Carious Exposure of PulpEarly Phase 1NCT05479877
A Comparative Clinical and Radiographic Study of Collagen Based Pulpotomy Versus Biodentine Pulpotomy in Children With Cariously Exposed Vital Primary Molars
A Early Phase 1 study testing sterile medicated collagen particles, Biofil-AB ,Eucare Pharmaceuticals Pvt. Ltd, Chennai, India and Biodentine (Septodont, Saint-Maur-des-Fossés, France) in people with Carious Exposure of Pulp, run by Cairo University.
Trial summary
Pulpotomy of vital primary molars is indicated when caries removal results in pulp exposure. Treatment approaches consist of devitalization using formocresol, preservation using ferric sulfate and regeneration of the remaining pulp tissue using mineral trioxide aggregate and recently Biodentine have been utilized. Read more about this study
- Who is it for?
- Ages 4 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Carious Exposure of Pulp
- What is being tested?
- sterile medicated collagen particles, Biofil-AB ,Eucare Pharmaceuticals Pvt. Ltd, Chennai, India and Biodentine (Septodont, Saint-Maur-des-Fossés, France)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Sep 2022to Oct 2023
- Phase
- Early Phase 1
- 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 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- • Children:
- Aged 4 to 7, in good general health and medically free.
- Cooperative patients who will comply to follow ups.
- Parents provided with written informed consent. • Teeth:
- <!-- -->
- Bilaterally Carious vital primary molars with reversible pulpitis.
- Restorable teeth with no more than 1/3 of root resorption.
Who cannot join
- • Children:
- Children with medical, physical, or mental conditions.
- Unable to attend follow up visits. • Teeth:
- <!-- -->
- Primary molars with any congenital anomalies.
- Previously accessed teeth.
- At operative procedure, haemorrhage control is unachievable after pulpotomy.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Comparative Clinical and Radiographic Study of Collagen Based Pulpotomy Versus Biodentine Pulpotomy in Children With Cariously Exposed Vital Primary Molars: A Randomized Clinical Trial
Pulpotomy of vital primary molars is indicated when caries removal results in pulp exposure. Treatment approaches consist of devitalization using formocresol, preservation using ferric sulfate and regeneration of the remaining pulp tissue using mineral trioxide aggregate and recently Biodentine have been utilized.
The ideal pulpotomy medicament would be biocompatible and bactericidal, in addition, to promoting the healing of the root pulp and be compatible with the physiological process of root resorption.
Read more
Searching for more pulpotomy agents, Collagen, a protein that's present abundantly in humans, is an important component of connective tissues and performs multiple functions including wound healing.
Enamel and dentin contain Collagen as one of the components in their organic ground matrix.
Collagen has been used widely in dentistry in periodontal and implant therapy as scaffold for preventing the migration of epithelial cells and encouraging wound repopulation by cells with high regenerative potential.
The Collagen available for dental implication is already sterilized and also reinforced with antibiotic particles to efficiently aid in regeneration and repair without any contamination. The collagen particles
Read the detailed description
Pulpotomy is considered the gold standard procedure for treating cariously exposed pulps in asymptomatic primary teeth. Which is based on the healing ability of the radicular pulp tissue following amputation of the infected coronal pulp.
Mineral trioxide aggregate (MTA) has been recommended as the gold standard for vital pulp therapy; however, it has some disadvantages, such as long setting time, poor handling properties, high cost, and the potential for tooth discoloration. Biodentine (Septodont, Saint-Maur-des-Fossés, France), one of the new-generation, bioactive endodontic cements, has been claimed to have improved properties over MTA.
Biodentine presents high biocompatibility with the dental pulp, it has high antibacterial effects and antifungal activity, has a shorter setting time than MTA as a result of the calcium chloride in the liquid component of Biodentine. It also has higher flexural strength, compressive strength and modulus of elasticity than MTA.
Consequently, Biodentine can be used as a pulp dressing as well as a base material.
Quest is on for newer pulpal medicaments that are biocompatible and capable of healing the dental pulp by producing reparative dentin and/or dentinal bridge in response to various stimuli and surgical exposure.
