Infected PulpNCT05347160
Evaluation Of Different Pulpotomy Agents Used For Treatment Of Immature Molars
A study testing Biodentine in people with Infected Pulp and Root Canal Treatment, run by Mansoura University at 1 site in Egypt.
Trial summary
The management of permanent teeth with incomplete root development with compromised pulpal integrity presents a unique challenge. The loss of pulpal vitality before the completion of dentin deposition leaves a weak root more prone to fracture as a result of the thin dentinal walls. Read more about this study
- Who is it for?
- Ages 7 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Infected Pulp, Root Canal Treatment
- What is being tested?
- Biodentine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2021to 1 Jan 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 7 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Apparent healthy and free from any systemic diseases
- child should have restorable carious first permanent molars with immature root
Who cannot join
- presence of signs and symptoms of pulp degenration
- presence of internal and external root resorption
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation Of Different Pulpotomy Agents Used For Treatment Of Immature Molars (Clinical Trial)
The management of permanent teeth with incomplete root development with compromised pulpal integrity presents a unique challenge. The loss of pulpal vitality before the completion of dentin deposition leaves a weak root more prone to fracture as a result of the thin dentinal walls. Every attempt should be made to preserve the vitality of these immature teeth until maturation has occured.
Read the detailed description
The management of permanent teeth with incomplete root development with compromised pulpal integrity presents a unique challenge. The loss of pulpal vitality before the completion of dentin deposition leaves a weak root more prone to fracture as a result of the thin dentinal walls. Every attempt should be made to preserve the vitality of these immature teeth until maturation has occured. (1)
Pulpotomy is a universally accepted treatment modality for pulp exposures in immature permanent teeth to preserve the vitality of the radicular pulp and to ensure continued root development. (2) Calcium Hydroxide has been the most commonly utilized pulpotomy agent for vital pulp therapy. However, owing to disadvantages such as degradation over time, formation of tunnel defects beneath dentinal bridges and poor sealing , it is slowly losing its popularity as a first choice agent for pulpotomy. (3)
Vital pulp therapy procedures in permanent teeth with incomplete root development have advanced in recent years. Despite Mineral trioxide aggregate has shown promising potential as a pulpotomy agent , it has some drawbacks that include the presence of toxic elements in the material composition (4) , higher cytotoxicity in its freshly mixed state (5)
,high pH during setting (6) , difficult handling characteristics (7) , long setting time (8) , tooth discoloration (9) and high cost. (10)
Consequently, newer calcium silicate-based materials that retain the desirable properties of original MTA but with easier handling and without tooth discoloration have been introduced . Biodentine has several
advantages, as its good sealing ability, adequate compressive strength , a relatively short initial setting time and the promotion of reparative dentin formation with a positive effect on vital pulp cells. (11, 12)
Recently, Regenerative Medicine , especially at the molecular and cellular level has been given great attention towards 'regeneration' instead of 'replacement' approaches. (13) resulting in 'vital pulp therapy' and regenerative endodontics Concepts. (14) In such treatments, clean environment is believed to be a necessity for further success.
Triple Antibiotic Paste (TAP) , is a combination of 3 antibiotics, ciprofloxacin , metronidazole and Minocycline is widely used to achieve a relatively aseptic environment in the radicular space so that the tissue repair and healing can occur. (15)
Promising results have attracted endodontists and general dental practitioners to endodontic regenerative procedures (ERPs). (16) which is considered as a form of a revolution in root canal therapy. (17-19) Now, it has now been taken into account as an alternative method to traditional calcium hydroxide-induced apexogenesis. (20-21)
Recently, the paste used in the regeneration and revascularization protocol. Studies have shown that the paste can eliminate the root canal microorganisms by removing the diverse groups of obligate and facultative gram-positive and gram-negative bacteria , providing an environment for healing. (22,23)
Platelet-rich fibrin (PRF) is a recent innovation in dentistry that has been prepared and used in 2001. (24) It is considered as an autologous healing biomaterial incorporating leukocytes, platelets, and a wide range of key healing proteins in a dense fibrin matrix. (25) PRF serves as a reservoir for the slow continuous release of growth factors that influence and direct the processes of reparative dentinogenesis (26) . Huang et al (27) investigated the effect of PRF on cultured primary dental pulp cells and concluded that PRF can increase dental pulp cell proliferation and differentiation.
