Root Canal TherapyPBSCIMMONCT03514264
Clinical Applicability of PBSCIMMO as a Single Material in Endodontic Obturations
A study testing Gutta Percha and AHPLUS cement (group A) and PBS CIMMO cement (group B) in people with Root Canal Therapy, run by Universidade do Vale do Sapucai at 1 site in Brazil.
Trial summary
A randomized, interventional, prospective, unicentric clinical study, 86 patients will be submitted to endodontic treatment of necrotic teeth. 43 patients will complete treatment with obturation with AHPlus cement and Gutta-Percha cones (group A) and 43 patients will complete treatment with PBS® CIMMO cement (single… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Root Canal Therapy
- What is being tested?
- Gutta Percha and AHPLUS cement (group A) and PBS CIMMO cement (group B)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteBrazil
- Study dates
- 9 Nov 2017to 26 Feb 2019
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients presenting with a diagnosis of necrosis.
Who cannot join
- Patients who drop out during the study
- Patients who do not return to the final exam after 6 months.
- Patients who present more than one tooth in need of treatment will choose only one tooth, the others will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
A randomized, interventional, prospective, unicentric clinical study, 86 patients will be submitted to endodontic treatment of necrotic teeth. 43 patients will complete treatment with obturation with AHPlus cement and Gutta-Percha cones (group A) and 43 patients will complete treatment with PBS® CIMMO cement (single material) (group B). The primary outcome will be the repair of the periradicular lesion demonstrated by integrity of the hard blade throughout the perimeter of the root identified by Tomography Cone Beam, performed after 6 months of treatment. The secondary endpoint will be the absence of fistula after 6 months of treatment identified by clinical examination.
Read the detailed description
GOALS PRIMARY OBJECTIVE-Evaluate the PBS CIMMO cement as a single element in endodontic obturations of necrotic teeth, through the analysis of integrity of the hard blade throughout the perimeter of the root of the treated tooth, identified by Tomography Cone Beam, after 6 months of treatment.
SECONDARY OBJECTIVE- Clinical evaluation of teeth treated after 6 months, with the purpose of identifying the absence of clinical signs and symptoms, through the finding of absence of fistula.
METHOD-DESIGN A randomized, interventional, prospective, unicentric, double blind clinical trial.
APPROVAL This work was approved by the Research Ethics Committee of the Vale do Sapucaí University (UNIVÁS) and is registered in the Brazilian Platform - Certificate of Approval for CAAE-number 77495717.7.0000.5102 CONSENT Relevant information from this study will be provided to all patients in an understandable way. Patients will have the opportunity to have their questions answered and will provide their consent by signing the free and informed consent form The study is being carried out in Brazil, in the urban area of the city of Pouso Alegre, state of Minas Geraes, in the Clinic of the Brazilian Association of Dentistry (ABO).
Interventions
The recommended techniques will be different for each group. GROUP A - CUTTING WITH CEMENT AHPLUS AND GUTTA HANGER
- First session Intra-channel medication and instrumentation procedures: Local anesthesia with lidocaine and phenylephrine 1: 100,000 (DFL® Industry and Commerce-Brazil) will be used a tube containing 1.8 ml. Absolute insulation with clamp W8A and 8ª (SSWhite ® -Duflex-Brasil), rubber sheet (Madeitex®-Brazil) and arch (JON® Brazil). The opening will be performed with a high-speed motor (Dabi Atlante® Equipamentos Odontológicos Brasil), low rotation (Dabi Atlante®) and endodontic probe (Duflex®) drill 1016 HL (KG®-Sorensen). Mechanized instrumentation will be carried out using the Endo Easy SI® motor in reciprocating module. The endodontic instrument for instrumentation will be the Logic Easy® file numbering (2505). Pre-crown-down instrumentation will be performed on the cervical, middle and apical thirds, with apparent measurements determined by the initial radiograph. Each channel will receive irrigation with 2.5% sodium hypochlorite through a 10ml disposable syringe with a 0.55x20 24G hypodermic needle. 3/4 SR®. Then, the localization of the foramen with Novapex® foramen locator will be performed and the working length will be determined and then instrumentation with the same file will be determined. Through a reciprocating Easy Clean® device, PUI (Passive Ultrasonic Irrigation) with ethylene diamino tetraacetic acid, surfactant (EDTA T) Formula \& Action® as well as sodium hypochlorite will be performed. Then, it will be installed in the channels, Callen PMCC SSWhite® (Calcium hydroxide paste with camphorated paramonoclorophenol) MIC (intra-canal medication) to perform disinfection of dentinal canaliculi. Such paste will temporarily seal these channels for 4 weeks.
