Direct Pulp CappingNCT04488679
Clinical and Radiographic Assessment of Platelet Rich Fibrin and Mineral Trioxide Aggregate as Pulp Capping Biomaterials
A study testing direct pulp capping in people with Direct Pulp Capping, run by Rahma Ahmed Ibrahem Hafiz at 1 site in Egypt.
Trial summary
eligible carious teeth with exposed pulp by the undergraduate students will be randomly divided into two groups to be treated with direct pulp capping (A), where (A1) represents the comparator group where teeth will be treated with direct application of MTA over the exposed pulp, (A2) represents teeth to be treated… Read more about this study
- Who is it for?
- Ages 15 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Direct Pulp Capping
- What is being tested?
- direct pulp capping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Sep 2022to 20 Aug 2024
- 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 15 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patient aged 15:40 years old.
- Patients exhibiting pulp exposure (carious, traumatic, or mechanical) during management of active carious lesions with less than 2 mm of carious exposure.
- Signs and symptoms indicative of pulp vitality, i.e. a positive response to thermal stimulation during a cold test.
- periapical radiograph showing closed apex and normal periapex
Who cannot join
- Teeth with spontaneous pain or sensitivity to percussion (signs of irreversible pulpitis).
- Teeth with periodontal lesions, internal or external root resorption, calcified canals, mobility of tooth, sinus opening, or abscessed tooth.
- Non restorable tooth.
- Radiographic examination revealed, interrupted or broken lamina dura, widened periodontal ligament space, periapical radiolucency.
- Pulp bleeding that could not be controlled within 10 minutes using 2.5% sodium hypochlorite
- Immune-compromised patients or with systemic medical disorders.
- pregnant females
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographic Assessment of Platelet Rich Fibrin and Mineral Trioxide Aggregate as Pulp Capping Biomaterials: A Randomized Control Trial
eligible carious teeth with exposed pulp by the undergraduate students will be randomly divided into two groups to be treated with direct pulp capping (A), where (A1) represents the comparator group where teeth will be treated with direct application of MTA over the exposed pulp, (A2) represents teeth to be treated with the application of PRF directly over exposed pulp followed by MTA application. clinical and radiographic assessment of tooth vitality, history of pain, pain on percussion, and dentin bridge formation will be performed at baseline, 6 months, and 1 year
- Conditions
- Direct Pulp Capping
- Being tested
- direct pulp capping
- Keywords
- platelet Rich fibrin , MTA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
direct pulp cappingOther
Also called vital pulp therapy
teeth with exposed pulp during caries removal will be capped either with PRF followed by mta or mta alone directly on exposed pulp, in both groups restoration will be placed over mta
| Study group | Role | What they receive |
|---|---|---|
| PRF along with MTA | Experimental | 5 ml of the participant blood will be drawn into 10 ml test tubes without an anticoagulant and centrifuged immediately .centrifugation will be done using a tabletop centrifuge for 10:12 min at 2700:3000 rounds per minute. The resultant product will exhibit three layers. platelet-poor plasma at the surface, PRF clot in the middle, and red blood cells at the bottom. Sterile tweezers inserted into a test tube to retrieve the PRF clot. The prepared fibrin membrane will be gently packed over the pulp Receives: Other: direct pulp capping |
| MTA direct pulp capping | Active comparator | MTA is primarily calcium oxide in the form of tricalcium silicate, dicalcium silicate and tricalcium aluminate. Bismuth oxide is added for radiopacity, MTA is considered a silicate cement rather than an oxide mixture, a so its biocompatibility is due to its reaction products. MTA elevates the expression of transcription factors, induces dentin bridge formation, possesses biocompatibility9, and sustains a high pH for a longer duration and a close physiochemical seal with dentin that forms an insoluble barrier to prevent microleakag Receives: Other: direct pulp capping |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical success rate
pulp vitality by thermal pulp testing
Measured: 6 months
clinical success rate
history of pain
Measured: 6 months
clinical success rate
pain on percussion
Measured: 6 months
clinical success rate
radiographic signs of pulp necrosis and apical periodontitis
Measured: 6 months
clinical success rate
pulp vitality by thermal pulp testing
Measured: 1 year
clinical success rate
history of pain
Measured: 1 year
clinical success rate
no pain on percussion
Measured: 1 year
clinical success rate
radiographic signs of pulp necrosis and apical periodontitis
Measured: 1 year
Secondary outcomes (1)
radiographic assessment of incidence of regenerative dentin (dentin bridge)
assessment of dentin bridge by digital radiography
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start5 Sep 2022
- Primary completion20 Aug 2024
- Study completion20 Aug 2024
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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rahma Ahmed Ibrahem Hafiz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rahma Ahmed Ibrahem Hafiz, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04488679
- Sponsor's protocol ID
- 111261
- Status last verified
- Sep 2024
- First submitted
- 18 Jul 2020
- Last updated
- 19 Sep 2024
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Assessment of Platelet Rich Fibrin and Mineral Trioxide Aggregate as Pulp Capping Biomaterials: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04488679
- Acronym / sponsor ID
- 111261
- Conditions
- Direct Pulp Capping
- Keywords
- platelet Rich fibrin , MTA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Rahma Ahmed Ibrahem HafizUniversity, hospital or other
- Study start
- 5 Sep 2022 (actual)
- Primary completion
- 20 Aug 2024 (actual)
- Study completion
- 20 Aug 2024 (actual)
- First posted
- 28 Jul 2020 (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.