Growth factors included in PRF are mitogenic , chemotactic and angiogenic. Therefore, they appear to be critical to the wound-healing process. PRF induces osteoblasts, gingival fibroblasts, and periodontal ligament cells proliferation as a mitogen . Because of growth factors concentrates, PRF promotes wound healing and regeneration which is used in various disciplines of dentistry to repair and regenerate dental and oral tissues. (28-30)
PRF has anti-inflammatory effect and act as an immune regulation mode. It presented as a perfect scaffold in revascularization of immature permanent teeth with necrotic pulps as it enhances cellular proliferation and differentiation. (31,32)
However, there is a limited number of studies reporting on the success of vital pulp therapy for Immature permanent molars. So, the present study will evaluate different pulpotomy modalities used in Immature permanent molars.
- Conditions
- Infected Pulp, Root Canal Treatment
- Being tested
- Biodentine
- Keywords
- Pulpotomy, Calcium Hydroxide, Biodentine, Platelet Rich Fibrin, Open apex, Immature root
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiodentineProcedure or surgery
Also called Platelet Rich Fibrin (PRF), Calcium Hydroxide CA(oh)2
using of biodentine , calcium hydroxide and platelet rich fibrin as pulpotomy agents
| Study group | Role | What they receive |
|---|---|---|
| calcium hydroxide : group 1 | Experimental | Immature permanent molars with immature root filled by ca(oh)2 Receives: Procedure: Biodentine |
| biodentine : group 2 | Experimental | clinically and radiographically evaluate BIODENTINE effect on permanent molars with immature root Receives: Procedure: Biodentine |
| platelet rich fibrin : group 3 | Experimental | filling of permanent molars with immature root by platelet rich fibrin Receives: Procedure: Biodentine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage % of patients with Success
Percentage of Success of treated infected immaature teeth with diffrent agent. Restorations were given the score Alpha for the ideal clinical situation, Bravo for clinically acceptable and Charlie for clinically unacceptable and in need for replacement.
Measured: Time Frame: 2 years after restoration procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start1 Aug 2021
- Primary completion30 Nov 2022 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infected PulpStudies 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
- Factorial
- Model description
- Evaluate the effect of different pulpotomy medicaments on permanent molars with immature root clinically and radiographically: 1. Calcium Hydroxide 2. Biodentine 3. Platelet Rich Fibrin
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Sponsor
- Investigators
- Salwa M Awad, Prof, Study director, head of pediatric dentistry and public health department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05347160
- Sponsor's protocol ID
- A04080920
- Status last verified
- Mar 2022
- First submitted
- 25 Mar 2022
- Last updated
- 26 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of Different Pulpotomy Agents Used For Treatment Of Immature Molars (Clinical Trial)
- ClinicalTrials.gov ID
- NCT05347160
- Acronym / sponsor ID
- A04080920
- Conditions
- Infected Pulp, Root Canal Treatment
- Keywords
- Pulpotomy, Calcium Hydroxide, Biodentine, Platelet Rich Fibrin, Open apex, Immature root
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 26 Apr 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 management of permanent teeth with incomplete root development with compromised pulpal integrity presents a unique challenge. The loss of pulpal vitality before the completion of dentin deposition leaves a weak root more prone to fracture as a result of the thin dentinal walls. Every attempt should be made to preserve the vitality of these immature teeth until maturation has occured.
Detailed description
The management of permanent teeth with incomplete root development with compromised pulpal integrity presents a unique challenge. The loss of pulpal vitality before the completion of dentin deposition leaves a weak root more prone to fracture as a result of the thin dentinal walls. Every attempt should be made to preserve the vitality of these immature teeth until maturation has occured. (1)
Pulpotomy is a universally accepted treatment modality for pulp exposures in immature permanent teeth to preserve the vitality of the radicular pulp and to ensure continued root development. (2) Calcium Hydroxide has been the most commonly utilized pulpotomy agent for vital pulp therapy. However, owing to disadvantages such as degradation over time, formation of tunnel defects beneath dentinal bridges and poor sealing , it is slowly losing its popularity as a first choice agent for pulpotomy. (3)
Vital pulp therapy procedures in permanent teeth with incomplete root development have advanced in recent years. Despite Mineral trioxide aggregate has shown promising potential as a pulpotomy agent , it has some drawbacks that include the presence of toxic elements in the material composition (4) , higher cytotoxicity in its freshly mixed state (5)
,high pH during setting (6) , difficult handling characteristics (7) , long setting time (8) , tooth discoloration (9) and high cost. (10)
Consequently, newer calcium silicate-based materials that retain the desirable properties of original MTA but with easier handling and without tooth discoloration have been introduced . Biodentine has several
advantages, as its good sealing ability, adequate compressive strength , a relatively short initial setting time and the promotion of reparative dentin formation with a positive effect on vital pulp cells. (11, 12)
Recently, Regenerative Medicine , especially at the molecular and cellular level has been given great attention towards 'regeneration' instead of 'replacement' approaches. (13) resulting in 'vital pulp therapy' and regenerative endodontics Concepts. (14) In such treatments, clean environment is believed to be a necessity for further success.
