Necrotic PulpPhase 1/2NCT04587089
Efficacy of Guedes-Pinto Paste and CTZ Paste in the Non-instrumental Endodontic Treatment of Primary Teeth
A Phase 1/2 study testing Irrigation, Filling with Guedes-Pinto Paste and Filling with CTZ Paste in people with Necrotic Pulp, run by University of Nove de Julho.
Trial summary
The maintenance of the deciduous tooth until its physiological exfoliation occurs is one of the main objectives of pediatric dentistry. Endodontic treatment in deciduous teeth resulting from carious or traumatic lesions with pulpal involvement is often necessary and we often find it difficult to perform it, due to the… Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Necrotic Pulp
- What is being tested?
- Irrigation, Filling with Guedes-Pinto Paste and Filling with CTZ Paste
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2023to 20 Jun 2024
- Phase
- Phase 1/2
- 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 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients aged 3 to 6 years old with at least one anterior deciduous tooth with pulp necrosis in a position to be restored and at least 2/3 of the remaining root.
- Healthy patients and who did not antibiotic treatment in the previous three months.
Who cannot join
- Compromised health, primary teeth with more than one third root loss, lack of internal pathological resorption, impossibility of restoration, cases of re-treatment and crypt involvement.
About this study
Official title: Efficacy of Guedes-Pinto Paste and CTZ Paste in the Non-instrumental Endodontic Treatment of Primary Teeth - Study Protocol for a Randomized Controlled Clinical Trial
The maintenance of the deciduous tooth until its physiological exfoliation occurs is one of the main objectives of pediatric dentistry. Endodontic treatment in deciduous teeth resulting from carious or traumatic lesions with pulpal involvement is often necessary and we often find it difficult to perform it, due to the difficult control of the child, the internal anatomy of the root canals, and root resorptions. The non-instrumental endodontic treatment technique (TENI) associated with antimicrobial drugs has advantages such as shorter chair time and less complexity than the conventional technique in which root canal instrumentation is performed. The objective of this study is to carry out a controlled and randomized clinical trial to compare the effectiveness of non-instrumental endodontic treatment (NIET) in primary teeth associated with the use of two filling pastes. 120 necrotic deciduous teeth of children aged between 3 and 6 years will be selected; and the teeth will be divided into two groups. In Group 1 and Group 2, the root canals will not be instrumented, just irrigated and filled with the respective pastes, CTZ and Guedes-Pinto. The radiographic aspects will be evaluated, considering the repair process, clinically will be evaluated: presence of fistula and mobility, the evaluations will be carried out in both groups on the day of treatment and in periods of 1, 3 and 6 months after treatment. The data obtained will be submitted to the Shapiro-Wilk normality test, where the statistical analysis that will be used for this study will be defined, adopting a significance level of 95% (p<0.05).
- Conditions
- Necrotic Pulp
- Being tested
- Irrigation, Filling with Guedes-Pinto Paste, Filling with CTZ Paste
- Medical subject headings
- Dental Pulp Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IrrigationProcedure or surgery
Irrigation and aspiration in the root canals with 1% sodium hypochlorite (Milton's solution).
Filling with Guedes-Pinto PasteProcedure or surgery
The root canals will be filled with Guedes-Pinto Paste, which is a composite of 3 medications: Rifocort® (dermatologic ointment), camphorated paramonochlorophenol (PMCC) and iodoform. It will be prepared at the moment of use with the same proportion in volume of 3 visually identical parts, one for each of its components.
Filling with CTZ PasteProcedure or surgery
The powder that composes the CTZ paste will be previously manipulated in a 1:1:2 ratio (500mg of Chloramphenicol, 500mg of Tetracycline and 1,000mg of Zinc Oxide) by Formula \& Ação (F\&A) and incorporated into the eugenol liquid at the time of use, with the aid of a flexible spatula nº 24 and on a sterile glass plate. The cleaning of the coronary chamber must be carried out with saline solution and drying with sterile cotton balls and the CTZ paste must be inserted into the cavity.
