Pulpitis - IrreversibleEarly Phase 1NCT04669392
The Effect of Using 70% Ethanol Alcohol as a Root Canal Irrigant on Increasing the Success Rate of Metapex in Pulpectomy Compared to Normal Saline in Primary Molars
A Early Phase 1 study testing 70% Ethanol Alcohol in people with Pulpitis - Irreversible and Resorption, Root, run by Cairo University.
Trial summary
The aim of the study is to perform a clinical and radiographic evaluation of 70% Ethanol Alcohol versus Normal Saline as root canal irrigating solutions in partial pulpectomy of primary molars with Metapex. Read more about this study
- Who is it for?
- Ages 4 to 7 years
- Conditions the study is for
- Pulpitis - Irreversible, Resorption, Root, Abscess Bone
- What is being tested?
- 70% Ethanol Alcohol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2021to 1 Jan 2023
- Phase
- Early Phase 1
- 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
- No healthy volunteers
- Child
Who may be able to join
- Patients medically within normal.
- Cooperative patients and cooperative parents.
- Children aged 4-7 years old.
- Primary mandibular second molar.
- Deep carious molars.
- A history of spontaneous pain.
Show all 10Show fewer
- Molars with pulp exposure due to caries.
- Absences of Internal resorption.
- Absences of external pathological resorption.
- where the bleeding could not be stopped following removal of the coronal pulp tissue
Who cannot join
- Parents unable to give informed consent.
- Necrotic pulp.
- Unrestorable Teeth.
Trial locations and contacts
No sites are listed yet.
Thamat Al-Gannah SM Rashed, Bachelor's degree of dentistry contact
About this study
Official title: Clinical and Radiographic Evaluation of 70% Ethanol Alcohol Versus Normal Saline as Root Canal Irrigating Solutions in Partial Pulpectomy of Primary Molars With Metapex A Randomized Controlled (Pilot Trial)
The aim of the study is to perform a clinical and radiographic evaluation of 70% Ethanol Alcohol versus Normal Saline as root canal irrigating solutions in partial pulpectomy of primary molars with Metapex.
Read the detailed description
In permanent dentition, Calcium Hydroxide-Iodoform paste (Metapex) has a high potential in forming a calcific barrier in the pulpal tissue. Yet, in primary dentition Metapex forms a chronic inflammatory reaction to the pulpal tissue leading to its internal and root resorption. Although the high success rate of Metapex in partial pulpectomy, the rapid resorption of Metapex has led to the presence of the hollow tube effect due to voids formation in the canals. However, this will cause early root resorption before the time of exfoliation. Due to its rapid resorption, Metapex is usually recommended to be used in the pulpectomy of teeth near exfoliation in order to avoid the early root resorption of primary dentition in order to avoid the premature loss of the endodontically treated vital primary teeth with Metapex.
Saline solution is the basic irrigating solution in root canal treatments, yet it has no antimicrobial activities and only results in cleaning the root canals. Ethanol irrigation is believed to be an alternative promising replacement in tissue fixation from Formocresol due to the concerns from its carcinogenicity and toxicity. Also, Ethanol has an excellent bactericidal, virucidal, and fungicidal, and most importantly it is one of the volatile liquids.
In this study, the effect of Ethanol Alcohol on increasing the success rate of Metapex in vital pulp therapy will be studied.
- Conditions
- Pulpitis - Irreversible, Resorption, Root, Abscess Bone, Mobility, Tooth, Pain
- Being tested
- 70% Ethanol Alcohol
- Keywords
- Metapex, Primary dentition
- Medical subject headings
- Root Resorption, Tooth Mobility, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
70% Ethanol AlcoholDrug
Ethanol, also called ethyl alcohol, grain alcohol, or alcohol, a member of a class of organic compounds that are given the general name alcohols.
Ethanol is a commonly used fixative. Fixation of the inner layers of the tissue depends on the ability of the fixative to diffuse into the tissue. Moreover, Ethanol has antibacterial antifungal, and antiviral properties.
70% Ethanol is the safest concentration because the water that has been mixed into the ethanol slows the drying time, creating a longer contact time. Ethanol needs to have a contact time of at least 10 seconds to kill Staphylococcus aureus and Streptococcus pyogenes. At a 10 second drying time.
| Study group | Role | What they receive |
|---|---|---|
| 70% Ethanol | Experimental | Using 70% Ethanol Alcohol as a root canal irrigating solution before obturating the lower primary second molar with Metapex Receives: Drug: 70% Ethanol Alcohol |
| Normal Saline | No intervention | Irrigating the canals with Normal Saline before obturating the lower primary second molar with Metapex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain of partial pulpectomy of Metapex using both 70% Ethanol Alcohol and Normal Saline as root canal irrigating solutions.