Collagen has a proven rate of success in the field of dentistry as guided tissue regeneration, root conditioning, hemostatic, and wound dressing agent. It has inherent properties like low immune response and toxicity, ability to promote cellular growth and attachment, homeostasis, and added advantage of antibiotic incorporation.
- Conditions
- Carious Exposure of Pulp
- Being tested
- sterile medicated collagen particles, Biofil-AB ,Eucare Pharmaceuticals Pvt. Ltd, Chennai, India, Biodentine (Septodont, Saint-Maur-des-Fossés, France)
- Keywords
- pulpotomy, biodentine, collagen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sterile medicated collagen particles, Biofil-AB ,Eucare Pharmaceuticals Pvt. Ltd, Chennai, IndiaDrug
Collagen based pulpotomy will be applied (sterile medicated collagen particles, Biofil-AB ,Eucare Pharmaceuticals Pvt. Ltd, Chennai, India)according to the manufacturer's instructions and gently placed over the pulp stumps to a thickness of 2 mm
Biodentine (Septodont, Saint-Maur-des-Fossés, France)Drug
Biodentine (Septodont, Saint-Maur-des-Fossés, France) will be applied according to the manufacturer's instructions and placed over the radicular pulp with the help of a suitable sterile amalgam carrier. Gentle condensation of the mix will be done in the pulp chamber with a moistened cotton pellet.
| Study group | Role | What they receive |
|---|---|---|
| (Experimental group) collagen based Pulpotomy | Experimental | (sterile medicated collagen particles, Biofil-AB ,Eucare Pharmaceuticals Pvt. Ltd, Chennai, India) Receives: Drug: sterile medicated collagen particles, Biofil-AB ,Eucare Pharmaceuticals Pvt. Ltd, Chennai, India |
| (Control group) Biodentine pulpotomy | Active comparator | Biodentine (Septodont, Saint-Maur-des-Fossés, France) Receives: Drug: Biodentine (Septodont, Saint-Maur-des-Fossés, France) |
What is being measured
The primary outcome is the main question the study is designed to answer.
absence of internal root resorption
radiographic measurement of internal root resorption
Measured: 12 months
Secondary outcomes (1)
absence of pain and swelling
number of participants with pain and swelling
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 posted29 Jul 2022
- Study startSep 2022 (estimated)
- Primary completionSep 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carious Exposure of PulpStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nihal Alaa Eldin Mohamed Mostafa Bayoumi, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05479877
- Sponsor's protocol ID
- 19071991
- Status last verified
- Aug 2022
- First submitted
- 26 Jul 2022
- Last updated
- 30 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Clinical and Radiographic Study of Collagen Based Pulpotomy Versus Biodentine Pulpotomy in Children With Cariously Exposed Vital Primary Molars: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05479877
- Acronym / sponsor ID
- 19071991
- Conditions
- Carious Exposure of Pulp
- Keywords
- pulpotomy, biodentine, collagen
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Sep 2022 (estimated)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 29 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.
Pulpotomy of vital primary molars is indicated when caries removal results in pulp exposure. Treatment approaches consist of devitalization using formocresol, preservation using ferric sulfate and regeneration of the remaining pulp tissue using mineral trioxide aggregate and recently Biodentine have been utilized.
The ideal pulpotomy medicament would be biocompatible and bactericidal, in addition, to promoting the healing of the root pulp and be compatible with the physiological process of root resorption.
Searching for more pulpotomy agents, Collagen, a protein that's present abundantly in humans, is an important component of connective tissues and performs multiple functions including wound healing.
Enamel and dentin contain Collagen as one of the components in their organic ground matrix.
Collagen has been used widely in dentistry in periodontal and implant therapy as scaffold for preventing the migration of epithelial cells and encouraging wound repopulation by cells with high regenerative potential.
The Collagen available for dental implication is already sterilized and also reinforced with antibiotic particles to efficiently aid in regeneration and repair without any contamination. The collagen particles
Detailed description
Pulpotomy is considered the gold standard procedure for treating cariously exposed pulps in asymptomatic primary teeth. Which is based on the healing ability of the radicular pulp tissue following amputation of the infected coronal pulp.