- Second session -After 30 days The obturation with AHPlus cement and Gutta Percha (group A) will be performed in 43 teeth, according to the following sequence: test of the main gutta percha Dentsply®, after foramen calibration. Handling of the AH Plus Dentsply® cement will be carried out. The medium cone will be greased with cement and taken to the canal. Through an Easy-Compressor term, the cone will be cut and compacted "hot" in the channel. New cone will be placed in the space conquered by compaction, will be cut "hot" by term compactor and then condensed by condenser instrument Schilder Oddus De Deus®. Soon after, the teeth will be restored with Charisma Kulzer® photopolymerizable resin, Radi® light curing. Patients will be submitted to final radiographs and receive systemic medication with analgesic Lisador® 1 tablet every 6 hours while there is pain. The recommended anti-inflammatory will be Decadron 4mg, 1 tablet every 12 hours for 3 days, if the patient can not use it, Maxulid 400 mg, 1 tablet every 12 hours for 3 days will be given. The antibiotic of choice will be Sinot Clav® 875 mg, 1 tablet every 12 hours for 7 days. In case of allergy to Amoxicillin, Dalacin 300 mg, 1 capsule every 8 hours for 7 days will be given. After 6 months, the patients will return to the Clinic of the Brazilian Association of Dentistry to perform a Cone Beam CT scan and clinical examination.
GROUP B - CUTTING WITH PBSCIMMO CEMENT SINGLE SESSION Instrumentation and filling procedures Local anesthesia with lidocaine and phenylephrine 1: 100,000 (DFL® Industry and Commerce-Brazil) will be used a tube containing 1.8 ml. Absolute insulation with clamp W8A and 8ª (SSWhite ® -Duflex-Brasil), rubber sheet (Madeitex®-Brazil) and arch (JON® Brazil). The opening will be performed with a high-speed motor (Dabi Atlante® Equipamentos Odontológicos Brasil), low rotation (Dabi Atlante®) and endodontic probe (Duflex®) drill 1016 HL (KG®-Sorensen). Mechanized instrumentation will be carried out using the Endo Easy SI® motor in reciprocating module. The endodontic instrument for instrumentation will be the Logic Easy® file numbering (2505). Pre-crown-down instrumentation will be performed on the cervical, middle and apical thirds, with apparent, determined by the initial radiography. Each channel will receive irrigation with 2.5% sodium hypochlorite through a 10ml disposable syringe with a 0.55x20 24G hypodermic needle. 3/4 SR®. Then, the localization of the foramen with Novapex® foramen locator will be performed and the working length will be determined and then instrumentation with the same file will be determined. Through a reciprocating Easy Clean® device, PUI (Passive Ultrasonic Irrigation) with ethylene diamino tetraacetic acid, surfactant (EDTA T) Formula \& Action® as well as sodium hypochlorite will be performed. Continuously, the PBS CIMMO® cement will be installed in the channels, as a single obturator element. The CBS® PBS Cement seal (Group B) will be made of 43 teeth as follows: the instruments used will be the number 40 nickel and titanium Macspaden Flex Pack® micro-motor capacitors coupled to the internal dental office system and nickel and titanium in numbers and standard colors: Green (0.35 and 0.70), Black (0.40 and 0.80), Yellow (0.50 and 1.00), Blue (0.60 and 1.20). Handling of CIMMO® PBS cement will follow manufacturer's recommendations: on sterile glass plate, a portion of the cement powder and a drop of distilled water will be dispensed. Through a flexible spatula, the powder will be mixed to the liquid and spatulate until the consistency of toothpaste. The Macspaden Flex Pack® 40 instrument will then be coupled to the micro-motor and embedded in cement. When it is taken to the channel, the micro-motor will be activated and the channel will be in and out. Then, condensation will occur with the green condenser tip thinner and then thicker. In the same way, more cement will be brought to the channel with Flex Pack® number 40 and again condensed now with the black, thin point and then thick capacitors. These maneuvers will be repeated until the fine and thick blue capacitors are used and the absence of spaces is verified. Soon after, the teeth will be restored with Charisma Kulzer® photopolymerizable resin, Radi® light curing. Patients will be submitted to final radiographs and receive systemic medication with analgesic Lisador® 1 tablet every 6 hours while there is pain. The recommended anti-inflammatory will be Decadron®, 4mg, 1 tablet every 12 hours for 3 days, if the patient is unable to use it, Maxulid® 400mg, 1 tablet every 12 hours for 3 days will be given. The antibiotic of choice will be Sinot Clav® 875 mg, 1 tablet every 12 hours for 7 days. In case of allergy to Amoxicillin, Dalacin 300 mg, 1 capsule every 8 hours for 7 days will be given. After 6 months, the patients will return to the Clinic of the Associação Brasileira de Odontologia to perform a Cone Beam tomografy scan and clinical examination.