Assessment through Visual Analog Scale , A score from (0-10) 0 is means no pain and 10 is the maximum level of pain.
Measured: Patients will be assessed at 12 months follow ups
Secondary outcomes (1)
Radiographic evaluation of partial pulpectomy of Metapex using both 70% Ethanol Alcohol and Normal Saline as root canal irrigating solutions.
Assessment through Visual interpretation of digital radiograph
Measured: Patients will be assessed at 12 months follow ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start1 Dec 2021 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pulpitis - IrreversibleStudies 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thamar Al-Gannah Samy Rashed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04669392
- Sponsor's protocol ID
- 12021
- Status last verified
- Jul 2021
- First submitted
- 12 Dec 2020
- Last updated
- 29 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Brand, C. & At, D. M. E. Guidelines for Disinfection and Sterilization in Healthcare Facilities , 2008 ( Centers for Disease Control ). 2008, (2008).
Nurko C, Ranly DM, Garcia-Godoy F, Lakshmyya KN. Resorption of a calcium hydroxide/iodoform paste (Vitapex) in root canal therapy for primary teeth: a case report. Pediatr Dent. 2000 Nov-Dec;22(6):517-20.
PubMed 11132515Al-Ostwani AO, Al-Monaqel BM, Al-Tinawi MK. A clinical and radiographic study of four different root canal fillings in primary molars. J Indian Soc Pedod Prev Dent. 2016 Jan-Mar;34(1):55-9. doi: 10.4103/0970-4388.175515.
PubMed 26838149Thiruvenkadam G, Asokan S, John B, Priya PG. Effect of 95% Ethanol as a Final Irrigant before Root Canal Obturation in Primary Teeth: An in vitro Study. Int J Clin Pediatr Dent. 2016 Jan-Mar;9(1):21-4. doi: 10.5005/jp-journals-10005-1327. Epub 2016 Apr 22.
PubMed 27274150Panzacchi S, Gnudi F, Mandrioli D, Montella R, Strollo V, Merrick BA, Belpoggi F, Tibaldi E. Effects of short and long-term alcohol-based fixation on Sprague-Dawley rat tissue morphology, protein and nucleic acid preservation. Acta Histochem. 2019 Aug;121(6):750-760. doi: 10.1016/j.acthis.2019.05.011. Epub 2019 Jul 3.
PubMed 31277893
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of 70% Ethanol Alcohol Versus Normal Saline as Root Canal Irrigating Solutions in Partial Pulpectomy of Primary Molars With Metapex A Randomized Controlled (Pilot Trial)
- ClinicalTrials.gov ID
- NCT04669392
- Acronym / sponsor ID
- 12021
- Conditions
- Pulpitis - Irreversible, Resorption, Root, Abscess Bone, Mobility, Tooth, Pain
- Keywords
- Metapex, Primary dentition
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 16 Dec 2020 (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 the study is to perform a clinical and radiographic evaluation of 70% Ethanol Alcohol versus Normal Saline as root canal irrigating solutions in partial pulpectomy of primary molars with Metapex.
Detailed description
In permanent dentition, Calcium Hydroxide-Iodoform paste (Metapex) has a high potential in forming a calcific barrier in the pulpal tissue. Yet, in primary dentition Metapex forms a chronic inflammatory reaction to the pulpal tissue leading to its internal and root resorption. Although the high success rate of Metapex in partial pulpectomy, the rapid resorption of Metapex has led to the presence of the hollow tube effect due to voids formation in the canals. However, this will cause early root resorption before the time of exfoliation. Due to its rapid resorption, Metapex is usually recommended to be used in the pulpectomy of teeth near exfoliation in order to avoid the early root resorption of primary dentition in order to avoid the premature loss of the endodontically treated vital primary teeth with Metapex.
Saline solution is the basic irrigating solution in root canal treatments, yet it has no antimicrobial activities and only results in cleaning the root canals. Ethanol irrigation is believed to be an alternative promising replacement in tissue fixation from Formocresol due to the concerns from its carcinogenicity and toxicity. Also, Ethanol has an excellent bactericidal, virucidal, and fungicidal, and most importantly it is one of the volatile liquids.
