Direct Pulp CappingPhase 3NCT05530954
Direct Pulp Capping in Primary Molars
A Phase 3 study testing Mineral trioxide aggregate (MTA) and Hard setting Calcium Hydroxide (Dycal) in people with Direct Pulp Capping, run by Mansoura University at 1 site in Egypt.
Trial summary
The purpose of this study is to Assess the effect of MTA and hard setting Calcium Hydroxide (Dycal) on the clinical and radiographic outcome of direct pulp capping in primary molars and evaluate overall success rate of direct pulp capping in primary molars. Read more about this study
- Who is it for?
- Ages 4 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Direct Pulp Capping
- What is being tested?
- Mineral trioxide aggregate (MTA) and Hard setting Calcium Hydroxide (Dycal)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 6 Jun 2023
- 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 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Cooperative child and compliant parent.
- Complete physical and mental health.
- Children who are known to be healthy and free from systemic diseases.
- Primary molars with deep carious lesions leading to pathological exposure but with no signs or symptoms of irreversible pulpitis or necrosis such as spontaneous pain, tenderness to percussion, abscess, fistula, periodontal tissue swelling, or abnormal tooth mobility.
Who cannot join
- A deep carious lesion in close proximity to the pulp with an intact lamina dura.
- Absence of widening of periodontal membrane space or radiolucency at the furcation and periapical region.
- Absence of pulpal calcifications, obliteration of the pulp and root canal, or internal/external root resorption.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient clinic of the Department of Pediatric Dentistry, Faculty of Dentistry- Mansoura University
Al Mansurah
About this study
Official title: Clinical Evaluation of Direct Pulp Capping in Primary Molars
The purpose of this study is to Assess the effect of MTA and hard setting Calcium Hydroxide (Dycal) on the clinical and radiographic outcome of direct pulp capping in primary molars and evaluate overall success rate of direct pulp capping in primary molars.
Read the detailed description
After informed consent, baseline clinical and radiographic assessment will be obtained and recorded in patient examination sheet.
Participants who met the inclusion criteria were randomly allocated to two groups (n = 26/group, N = 52 in total) according to the capping martials using the envelope randomization method.
2 study groups according to capping material that will be used (Dycal or MTA) and each group will be divided to 2 subgroups according to site of exposure axial or pulpal.
All patients were recalled and their treated molars were evaluated clinically and radiographically at 3months, 6months, 9months ,12months follow up periods.
- Conditions
- Direct Pulp Capping
- Being tested
- Mineral trioxide aggregate (MTA), Hard setting Calcium Hydroxide (Dycal)
- Keywords
- primary dentition, MTA, Dycal, bioactive material, deciduous dentition, Direct pulp capping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mineral trioxide aggregate (MTA)Other
Also called BIO MTA, CERKAMED, Poland
Materials for Vital Pulp Capping
Hard setting Calcium Hydroxide (Dycal)Other
Also called Dycal, Promedica Urbical, Germany
Materials for Vital Pulp Capping
| Study group | Role | What they receive |
|---|---|---|
| Mineral trioxide aggregate (MTA) | Active comparator | * where the pulp tissue is exposed during final caries removal, hemostasis will be achieved by cavity irrigation with sterile saline solution for up to 4 minutes till control of bleeding
* Teeth with pulp exposure less than 1mm in diameter surrounded by sound dentin will be candidates for direct pulp capping
* Following the removal of the saline, the exposed pulp will be irrigated with 17% EDTA solution (Prevest Direct, India) for 1 minute
* According to site of exposure, the groups will be further subdivided into Group A (n=13) with exposure in pulpal floor and Group B (n=13) with exposure in axial wall of the cavity.
* Exposed pulp will be covered with fast set MTA paste after cavity dryness with sterile cotton pellet then the tooth will be restored with Self-cured glass ionomer restorative material (SDI Riva self-cure, Australia) and tooth will be covered by stainless steel crown Receives: Other: Mineral trioxide aggregate (MTA) |
| Hard setting Calcium Hydroxide (Dycal) | Active comparator | * where the pulp tissue is exposed during final caries removal, hemostasis will be achieved by cavity irrigation with sterile saline solution for up to 4 minutes till control of bleeding
* Teeth with pulp exposure less than 1mm in diameter surrounded by sound dentin will be candidates for direct pulp capping
* Following the removal of the saline, the exposed pulp will be irrigated with 17% EDTA solution (Prevest Direct, India) for 1 minute
* According to site of exposure, the groups will be further subdivided into Group A (n=13) with exposure in pulpal floor and Group B (n=13) with exposure in axial wall of the cavity.
