CariesPhase 3NCT05314842
Pulpotomy in Primary Molars Treated With Premixed Bio-ceramic MTA Versus Formocresol
A Phase 3 study testing Formocresol and Premixed bioceramic MTA in people with Caries, run by Sarah Abdelbar Mahmoud.
Trial summary
examine the results of pulpotomy in primary molars using premixed bioceramic MTA versus Formocresol. Clinical and radiographic success rates were used as outcomes. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries
- What is being tested?
- Formocresol and Premixed bioceramic MTA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2022to 1 May 2023
- Phase
- Phase 3
- 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
- Medically fit and cooperative children.
- Pediatric patients aged 4-6 years.
- A deep carious lesion in vital primary molars.
- Absence of clinical signs and symptoms of pulpal exposure.
- Absence of radiographic signs and symptoms of people degeneration.
- Positive parental informed consent.
Who cannot join
- Uncooperative children.
- Medically compromised children.
- Presence of clinical signs and symptoms of pulpal exposure.
- Presence of radiographic signs and symptoms of pulp degeneration.
- Physiologic root resorption more than one-third.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical and Radiographic Evaluation of Pulpotomy in Primary Molars Treated With Premixed Bio-ceramic MTA Versus Formocresol Among a Group of Egyptian Children: A Pilot Study.
examine the results of pulpotomy in primary molars using premixed bioceramic MTA versus Formocresol. Clinical and radiographic success rates were used as outcomes.
Read the detailed description
Primary outcome:
Soft-tissue pathology
- Post-treatment swelling will be assessed through visual examination by the operator, either intraorally or extra orally.
- Sinus tract or fistula will be assessed through visual examination by the operator
Secondary outcomes:
- Pain to the percussion will be assessed by gentle tapping on the tooth with the end of a dental mirror
- mobility will be assessed through the back of two mirrors
- radiographic assessments:- for any radiolucency and pathologic root resorption (periapical or bifurcation) will be examined (present or not). clinical assessment on every recall visit during the 3-, 6-, and 12-month follow-up period.
- These radiographic assessments will be performed as baseline data at the first visit following the operating procedure, as well as at 3, 6, and 12 months after the baseline.
- Conditions
- Caries
- Being tested
- Formocresol, Premixed bioceramic MTA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FormocresolDrug
dressing agents in pulpotomized primary molas using formocresol in cariously exposed vital primary molars
Premixed bioceramic MTADrug
Also called Neoputty
dressing agents in pulpotomized primary molas using premixed bioceramic MTA in cariously exposed vital primary molars
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | the group that have caries in primary molars and treat them with formocresol Receives: Drug: Formocresol |
| experimental group | Experimental | the group that have caries in primary molars and treat them with premixed bioceramic MTA Receives: Drug: Premixed bioceramic MTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Soft-tissue pathology
- Post-treatment swelling will be assessed through visual examination by the operator, either intraorally or extra orally.
- Sinus tract or fistula will be assessed through visual examination by the operator.
Binary (present or absent)
Measured: at 0 day
Soft-tissue pathology
- Post-treatment swelling will be assessed through visual examination by the operator, either intraorally or extra orally.
- Sinus tract or fistula will be assessed through visual examination by the operator.
Binary (present or absent)
Measured: at 3 month
Soft-tissue pathology
- Post-treatment swelling will be assessed through visual examination by the operator, either intraorally or extra orally.
- Sinus tract or fistula will be assessed through visual examination by the operator.
Binary (present or absent)
Measured: at 6 month
Soft-tissue pathology
Post-treatment swelling will be assessed through visual examination by the operator, either intraorally or extra orally.
-Sinus tract or fistula will be assessed through visual examination by the operator.
Binary (present or absent)
Measured: at 1 year
Secondary outcomes (12)
• Pain to the percussion
will be assessed by gentle tapping on the tooth with the end of a dental mirror.
Binary (present or absent)
Measured: at 0 day
• Pain to the percussion
will be assessed by gentle tapping on the tooth with the end of a dental mirror.
Binary (present or absent)
Measured: at 3 month
• Pain to the percussion
will be assessed by gentle tapping on the tooth with the end of a dental mirror.
Binary (present or absent)
Measured: at 6 month
• Pain to the percussion
will be assessed by gentle tapping on the tooth with the end of a dental mirror.
Binary (present or absent)
Measured: at 1 year
mobility
- Mobility is scored on a scale of 1-3 as follows:
- the movement that is greater than normal (physiological) movement.
- a maximum of 1 mm in the buccolingual direction.
- depreciable buccolingual movement of more than 1 mm. Miller's Grades
Measured: at 0 day
mobility
- Mobility is scored on a scale of 1-3 as follows:
- the movement that is greater than normal (physiological) movement.
- a maximum of 1 mm in the buccolingual direction.
- depreciable buccolingual movement of more than 1 mm. Miller's Grades
Measured: at 3 month
mobility
- Mobility is scored on a scale of 1-3 as follows:
- the movement that is greater than normal (physiological) movement.
- a maximum of 1 mm in the buccolingual direction.
- depreciable buccolingual movement of more than 1 mm. Miller's Grades
Measured: at 6 month
mobility
- Mobility is scored on a scale of 1-3 as follows:
- the movement that is greater than normal (physiological) movement.
- a maximum of 1 mm in the buccolingual direction.
- depreciable buccolingual movement of more than 1 mm. Miller's Grades
Measured: at 1 year
radiographic indications of radiolucency and pathologic root resorption (periapical or bifurcation) will be examined (present or not).