Sample size: 86 patients The observed response will be dichotomous, the type of analysis will be by comparing two proportions. The investigators accessed the site www.lee.dante.br 25, Lee-Samples for verification of possible identification of n. The proportions were based on the literature.
Proportion in group 1: 36% Proportion in group 2: 10% Level of significance: 5% Power of the test: 90% Hypothesis test: monocaudal Sample size calculated for each group: 43
Allocation: Patients are allocated to the study or control group in a 1: 1 ratio using a software-generated randomizer - RANDOMIZATION.COM (http://www.randomization.com)26. Concealment Mechanism: Opaque, sealed and serial number envelopes containing the group as well as the material to be used will be used to maintain the confidentiality of the random allocation. The envelopes will be delivered to the professional who performed the intervention at the initial moment Patients will not know which research group will participate. After 6 months, a CT scan and clinical examination will be performed. The evaluations will be performed by professionals who did not participate in the intervention and have more than 20 years of experience in endodontics. These professionals will not know to which group the patient belongs.
Recruitment of patients-waiting list of patients who seek the clinic of the Associação Brasileira de Odontologia (ABO) -UNIVÁS.
Beginning of appointments: November 2017 Data collection: June 2018.
- Conditions
- Root Canal Therapy
- Being tested
- Gutta Percha and AHPLUS cement (group A), PBS CIMMO cement (group B)
- Keywords
- Endodontics, Biomaterials, Dental pulp cavity, Periapical abscess, Root canal therapy, Root canal obturation
- Medical subject headings
- Dental Caries, Periapical Abscess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gutta Percha and AHPLUS cement (group A)Procedure or surgery
First intervention: endodontic instrumentation and introduction of intact medication that will remain inside the tooth for 4 weeks.
Second intervention: removal of intracanal medication and canal filling with cement AHPLUS and guttapercha
PBS CIMMO cement (group B)Procedure or surgery
Single intervention: endodontic instrumentation and obturation with cement PBS CIMMO
| Study group | Role | What they receive |
|---|---|---|
| GUTTA PERCHA and AHPLUS cement (group A) | Experimental | 43 patients will undergo endodontic treatment with obturation with AHPlus cement and Gutta-Percha cones. This treatment will be performed in 2 sessions. First intervention: endodontic instrumentation and introduction of intra-canal medication that will remain in the tooth for 4 weeks. Second intervention: removal of intracanal medication and filling with cement and gutta percha AHPlus. Receives: Procedure: Gutta Percha and AHPLUS cement (group A) |
| PBS CIMMO cement (group B) | Experimental | 43 patients will undergo endodontic treatment with PBS CIMMO® cement (single material).This treatment will be performed in 1 session.Single intervention: endodontic instrumentation and cement filling PBS CIMMO. Receives: Procedure: PBS CIMMO cement (group B) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients with necrotic teeth and periradicular lesion evaluated by cone beam tomography
The data will be aggregated by presence of hard blade that determines the phylogenetic parameter of success of the treatment. This physiological parameter is the presence of hard blade integrated in the tomography image, which will determine healthy periodontal ligament
Measured: Patients will return six months after the procedure to undergo a exam cone Beam tomografy
Secondary outcomes (1)
Clinical examination of patients' treated teeth
The physiological parameter for this examination will be the absence of fistula that will determine treatment success
Measured: Patients will return six months after the procedure to undergo a clinical examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2018
- Study start9 Nov 2017
- Primary completion5 Jun 2018 (estimated)
- Study completion26 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Root Canal TherapyStudies of the same condition, open and under way.