eligible carious teeth with exposed pulp by the undergraduate students will be randomly divided into two groups to be treated with direct pulp capping (A), where (A1) represents the comparator group where teeth will be treated with direct application of MTA over the exposed pulp, (A2) represents teeth to be treated with the application of PRF directly over exposed pulp followed by MTA application. clinical and radiographic assessment of tooth vitality, history of pain, pain on percussion, and dentin bridge formation will be performed at baseline, 6 months, and 1 year
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRF along with MTA | Experimental | Other: direct pulp capping5 ml of the participant blood will be drawn into 10 ml test tubes without an anticoagulant and centrifuged immediately .centrifugation will be done using a tabletop centrifuge for 10:12 min at 2700:3000 rounds per minute. The resultant product will exhibit three layers. platelet-poor plasma at the surface, PRF clot in the middle, and red blood cells at the bottom. Sterile tweezers inserted into a test tube to retrieve the PRF clot. The prepared fibrin membrane will be gently packed over the pulp |
| MTA direct pulp capping | Active comparator | Other: direct pulp cappingMTA is primarily calcium oxide in the form of tricalcium silicate, dicalcium silicate and tricalcium aluminate. Bismuth oxide is added for radiopacity, MTA is considered a silicate cement rather than an oxide mixture, a so its biocompatibility is due to its reaction products. MTA elevates the expression of transcription factors, induces dentin bridge formation, possesses biocompatibility9, and sustains a high pH for a longer duration and a close physiochemical seal with dentin that forms an insoluble barrier to prevent microleakag |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patient aged 15:40 years old.
- Patients exhibiting pulp exposure (carious, traumatic, or mechanical) during management of active carious lesions with less than 2 mm of carious exposure.
- Signs and symptoms indicative of pulp vitality, i.e. a positive response to thermal stimulation during a cold test.
- periapical radiograph showing closed apex and normal periapex
Key exclusion criteria (7 listed)
- Teeth with spontaneous pain or sensitivity to percussion (signs of irreversible pulpitis).
- Teeth with periodontal lesions, internal or external root resorption, calcified canals, mobility of tooth, sinus opening, or abscessed tooth.
- Non restorable tooth.
- Radiographic examination revealed, interrupted or broken lamina dura, widened periodontal ligament space, periapical radiolucency.
- Pulp bleeding that could not be controlled within 10 minutes using 2.5% sodium hypochlorite
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 cappingAlso: vital pulp therapyteeth with exposed pulp during caries removal will be capped either with PRF followed by mta or mta alone directly on exposed pulp, in both groups restoration will be placed over mta | Other | MTA direct pulp capping, PRF along with MTA |
Primary outcome
clinical success rate
Time frame: 6 months
pulp vitality by thermal pulp testing
clinical success rate
Time frame: 6 months
history of pain
clinical success rate
Time frame: 6 months
pain on percussion
clinical success rate
Time frame: 6 months
radiographic signs of pulp necrosis and apical periodontitis
clinical success rate
Time frame: 1 year
pulp vitality by thermal pulp testing
clinical success rate
Time frame: 1 year
history of pain
clinical success rate
Time frame: 1 year
no pain on percussion
clinical success rate
Time frame: 1 year
radiographic signs of pulp necrosis and apical periodontitis
1 secondary outcome
radiographic assessment of incidence of regenerative dentin (dentin bridge)
Time frame: 1 year
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 19 Sep 2024.
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Influence of Proximal Caries on Outcome of Direct Pulp Capping in Permanent Mandibular Molars With Reversible Pulpitis
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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 study testing direct pulp capping in people with Direct Pulp Capping, run by Rahma Ahmed Ibrahem Hafiz 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 7 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 19 Sep 2024. 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?
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 rate (time frame: 6 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?
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 19 Sep 2024.