Pulp DisorderPhase 3NCT03839485
Endodontic Treatment of Primary Teeth With Guedes-Pinto Paste Without Antibiotic
A Phase 3 study testing Endodontic treatment using Guedes-Pinto Paste and Endodontic using Guedes-Pinto Paste without antibiotic in people with Pulp Disorder, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The pulp therapy in primary teeth is still necessary even with all odontopediatrics evolution in prevention and minimal intervention, aiming to keep the tooth free of inflammation or infection and in a functional state until its exfoliation. Several materials are used as filling paste of primary teeth. Read more about this study
- Who is it for?
- Ages 4 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulp Disorder
- What is being tested?
- Endodontic treatment using Guedes-Pinto Paste and Endodontic using Guedes-Pinto Paste without antibiotic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- 8 Jun 2018to 10 Apr 2021
- Phase
- Phase 3
- 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 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Primary molar teeth with necessity of endodontic treatment.
- Patients whose parents or guardians consent to their participation in the study
Who cannot join
- Systemic health problems, congenital facial deformities, facial tumors or syndromes
- Teeth presenting one of the following:
- Resorption of more than 2/3 of the root
- Destruction of the crypt of the permanent successor
- Pulp chamber floor drilling.
- Presence of internal resorption
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endodontic Treatment of Primary Teeth With Guedes-Pinto Paste Without Antibiotic: Randomized Non-inferiority Clinical Trial
The pulp therapy in primary teeth is still necessary even with all odontopediatrics evolution in prevention and minimal intervention, aiming to keep the tooth free of inflammation or infection and in a functional state until its exfoliation. Several materials are used as filling paste of primary teeth. In Brazil, the Guedes-Pinto Paste (PGP), an association of iodofórmio, camphorated paramonochlorophenol, prednisolone and rifamycin, has been widely used for some decades. However, current Brazilian legislation has made it difficult to commercialize antibiotics, which has made it difficult to obtain the ointment that is the association between prednisolone and rifamycin. Therefore, the objective of this clinical trial will be to test PGP without rifamycin in the pulpectomy of primary teeth, and to compare it with the treatment performed with conventional PGP.
Read the detailed description
A randomized triple-blind non-inferiority clinical study with two parallel arms, with a 12-month follow-up, will be performed. The experimental group will be PGP formulated without the antibiotic, while the control group is the conventional PGP, containing rifamycin. The conventional pulpectomy will be performed using manual files, performing the instrumentation aided by Endo-PTC and 1% sodium hypochlorite. At the end of the instrumentation, just before the obturation, the groups will be drawn, with the strategy of randomization in permuted blocks and stratified by the initial condition of the tooth (with or without periapical lesion). The main outcome will be the clinical and radiographic success of endodontic treatment after 12 months. Patients who seek the dental service of the municipality and require endodontic treatment will be invited to participate in the study. The data will be statistically analyzed using the statistical package Stata 12.0 (Stata Corporation, College Station, TX, USA). The longevity of the treatments will be evaluated by estimating survival rates using the Kaplan-Meier method. The differences between survival rates according to the type of endodontic treatment proposed will be analyzed through the Log-rank test.
- Conditions
- Pulp Disorder
- Being tested
- Endodontic treatment using Guedes-Pinto Paste, Endodontic using Guedes-Pinto Paste without antibiotic
- Keywords
- pulpectomy, primary teeth, root canal filling materials
- Medical subject headings
- Dental Pulp Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endodontic treatment using Guedes-Pinto PasteDrug
Also called Pulpectomy with Guedes-Pinto paste
Dental procedure in which the entire pulp chamber is removed from the crown and roots of a tooth and the root filling material Guedes-Pinto paste is applied
Endodontic using Guedes-Pinto Paste without antibioticDrug
Also called Pulpectomy with Guedes-Pinto paste without antibiotic
Dental procedure in which the entire pulp chamber is removed from the crown and roots of a tooth and the root filling material Guedes-Pinto paste without antibiotic is applied
| Study group | Role | What they receive |
|---|---|---|
| Pasta Guedes-Pinto | Active comparator | Endodontic treatment using Guedes-Pinto Paste Receives: Drug: Endodontic treatment using Guedes-Pinto Paste |
| Pasta Guedes-Pinto without antibiotic | Experimental | Endodontic using Guedes-Pinto paste without antibiotic Receives: Drug: Endodontic using Guedes-Pinto Paste without antibiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success or failure of treatment
The success or failure of endodontic treatments evaluated by the time spent in the tooth arch in clinical conditions of normality. Clinical criteria for determining success are: absence of fistula, absence of painful symptoms and pathological absence of adequate mobility and gingival contour. Radiographically, the success criteria are: no occurrence of a periapical rarefaction in the furcation area; reduction or maintenance of an already present bone rarefaction in the furcation area of posterior teeth, maintaining the periradicular space, root resorption compatible with the eruptive phase and absence of pathological bone resorption. To evaluate the reduction of lesions or appearance of new lesions, we will compare the initial and final radiographs.