| Study group | Role | What they receive |
|---|---|---|
| Non-instrumental Endodontic Treatment (NIET) + Guedes-Pinto Paste Group | Experimental | In this group, the canals will not be instrumented and the filling will be performed with Guedes-Pinto paste. Receives: Procedure: Irrigation; Procedure: Filling with Guedes-Pinto Paste |
| Non-instrumental Endodontic Treatment (NIET) + CTZ Paste Group | Experimental | In this group, the canals will not be instrumented and the filling will be performed with CTZ paste (Chlorophenicol, Tetracycline and Zinc Oxide and Eugenol). Receives: Procedure: Irrigation; Procedure: Filling with CTZ Paste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Investigation of the Change in the Presence of Fistulas in Each Treated Tooth
In the follow-up consultations, teeth and gums will be clinically evaluated to check the presence of fistulas.
Measured: Baseline, one month, 3 months and 6 months after treatment.
Clinical Investigation of Changes in Tooth Mobility in Each Treated Tooth
In the follow-up consultations, teeth will be clinically evaluated to check the presence of mobility.
Measured: Baseline, one month, 3 months and 6 months after treatment.
Secondary outcomes (1)
Radiographic Evaluation of the Changes in the Presence of Periapical Lesions in Each Treated Tooth
In the follow-up consultations, periapical radiographs will be taken to check for the presence of periapical lesions.
Measured: One month, 3 months and 6 months after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start20 Aug 2023 (estimated)
- Primary completion20 Mar 2024 (estimated)
- Study completion20 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Necrotic PulpStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade Metropolitana de Santos
- Responsible party
- Principal investigator, Sandra Kalil Bussadori, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04587089
- Sponsor's protocol ID
- EndoDeciduos
- Status last verified
- May 2023
- First submitted
- 7 Oct 2020
- Last updated
- 17 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sobral APT, Santos EM, Leal Goncalves ML, Ferri EP, Junior WSB, Gimenez T, Gallo JMAS, Horliana ACRT, Motta LJ, Kalil Bussadori S. Efficacy of antibiotic and iodoform pastes in non-instrumental endodontic treatment of anterior primary teeth-Protocol for a randomized controlled clinical. PLoS One. 2023 Sep 8;18(9):e0291133. doi: 10.1371/journal.pone.0291133. eCollection 2023.
PubMed 37682887
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Guedes-Pinto Paste and CTZ Paste in the Non-instrumental Endodontic Treatment of Primary Teeth - Study Protocol for a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04587089
- Acronym / sponsor ID
- EndoDeciduos
- Conditions
- Necrotic Pulp
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Collaborators
- Universidade Metropolitana de Santos
- Study start
- 20 Aug 2023 (estimated)
- Primary completion
- 20 Mar 2024 (estimated)
- Study completion
- 20 Jun 2024 (estimated)
- First posted
- 14 Oct 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 maintenance of the deciduous tooth until its physiological exfoliation occurs is one of the main objectives of pediatric dentistry. Endodontic treatment in deciduous teeth resulting from carious or traumatic lesions with pulpal involvement is often necessary and we often find it difficult to perform it, due to the difficult control of the child, the internal anatomy of the root canals, and root resorptions. The non-instrumental endodontic treatment technique (TENI) associated with antimicrobial drugs has advantages such as shorter chair time and less complexity than the conventional technique in which root canal instrumentation is performed. The objective of this study is to carry out a controlled and randomized clinical trial to compare the effectiveness of non-instrumental endodontic treatment (NIET) in primary teeth associated with the use of two filling pastes. 120 necrotic deciduous teeth of children aged between 3 and 6 years will be selected; and the teeth will be divided into two groups. In Group 1 and Group 2, the root canals will not be instrumented, just irrigated and filled with the respective pastes, CTZ and Guedes-Pinto. The radiographic aspects will be evaluated, considering the repair process, clinically will be evaluated: presence of fistula and mobility, the evaluations will be carried out in both groups on the day of treatment and in periods of 1, 3 and 6 months after treatment. The data obtained will be submitted to the Shapiro-Wilk normality test, where the statistical analysis that will be used for this study will be defined, adopting a significance level of 95% (p<0.05).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-instrumental Endodontic Treatment (NIET) + Guedes-Pinto Paste Group | Experimental | Procedure: Irrigation, Procedure: Filling with Guedes-Pinto PasteIn this group, the canals will not be instrumented and the filling will be performed with Guedes-Pinto paste. |
| Non-instrumental Endodontic Treatment (NIET) + CTZ Paste Group | Experimental | Procedure: Irrigation, Procedure: Filling with CTZ PasteIn this group, the canals will not be instrumented and the filling will be performed with CTZ paste (Chlorophenicol, Tetracycline and Zinc Oxide and Eugenol). |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patients aged 3 to 6 years old with at least one anterior deciduous tooth with pulp necrosis in a position to be restored and at least 2/3 of the remaining root.