Mineral trioxide aggregate (MTA) has been recommended as the gold standard for vital pulp therapy; however, it has some disadvantages, such as long setting time, poor handling properties, high cost, and the potential for tooth discoloration. Biodentine (Septodont, Saint-Maur-des-Fossés, France), one of the new-generation, bioactive endodontic cements, has been claimed to have improved properties over MTA.
Biodentine presents high biocompatibility with the dental pulp, it has high antibacterial effects and antifungal activity, has a shorter setting time than MTA as a result of the calcium chloride in the liquid component of Biodentine. It also has higher flexural strength, compressive strength and modulus of elasticity than MTA.
Consequently, Biodentine can be used as a pulp dressing as well as a base material.
Quest is on for newer pulpal medicaments that are biocompatible and capable of healing the dental pulp by producing reparative dentin and/or dentinal bridge in response to various stimuli and surgical exposure.
Collagen has a proven rate of success in the field of dentistry as guided tissue regeneration, root conditioning, hemostatic, and wound dressing agent. It has inherent properties like low immune response and toxicity, ability to promote cellular growth and attachment, homeostasis, and added advantage of antibiotic incorporation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| (Experimental group) collagen based Pulpotomy | Experimental | Drug: sterile medicated collagen particles, Biofil-AB ,Eucare Pharmaceuticals Pvt. Ltd, Chennai, India(sterile medicated collagen particles, Biofil-AB ,Eucare Pharmaceuticals Pvt. Ltd, Chennai, India) |
| (Control group) Biodentine pulpotomy | Active comparator | Drug: Biodentine (Septodont, Saint-Maur-des-Fossés, France)Biodentine (Septodont, Saint-Maur-des-Fossés, France) |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- • Children:
- <!-- -->
Key exclusion criteria (7 listed)
- • Children:
- <!-- -->
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 |
|---|---|---|
| sterile medicated collagen particles, Biofil-AB ,Eucare Pharmaceuticals Pvt. Ltd, Chennai, IndiaCollagen based pulpotomy will be applied (sterile medicated collagen particles, Biofil-AB ,Eucare Pharmaceuticals Pvt. Ltd, Chennai, India)according to the manufacturer's instructions and gently placed over the pulp stumps to a thickness of 2 mm | Drug | (Experimental group) collagen based Pulpotomy |
| Biodentine (Septodont, Saint-Maur-des-Fossés, France)Biodentine (Septodont, Saint-Maur-des-Fossés, France) will be applied according to the manufacturer's instructions and placed over the radicular pulp with the help of a suitable sterile amalgam carrier. Gentle condensation of the mix will be done in the pulp chamber with a moistened cotton pellet. | Drug | (Control group) Biodentine pulpotomy |
Primary outcome
absence of internal root resorption
Time frame: 12 months
radiographic measurement of internal root resorption
1 secondary outcome
absence of pain and swelling
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2022.
- Individual participant dataSharing planned: Yes
Related trials for Carious Exposure of Pulp
Active, not recruiting
Laser Assisted Pulpotomy Versus MTA Pulpotomy in Permanent Teeth With Irreversible Pulpitis
Irreversible Pulpitis (Toothache)
Active, not recruiting
Pulpotomy in Hypominerlized Permanent Molars.
Molar Hypomineralization
Active, not recruiting
Pulp Inflammatory Markers and Outcome of Pulpotomy
Pulpitis in Permanent Teeth, Dental Caries Extending to Pulp
Active, not recruiting
Direct Pulp Capping Compared to Partial Pulpotomy in Carious Pulp Exposures
Deep Caries
Not yet recruiting
Oxymetazoline Versus Sodium Hypochlorite as Hemostatic Agents in MTA Pulpotomy of Primary Molars
Pulp Disease, Dental, Pulp Therapy in Primary Molars
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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing sterile medicated collagen particles, Biofil-AB ,Eucare Pharmaceuticals Pvt. Ltd, Chennai, India and Biodentine (Septodont, Saint-Maur-des-Fossés, France) in people with Carious Exposure of Pulp, run by Cairo University.
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 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: status not confirmed, as of the sponsor's last update on 30 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Nihal Bayoumi, Msc (+201227610630, nihal.mostafa@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
absence of internal root resorption (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 30 Aug 2022.