Pulpectomy AgentsSLM2204NCT03731975
Endodontic Treatment Using CTZ Paste in Primary Teeth
A study testing CTZ Paste and GP Paste in people with Pulpectomy Agents, run by Faculty Sao Leopoldo Mandic Campinas at 1 site in Brazil.
Trial summary
The aim of this study is to evaluate the efficacy of CTZ Paste in primary teeth, compared to endodontic treatment with Guedes-Pinto Paste. This is a multicenter, randomized, double-blind (patient), controlled and non-inferiority clinical study on 174 primary molars and 174 primary incisors of 3-6 years-old children… Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulpectomy Agents
- What is being tested?
- CTZ Paste and GP Paste
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jul 2017to 1 Dec 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 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children aged from 3 to 6 years and 11 months;
- children present at least one upper or lower molar or primary upper incisor with untreated carious lesion with pulp envelopment;
- children assent to participate in the study through collaborative behavior;
- children's parents/guardians consent to their participation by signing the Informed Consent Form (ICF).
Who cannot join
- tooth with carious lesion involving three or more dental surfaces, making the restoration extremely difficult or impossible;
- tooth with internal or external resorption in more than 1/3 of the root length;
- tooth whose crypt of the successor permanent is affected;
- tooth which have less than 2/3 of the root;
- patients who present health problems with oral impairment.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Faculdade Sao Leopoldo Mandic
Campinas, São Paulo, 13045-755
Jose P Imparato, PhD, 55193518-3600, jimparato@usp.br
About this study
Official title: Efficacy of Endodontic Treatment Using CTZ Paste in Primary Teeth: Randomized Clinical Trial
The aim of this study is to evaluate the efficacy of CTZ Paste in primary teeth, compared to endodontic treatment with Guedes-Pinto Paste. This is a multicenter, randomized, double-blind (patient), controlled and non-inferiority clinical study on 174 primary molars and 174 primary incisors of 3-6 years-old children with carious lesions with pulp involvement. The sample unit will be the tooth, which will be randomized into two groups. The teeth allocated to the experimental group will be treated with CTZ Paste, whereas the treatment of those teeth allocated to the control group will employ the Guedes-Pinto Paste. The procedures performed will be evaluated clinically and radiographically at 6 and 12 months. Secondary outcomes such as cost, discomfort, satisfaction and quality of life will also be evaluated.
- Conditions
- Pulpectomy Agents
- Being tested
- CTZ Paste, GP Paste
- Keywords
- Tooth, deciduous, Pulp Capping and Pulpectomy Agents, Pulpectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTZ PasteProcedure or surgery
Tooth allocated to this group will be treated with CTZ paste, according to the Cappielo's protocol (1964), updated by Moura et al. (2016).
GP PasteProcedure or surgery
Tooth allocated to this group will be treated with Guedes-Pinto paste, according to the Guedes-Pinto's protocol (1981), updated by Mello-Moura et al. (2011).
| Study group | Role | What they receive |
|---|---|---|
| CTZ Paste | Active comparator | Endodontic treatment with CTZ paste. Receives: Procedure: CTZ Paste |
| GP Paste | Experimental | Endodontic treatment with Guedes-Pinto paste. Receives: Procedure: GP Paste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical and radiographical efficacy of the endodontic treatment
The tooth will be evaluated according to the presence of mobility (yes or no) and regarding radiolucency area on initial and final radiography (measured and compared with the program ImageJ).
Measured: 12 Months
Secondary outcomes (4)
Cost-efficacy
The costs of each treatment procedure will be calculated and compared with thresholds values for intervention cost-effectiveness by region, determined by World Health Organization (http://www.who.int/choice/costs/CER_levels/en/). These values will be combined with the evaluated efficacy of the treatments (according description of Outcome 1).
Measured: Through study completion (12 months)
Children's satisfaction with treatment
The satisfaction of each treatment will be evaluated using the Wong-Baker Facial Scale (Wong \& Baker, 1988). The patient will be asked to choose the face that is more similar to how he/she felt during the treatment. The answer should be given solely by the child, which means no parental or professional interferences.
Measured: Through study completion (12 months)
Parents/Guardians' satisfaction with children's treatment
The parents' satisfaction with each treatment will be evaluated using the Parent's Questionnaire about Teeth Appearance (Furtado et al., 2012).
