Direct Pulp CappingNCT05496257
Calcium Hydroxide Versus Premixed Bioceramic Putty in Direct Pulp Capping of Primary Molars
A study testing direct pulp capping in primary molars in people with Direct Pulp Capping, run by Minia University at 1 site in Egypt.
Trial summary
The trial will be conducted to evaluate and compare calcium hydroxide and premixed bioceramic putty regarding the clinical and radiographic outcomes of direct pulp capping in primary molars. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Direct Pulp Capping
- What is being tested?
- direct pulp capping in primary molars
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Nov 2021to 2 Dec 2023
- 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 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 1. Clinical:
- Children categorized as class I or II according to American Society of Anaesthesiologists (ASA) scale.
- Children rated as no. 3 or 4 in Frankl behaviour rating scale (FBRS).
- Presence of a small carious or traumatic pulp exposure (1 mm or less). 2. Radiographic:
- <!-- -->
- Presence of at least two-thirds of root length.
- Normal lamina dura and periodontal ligament space.
Who cannot join
- 1. Clinical:
- History of spontaneous unprovoked toothache.
- Extensive crown destruction that preclude coronal restoration.
- Gingival swelling, sinus tract or other soft tissue pathology.
- Abnormal tooth mobility.
- A frank pulp exposure (i.e., greater than 1.0mm), requiring pulpotomy.
Show all 12Show fewer
- No evidence of visible pulp exposure.
- 2. Radiographic:
- <!-- -->
- Furcation/periapical radiolucency.
- Pathological internal/external root resorption.
- Absence of underlying permanent successor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Calcium Hydroxide Versus Premixed Bioceramic Putty in Direct Pulp Capping of Primary Molars: An Equivalent Parallel Randomized Controlled Trial
The trial will be conducted to evaluate and compare calcium hydroxide and premixed bioceramic putty regarding the clinical and radiographic outcomes of direct pulp capping in primary molars.
Read the detailed description
The current equivalent parallel randomized controlled trial will be conducted to evaluate and compare calcium hydroxide and premixed bioceramic putty regarding the clinical and radiographic outcomes of direct pulp capping in primary molars over a 24-month follow-up period.
- Conditions
- Direct Pulp Capping
- Being tested
- direct pulp capping in primary molars
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
direct pulp capping in primary molarsOther
caries will be removed, and if the pulps are exposed, the material will be place directly over the exposed pulp.
| Study group | Role | What they receive |
|---|---|---|
| Group I (control): Calcium hydroxide cement | Active comparator | Pulp capping material Receives: Other: direct pulp capping in primary molars |
| Group 2: Premixed bioceramic putty | Active comparator | Pulp capping material Receives: Other: direct pulp capping in primary molars |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical findings
The children will be recalled for postoperative clinical \& radiographic assessments at the following intervals; six, twelve, eighteen,and twenty-four months.the treatment will be considered successful if none of the following clinical or radiographic findings is present:
Clinical criteria:
- Pain.
- Tenderness to palpation or percussion
- Gingival swelling or sinus tract.
- Purulent exudate expressed from the gingival margin.
- Abnormal tooth mobility.
Measured: 2 year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start2 Nov 2021
- Primary completion2 Nov 2023 (estimated)
- Study completion2 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merrette Basem Khalaf Sedhom, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05496257
- Sponsor's protocol ID
- 524_1/11/2021
- Status last verified
- Aug 2022
- First submitted
- 5 Aug 2022
- Last updated
- 11 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calcium Hydroxide Versus Premixed Bioceramic Putty in Direct Pulp Capping of Primary Molars: An Equivalent Parallel Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05496257
- Acronym / sponsor ID
- 524_1/11/2021
- Conditions
- Direct Pulp Capping
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 2 Nov 2021 (actual)
- Primary completion
- 2 Nov 2023 (estimated)
- Study completion
- 2 Dec 2023 (estimated)
- First posted
- 11 Aug 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 trial will be conducted to evaluate and compare calcium hydroxide and premixed bioceramic putty regarding the clinical and radiographic outcomes of direct pulp capping in primary molars.
Detailed description
The current equivalent parallel randomized controlled trial will be conducted to evaluate and compare calcium hydroxide and premixed bioceramic putty regarding the clinical and radiographic outcomes of direct pulp capping in primary molars over a 24-month follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (control): Calcium hydroxide cement | Active comparator | Other: direct pulp capping in primary molarsPulp capping material |
| Group 2: Premixed bioceramic putty | Active comparator | Other: direct pulp capping in primary molarsPulp capping material |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 1. Clinical:
- <!-- -->
Key exclusion criteria (12 listed)
- 1. Clinical:
- <!-- -->
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 in primary molarscaries will be removed, and if the pulps are exposed, the material will be place directly over the exposed pulp. | Other | Group 2: Premixed bioceramic putty, Group I (control): Calcium hydroxide cement |
Primary outcome
Clinical findings
Time frame: 2 year follow up
The children will be recalled for postoperative clinical \& radiographic assessments at the following intervals; six, twelve, eighteen,and twenty-four months.the treatment will be considered successful if none of the following clinical or radiographic findings is present: Clinical criteria: 1. Pain. 2. Tenderness to palpation or percussion 3. Gingival swelling or sinus tract. 4. Purulent exudate expressed from the gingival margin. 5. Abnormal tooth mobility.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2022.
Related trials for Direct Pulp Capping
Active, not recruiting
Direct Pulp Capping Compared to Partial Pulpotomy in Carious Pulp Exposures
Deep Caries
Recruiting
Comparative Evaluation of Direct Pulp Capping Between Deep and Extremely Deep Caries in Mature Permanent Mandibular Molars .
Reversible Pulpitis, Deep Caries
Recruiting
Influence of Proximal Caries on Outcome of Direct Pulp Capping in Permanent Mandibular Molars With Reversible Pulpitis
Reversible Pulpitis, Extremely Deep Caries
Recruiting
Comparative Evaluation of Indirect vs. Direct Pulp Capping in Deep Carious Mandibular Molars
Indirect Pulp Capping, Reversible Pulpitis
Not yet recruiting
Outcome of Direct Pulp Capping and Partial Pulpotomy in Reversible Pulpitis
Reversible Pulpitis, Extremely Deep Caries
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 study testing direct pulp capping in primary molars in people with Direct Pulp Capping, run by Minia 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 7 inclusion and 12 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 11 Aug 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.
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 findings (time frame: 2 year follow up). 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 11 Aug 2022.