Vital Pulp TherapyNCT05464797
Diagnostic Biomarkers to Correlate Molecular Changes and Inflammatory Cascade in the Dental Pulp.
A study testing Pulp therapy and Cytokines level in pulpal blood. in people with Vital Pulp Therapy, run by Mansoura University at 1 site in Egypt.
Trial summary
This study aimed to evaluate the molecular changes that occur within the pulp tissue during inflammation and its correlation with vital pulp therapy with its different treatment modalities (Direct pulp capping, Partial Pulpotomy and Complete Pulpotomy). Read more about this study
- Who is it for?
- Ages 15 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Vital Pulp Therapy
- What is being tested?
- Pulp therapy and Cytokines level in pulpal blood.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Dec 2020to 30 Jun 2022
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Positive response to cold testing.
- The age range from 15-45 years.
- Patients of both sex.
- Has clinical symptoms of pulpitis with normal apical tissues and supported by radiographic evaluation with no periradicular changes.
Who cannot join
- Patients over 45 years of age.
- Patients with clinical symptoms of periradicular inflammation or periradicular radiographic changes.
- Negative response to cold testing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Biomarkers to Correlate Molecular Changes and Early Inflammatory Cascade in Deep Carious Lesions With Dental Pulp Exposure.
This study aimed to evaluate the molecular changes that occur within the pulp tissue during inflammation and its correlation with vital pulp therapy with its different treatment modalities (Direct pulp capping, Partial Pulpotomy and Complete Pulpotomy).
Read the detailed description
The diagnosis of irreversible pulpitis was based only on the clinical signs and symptoms which does not always match that of the histological changes of the pulp tissues. So, it is more appropriate to diagnose the pulp according to the molecular changes taking place throughout the pulp tissues. Different studies have been conducted to study the molecular changes that take place in the inflamed pulp, Including a study that was conducted by Rechenberg et al in 2014 which states different locations to obtain samples for these molecules. The best of which was the dental pulp blood sample. Many studies stated the way to obtain a blood sample from the pulp and how to prepare and test it to evaluate the levels and concentrations of different inflammatory molecules. Many studies were also conducted to study the different changes and accurateness of measurement of different molecules.
The pulp inflammation occurs in a low compliance environment of dentinal walls. So, During acute inflammatory reaction, Vasodilatation occurs along with increased capillary permeability, Which leads to increase in the pulp interstitial fluid pressure which creates more pressure on blood vessels and this prevents beneficial blood flow, which decreases the ability of the pulp to defend itself from bacterial attacks causing tissue necrosis. This necrotic tissue is colonized by bacterial tissues.
In the literature, one of the novel treatment modalities for irrevesible inflammation of the pulp is partial removal of the inflammed pulp tissue according to clinical sign (bleeding control), The pulp tissue is removed partially until reaching complete coronal pulp removal or complete pulpectomy until hemostasis is obtained after 10 minutes of moist cotton pellet application.So, The normal pulp is preserved.
In 2019, Ricucci et al conducted a systematic review for treatment of deep carious lesions with pulp exposure. With treatment modalities ranging from direct pulp capping, partial pulpotomy, complete pulpotomy and pulpectomy. Based only on clinical signs of normal appearance of the pulp tissue under magnification with dental operating microscope and bleeding control within 10 minutes with a moist cotton pellet.
- Conditions
- Vital Pulp Therapy
- Being tested
- Pulp therapy, Cytokines level in pulpal blood.
- Keywords
- Partial Pulpotomy, Cytokines, Direct Pulp Capping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulp therapyProcedure or surgery
partial or complete removal of inflamed pulp tissue
Cytokines level in pulpal blood.Diagnostic test
Measuring the concentration of IL-8 and MMP-9 in the dental pulp during inflammation.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Not described Receives: Diagnostic Test: Cytokines level in pulpal blood. |
| Direct Pulp Capping group | Experimental | Not described Receives: Procedure: Pulp therapy; Diagnostic Test: Cytokines level in pulpal blood. |
| Partial Pulpotomy group | Experimental | Not described Receives: Procedure: Pulp therapy; Diagnostic Test: Cytokines level in pulpal blood. |
| Complete Pulpotomy group | Experimental | Not described Receives: Procedure: Pulp therapy; Diagnostic Test: Cytokines level in pulpal blood. |
| Root canal treatment group | Experimental | Not described Receives: Procedure: Pulp therapy; Diagnostic Test: Cytokines level in pulpal blood. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periradicular condition of the teeth
Presence of any radiographic abnormal periapical change
Measured: 6 months
Level of Interleukin 8 in pulpal blood
Severity of inflammation
Measured: 6 months
Secondary outcomes (1)
Level of Matrix metalloproteinase 9 in pulpal blood
Cytokines level in pulpal blood
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start12 Dec 2020
- Primary completion1 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vital Pulp TherapyStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- 48 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
- NCT05464797
- Sponsor's protocol ID
- M02031120
- Status last verified
- Oct 2020
- First submitted
- 11 Jul 2022
- Last updated
- 19 Jul 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 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Biomarkers to Correlate Molecular Changes and Early Inflammatory Cascade in Deep Carious Lesions With Dental Pulp Exposure.