Measured: Through study completion (12 months)
Impact of treatment on children's quality of life
The oral health related quality of life will be measured using a validated questionnaire according to the children's age. The "Early Childhood Oral Health Impact Scale" (ECOHIS) (Tesch et al., 2008) will be applied with 4-5 years old patients. The "Child Perceptions Questionnaire" (CPQ) will be used for 6-9 years old patients (Martins et al., 2009). The same questionnaire will be applied immediately before the procedure and on 12 months follow-up. Only one type of questionnaire will be used with each child, according to its age.
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start1 Jul 2017
- Primary completion1 Dec 2018
- Study completion1 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pulpectomy AgentsStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Faculty Sao Leopoldo Mandic Campinas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Carlos P Imparato, Faculty Sao Leopoldo Mandic Campinas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03731975
- Sponsor's protocol ID
- SLM4
- Acronym
- SLM2204
- Status last verified
- Dec 2018
- First submitted
- 25 Oct 2018
- Last updated
- 24 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cappiello J. Tratamientos pulpares en incisivos primários. Rev Circ Od Ros 1964;52(4):133-45.
de Deus Moura Lde F, de Lima Mde D, Lima CC, Machado JI, de Moura MS, de Carvalho PV. Endodontic Treatment of Primary Molars with Antibiotic Paste: A Report of 38 Cases. J Clin Pediatr Dent. 2016;40(3):175-7. doi: 10.17796/1053-4628-40.3.175.
PubMed 27472562Furtado GE, Sousa ML, Barbosa TS, Wada RS, Martinez-Mier EA, Almeida ME. [Perceptions of dental fluorosis and evaluation of agreement between parents and children: validation of a questionnaire]. Cad Saude Publica. 2012 Aug;28(8):1493-505. doi: 10.1590/s0102-311x2012000800008. Portuguese.
PubMed 22892969Guedes-Pinto AC, De Paiva JG, Bozzola JR. [Endodontic treatment of deciduous teeth with pulp necrosis]. Rev Assoc Paul Cir Dent. 1981 May-Jun;35(3):240-4. No abstract available. Portuguese.
PubMed 6943625Mello-Moura AC, Fanaro J, Nicoletti MA, Mendes FM, Wanderley MT, Guedes-Pinto AC. Variability in the proportion of components of iodoform-based Guedes-Pinto paste mixed by dental students and pediatric dentists. Indian J Dent Res. 2011 Nov-Dec;22(6):781-5. doi: 10.4103/0970-9290.94668.
PubMed 22484870Monse B, Heinrich-Weltzien R, Benzian H, Holmgren C, van Palenstein Helderman W. PUFA--an index of clinical consequences of untreated dental caries. Community Dent Oral Epidemiol. 2010 Feb;38(1):77-82. doi: 10.1111/j.1600-0528.2009.00514.x. Epub 2009 Dec 7.
PubMed 20002630Wong DL, Baker CM. Smiling faces as anchor for pain intensity scales. Pain. 2001 Jan;89(2-3):295-300. doi: 10.1016/s0304-3959(00)00375-4. No abstract available.
PubMed 11291631
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Endodontic Treatment Using CTZ Paste in Primary Teeth: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03731975
- Acronym / sponsor ID
- SLM2204 / SLM4
- Conditions
- Pulpectomy Agents
- Keywords
- Tooth, deciduous, Pulp Capping and Pulpectomy Agents, Pulpectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Faculty Sao Leopoldo Mandic CampinasUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 6 Nov 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.
The aim of this study is to evaluate the efficacy of CTZ Paste in primary teeth, compared to endodontic treatment with Guedes-Pinto Paste. This is a multicenter, randomized, double-blind (patient), controlled and non-inferiority clinical study on 174 primary molars and 174 primary incisors of 3-6 years-old children with carious lesions with pulp involvement. The sample unit will be the tooth, which will be randomized into two groups. The teeth allocated to the experimental group will be treated with CTZ Paste, whereas the treatment of those teeth allocated to the control group will employ the Guedes-Pinto Paste. The procedures performed will be evaluated clinically and radiographically at 6 and 12 months. Secondary outcomes such as cost, discomfort, satisfaction and quality of life will also be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CTZ Paste | Active comparator | Procedure: CTZ PasteEndodontic treatment with CTZ paste. |
| GP Paste | Experimental | Procedure: GP PasteEndodontic treatment with Guedes-Pinto paste. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- children aged from 3 to 6 years and 11 months;
- children present at least one upper or lower molar or primary upper incisor with untreated carious lesion with pulp envelopment;
- children assent to participate in the study through collaborative behavior;
- children's parents/guardians consent to their participation by signing the Informed Consent Form (ICF).