Despite the anticipated time frame of 1 year, some participants were evaluated after this period due to the pandemic. The follow-up periods were until 24 months, and the final analysis were adjusted for this protocol deviation.
Measured: 1 year
Secondary outcomes (4)
Post-operative fistula
Report of fistula or presence of pus on the area of the endodontic treatment. This variable was recorded through a phone call to the children\'s guardians, who answered if they had noticed any purulent secretion in the area of the endodontically treated tooth (yes or no - dichotomous variable).
Measured: 7 days
Post-operative pain
Report of post-operative pain until 7 days after the procedure. This outcome was collected through a phone call with the children\'s guardians, who asked if their child had reported any pain in the area of the procedure and if the participant had taken an analgesic (yes or no - dichotomous variable).
Measured: 7 days
Post-operatve oedema
Report of post-operative oedema on the area of the endodontic treatment. This variable was recorded through a phone call to the children's guardians, who answered if they had noticed any oedema or swelling in the area of the endodontically treated tooth (yes or no - dichotomous variable).
Measured: 7 days
Quality of root canal filling
This variable was evaluated in the radiographs taken immediately after the endodontic treatment. An external observer, blinded to the allocated group, classified the quality of the root canal filling in adequate (filling to within 1 mm of the radiographic apex), before the apex (more than 1 mm of the radiographic apex) or with filling material overflow. This is a nominal qualitative variable (3 categories).
Measured: Imediatelly after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start8 Jun 2018
- Primary completion30 Jun 2019
- Study completion10 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulp DisorderStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fausto Medeiros Mendes, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03839485
- Sponsor's protocol ID
- FouspPGP
- Status last verified
- Mar 2025
- First submitted
- 11 Feb 2019
- Last updated
- 28 Mar 2025
- 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 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endodontic Treatment of Primary Teeth With Guedes-Pinto Paste Without Antibiotic: Randomized Non-inferiority Clinical Trial
- ClinicalTrials.gov ID
- NCT03839485
- Acronym / sponsor ID
- FouspPGP
- Conditions
- Pulp Disorder
- Keywords
- pulpectomy, primary teeth, root canal filling materials
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 8 Jun 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 10 Apr 2021 (actual)
- First posted
- 15 Feb 2019 (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 pulp therapy in primary teeth is still necessary even with all odontopediatrics evolution in prevention and minimal intervention, aiming to keep the tooth free of inflammation or infection and in a functional state until its exfoliation. Several materials are used as filling paste of primary teeth. In Brazil, the Guedes-Pinto Paste (PGP), an association of iodofórmio, camphorated paramonochlorophenol, prednisolone and rifamycin, has been widely used for some decades. However, current Brazilian legislation has made it difficult to commercialize antibiotics, which has made it difficult to obtain the ointment that is the association between prednisolone and rifamycin. Therefore, the objective of this clinical trial will be to test PGP without rifamycin in the pulpectomy of primary teeth, and to compare it with the treatment performed with conventional PGP.
