Chronic InfectionNCT03684915
Clinical Post-operative Assessment of Chronic Signs & Symptoms Related to Infected Primary Molars After Using Rotary Versus Manual Systems in Cleaning the Root Canals
A study testing Rotary files in people with Chronic Infection, run by Cairo University.
Trial summary
One of the most important concerns in pediatric dentistry is the loss of necrotic primary molars leading to space loss. pulpectomies for primary teeth with severe pulpal involvement should be considered as the treatment of choice. Read more about this study
- Who is it for?
- Ages 4 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Infection
- What is being tested?
- Rotary files
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2018to Oct 2019
- 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- primary molars with fistula / chronic abscess
- teeth which if lost possibility of space maintainer construction exists
- pre-operative radiograph showing absence of severe root resorption
Who cannot join
- teeth with non-restorable crowns
- expected shedding time within one year
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Post-operative Assessment of Chronic Signs & Symptoms Related to Infected Primary Molars After Using Rotary Versus Manual Systems in Cleaning the Root Canals: A Randomized Clinical Trial
One of the most important concerns in pediatric dentistry is the loss of necrotic primary molars leading to space loss. pulpectomies for primary teeth with severe pulpal involvement should be considered as the treatment of choice.
Bacteria plays an essential role in the initiation and perpetuation of pulpal and periapical disease. The investigator's target when cleaning and shaping the root canal system is to remove bacteria-containing tissue.
Read more
The removal of organic debris is the main purpose of instrumentation in pulpectomy procedures in primary teeth, this could be achieved using manual or rotary Ni-Ti files. A practical pulpectomy technique for the primary teeth should include the following:1) Fast procedure with short treatment time and minimal number of appointments.2) Effective debridement of the root canal without weakening the tooth structure or endangering the underlining permanent teeth.3) Minimal procedural complications. 4) Maintaining tooth function until it is naturally exfoliated.
Manufacturers using rotary files highlight their cleaning efficiency for root canal preparations, simple procedures, and decreased procedure time, which is especially important in children.
Considering that preparation time is an important clinical factor in pediatric patient management, the use of rotary instruments for pulpectomies in primary teeth is recommended.
- Conditions
- Chronic Infection
- Being tested
- Rotary files
- Keywords
- Rotary instrumentation, pulpectomy, primary teeth
- Medical subject headings
- Persistent Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotary filesDevice
using rotary files in cleaning root canals of infected primary molars
| Study group | Role | What they receive |
|---|---|---|
| rotary files | Experimental | 1. Pre-operative radiograph showing all roots and their apices.
2. Local anaesthetic (to enable use of rubber dam clamp).
3. Rubber dam isolation.
4. Removal of caries.
5. Removal of roof of pulp chamber.
6. Removal of any remains of coronal pulp tissue with sharp sterile excavator or large bur in slow hand piece.
7. Identify root canals.
8. Irrigate with normal saline (0.9%)
9. Estimate working lengths of root canals keeping 2 mm short of the radiographic apex.
10. Insert rotary files into canals and debride the canals lightly and gently.
11. Irrigate the root canals.
12. Dry canals with pre-measured paper points, keeping 2 mm from root apices.
13. Canals will be dried with paper points, obturated by injecting Metapex. (Meta Biomed - Metapex Root Canal Filling Material)
14. Stainless steel crown will be performed Receives: Device: Rotary files |
| manual files | Active comparator | All steps as that of intervention group are to be followed except step (j) instead of it; a manual files will be inserted into the canals for debridement lightly and gently Receives: Device: Rotary files |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of fistula
unit of measurement: Yes/No using visual examination
Measured: 3 months
Secondary outcomes (1)
assessment of tooth mobility
unit of measurements : grades from 0-3 ,assessed by moving the tooth using two instruments ,one on the facial \& the other on the lingual surfaces of the tooth
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study start1 Oct 2018 (estimated)
- Primary completionApr 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic InfectionStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Basma Mohamed Zakaria Ahmed Zain, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03684915
- Sponsor's protocol ID
- CEBD-CU-2018-08-26
- Status last verified
- Sep 2018
- First submitted
- 10 Sep 2018
- Last updated
- 26 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Post-operative Assessment of Chronic Signs & Symptoms Related to Infected Primary Molars After Using Rotary Versus Manual Systems in Cleaning the Root Canals: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03684915
- Acronym / sponsor ID
- CEBD-CU-2018-08-26
- Conditions
- Chronic Infection
- Keywords
- Rotary instrumentation, pulpectomy, primary teeth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (estimated)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 26 Sep 2018 (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.
One of the most important concerns in pediatric dentistry is the loss of necrotic primary molars leading to space loss. pulpectomies for primary teeth with severe pulpal involvement should be considered as the treatment of choice.
Bacteria plays an essential role in the initiation and perpetuation of pulpal and periapical disease. The investigator's target when cleaning and shaping the root canal system is to remove bacteria-containing tissue.
The removal of organic debris is the main purpose of instrumentation in pulpectomy procedures in primary teeth, this could be achieved using manual or rotary Ni-Ti files. A practical pulpectomy technique for the primary teeth should include the following:1) Fast procedure with short treatment time and minimal number of appointments.2) Effective debridement of the root canal without weakening the tooth structure or endangering the underlining permanent teeth.3) Minimal procedural complications. 4) Maintaining tooth function until it is naturally exfoliated.
Manufacturers using rotary files highlight their cleaning efficiency for root canal preparations, simple procedures, and decreased procedure time, which is especially important in children.
Considering that preparation time is an important clinical factor in pediatric patient management, the use of rotary instruments for pulpectomies in primary teeth is recommended.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rotary files | Experimental | Device: Rotary files1. Pre-operative radiograph showing all roots and their apices. 2. Local anaesthetic (to enable use of rubber dam clamp). 3. Rubber dam isolation. 4. Removal of caries. 5. Removal of roof of pulp chamber. 6. Removal of any remains of coronal pulp tissue with sharp sterile excavator or large bur in slow hand piece. 7. Identify root canals. 8. Irrigate with normal saline (0.9%) 9. Estimate working lengths of root canals keeping 2 mm short of the radiographic apex. 10. Insert rotary files into canals and debride the canals lightly and gently. 11. Irrigate the root canals. 12. Dry canals with pre-measured paper points, keeping 2 mm from root apices. 13. Canals will be dried with paper points, obturated by injecting Metapex. (Meta Biomed - Metapex Root Canal Filling Material) 14. Stainless steel crown will be performed |
| manual files | Active comparator | Device: Rotary filesAll steps as that of intervention group are to be followed except step (j) instead of it; a manual files will be inserted into the canals for debridement lightly and gently |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- primary molars with fistula / chronic abscess
- teeth which if lost possibility of space maintainer construction exists
- pre-operative radiograph showing absence of severe root resorption
Key exclusion criteria (2 listed)
- teeth with non-restorable crowns
- expected shedding time within one year
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 |
|---|---|---|
| Rotary filesusing rotary files in cleaning root canals of infected primary molars | Device | manual files, rotary files |
Primary outcome
Resolution of fistula
Time frame: 3 months
unit of measurement: Yes/No using visual examination
1 secondary outcome
assessment of tooth mobility
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2018.
- Individual participant dataSharing planned: Undecided
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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 Rotary files in people with Chronic Infection, 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 3 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 Sep 2018. 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 Basma Mohamed Zakaria, B.D.S (00201120006929, basma.mohamed@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resolution of fistula (time frame: 3 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 26 Sep 2018.