Key exclusion criteria (5 listed)
- tooth with carious lesion involving three or more dental surfaces, making the restoration extremely difficult or impossible;
- tooth with internal or external resorption in more than 1/3 of the root length;
- tooth whose crypt of the successor permanent is affected;
- tooth which have less than 2/3 of the root;
- patients who present health problems with oral impairment.
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 |
|---|---|---|
| CTZ PasteTooth allocated to this group will be treated with CTZ paste, according to the Cappielo's protocol (1964), updated by Moura et al. (2016). | Procedure or surgery | CTZ Paste |
| GP PasteTooth allocated to this group will be treated with Guedes-Pinto paste, according to the Guedes-Pinto's protocol (1981), updated by Mello-Moura et al. (2011). | Procedure or surgery | GP Paste |
Primary outcome
Clinical and radiographical efficacy of the endodontic treatment
Time frame: 12 Months
The tooth will be evaluated according to the presence of mobility (yes or no) and regarding radiolucency area on initial and final radiography (measured and compared with the program ImageJ).
4 secondary outcomes
Cost-efficacy
Time frame: Through study completion (12 months)
Children's satisfaction with treatment
Time frame: Through study completion (12 months)
Parents/Guardians' satisfaction with children's treatment
Time frame: Through study completion (12 months)
Impact of treatment on children's quality of life
Time frame: Baseline and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2018.
- BackgroundCappiello J. Tratamientos pulpares en incisivos primários. Rev Circ Od Ros 1964;52(4):133-45.
- Background: PubMed 27472562de Deus Moura Lde F, de Lima Mde D, Lima CC, Machado JI, de Moura MS, de Carvalho PV. Endodontic Treatment of Primary Molars with Antibiotic Paste: A Report of 38 Cases. J Clin Pediatr Dent. 2016;40(3):175-7. doi: 10.17796/1053-4628-40.3.175.
- Background: PubMed 22892969Furtado GE, Sousa ML, Barbosa TS, Wada RS, Martinez-Mier EA, Almeida ME. [Perceptions of dental fluorosis and evaluation of agreement between parents and children: validation of a questionnaire]. Cad Saude Publica. 2012 Aug;28(8):1493-505. doi: 10.1590/s0102-311x2012000800008. Portuguese.
- Background: PubMed 6943625Guedes-Pinto AC, De Paiva JG, Bozzola JR. [Endodontic treatment of deciduous teeth with pulp necrosis]. Rev Assoc Paul Cir Dent. 1981 May-Jun;35(3):240-4. No abstract available. Portuguese.
- Background: PubMed 22484870Mello-Moura AC, Fanaro J, Nicoletti MA, Mendes FM, Wanderley MT, Guedes-Pinto AC. Variability in the proportion of components of iodoform-based Guedes-Pinto paste mixed by dental students and pediatric dentists. Indian J Dent Res. 2011 Nov-Dec;22(6):781-5. doi: 10.4103/0970-9290.94668.
- Background: PubMed 20002630Monse B, Heinrich-Weltzien R, Benzian H, Holmgren C, van Palenstein Helderman W. PUFA--an index of clinical consequences of untreated dental caries. Community Dent Oral Epidemiol. 2010 Feb;38(1):77-82. doi: 10.1111/j.1600-0528.2009.00514.x. Epub 2009 Dec 7.
- Background: PubMed 11291631Wong DL, Baker CM. Smiling faces as anchor for pain intensity scales. Pain. 2001 Jan;89(2-3):295-300. doi: 10.1016/s0304-3959(00)00375-4. No abstract available.
- Individual participant dataSharing planned: Undecided
Related trials for Pulpectomy Agents
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CTZ Paste and GP Paste in people with Pulpectomy Agents, run by Faculty Sao Leopoldo Mandic Campinas 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 4 inclusion and 5 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 24 Dec 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?
Contact Jose Imparato, Dr (+551130851046, jimparato@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical and radiographical efficacy of the endodontic treatment (time frame: 12 Months). 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 NCT03731975, which also lists 7 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 24 Dec 2018.