Detailed description
A randomized triple-blind non-inferiority clinical study with two parallel arms, with a 12-month follow-up, will be performed. The experimental group will be PGP formulated without the antibiotic, while the control group is the conventional PGP, containing rifamycin. The conventional pulpectomy will be performed using manual files, performing the instrumentation aided by Endo-PTC and 1% sodium hypochlorite. At the end of the instrumentation, just before the obturation, the groups will be drawn, with the strategy of randomization in permuted blocks and stratified by the initial condition of the tooth (with or without periapical lesion). The main outcome will be the clinical and radiographic success of endodontic treatment after 12 months. Patients who seek the dental service of the municipality and require endodontic treatment will be invited to participate in the study. The data will be statistically analyzed using the statistical package Stata 12.0 (Stata Corporation, College Station, TX, USA). The longevity of the treatments will be evaluated by estimating survival rates using the Kaplan-Meier method. The differences between survival rates according to the type of endodontic treatment proposed will be analyzed through the Log-rank test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pasta Guedes-Pinto | Active comparator | Drug: Endodontic treatment using Guedes-Pinto PasteEndodontic treatment using Guedes-Pinto Paste |
| Pasta Guedes-Pinto without antibiotic | Experimental | Drug: Endodontic using Guedes-Pinto Paste without antibioticEndodontic using Guedes-Pinto paste without antibiotic |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Primary molar teeth with necessity of endodontic treatment.
- Patients whose parents or guardians consent to their participation in the study
Key exclusion criteria (6 listed)
- Systemic health problems, congenital facial deformities, facial tumors or syndromes
- Teeth presenting one of the following:
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 |
|---|---|---|
| Endodontic treatment using Guedes-Pinto PasteAlso: Pulpectomy with Guedes-Pinto pasteDental procedure in which the entire pulp chamber is removed from the crown and roots of a tooth and the root filling material Guedes-Pinto paste is applied | Drug | Pasta Guedes-Pinto |
| Endodontic using Guedes-Pinto Paste without antibioticAlso: Pulpectomy with Guedes-Pinto paste without antibioticDental procedure in which the entire pulp chamber is removed from the crown and roots of a tooth and the root filling material Guedes-Pinto paste without antibiotic is applied | Drug | Pasta Guedes-Pinto without antibiotic |
Primary outcome
Success or failure of treatment
Time frame: 1 year
The success or failure of endodontic treatments evaluated by the time spent in the tooth arch in clinical conditions of normality. Clinical criteria for determining success are: absence of fistula, absence of painful symptoms and pathological absence of adequate mobility and gingival contour. Radiographically, the success criteria are: no occurrence of a periapical rarefaction in the furcation area; reduction or maintenance of an already present bone rarefaction in the furcation area of posterior teeth, maintaining the periradicular space, root resorption compatible with the eruptive phase and absence of pathological bone resorption. To evaluate the reduction of lesions or appearance of new lesions, we will compare the initial and final radiographs. Despite the anticipated time frame of 1 year, some participants were evaluated after this period due to the pandemic. The follow-up periods were until 24 months, and the final analysis were adjusted for this protocol deviation.
4 secondary outcomes
Post-operative fistula
Time frame: 7 days
Post-operative pain
Time frame: 7 days
Post-operatve oedema
Time frame: 7 days
Quality of root canal filling
Time frame: Imediatelly after the treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Pulp Disorder
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
Not yet recruiting
PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
Pulp Necrosis, Apical Periodontitis
Not yet recruitingPhase 3
Submucosal Cryotherapy and Anti-inflammatory Drugs for Postoperative Pain Following Root Canal Treatment in Maxillary Molars
Pulpitis
Not yet recruiting
Clinical and Inflammatory Outcomes of Regenerative Endodontic Treatment Using Injectable Platelet-Rich Fibrin in Mature Necrotic Teeth With Chronic Apical Periodontitis.
Chronic Apical Periodontitis, Pulp Necrosis
Active, not recruiting
Multiple-Visit RCT in Teeth With SAP: Interappointment Dressing or Not?
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Endodontic treatment using Guedes-Pinto Paste and Endodontic using Guedes-Pinto Paste without antibiotic in people with Pulp Disorder, run by University of Sao Paulo 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 2 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: finished, as of the sponsor's last update on 28 Mar 2025. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Success or failure of treatment (time frame: 1 year). 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 28 Mar 2025.