Dental Pulp NecrosesNCT06071663
Single and Two-visit Pulpectomy in Primary Molars
A study testing Single and two visits pulpectomy in people with Dental Pulp Necroses, run by Mansoura University.
Trial summary
A total of 64 primary molars of 5-8 years old children will be randomly selected from Pediatric dental clinic at Faculty of Dentistry, Mansoura University. Children will have two bilateral carious primary molars indicated for pulpectomy ; One side will be treated in one visit and the other will be treated in two… Read more about this study
- Who is it for?
- Ages 5 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Pulp Necroses
- What is being tested?
- Single and two visits pulpectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 5 Oct 2023to 5 Oct 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 5 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Cooperative 5-8 years old children with no systemic diseases or chronic conditions. _Every child should have bilateral necrotic primary molars indicated for pulpectomy with sufficient coronal tooth structure.
Who cannot join
- Children received antibiotics in the past month before the study. Primary molars with sinus tract, abscess, or facial cellulitis. Primary molas with root resorption exceeding one third of root length
Trial locations and contacts
No sites are listed yet.
Mahmoud Mahmoud Shaaban, Bachelor of Dentistry contact
About this study
Official title: Clinical and Radiographic Evaluation of Single-Versus Two-visit Pulpectomy in Primary Molars: Randomized Controlled Clinical Trial
A total of 64 primary molars of 5-8 years old children will be randomly selected from Pediatric dental clinic at Faculty of Dentistry, Mansoura University.
Children will have two bilateral carious primary molars indicated for pulpectomy ; One side will be treated in one visit and the other will be treated in two visits.
Clinical and radiographic evaluation for 3 , 6, 12 months
Read the detailed description
All the pulpectomy steps will be carried out by a single operator. After confirming the diagnosis clinically and radiographically, the necrotic tooth will be anesthetized by local anesthesia and isolated by rubber dam.
Caries will be removed by sterile round diamond burs. Proper access cavity will be prepared with complete deroofing and the pulp chamber will be irrigated by saline 0.9%. The working length will be established by apex locator and confirmed by periapical film (1 mm short of radiographic apex). Mechanical instrumentation will be done using rotary files followed by irrigation with no excessive pressure between files using sodium hypochlorite 2.5%. Then, root canal system will be dried by sterile paper points.
In case of single visit pulpectomy (21):
Root canals will be obturated by metapex and the tooth will be finally restored by glass ionomer filling and stainless-steel crown.
In case of two visit pulpectomy (13):
First, root canals will be filled by calcium hydroxide powder mixed with saline followed by temporary coronal restoration and left for 7 days.
In the second visit, calcium hydroxide will be removed from the canals using K -files then irrigated by NaOCL 2.5%. The canals will be dried by sterile paper points before obturation and final restoration as mentioned in single- visit treatment protocol. A postoperative periapical x-ray film will be taken for future review.
Clinical and radiographic follow up will be carried out after 3, 6, 12 months respectively.
- Conditions
- Dental Pulp Necroses
- Being tested
- Single and two visits pulpectomy
- Keywords
- Pulpectomy, single visit, two visits
- Medical subject headings
- Dental Pulp Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single and two visits pulpectomyProcedure or surgery
Comparison of clinical and radiographic outcome of Single and two visits pulpectomy
| Study group | Role | What they receive |
|---|---|---|
| single visit | Active comparator | Necrotic primary molar treated in single visit Receives: Procedure: Single and two visits pulpectomy |
| Two visits | Active comparator | Necrotic primary molar treated in two visits Receives: Procedure: Single and two visits pulpectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical and Radiographic outcomes
Proportion of clinical and radiographic success in both treatment protocols
Measured: 3 , 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start5 Oct 2023 (estimated)
- Primary completion5 Jan 2024 (estimated)
- Study completion5 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Pulp NecrosesStudies 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
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moustafa Reda, Mansoura University
- Investigators
- Nadia Moustafa Fareag, Professor, Study director, Pediatric dentistry department. MANSOURA UNIVERSITY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06071663
- Sponsor's protocol ID
- A0603023PP
- Status last verified
- Oct 2023
- First submitted
- 1 Oct 2023
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Single-Versus Two-visit Pulpectomy in Primary Molars: Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06071663
- Acronym / sponsor ID
- A0603023PP
- Conditions
- Dental Pulp Necroses
- Keywords
- Pulpectomy, single visit, two visits
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 5 Oct 2023 (estimated)
- Primary completion
- 5 Jan 2024 (estimated)
- Study completion
- 5 Oct 2024 (estimated)
- First posted
- 6 Oct 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.