In this study, the effect of Ethanol Alcohol on increasing the success rate of Metapex in vital pulp therapy will be studied.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 70% Ethanol | Experimental | Drug: 70% Ethanol AlcoholUsing 70% Ethanol Alcohol as a root canal irrigating solution before obturating the lower primary second molar with Metapex |
| Normal Saline | No intervention | –Irrigating the canals with Normal Saline before obturating the lower primary second molar with Metapex |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Patients medically within normal.
- Cooperative patients and cooperative parents.
- Children aged 4-7 years old.
- Primary mandibular second molar.
- Deep carious molars.
Key exclusion criteria (3 listed)
- Parents unable to give informed consent.
- Necrotic pulp.
- Unrestorable Teeth.
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 |
|---|---|---|
| 70% Ethanol AlcoholEthanol, also called ethyl alcohol, grain alcohol, or alcohol, a member of a class of organic compounds that are given the general name alcohols. Ethanol is a commonly used fixative. Fixation of the inner layers of the tissue depends on the ability of the fixative to diffuse into the tissue. Moreover, Ethanol has antibacterial antifungal, and antiviral properties. 70% Ethanol is the safest concentration because the water that has been mixed into the ethanol slows the drying time, creating a longer contact time. Ethanol needs to have a contact time of at least 10 seconds to kill Staphylococcus aureus and Streptococcus pyogenes. At a 10 second drying time. | Drug | 70% Ethanol |
Primary outcome
Postoperative pain of partial pulpectomy of Metapex using both 70% Ethanol Alcohol and Normal Saline as root canal irrigating solutions.
Time frame: Patients will be assessed at 12 months follow ups
Assessment through Visual Analog Scale , A score from (0-10) 0 is means no pain and 10 is the maximum level of pain.
1 secondary outcome
Radiographic evaluation of partial pulpectomy of Metapex using both 70% Ethanol Alcohol and Normal Saline as root canal irrigating solutions.
Time frame: Patients will be assessed at 12 months follow ups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2021.
- BackgroundBrand, C. & At, D. M. E. Guidelines for Disinfection and Sterilization in Healthcare Facilities , 2008 ( Centers for Disease Control ). 2008, (2008).
- Results publication: PubMed 11132515Nurko C, Ranly DM, Garcia-Godoy F, Lakshmyya KN. Resorption of a calcium hydroxide/iodoform paste (Vitapex) in root canal therapy for primary teeth: a case report. Pediatr Dent. 2000 Nov-Dec;22(6):517-20.
- Results publication: PubMed 26838149Al-Ostwani AO, Al-Monaqel BM, Al-Tinawi MK. A clinical and radiographic study of four different root canal fillings in primary molars. J Indian Soc Pedod Prev Dent. 2016 Jan-Mar;34(1):55-9. doi: 10.4103/0970-4388.175515.
- Results publication: PubMed 27274150Thiruvenkadam G, Asokan S, John B, Priya PG. Effect of 95% Ethanol as a Final Irrigant before Root Canal Obturation in Primary Teeth: An in vitro Study. Int J Clin Pediatr Dent. 2016 Jan-Mar;9(1):21-4. doi: 10.5005/jp-journals-10005-1327. Epub 2016 Apr 22.
- Results publication: PubMed 31277893Panzacchi S, Gnudi F, Mandrioli D, Montella R, Strollo V, Merrick BA, Belpoggi F, Tibaldi E. Effects of short and long-term alcohol-based fixation on Sprague-Dawley rat tissue morphology, protein and nucleic acid preservation. Acta Histochem. 2019 Aug;121(6):750-760. doi: 10.1016/j.acthis.2019.05.011. Epub 2019 Jul 3.
- Individual participant dataSharing planned: Undecided
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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.
Thamat Al-Gannah SM Rashed, Bachelor's degree of dentistry contact
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 70% Ethanol Alcohol in people with Pulpitis - Irreversible and Resorption, Root, 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 10 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 29 Jul 2021. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Thamat Al-Gannah SM Rashed, Bachelor's degree of dentistry (00201111760022, ThamarAlGannah.Mohamed@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain of partial pulpectomy of Metapex using both 70% Ethanol Alcohol and Normal Saline as root canal irrigating solutions. (time frame: Patients will be assessed at 12 months follow ups). 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 NCT04669392, which also lists 5 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 29 Jul 2021.