- 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
- A randomized, interventional, prospective, unicentric, double blind clinical trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Vale do Sapucai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rubia Moura Leite Boczar, Universidade do Vale do Sapucai
- Investigators
- Rubia Boczar, Principal investigator, Univás-Universidade do Vale do Sapucaí- Pouso Alegre Minas GeraesTaylor b Schnaider, MD,PhD, Study director, Universidade Vale do SapucaíDaniela F Veiga, MD,PhD, Study chair, Universidade Vale do Sapucaí
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03514264
- Sponsor's protocol ID
- PBS
- Acronym
- PBSCIMMO
- Status last verified
- Jun 2018
- First submitted
- 26 Feb 2018
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Applicability of PBSCIMMO as a Single Material in Endodontic Obturations
- ClinicalTrials.gov ID
- NCT03514264
- Acronym / sponsor ID
- PBSCIMMO / PBS
- Conditions
- Root Canal Therapy
- Keywords
- Endodontics, Biomaterials, Dental pulp cavity, Periapical abscess, Root canal therapy, Root canal obturation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Universidade do Vale do SapucaiUniversity, hospital or other
- Study start
- 9 Nov 2017 (actual)
- Primary completion
- 5 Jun 2018 (estimated)
- Study completion
- 26 Feb 2019 (estimated)
- First posted
- 2 May 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.
A randomized, interventional, prospective, unicentric clinical study, 86 patients will be submitted to endodontic treatment of necrotic teeth. 43 patients will complete treatment with obturation with AHPlus cement and Gutta-Percha cones (group A) and 43 patients will complete treatment with PBS® CIMMO cement (single material) (group B). The primary outcome will be the repair of the periradicular lesion demonstrated by integrity of the hard blade throughout the perimeter of the root identified by Tomography Cone Beam, performed after 6 months of treatment. The secondary endpoint will be the absence of fistula after 6 months of treatment identified by clinical examination.
Detailed description
GOALS PRIMARY OBJECTIVE-Evaluate the PBS CIMMO cement as a single element in endodontic obturations of necrotic teeth, through the analysis of integrity of the hard blade throughout the perimeter of the root of the treated tooth, identified by Tomography Cone Beam, after 6 months of treatment.
SECONDARY OBJECTIVE- Clinical evaluation of teeth treated after 6 months, with the purpose of identifying the absence of clinical signs and symptoms, through the finding of absence of fistula.
METHOD-DESIGN A randomized, interventional, prospective, unicentric, double blind clinical trial.
APPROVAL This work was approved by the Research Ethics Committee of the Vale do Sapucaí University (UNIVÁS) and is registered in the Brazilian Platform - Certificate of Approval for CAAE-number 77495717.7.0000.5102 CONSENT Relevant information from this study will be provided to all patients in an understandable way. Patients will have the opportunity to have their questions answered and will provide their consent by signing the free and informed consent form The study is being carried out in Brazil, in the urban area of the city of Pouso Alegre, state of Minas Geraes, in the Clinic of the Brazilian Association of Dentistry (ABO).
Interventions
The recommended techniques will be different for each group. GROUP A - CUTTING WITH CEMENT AHPLUS AND GUTTA HANGER
- First session Intra-channel medication and instrumentation procedures: Local anesthesia with lidocaine and phenylephrine 1: 100,000 (DFL® Industry and Commerce-Brazil) will be used a tube containing 1.8 ml. Absolute insulation with clamp W8A and 8ª (SSWhite ® -Duflex-Brasil), rubber sheet (Madeitex®-Brazil) and arch (JON® Brazil). The opening will be performed with a high-speed motor (Dabi Atlante® Equipamentos Odontológicos Brasil), low rotation (Dabi Atlante®) and endodontic probe (Duflex®) drill 1016 HL (KG®-Sorensen). Mechanized instrumentation will be carried out using the Endo Easy SI® motor in reciprocating module. The endodontic instrument for instrumentation will be the Logic Easy® file numbering (2505). Pre-crown-down instrumentation will be performed on the cervical, middle and apical thirds, with apparent measurements determined by the initial radiograph. Each channel will receive irrigation with 2.5% sodium hypochlorite through a 10ml disposable syringe with a 0.55x20 24G hypodermic needle. 3/4 SR®. Then, the localization of the foramen with Novapex® foramen locator will be performed and the working length will be determined and then instrumentation with the same file will be determined. Through a reciprocating Easy Clean® device, PUI (Passive Ultrasonic Irrigation) with ethylene diamino tetraacetic acid, surfactant (EDTA T) Formula \& Action® as well as sodium hypochlorite will be performed. Then, it will be installed in the channels, Callen PMCC SSWhite® (Calcium hydroxide paste with camphorated paramonoclorophenol) MIC (intra-canal medication) to perform disinfection of dentinal canaliculi. Such paste will temporarily seal these channels for 4 weeks.