* Exposed pulp will be covered with Dycal paste after cavity dryness with sterile cotton pellet then the tooth will be restored with Self-cured glass ionomer restorative material (SDI Riva self-cure, Australia) and tooth will be covered by stainless steel crown Receives: Other: Hard setting Calcium Hydroxide (Dycal) |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical success of direct pulp capping treatment after 3 months follow up
Presence of any of these clinical findings will be considered failure:
pain on mastication or spontaneous pain, as reported by the patient, without clinical evidence of plaque retention around the crown margin denoting bad oral hygiene.
pain on percussion on clinical examination . non-physiologic mobility. fistula or sinus tract.
Measured: 3 months
clinical success of direct pulp capping treatment after 6 months follow up
Presence of any of these clinical findings will be considered failure:
pain on mastication or spontaneous pain, as reported by the patient, without clinical evidence of plaque retention around the crown margin denoting bad oral hygiene.
pain on percussion on clinical examination . non-physiologic mobility. fistula or sinus tract.
Measured: 6 months follow up
clinical success of direct pulp capping treatment after 9 months follow up
Presence of any of these clinical findings will be considered failure:
pain on mastication or spontaneous pain, as reported by the patient, without clinical evidence of plaque retention around the crown margin denoting bad oral hygiene.
pain on percussion on clinical examination . non-physiologic mobility. fistula or sinus tract.
Measured: 9 months follow up
clinical success of direct pulp capping treatment after 12 months follow up
Presence of any of these clinical findings will be considered failure:
pain on mastication or spontaneous pain, as reported by the patient, without clinical evidence of plaque retention around the crown margin denoting bad oral hygiene.
pain on percussion on clinical examination . non-physiologic mobility. fistula or sinus tract.
Measured: 12 months follow up
radiographic success of direct pulp capping treatment after 3 months follow up
the absence of the following radiographic findings indicate the success of capping material in pulp therapy:
- pathological internal or external root resorption.
- PDL widening.
- inter-radicular radiolucency formation postoperatively.
- periapical radiolucency formation postoperatively.
Measured: 3 months follow up
radiographic success of direct pulp capping treatment after 6 months follow up
the absence of the following radiographic findings indicate the success of capping material in pulp therapy:
- pathological internal or external root resorption.
- PDL widening.
- inter-radicular radiolucency formation postoperatively.
- periapical radiolucency formation postoperatively.
Measured: 6 months follow up
radiographic success of direct pulp capping treatment after 9 months follow up
the absence of the following radiographic findings indicate the success of capping material in pulp therapy:
- pathological internal or external root resorption.
- PDL widening.
- inter-radicular radiolucency formation postoperatively.
- periapical radiolucency formation postoperatively.
Measured: 9 months follow up
radiographic success of direct pulp capping treatment after 12 months follow up
the absence of the following radiographic findings indicate the success of capping material in pulp therapy:
- pathological internal or external root resorption.
- PDL widening.
- inter-radicular radiolucency formation postoperatively.
- periapical radiolucency formation postoperatively.
Measured: 12 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start1 Jan 2022
- Primary completion27 May 2023
- Study completion6 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Direct Pulp CappingStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After informed consent, baseline clinical and radiographic assessment will be obtained and recorded in patient examination sheet. Participants who met the inclusion criteria were randomly allocated to two groups (n = 26/group, N = 52 in total) according to the capping martials using the envelope randomization method. All patients were recalled and their treated molars were evaluated clinically and radiographically at 3months, 6months, 9months ,12months follow up periods. 2 study groups according to capping material that will be used (Dycal or MTA) and each group will be divided to 2 subgroups according to site of exposure axial or pulpal
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nayera tarek, Mansoura University
- Investigators
- S M Awad, PhD/Prof, Study chair, Head of Pediatric Dentistry and Dental Public Health, Mansoura UniversityA Y El Hosainy, PhD, Study director, Lecturer of Pediatric Dentistry, Faculty of Dentistry, Mansoura UniversityN T El Saied, MSc, Principal investigator, PhD researcher at Faculty of Dentistry, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05530954
- Sponsor's protocol ID
- DPC in primary molars
- Status last verified
- Sep 2023
- First submitted
- 3 Sep 2022
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Caicedo R, Abbott PV, Alongi DJ, Alarcon MY. Clinical, radiographic and histological analysis of the effects of mineral trioxide aggregate used in direct pulp capping and pulpotomies of primary teeth. Aust Dent J. 2006 Dec;51(4):297-305. doi: 10.1111/j.1834-7819.2006.tb00447.x.
PubMed 17256303Faraco IM Jr, Holland R. Response of the pulp of dogs to capping with mineral trioxide aggregate or a calcium hydroxide cement. Dent Traumatol. 2001 Aug;17(4):163-6. doi: 10.1034/j.1600-9657.2001.170405.x.