Triple Antibiotic Paste (TAP) , is a combination of 3 antibiotics, ciprofloxacin , metronidazole and Minocycline is widely used to achieve a relatively aseptic environment in the radicular space so that the tissue repair and healing can occur. (15)
Promising results have attracted endodontists and general dental practitioners to endodontic regenerative procedures (ERPs). (16) which is considered as a form of a revolution in root canal therapy. (17-19) Now, it has now been taken into account as an alternative method to traditional calcium hydroxide-induced apexogenesis. (20-21)
Recently, the paste used in the regeneration and revascularization protocol. Studies have shown that the paste can eliminate the root canal microorganisms by removing the diverse groups of obligate and facultative gram-positive and gram-negative bacteria , providing an environment for healing. (22,23)
Platelet-rich fibrin (PRF) is a recent innovation in dentistry that has been prepared and used in 2001. (24) It is considered as an autologous healing biomaterial incorporating leukocytes, platelets, and a wide range of key healing proteins in a dense fibrin matrix. (25) PRF serves as a reservoir for the slow continuous release of growth factors that influence and direct the processes of reparative dentinogenesis (26) . Huang et al (27) investigated the effect of PRF on cultured primary dental pulp cells and concluded that PRF can increase dental pulp cell proliferation and differentiation.
Growth factors included in PRF are mitogenic , chemotactic and angiogenic. Therefore, they appear to be critical to the wound-healing process. PRF induces osteoblasts, gingival fibroblasts, and periodontal ligament cells proliferation as a mitogen . Because of growth factors concentrates, PRF promotes wound healing and regeneration which is used in various disciplines of dentistry to repair and regenerate dental and oral tissues. (28-30)
PRF has anti-inflammatory effect and act as an immune regulation mode. It presented as a perfect scaffold in revascularization of immature permanent teeth with necrotic pulps as it enhances cellular proliferation and differentiation. (31,32)
However, there is a limited number of studies reporting on the success of vital pulp therapy for Immature permanent molars. So, the present study will evaluate different pulpotomy modalities used in Immature permanent molars.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Evaluate the effect of different pulpotomy medicaments on permanent molars with immature root clinically and radiographically: 1. Calcium Hydroxide 2. Biodentine 3. Platelet Rich Fibrin
| Arm | Type | Receives |
|---|---|---|
| calcium hydroxide : group 1 | Experimental | Procedure: BiodentineImmature permanent molars with immature root filled by ca(oh)2 |
| biodentine : group 2 | Experimental | Procedure: Biodentineclinically and radiographically evaluate BIODENTINE effect on permanent molars with immature root |
| platelet rich fibrin : group 3 | Experimental | Procedure: Biodentinefilling of permanent molars with immature root by platelet rich fibrin |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Apparent healthy and free from any systemic diseases
- child should have restorable carious first permanent molars with immature root
Key exclusion criteria (2 listed)
- presence of signs and symptoms of pulp degenration
- presence of internal and 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 |
|---|---|---|
| BiodentineAlso: Platelet Rich Fibrin (PRF), Calcium Hydroxide CA(oh)2using of biodentine , calcium hydroxide and platelet rich fibrin as pulpotomy agents | Procedure or surgery | biodentine : group 2, calcium hydroxide : group 1, platelet rich fibrin : group 3 |
Primary outcome
Percentage % of patients with Success
Time frame: Time Frame: 2 years after restoration procedure
Percentage of Success of treated infected immaature teeth with diffrent agent. Restorations were given the score Alpha for the ideal clinical situation, Bravo for clinically acceptable and Charlie for clinically unacceptable and in need for replacement.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Infected Pulp
Recruiting
One vs Two Visits Root Canal Treatments in Infected Teeth
Apical Periodontitis, Pain
Recruiting
Bacterial Reduction After Supplementary Disinfection Procedures in Infected Root Canals
Dental Pulp Necroses
Not yet recruiting
Metagenomic Analysis and Postoperative Pain in Infected Root Canals Using Different Irrigation Protocols
Dental Pulp Necrosis, Pulpitis
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.
Salwa M Awad, Prof study director
head of pediatric dentistry and public health department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biodentine in people with Infected Pulp and Root Canal Treatment, 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 2 inclusion and 2 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 26 Apr 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?
Percentage % of patients with Success (time frame: Time Frame: 2 years after restoration procedure). 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 26 Apr 2022.