- Second session -After 30 days The obturation with AHPlus cement and Gutta Percha (group A) will be performed in 43 teeth, according to the following sequence: test of the main gutta percha Dentsply®, after foramen calibration. Handling of the AH Plus Dentsply® cement will be carried out. The medium cone will be greased with cement and taken to the canal. Through an Easy-Compressor term, the cone will be cut and compacted "hot" in the channel. New cone will be placed in the space conquered by compaction, will be cut "hot" by term compactor and then condensed by condenser instrument Schilder Oddus De Deus®. Soon after, the teeth will be restored with Charisma Kulzer® photopolymerizable resin, Radi® light curing. Patients will be submitted to final radiographs and receive systemic medication with analgesic Lisador® 1 tablet every 6 hours while there is pain. The recommended anti-inflammatory will be Decadron 4mg, 1 tablet every 12 hours for 3 days, if the patient can not use it, Maxulid 400 mg, 1 tablet every 12 hours for 3 days will be given. The antibiotic of choice will be Sinot Clav® 875 mg, 1 tablet every 12 hours for 7 days. In case of allergy to Amoxicillin, Dalacin 300 mg, 1 capsule every 8 hours for 7 days will be given. After 6 months, the patients will return to the Clinic of the Brazilian Association of Dentistry to perform a Cone Beam CT scan and clinical examination.
GROUP B - CUTTING WITH PBSCIMMO CEMENT SINGLE SESSION Instrumentation and filling procedures Local anesthesia with lidocaine and phenylephrine 1: 100,000 (DFL® Industry and Commerce-Brazil) will be used a tube containing 1.8 ml. Absolute insulation with clamp W8A and 8ª (SSWhite ® -Duflex-Brasil), rubber sheet (Madeitex®-Brazil) and arch (JON® Brazil). The opening will be performed with a high-speed motor (Dabi Atlante® Equipamentos Odontológicos Brasil), low rotation (Dabi Atlante®) and endodontic probe (Duflex®) drill 1016 HL (KG®-Sorensen). Mechanized instrumentation will be carried out using the Endo Easy SI® motor in reciprocating module. The endodontic instrument for instrumentation will be the Logic Easy® file numbering (2505). Pre-crown-down instrumentation will be performed on the cervical, middle and apical thirds, with apparent, determined by the initial radiography. Each channel will receive irrigation with 2.5% sodium hypochlorite through a 10ml disposable syringe with a 0.55x20 24G hypodermic needle. 3/4 SR®. Then, the localization of the foramen with Novapex® foramen locator will be performed and the working length will be determined and then instrumentation with the same file will be determined. Through a reciprocating Easy Clean® device, PUI (Passive Ultrasonic Irrigation) with ethylene diamino tetraacetic acid, surfactant (EDTA T) Formula \& Action® as well as sodium hypochlorite will be performed. Continuously, the PBS CIMMO® cement will be installed in the channels, as a single obturator element. The CBS® PBS Cement seal (Group B) will be made of 43 teeth as follows: the instruments used will be the number 40 nickel and titanium Macspaden Flex Pack® micro-motor capacitors coupled to the internal dental office system and nickel and titanium in numbers and standard colors: Green (0.35 and 0.70), Black (0.40 and 0.80), Yellow (0.50 and 1.00), Blue (0.60 and 1.20). Handling of CIMMO® PBS cement will follow manufacturer's recommendations: on sterile glass plate, a portion of the cement powder and a drop of distilled water will be dispensed. Through a flexible spatula, the powder will be mixed to the liquid and spatulate until the consistency of toothpaste. The Macspaden Flex Pack® 40 instrument will then be coupled to the micro-motor and embedded in cement. When it is taken to the channel, the micro-motor will be activated and the channel will be in and out. Then, condensation will occur with the green condenser tip thinner and then thicker. In the same way, more cement will be brought to the channel with Flex Pack® number 40 and again condensed now with the black, thin point and then thick capacitors. These maneuvers will be repeated until the fine and thick blue capacitors are used and the absence of spaces is verified. Soon after, the teeth will be restored with Charisma Kulzer® photopolymerizable resin, Radi® light curing. Patients will be submitted to final radiographs and receive systemic medication with analgesic Lisador® 1 tablet every 6 hours while there is pain. The recommended anti-inflammatory will be Decadron®, 4mg, 1 tablet every 12 hours for 3 days, if the patient is unable to use it, Maxulid® 400mg, 1 tablet every 12 hours for 3 days will be given. The antibiotic of choice will be Sinot Clav® 875 mg, 1 tablet every 12 hours for 7 days. In case of allergy to Amoxicillin, Dalacin 300 mg, 1 capsule every 8 hours for 7 days will be given. After 6 months, the patients will return to the Clinic of the Associação Brasileira de Odontologia to perform a Cone Beam tomografy scan and clinical examination.
