Dental Caries in ChildrenNCT05829304
A Comparative Clinical and Radiographic Study Of Collagen Based Pulpotomy in Cariously Exposed Vital Primary Molars
A study testing MTA based pulpotomy and Collagen based pulpotomy in people with Dental Caries in Children, run by sherouk atef elsayed.
Trial summary
To assess post operative pain and survival rate after collagen based pulpotomy versus MTA pulpotomy in children with vital 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
- Dental Caries in Children
- What is being tested?
- MTA based pulpotomy and Collagen based pulpotomy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- Jun 2023to 30 Jun 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 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Primary molar tooth not more than one-third of root resorption.
- Children with bilateral deep dental caries approximating the pulp in primary molars assessed both clinically and radiographically.
- systemically healthy.
- cooperative patients who will comply to follow up visits.
Who cannot join
- Children with medical, physical, or mental conditions.
- Primary molars with any congenital deformities.
- 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 MTA Pulpotomy in Cariously Exposed Vital Primary Molars
To assess post operative pain and survival rate after collagen based pulpotomy versus MTA pulpotomy in children with vital primary molars.
Read the detailed description
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 using mineral trioxide aggregate of the remaining pulp tissue have been utilized to date. The ideal pulpotomy medicament would be biocompatible and bactericidal, in addition, to promote the healing of the root pulp and be compatible with the physiological process of root resorption.
Collagen, which is available for dental implication, is already sterilized and also reinforced with antibiotic particles to efficiently aid in regeneration and repair without any contaminations. The collagen particles can be sterilized by various methods like irradiation, dry heat, and ethylene oxide, among which irradiation is the most frequently used method as it does not affect the structural stability
- Conditions
- Dental Caries in Children
- Being tested
- MTA based pulpotomy, Collagen based pulpotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTA based pulpotomyOther
The principal investigator will carry out all treatment procedures, and the patients will be assigned. It will be as split mouth, both groups A\&B will be at the same patient.
Collagen based pulpotomyOther
The principal investigator will carry out all treatment procedures, and the patients will be assigned. It will be as split mouth, both groups A\&B will be at the same patient.
| Study group | Role | What they receive |
|---|---|---|
| Collagen based pulpotomy | Active comparator | Application of rubber dam for isolation, then a standardized pulpotomy procedure will be performed. Remove pulpal tissues to the orifice level. Haemostasis will be achieved by the application of a wet cotton pellet.
Group I collagen-based Pulpotomy:
1. After complete haemostasis, collagen based pulpotomy will be applied according to the manufacturer's instructions and gently placed over the pulp stumps to a thickness of 2 mm then the rest of the pulp chamber will be filled with glass ionomer cement.
2. Tooth will be restored with stainless steel crown. Receives: Other: MTA based pulpotomy; Other: Collagen based pulpotomy |
| MTA based pulpotomy | Active comparator | Application of rubber dam for isolation, then a standardized pulpotomy procedure will be performed. Remove pulpal tissues to the orifice level. Haemostasis will be achieved by the application of a wet cotton pellet.
Group II MTA pulpotomy:
1. After complete hemostasis, MTA+ Cerkamed will be manipulated to obtain a putty mix. This mix will be placed over the radicular pulp. condensation of the mix with a moistened cotton pellet, followed by application of glass ionomer cement.
2. Tooth will then be restored with stainless steel crown. Receives: Other: MTA based pulpotomy; Other: Collagen based pulpotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain
postoperative pain following the placement of restoration by questioning the patient. using numerical pain rating scale Zero means patient have no pain, while 10 represents the most intense pain possible.
Measured: 3 days
Secondary outcomes (2)
Absence of internal root resorption
binary outcome detected with periapical x-ray by parallel technique using XCP film holder
Measured: up to 24 week
absence of swelling
binary outcome detected with periapical x-ray by parallel technique using XCP film holder
Measured: up to 24 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study startJun 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental Caries in ChildrenStudies 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
- Model description
- Teeth that will be included in the current trial will be randomly assigned one of the experimental groups using closed white envelopes (simple randomization 1:1 ratio).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 19 participants (estimated)
Sponsor and investigators
- Lead sponsor
- sherouk atef elsayed
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Sponsor-investigator, sherouk atef elsayed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05829304
- Sponsor's protocol ID
- 251293
- Status last verified
- Apr 2023
- First submitted
- 21 Dec 2022
- Last updated
- 25 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Anandan V, Inbanathan J, Saket P, Krishnamoorthy V, Gandhi S, Chandrababu VK. Assessment of Clinical and Radiographic Success Rate of Formocresol-based Pulpotomy versus Collagen-based Pulpotomy: An In Vivo Study. J Contemp Dent Pract. 2021 Jun 1;22(6):680-685.