- Healthy patients and who did not antibiotic treatment in the previous three months.
Key exclusion criteria (1 listed)
- Compromised health, primary teeth with more than one third root loss, lack of internal pathological resorption, impossibility of restoration, cases of re-treatment and crypt involvement.
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 |
|---|---|---|
| IrrigationIrrigation and aspiration in the root canals with 1% sodium hypochlorite (Milton's solution). | Procedure or surgery | Non-instrumental Endodontic Treatment (NIET) + CTZ Paste Group, Non-instrumental Endodontic Treatment (NIET) + Guedes-Pinto Paste Group |
| Filling with Guedes-Pinto PasteThe root canals will be filled with Guedes-Pinto Paste, which is a composite of 3 medications: Rifocort® (dermatologic ointment), camphorated paramonochlorophenol (PMCC) and iodoform. It will be prepared at the moment of use with the same proportion in volume of 3 visually identical parts, one for each of its components. | Procedure or surgery | Non-instrumental Endodontic Treatment (NIET) + Guedes-Pinto Paste Group |
| Filling with CTZ PasteThe powder that composes the CTZ paste will be previously manipulated in a 1:1:2 ratio (500mg of Chloramphenicol, 500mg of Tetracycline and 1,000mg of Zinc Oxide) by Formula \& Ação (F\&A) and incorporated into the eugenol liquid at the time of use, with the aid of a flexible spatula nº 24 and on a sterile glass plate. The cleaning of the coronary chamber must be carried out with saline solution and drying with sterile cotton balls and the CTZ paste must be inserted into the cavity. | Procedure or surgery | Non-instrumental Endodontic Treatment (NIET) + CTZ Paste Group |
Primary outcome
Clinical Investigation of the Change in the Presence of Fistulas in Each Treated Tooth
Time frame: Baseline, one month, 3 months and 6 months after treatment.
In the follow-up consultations, teeth and gums will be clinically evaluated to check the presence of fistulas.
Clinical Investigation of Changes in Tooth Mobility in Each Treated Tooth
Time frame: Baseline, one month, 3 months and 6 months after treatment.
In the follow-up consultations, teeth will be clinically evaluated to check the presence of mobility.
1 secondary outcome
Radiographic Evaluation of the Changes in the Presence of Periapical Lesions in Each Treated Tooth
Time frame: One month, 3 months and 6 months after treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
- Derived from this study: PubMed 37682887Sobral APT, Santos EM, Leal Goncalves ML, Ferri EP, Junior WSB, Gimenez T, Gallo JMAS, Horliana ACRT, Motta LJ, Kalil Bussadori S. Efficacy of antibiotic and iodoform pastes in non-instrumental endodontic treatment of anterior primary teeth-Protocol for a randomized controlled clinical. PLoS One. 2023 Sep 8;18(9):e0291133. doi: 10.1371/journal.pone.0291133. eCollection 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Irrigation, Filling with Guedes-Pinto Paste and Filling with CTZ Paste in people with Necrotic Pulp, run by University of Nove de Julho.
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 2 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 17 May 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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?
Clinical Investigation of the Change in the Presence of Fistulas in Each Treated Tooth (time frame: Baseline, one month, 3 months and 6 months after treatment.). The study lists 2 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 NCT04587089, which also lists 1 linked publication.
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 17 May 2023.