A total of 64 primary molars of 5-8 years old children will be randomly selected from Pediatric dental clinic at Faculty of Dentistry, Mansoura University.
Children will have two bilateral carious primary molars indicated for pulpectomy ; One side will be treated in one visit and the other will be treated in two visits.
Clinical and radiographic evaluation for 3 , 6, 12 months
Detailed description
All the pulpectomy steps will be carried out by a single operator. After confirming the diagnosis clinically and radiographically, the necrotic tooth will be anesthetized by local anesthesia and isolated by rubber dam.
Caries will be removed by sterile round diamond burs. Proper access cavity will be prepared with complete deroofing and the pulp chamber will be irrigated by saline 0.9%. The working length will be established by apex locator and confirmed by periapical film (1 mm short of radiographic apex). Mechanical instrumentation will be done using rotary files followed by irrigation with no excessive pressure between files using sodium hypochlorite 2.5%. Then, root canal system will be dried by sterile paper points.
In case of single visit pulpectomy (21):
Root canals will be obturated by metapex and the tooth will be finally restored by glass ionomer filling and stainless-steel crown.
In case of two visit pulpectomy (13):
First, root canals will be filled by calcium hydroxide powder mixed with saline followed by temporary coronal restoration and left for 7 days.
In the second visit, calcium hydroxide will be removed from the canals using K -files then irrigated by NaOCL 2.5%. The canals will be dried by sterile paper points before obturation and final restoration as mentioned in single- visit treatment protocol. A postoperative periapical x-ray film will be taken for future review.
Clinical and radiographic follow up will be carried out after 3, 6, 12 months respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| single visit | Active comparator | Procedure: Single and two visits pulpectomyNecrotic primary molar treated in single visit |
| Two visits | Active comparator | Procedure: Single and two visits pulpectomyNecrotic primary molar treated in two visits |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Cooperative 5-8 years old children with no systemic diseases or chronic conditions. _Every child should have bilateral necrotic primary molars indicated for pulpectomy with sufficient coronal tooth structure.
Key exclusion criteria (1 listed)
- Children received antibiotics in the past month before the study. Primary molars with sinus tract, abscess, or facial cellulitis. Primary molas with root resorption exceeding one third of root length
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 |
|---|---|---|
| Single and two visits pulpectomyComparison of clinical and radiographic outcome of Single and two visits pulpectomy | Procedure or surgery | Two visits, single visit |
Primary outcome
Clinical and Radiographic outcomes
Time frame: 3 , 6 and 12 months
Proportion of clinical and radiographic success in both treatment protocols
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
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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.
Mahmoud Mahmoud Shaaban, Bachelor of Dentistry contact
Nadia Moustafa Fareag, Professor study director
Pediatric dentistry department. MANSOURA UNIVERSITY
Questions about this trial
What is this clinical trial studying?
A study testing Single and two visits pulpectomy in people with Dental Pulp Necroses, run by Mansoura 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 1 inclusion and 1 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 Oct 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 Moustafa Omar, Bachelor of Dentistry (01062685288, ahmedwael241014@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical and Radiographic outcomes (time frame: 3 , 6 and 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 6 Oct 2023.