Binary (present or absent)
Measured: at 0 day
radiographic indications of radiolucency and pathologic root resorption (periapical or bifurcation) will be examined (present or not).
Binary (present or absent)
Measured: at 3 month
radiographic indications of radiolucency and pathologic root resorption (periapical or bifurcation) will be examined (present or not).
Binary (present or absent)
Measured: at 6 month
radiographic indications of radiolucency and pathologic root resorption (periapical or bifurcation) will be examined (present or not).
Binary (present or absent)
Measured: at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start1 Apr 2022 (estimated)
- Primary completion1 Apr 2023 (estimated)
- Study completion1 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CariesStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sarah Abdelbar Mahmoud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sarah Abdelbar Mahmoud, Cairo University
- Investigators
- ahmed m Elkhadem, Ass.Prof, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05314842
- Sponsor's protocol ID
- 203
- Status last verified
- Mar 2022
- First submitted
- 25 Mar 2022
- Last updated
- 6 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 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Pulpotomy in Primary Molars Treated With Premixed Bio-ceramic MTA Versus Formocresol Among a Group of Egyptian Children: A Pilot Study.
- ClinicalTrials.gov ID
- NCT05314842
- Acronym / sponsor ID
- 203
- Conditions
- Caries
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sarah Abdelbar MahmoudUniversity, hospital or other
- Study start
- 1 Apr 2022 (estimated)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 6 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.
examine the results of pulpotomy in primary molars using premixed bioceramic MTA versus Formocresol. Clinical and radiographic success rates were used as outcomes.
Detailed description
Primary outcome:
Soft-tissue pathology
- Post-treatment swelling will be assessed through visual examination by the operator, either intraorally or extra orally.
- Sinus tract or fistula will be assessed through visual examination by the operator
Secondary outcomes:
- Pain to the percussion will be assessed by gentle tapping on the tooth with the end of a dental mirror
- mobility will be assessed through the back of two mirrors
- radiographic assessments:- for any radiolucency and pathologic root resorption (periapical or bifurcation) will be examined (present or not). clinical assessment on every recall visit during the 3-, 6-, and 12-month follow-up period.
- These radiographic assessments will be performed as baseline data at the first visit following the operating procedure, as well as at 3, 6, and 12 months after the baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Drug: Formocresolthe group that have caries in primary molars and treat them with formocresol |
| experimental group | Experimental | Drug: Premixed bioceramic MTAthe group that have caries in primary molars and treat them with premixed bioceramic MTA |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Medically fit and cooperative children.
- Pediatric patients aged 4-6 years.
- A deep carious lesion in vital primary molars.
- Absence of clinical signs and symptoms of pulpal exposure.
- Absence of radiographic signs and symptoms of people degeneration.
Key exclusion criteria (5 listed)
- Uncooperative children.
- Medically compromised children.
- Presence of clinical signs and symptoms of pulpal exposure.
- Presence of radiographic signs and symptoms of pulp degeneration.
- Physiologic root resorption more than one-third.
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 |
|---|---|---|
| Formocresoldressing agents in pulpotomized primary molas using formocresol in cariously exposed vital primary molars | Drug | control group |
| Premixed bioceramic MTAAlso: Neoputtydressing agents in pulpotomized primary molas using premixed bioceramic MTA in cariously exposed vital primary molars | Drug | experimental group |
Primary outcome
Soft-tissue pathology
Time frame: at 0 day
* Post-treatment swelling will be assessed through visual examination by the operator, either intraorally or extra orally. * Sinus tract or fistula will be assessed through visual examination by the operator. Binary (present or absent)
Soft-tissue pathology
Time frame: at 3 month
* Post-treatment swelling will be assessed through visual examination by the operator, either intraorally or extra orally. * Sinus tract or fistula will be assessed through visual examination by the operator. Binary (present or absent)
Soft-tissue pathology
Time frame: at 6 month
* Post-treatment swelling will be assessed through visual examination by the operator, either intraorally or extra orally. * Sinus tract or fistula will be assessed through visual examination by the operator. Binary (present or absent)
Soft-tissue pathology
Time frame: at 1 year
Post-treatment swelling will be assessed through visual examination by the operator, either intraorally or extra orally. -Sinus tract or fistula will be assessed through visual examination by the operator. Binary (present or absent)
12 secondary outcomes
• Pain to the percussion
Time frame: at 0 day
• Pain to the percussion
Time frame: at 3 month
• Pain to the percussion
Time frame: at 6 month
• Pain to the percussion
Time frame: at 1 year
mobility
Time frame: at 0 day
mobility
Time frame: at 3 month
mobility
Time frame: at 6 month
mobility
Time frame: at 1 year
radiographic indications of radiolucency and pathologic root resorption (periapical or bifurcation) will be examined (present or not).
Time frame: at 0 day
radiographic indications of radiolucency and pathologic root resorption (periapical or bifurcation) will be examined (present or not).
Time frame: at 3 month
radiographic indications of radiolucency and pathologic root resorption (periapical or bifurcation) will be examined (present or not).
Time frame: at 6 month
radiographic indications of radiolucency and pathologic root resorption (periapical or bifurcation) will be examined (present or not).
Time frame: at 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Individual participant dataSharing planned: No
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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.
ahmed m Elkhadem, Ass.Prof study chair
Cairo University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Formocresol and Premixed bioceramic MTA in people with Caries, run by Sarah Abdelbar Mahmoud.
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 6 inclusion and 5 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 6 Apr 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?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 sarah A Mahmoud, B.D.S (01023469565, sarah_mahmoud@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Soft-tissue pathology (time frame: at 0 day). The study lists 4 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 6 Apr 2022.