PubMed 34393127
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. 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 MTA Pulpotomy in Cariously Exposed Vital Primary Molars
- ClinicalTrials.gov ID
- NCT05829304
- Acronym / sponsor ID
- 251293
- Conditions
- Dental Caries in Children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 19 participants (estimated)
- Lead sponsor
- sherouk atef elsayedUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- Jun 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 25 Apr 2023 (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.
To assess post operative pain and survival rate after collagen based pulpotomy versus MTA pulpotomy in children with vital primary molars.
Detailed description
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 using mineral trioxide aggregate of the remaining pulp tissue have been utilized to date. The ideal pulpotomy medicament would be biocompatible and bactericidal, in addition, to promote the healing of the root pulp and be compatible with the physiological process of root resorption.
Collagen, which is available for dental implication, is already sterilized and also reinforced with antibiotic particles to efficiently aid in regeneration and repair without any contaminations. The collagen particles can be sterilized by various methods like irradiation, dry heat, and ethylene oxide, among which irradiation is the most frequently used method as it does not affect the structural stability
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Teeth that will be included in the current trial will be randomly assigned one of the experimental groups using closed white envelopes (simple randomization 1:1 ratio).
| Arm | Type | Receives |
|---|---|---|
| Collagen based pulpotomy | Active comparator | Other: MTA based pulpotomy, Other: Collagen based pulpotomyApplication of rubber dam for isolation, then a standardized pulpotomy procedure will be performed. Remove pulpal tissues to the orifice level. Haemostasis will be achieved by the application of a wet cotton pellet. Group I collagen-based Pulpotomy: 1. After complete haemostasis, collagen based pulpotomy will be applied according to the manufacturer's instructions and gently placed over the pulp stumps to a thickness of 2 mm then the rest of the pulp chamber will be filled with glass ionomer cement. 2. Tooth will be restored with stainless steel crown. |
| MTA based pulpotomy | Active comparator | Other: MTA based pulpotomy, Other: Collagen based pulpotomyApplication of rubber dam for isolation, then a standardized pulpotomy procedure will be performed. Remove pulpal tissues to the orifice level. Haemostasis will be achieved by the application of a wet cotton pellet. Group II MTA pulpotomy: 1. After complete hemostasis, MTA+ Cerkamed will be manipulated to obtain a putty mix. This mix will be placed over the radicular pulp. condensation of the mix with a moistened cotton pellet, followed by application of glass ionomer cement. 2. Tooth will then be restored with stainless steel crown. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Primary molar tooth not more than one-third of root resorption.
- Children with bilateral deep dental caries approximating the pulp in primary molars assessed both clinically and radiographically.
- systemically healthy.
- cooperative patients who will comply to follow up visits.
Key exclusion criteria (4 listed)
- Children with medical, physical, or mental conditions.
- Primary molars with any congenital deformities.
- Previously accessed teeth.
- At operative procedure haemorrhage control is unachievable after pulpotomy.
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 |
|---|---|---|
| MTA based pulpotomyThe principal investigator will carry out all treatment procedures, and the patients will be assigned. It will be as split mouth, both groups A\&B will be at the same patient. | Other | Collagen based pulpotomy, MTA based pulpotomy |
| Collagen based pulpotomyThe principal investigator will carry out all treatment procedures, and the patients will be assigned. It will be as split mouth, both groups A\&B will be at the same patient. | Other | Collagen based pulpotomy, MTA based pulpotomy |
Primary outcome
postoperative pain
Time frame: 3 days
postoperative pain following the placement of restoration by questioning the patient. using numerical pain rating scale Zero means patient have no pain, while 10 represents the most intense pain possible.
2 secondary outcomes
Absence of internal root resorption
Time frame: up to 24 week
absence of swelling
Time frame: up to 24 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Background: PubMed 34393127Anandan V, Inbanathan J, Saket P, Krishnamoorthy V, Gandhi S, Chandrababu VK. Assessment of Clinical and Radiographic Success Rate of Formocresol-based Pulpotomy versus Collagen-based Pulpotomy: An In Vivo Study. J Contemp Dent Pract. 2021 Jun 1;22(6):680-685.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing MTA based pulpotomy and Collagen based pulpotomy in people with Dental Caries in Children, run by sherouk atef elsayed.
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 4 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 25 Apr 2023. 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.
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 Sherouk Elsayed, bachelor (+201005544373, sherouk.elsayed@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05829304, which also lists 1 linked publication.
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 25 Apr 2023.