Sample size: 86 patients The observed response will be dichotomous, the type of analysis will be by comparing two proportions. The investigators accessed the site www.lee.dante.br 25, Lee-Samples for verification of possible identification of n. The proportions were based on the literature.
Proportion in group 1: 36% Proportion in group 2: 10% Level of significance: 5% Power of the test: 90% Hypothesis test: monocaudal Sample size calculated for each group: 43
Allocation: Patients are allocated to the study or control group in a 1: 1 ratio using a software-generated randomizer - RANDOMIZATION.COM (http://www.randomization.com)26. Concealment Mechanism: Opaque, sealed and serial number envelopes containing the group as well as the material to be used will be used to maintain the confidentiality of the random allocation. The envelopes will be delivered to the professional who performed the intervention at the initial moment Patients will not know which research group will participate. After 6 months, a CT scan and clinical examination will be performed. The evaluations will be performed by professionals who did not participate in the intervention and have more than 20 years of experience in endodontics. These professionals will not know to which group the patient belongs.
Recruitment of patients-waiting list of patients who seek the clinic of the Associação Brasileira de Odontologia (ABO) -UNIVÁS.
Beginning of appointments: November 2017 Data collection: June 2018.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized, interventional, prospective, unicentric, double blind clinical trial.
| Arm | Type | Receives |
|---|---|---|
| GUTTA PERCHA and AHPLUS cement (group A) | Experimental | Procedure: Gutta Percha and AHPLUS cement (group A)43 patients will undergo endodontic treatment with obturation with AHPlus cement and Gutta-Percha cones. This treatment will be performed in 2 sessions. First intervention: endodontic instrumentation and introduction of intra-canal medication that will remain in the tooth for 4 weeks. Second intervention: removal of intracanal medication and filling with cement and gutta percha AHPlus. |
| PBS CIMMO cement (group B) | Experimental | Procedure: PBS CIMMO cement (group B)43 patients will undergo endodontic treatment with PBS CIMMO® cement (single material).This treatment will be performed in 1 session.Single intervention: endodontic instrumentation and cement filling PBS CIMMO. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients presenting with a diagnosis of necrosis.
Key exclusion criteria (3 listed)
- Patients who drop out during the study
- Patients who do not return to the final exam after 6 months.
- Patients who present more than one tooth in need of treatment will choose only one tooth, the others will be excluded.
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 |
|---|---|---|
| Gutta Percha and AHPLUS cement (group A)First intervention: endodontic instrumentation and introduction of intact medication that will remain inside the tooth for 4 weeks. Second intervention: removal of intracanal medication and canal filling with cement AHPLUS and guttapercha | Procedure or surgery | GUTTA PERCHA and AHPLUS cement (group A) |
| PBS CIMMO cement (group B)Single intervention: endodontic instrumentation and obturation with cement PBS CIMMO | Procedure or surgery | PBS CIMMO cement (group B) |
Primary outcome
Patients with necrotic teeth and periradicular lesion evaluated by cone beam tomography
Time frame: Patients will return six months after the procedure to undergo a exam cone Beam tomografy
The data will be aggregated by presence of hard blade that determines the phylogenetic parameter of success of the treatment. This physiological parameter is the presence of hard blade integrated in the tomography image, which will determine healthy periodontal ligament
1 secondary outcome
Clinical examination of patients' treated teeth
Time frame: Patients will return six months after the procedure to undergo a clinical examination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
- 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.
Rubia Boczar principal investigator
Univás-Universidade do Vale do Sapucaí- Pouso Alegre Minas Geraes
Taylor b Schnaider, MD,PhD study director
Universidade Vale do Sapucaí
Daniela F Veiga, MD,PhD study chair
Universidade Vale do Sapucaí
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gutta Percha and AHPLUS cement (group A) and PBS CIMMO cement (group B) in people with Root Canal Therapy, run by Universidade do Vale do Sapucai at 1 site in Brazil.
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 1 inclusion and 3 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 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients with necrotic teeth and periradicular lesion evaluated by cone beam tomography (time frame: Patients will return six months after the procedure to undergo a exam cone Beam tomografy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jun 2018.