PubMed 11585142de Lourdes Rodrigues Accorinte M, Reis A, Dourado Loguercio A, Cavalcanti de Araujo V, Muench A. Influence of rubber dam isolation on human pulp responses after capping with calcium hydroxide and an adhesive system. Quintessence Int. 2006 Mar;37(3):205-12.
PubMed 16536148
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Direct Pulp Capping in Primary Molars
- ClinicalTrials.gov ID
- NCT05530954
- Acronym / sponsor ID
- DPC in primary molars
- Conditions
- Direct Pulp Capping
- Keywords
- primary dentition, MTA, Dycal, bioactive material, deciduous dentition, Direct pulp capping
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 27 May 2023 (actual)
- Study completion
- 6 Jun 2023 (actual)
- First posted
- 7 Sep 2022 (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 purpose of this study is to Assess the effect of MTA and hard setting Calcium Hydroxide (Dycal) on the clinical and radiographic outcome of direct pulp capping in primary molars and evaluate overall success rate of direct pulp capping in primary molars.
Detailed description
After informed consent, baseline clinical and radiographic assessment will be obtained and recorded in patient examination sheet.
Participants who met the inclusion criteria were randomly allocated to two groups (n = 26/group, N = 52 in total) according to the capping martials using the envelope randomization method.
2 study groups according to capping material that will be used (Dycal or MTA) and each group will be divided to 2 subgroups according to site of exposure axial or pulpal.
All patients were recalled and their treated molars were evaluated clinically and radiographically at 3months, 6months, 9months ,12months follow up periods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- After informed consent, baseline clinical and radiographic assessment will be obtained and recorded in patient examination sheet. Participants who met the inclusion criteria were randomly allocated to two groups (n = 26/group, N = 52 in total) according to the capping martials using the envelope randomization method. All patients were recalled and their treated molars were evaluated clinically and radiographically at 3months, 6months, 9months ,12months follow up periods. 2 study groups according to capping material that will be used (Dycal or MTA) and each group will be divided to 2 subgroups according to site of exposure axial or pulpal
| Arm | Type | Receives |
|---|---|---|
| Mineral trioxide aggregate (MTA) | Active comparator | Other: Mineral trioxide aggregate (MTA)* where the pulp tissue is exposed during final caries removal, hemostasis will be achieved by cavity irrigation with sterile saline solution for up to 4 minutes till control of bleeding * Teeth with pulp exposure less than 1mm in diameter surrounded by sound dentin will be candidates for direct pulp capping * Following the removal of the saline, the exposed pulp will be irrigated with 17% EDTA solution (Prevest Direct, India) for 1 minute * According to site of exposure, the groups will be further subdivided into Group A (n=13) with exposure in pulpal floor and Group B (n=13) with exposure in axial wall of the cavity. * Exposed pulp will be covered with fast set MTA paste after cavity dryness with sterile cotton pellet then the tooth will be restored with Self-cured glass ionomer restorative material (SDI Riva self-cure, Australia) and tooth will be covered by stainless steel crown |
| Hard setting Calcium Hydroxide (Dycal) | Active comparator | Other: Hard setting Calcium Hydroxide (Dycal)* where the pulp tissue is exposed during final caries removal, hemostasis will be achieved by cavity irrigation with sterile saline solution for up to 4 minutes till control of bleeding * Teeth with pulp exposure less than 1mm in diameter surrounded by sound dentin will be candidates for direct pulp capping * Following the removal of the saline, the exposed pulp will be irrigated with 17% EDTA solution (Prevest Direct, India) for 1 minute * According to site of exposure, the groups will be further subdivided into Group A (n=13) with exposure in pulpal floor and Group B (n=13) with exposure in axial wall of the cavity. * Exposed pulp will be covered with Dycal paste after cavity dryness with sterile cotton pellet then the tooth will be restored with Self-cured glass ionomer restorative material (SDI Riva self-cure, Australia) and tooth will be covered by stainless steel crown |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Cooperative child and compliant parent.
- Complete physical and mental health.
- Children who are known to be healthy and free from systemic diseases.
- Primary molars with deep carious lesions leading to pathological exposure but with no signs or symptoms of irreversible pulpitis or necrosis such as spontaneous pain, tenderness to percussion, abscess, fistula, periodontal tissue swelling, or abnormal tooth mobility.
Key exclusion criteria (3 listed)
- A deep carious lesion in close proximity to the pulp with an intact lamina dura.
- Absence of widening of periodontal membrane space or radiolucency at the furcation and periapical region.
- Absence of pulpal calcifications, obliteration of the pulp and root canal, or internal/external root resorption.
