterilization and tissue repair in primary teeth. SRM Journal of Research in Dental Sciences. 2020;11(2):99. doi:10.4103/srmjrds.srmjrds_87_19
- 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 34290069Motiwala MA, Habib S, Ghafoor R, Irfan S. Comparison of antimicrobial efficacy of Calcipex and Metapex in endodontic treatment of chronic apical periodontitis: a randomised controlled trial study protocol. BMJ Open. 2021 Jul 21;11(7):e048947. doi: 10.1136/bmjopen-2021-048947.
- Background: PubMed 23323217Mohammadi Z, Shalavi S, Yazdizadeh M. Antimicrobial activity of calcium hydroxide in endodontics: a review. Chonnam Med J. 2012 Dec;48(3):133-40. doi: 10.4068/cmj.2012.48.3.133. Epub 2012 Dec 21.
- Background: PubMed 26327612Afkhami F, Pourhashemi SJ, Sadegh M, Salehi Y, Fard MJ. Antibiofilm efficacy of silver nanoparticles as a vehicle for calcium hydroxide medicament against Enterococcus faecalis. J Dent. 2015 Dec;43(12):1573-9. doi: 10.1016/j.jdent.2015.08.012. Epub 2015 Aug 29.
- BackgroundZapór L. Effects of silver nanoparticles of different sizes on cytotoxicity and oxygen metabolism disorders in both reproductive and respiratory system cells. Archives of Environmental Protection. 2016;42(4):32-47. doi:10.1515/aep-2016-0038
- BackgroundRiaz Z, Raza M, Hanif A, Haider B, Akram S, Safdar S. Antibacterial efficacy of silver nanoparticles impregnated calcium hydroxide: An in vitro study. J Pak Dent Assoc 2022;31(1):1-4
- Background: PubMed 34720513Deepak BM, Prabhakar AR, Karuna YM, Sugandhan S, Zahoor N, Mahendrapa Shagale A. Evaluation of the Antibacterial Activity of Triclosan-incorporated Root Canal Filling Materials for Primary Teeth against Enterococcus faecalis. Int J Clin Pediatr Dent. 2021 May-Jun;14(3):393-397. doi: 10.5005/jp-journals-10005-1960.
Related trials for Root Canal Infection
Active, not recruitingObservational study
A Retrospective Cohort Study on the Non-Surgical Treatment of Periapical Inflammatory Lesions With Vitapex Paste
Periapical Periodontitis, Periapical Abscess
Not yet recruitingPhase 1/2
Effect of Temperature Elevation on the Antimicrobial Efficacy of Two Root Canal Irrigants in Primary Root Canal Infections: A Randomized Controlled Clinical Trial
Irreversible Pulpitis
Enrolling by invitationPhase 4
Nanozymes in Endodontics
Apical Periodontitis, Endodontic Disease
Recruiting
One vs Two Visits Root Canal Treatments in Infected Teeth
Apical Periodontitis, Pain
Active, not recruitingObservational study
Lesion Sterilization Tissue Repair and Conventional Pulpectomy in Primary Molars
Pulpitis - Irreversible, Pulp Necroses
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.
Reem M. Wahby, PhD contact
Rania A. Nasr, PhD study chair
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Nano silver particles and calcium hydroxide and TAP in people with Root Canal Infection, 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 9 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 12 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 Sohair M. Aly, BSc (+201006202025, sohair_magdy@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological mobility (time frame: 1 year.). The study lists 4 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 NCT05681221, which also lists 8 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 12 Jan 2023.