Direct Pulp Capping in Primary TeethPhase 4NCT05222243
DPC in Primary Molars.
A Phase 4 study testing Direct pulp capping with calcium hydroxide, Direct pulp capping with MTA and Direct pulp capping with Formocresol in people with Direct Pulp Capping in Primary Teeth, run by Mansoura University at 1 site in Egypt.
Trial summary
To evaluate clinical and radiographical outcomes of direct pulp capping using calcium hydroxide (CH), mineral trioxide aggregate (MTA), and premedicated direct pulp capping (PDPC) with formocresol (FC) in 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
- Direct Pulp Capping in Primary Teeth
- What is being tested?
- Direct pulp capping with calcium hydroxide, Direct pulp capping with MTA and Direct pulp capping with Formocresol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 1 Dec 2020
- Phase
- Phase 4
- 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
- Absence of chronic systemic disease and any type of medical treatment or continues use of any medication.
- Absence of drug allergies, anesthetics, and environmental allergies.
- Cooperative patients.
- Restorable teeth with deep decay lesions.
- Teeth with signs of reversible pulpitis; no spontaneous pain; and absence of edema, pain, fistula, pathological mobility, and sensitivity to percussion.
- True pinpoint exposure (small exposure surrounded by sound dentin with normal bleeding easily controlled)
- Teeth with no pathological root resorption, periradicular or furcal radiolucency.
- Teeth with less than one-third physiological root resorption (no resorption or one-fourth resorption of the root).
Who cannot join
- otherwise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Calcium Hydroxide Paste, Mineral Trioxide Aggregate and Formocresol as A Direct Pulp Capping in Primary Molars. Randomized Controlled Clinical Trial
To evaluate clinical and radiographical outcomes of direct pulp capping using calcium hydroxide (CH), mineral trioxide aggregate (MTA), and premedicated direct pulp capping (PDPC) with formocresol (FC) in primary teeth.
Read the detailed description
The pulp is imperiled by many environmental impacts. Caries, trauma, restorations, and mechanical injury during cleaning, all are possible aggressions that may injury the pulp tissue. When lesion disrupt enamel barrier, dentin can be degraded by Gram-positive bacteria, such as actinomyces, lactobacilli, and streptococci, that largely dominate the microflora of carious lesion. Pulp response differs according to the degree of the insult. The inflammatory reaction can cause permanent damage or be followed by repair, as the pulp cells have the ability to differentiate into odontoblasts forming dentin matrix facilitating wound healing.
Calcium hydroxide was introduced to the dental practice in the 1920s, and early clinical studies using it in direct pulp capping showed an 80-90 percent success rate.Recent studies with longer follow-up periods suggest lower success rates for it.Calcium hydroxide was used in many forms alone and mixed with other materials for many applications in the dental profession. For direct pulp capping calcium hydroxide powder and aqueous paste were used at first then premixed and cement-based types were developed.
Mineral trioxide aggregate (MTA) was introduced to the dental practice in the 1990s as a root-end filling material. MTA is used as a gold standard in endodontics and has a variety of applications such as root-end filling, apexification, root and truck perforations, apexogenesis, pulp capping in permanent and primary teeth, and dressing for pulpotomy in primary teeth. It is mainly composed of tricalcium silicate, tricalcium aluminate, dicalcium silicate, bismuth oxide, and calcium sulfate dehydrate.
Several studies have shown the efficacy of direct pulp capping using calcium hydroxide and MTA in permanent teeth. However, its use in primary teeth is controversial and few studies are available regarding that subject. Formocresol is not known to be used in direct pulp capping techniques, however, its high clinical success in pulpotomy techniques for primary teeth promoted the investigation of its possible use as direct capping medicament. In addition, there are not enough collected clinical and histological data about direct capping in primary teeth to assess the true success of treatment. Accordingly, the study was directed to evaluate the histological and clinical success of different materials in direct pulp capping for primary teeth.
- Conditions
- Direct Pulp Capping in Primary Teeth
- Being tested
- Direct pulp capping with calcium hydroxide, Direct pulp capping with MTA, Direct pulp capping with Formocresol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct pulp capping with calcium hydroxideDrug
Capping exposed dental pulps during cavity preparation in primary teeth with calcium hydroxide
Direct pulp capping with MTADrug
Capping exposed dental pulps during cavity preparation in primary teeth with MTA
Direct pulp capping with FormocresolDrug
Capping exposed dental pulps during cavity preparation in primary teeth with zinc oxide eugenol after medication with formocresol
| Study group | Role | What they receive |
|---|---|---|
| Calcium Hydroxide (CH) | Active comparator | Calcium Hydroxide is the gold standard for direct pulp capping depends on regeneration Receives: Drug: Direct pulp capping with calcium hydroxide |
| MTA | Experimental | Mineral trioxide aggregate used for pulp regeneration Receives: Drug: Direct pulp capping with MTA |
| Formocresol (FC) | Experimental | composed of formaldehyde, cresol, glycerin and water used for fixation of pulp tissue Receives: Drug: Direct pulp capping with Formocresol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiolucency of the periapical or furcation area
measuring tool is x-ray
Measured: 12 months
Secondary outcomes (7)
Pathological internal or external root resorption
measuring tool is x-ray
Measured: 12 months
Widening of the periodontal space
measuring tool is x-ray
Measured: 12 months
Calcification of the pulp canal
measuring tool is x-ray
Measured: 12 months
Spontaneous pain
numeric rating scale (presence or abscence of pain) 0 is best result 10 is the worst
Measured: 12 months
Sensitivity on percussion and palpation
methods of tapping on surface in clinical examination
Measured: 12 months
Presence or absence of fistula
visual inspection
Measured: 12 months
Pathological mobility
mobility is graded clinically by applying pressure with ends of two metal instruments
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start1 Jan 2019
- Primary completion3 Aug 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Direct Pulp Capping in Primary TeethStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05222243
- Sponsor's protocol ID
- 05030718
- Status last verified
- Jul 2018
- First submitted
- 8 Dec 2021
- Last updated
- 3 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Calcium Hydroxide Paste, Mineral Trioxide Aggregate and Formocresol as A Direct Pulp Capping in Primary Molars. Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05222243
- Acronym / sponsor ID
- 05030718
- Conditions
- Direct Pulp Capping in Primary Teeth
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 3 Aug 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 3 Feb 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.