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 |
|---|---|---|
| Mineral trioxide aggregate (MTA)Also: BIO MTA, CERKAMED, PolandMaterials for Vital Pulp Capping | Other | Mineral trioxide aggregate (MTA) |
| Hard setting Calcium Hydroxide (Dycal)Also: Dycal, Promedica Urbical, GermanyMaterials for Vital Pulp Capping | Other | Hard setting Calcium Hydroxide (Dycal) |
Primary outcome
clinical success of direct pulp capping treatment after 3 months follow up
Time frame: 3 months
Presence of any of these clinical findings will be considered failure: pain on mastication or spontaneous pain, as reported by the patient, without clinical evidence of plaque retention around the crown margin denoting bad oral hygiene. pain on percussion on clinical examination . non-physiologic mobility. fistula or sinus tract.
clinical success of direct pulp capping treatment after 6 months follow up
Time frame: 6 months follow up
Presence of any of these clinical findings will be considered failure: pain on mastication or spontaneous pain, as reported by the patient, without clinical evidence of plaque retention around the crown margin denoting bad oral hygiene. pain on percussion on clinical examination . non-physiologic mobility. fistula or sinus tract.
clinical success of direct pulp capping treatment after 9 months follow up
Time frame: 9 months follow up
Presence of any of these clinical findings will be considered failure: pain on mastication or spontaneous pain, as reported by the patient, without clinical evidence of plaque retention around the crown margin denoting bad oral hygiene. pain on percussion on clinical examination . non-physiologic mobility. fistula or sinus tract.
clinical success of direct pulp capping treatment after 12 months follow up
Time frame: 12 months follow up
Presence of any of these clinical findings will be considered failure: pain on mastication or spontaneous pain, as reported by the patient, without clinical evidence of plaque retention around the crown margin denoting bad oral hygiene. pain on percussion on clinical examination . non-physiologic mobility. fistula or sinus tract.
radiographic success of direct pulp capping treatment after 3 months follow up
Time frame: 3 months follow up
the absence of the following radiographic findings indicate the success of capping material in pulp therapy: * pathological internal or external root resorption. * PDL widening. * inter-radicular radiolucency formation postoperatively. * periapical radiolucency formation postoperatively.
radiographic success of direct pulp capping treatment after 6 months follow up
Time frame: 6 months follow up
the absence of the following radiographic findings indicate the success of capping material in pulp therapy: * pathological internal or external root resorption. * PDL widening. * inter-radicular radiolucency formation postoperatively. * periapical radiolucency formation postoperatively.
radiographic success of direct pulp capping treatment after 9 months follow up
Time frame: 9 months follow up
the absence of the following radiographic findings indicate the success of capping material in pulp therapy: * pathological internal or external root resorption. * PDL widening. * inter-radicular radiolucency formation postoperatively. * periapical radiolucency formation postoperatively.
radiographic success of direct pulp capping treatment after 12 months follow up
Time frame: 12 months follow up
the absence of the following radiographic findings indicate the success of capping material in pulp therapy: * pathological internal or external root resorption. * PDL widening. * inter-radicular radiolucency formation postoperatively. * periapical radiolucency formation postoperatively.
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 26 Sep 2023.
- Results publication: PubMed 17256303Caicedo R, Abbott PV, Alongi DJ, Alarcon MY. Clinical, radiographic and histological analysis of the effects of mineral trioxide aggregate used in direct pulp capping and pulpotomies of primary teeth. Aust Dent J. 2006 Dec;51(4):297-305. doi: 10.1111/j.1834-7819.2006.tb00447.x.
- Results publication: PubMed 11585142Faraco IM Jr, Holland R. Response of the pulp of dogs to capping with mineral trioxide aggregate or a calcium hydroxide cement. Dent Traumatol. 2001 Aug;17(4):163-6. doi: 10.1034/j.1600-9657.2001.170405.x.
- Results publication: PubMed 16536148de Lourdes Rodrigues Accorinte M, Reis A, Dourado Loguercio A, Cavalcanti de Araujo V, Muench A. Influence of rubber dam isolation on human pulp responses after capping with calcium hydroxide and an adhesive system. Quintessence Int. 2006 Mar;37(3):205-12.
- © European Academy of Paediatric Dentistry 2018Link provided by the sponsor.
- 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.
S M Awad, PhD/Prof study chair
Head of Pediatric Dentistry and Dental Public Health, Mansoura University
A Y El Hosainy, PhD study director
Lecturer of Pediatric Dentistry, Faculty of Dentistry, Mansoura University
N T El Saied, MSc principal investigator
PhD researcher at Faculty of Dentistry, Mansoura University
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 Mineral trioxide aggregate (MTA) and Hard setting Calcium Hydroxide (Dycal) in people with Direct Pulp Capping, run by Mansoura University at 1 site in Egypt.
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 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: finished, as of the sponsor's last update on 26 Sep 2023. 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 Egypt. 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?
clinical success of direct pulp capping treatment after 3 months follow up (time frame: 3 months). The study lists 8 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 NCT05530954, which also lists 3 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 26 Sep 2023.