- ClinicalTrials.gov ID
- NCT05464797
- Acronym / sponsor ID
- M02031120
- Conditions
- Vital Pulp Therapy
- Keywords
- Partial Pulpotomy, Cytokines, Direct Pulp Capping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 12 Dec 2020 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 19 Jul 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.
This study aimed to evaluate the molecular changes that occur within the pulp tissue during inflammation and its correlation with vital pulp therapy with its different treatment modalities (Direct pulp capping, Partial Pulpotomy and Complete Pulpotomy).
Detailed description
The diagnosis of irreversible pulpitis was based only on the clinical signs and symptoms which does not always match that of the histological changes of the pulp tissues. So, it is more appropriate to diagnose the pulp according to the molecular changes taking place throughout the pulp tissues. Different studies have been conducted to study the molecular changes that take place in the inflamed pulp, Including a study that was conducted by Rechenberg et al in 2014 which states different locations to obtain samples for these molecules. The best of which was the dental pulp blood sample. Many studies stated the way to obtain a blood sample from the pulp and how to prepare and test it to evaluate the levels and concentrations of different inflammatory molecules. Many studies were also conducted to study the different changes and accurateness of measurement of different molecules.
The pulp inflammation occurs in a low compliance environment of dentinal walls. So, During acute inflammatory reaction, Vasodilatation occurs along with increased capillary permeability, Which leads to increase in the pulp interstitial fluid pressure which creates more pressure on blood vessels and this prevents beneficial blood flow, which decreases the ability of the pulp to defend itself from bacterial attacks causing tissue necrosis. This necrotic tissue is colonized by bacterial tissues.
In the literature, one of the novel treatment modalities for irrevesible inflammation of the pulp is partial removal of the inflammed pulp tissue according to clinical sign (bleeding control), The pulp tissue is removed partially until reaching complete coronal pulp removal or complete pulpectomy until hemostasis is obtained after 10 minutes of moist cotton pellet application.So, The normal pulp is preserved.
In 2019, Ricucci et al conducted a systematic review for treatment of deep carious lesions with pulp exposure. With treatment modalities ranging from direct pulp capping, partial pulpotomy, complete pulpotomy and pulpectomy. Based only on clinical signs of normal appearance of the pulp tissue under magnification with dental operating microscope and bleeding control within 10 minutes with a moist cotton pellet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Diagnostic Test: Cytokines level in pulpal blood. |
| Direct Pulp Capping group | Experimental | Procedure: Pulp therapy, Diagnostic Test: Cytokines level in pulpal blood. |
| Partial Pulpotomy group | Experimental | Procedure: Pulp therapy, Diagnostic Test: Cytokines level in pulpal blood. |
| Complete Pulpotomy group | Experimental | Procedure: Pulp therapy, Diagnostic Test: Cytokines level in pulpal blood. |
| Root canal treatment group | Experimental | Procedure: Pulp therapy, Diagnostic Test: Cytokines level in pulpal blood. |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Positive response to cold testing.
- The age range from 15-45 years.
- Patients of both sex.
- Has clinical symptoms of pulpitis with normal apical tissues and supported by radiographic evaluation with no periradicular changes.
Key exclusion criteria (3 listed)
- Patients over 45 years of age.
- Patients with clinical symptoms of periradicular inflammation or periradicular radiographic changes.
- Negative response to cold testing.
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 |
|---|---|---|
| Pulp therapypartial or complete removal of inflamed pulp tissue | Procedure or surgery | Complete Pulpotomy group, Direct Pulp Capping group, Partial Pulpotomy group, Root canal treatment group |
| Cytokines level in pulpal blood.Measuring the concentration of IL-8 and MMP-9 in the dental pulp during inflammation. | Diagnostic test | Complete Pulpotomy group, Control group, Direct Pulp Capping group, Partial Pulpotomy group, Root canal treatment group |
Primary outcome
Periradicular condition of the teeth
Time frame: 6 months
Presence of any radiographic abnormal periapical change
Level of Interleukin 8 in pulpal blood
Time frame: 6 months
Severity of inflammation
1 secondary outcome
Level of Matrix metalloproteinase 9 in pulpal blood
Time frame: 6 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 19 Jul 2022.
Related trials for Vital Pulp Therapy
Not yet recruitingObservational study
Age-Related Inflammatory Proteins as Indicators of Vital Pulp Therapy Outcomes
Vital Pulp Therapy
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Effect of Hemostatic Agents on TheraCal PT Pulpotomy Success in Primary Molars
Reversible Pulpitis, Dental Caries
Recruiting
Laser-Assisted vs Conventional Total Pulpotomy in Symptomatic Irreversible Pulpitis
Symptomatic Irreversible Pulpitis and Post Operative Pain
Not yet recruitingObservational study
Prognostic Value of Pulpal Blood pH and Oxygen Saturation in Vital Pulp Therapy: Determination of Clinically Relevant Thresholds in a Prospective Clinical Study
Vital Pulp Therapies, pH
Active, not recruitingObservational study
Clinical Evaluation of Discoloration Induced by Root Canal Treatment in Vital and Devital Teeth
Tooth Discoloration Following Root Canal Treatment, Tooth Discoloration
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 Pulp therapy and Cytokines level in pulpal blood. in people with Vital Pulp Therapy, 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 19 Jul 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. Some participants in this study may receive a placebo. 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?
Periradicular condition of the teeth (time frame: 6 months). The study lists 2 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 Jul 2022.