To evaluate clinical and radiographical outcomes of direct pulp capping using calcium hydroxide (CH), mineral trioxide aggregate (MTA), and premedicated direct pulp capping (PDPC) with formocresol (FC) in primary teeth.
Detailed description
The pulp is imperiled by many environmental impacts. Caries, trauma, restorations, and mechanical injury during cleaning, all are possible aggressions that may injury the pulp tissue. When lesion disrupt enamel barrier, dentin can be degraded by Gram-positive bacteria, such as actinomyces, lactobacilli, and streptococci, that largely dominate the microflora of carious lesion. Pulp response differs according to the degree of the insult. The inflammatory reaction can cause permanent damage or be followed by repair, as the pulp cells have the ability to differentiate into odontoblasts forming dentin matrix facilitating wound healing.
Calcium hydroxide was introduced to the dental practice in the 1920s, and early clinical studies using it in direct pulp capping showed an 80-90 percent success rate.Recent studies with longer follow-up periods suggest lower success rates for it.Calcium hydroxide was used in many forms alone and mixed with other materials for many applications in the dental profession. For direct pulp capping calcium hydroxide powder and aqueous paste were used at first then premixed and cement-based types were developed.
Mineral trioxide aggregate (MTA) was introduced to the dental practice in the 1990s as a root-end filling material. MTA is used as a gold standard in endodontics and has a variety of applications such as root-end filling, apexification, root and truck perforations, apexogenesis, pulp capping in permanent and primary teeth, and dressing for pulpotomy in primary teeth. It is mainly composed of tricalcium silicate, tricalcium aluminate, dicalcium silicate, bismuth oxide, and calcium sulfate dehydrate.
Several studies have shown the efficacy of direct pulp capping using calcium hydroxide and MTA in permanent teeth. However, its use in primary teeth is controversial and few studies are available regarding that subject. Formocresol is not known to be used in direct pulp capping techniques, however, its high clinical success in pulpotomy techniques for primary teeth promoted the investigation of its possible use as direct capping medicament. In addition, there are not enough collected clinical and histological data about direct capping in primary teeth to assess the true success of treatment. Accordingly, the study was directed to evaluate the histological and clinical success of different materials in direct pulp capping for primary teeth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Calcium Hydroxide (CH) | Active comparator | Drug: Direct pulp capping with calcium hydroxideCalcium Hydroxide is the gold standard for direct pulp capping depends on regeneration |
| MTA | Experimental | Drug: Direct pulp capping with MTAMineral trioxide aggregate used for pulp regeneration |
| Formocresol (FC) | Experimental | Drug: Direct pulp capping with Formocresolcomposed of formaldehyde, cresol, glycerin and water used for fixation of pulp tissue |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Absence of chronic systemic disease and any type of medical treatment or continues use of any medication.
- Absence of drug allergies, anesthetics, and environmental allergies.
- Cooperative patients.
- Restorable teeth with deep decay lesions.
- Teeth with signs of reversible pulpitis; no spontaneous pain; and absence of edema, pain, fistula, pathological mobility, and sensitivity to percussion.
Key exclusion criteria (1 listed)
- otherwise
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 |
|---|---|---|
| Direct pulp capping with calcium hydroxideCapping exposed dental pulps during cavity preparation in primary teeth with calcium hydroxide | Drug | Calcium Hydroxide (CH) |
| Direct pulp capping with MTACapping exposed dental pulps during cavity preparation in primary teeth with MTA | Drug | MTA |
| Direct pulp capping with FormocresolCapping exposed dental pulps during cavity preparation in primary teeth with zinc oxide eugenol after medication with formocresol | Drug | Formocresol (FC) |
Primary outcome
Radiolucency of the periapical or furcation area
Time frame: 12 months
measuring tool is x-ray
7 secondary outcomes
Pathological internal or external root resorption
Time frame: 12 months
Widening of the periodontal space
Time frame: 12 months
Calcification of the pulp canal
Time frame: 12 months
Spontaneous pain
Time frame: 12 months
Sensitivity on percussion and palpation
Time frame: 12 months
Presence or absence of fistula
Time frame: 12 months
Pathological mobility
Time frame: 12 months
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 3 Feb 2022.
- Individual participant dataSharing planned: Yes
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 4 study testing Direct pulp capping with calcium hydroxide, Direct pulp capping with MTA and Direct pulp capping with Formocresol in people with Direct Pulp Capping in Primary Teeth, 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 8 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: finished, as of the sponsor's last update on 3 Feb 2022. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Radiolucency of the periapical or furcation area (time frame: 12 months). 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 3 Feb 2022.