Primary TeethNCT05181813
Treatment of Infected Pulp in Primary Teeth With a Mixture of Calcium Hydroxide and Gingerols
A study testing Ginge-Cal and Metapex in people with Primary Teeth and Pulp Necroses, run by Mansoura University at 1 site in Egypt.
Trial summary
This study was conducted to evaluate Calcium Hydroxide mixed with Gingerols versus Metapex in treatment of primary teeth with infected necrotic pulp Read more about this study
- Who is it for?
- Ages 4 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Teeth, Pulp Necroses, Infected Pulp
- What is being tested?
- Ginge-Cal and Metapex
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Oct 2020to 30 Aug 2022
- 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 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The cooperation of the child and parents, during the treatment plan, and the commitment to attend the follow-up appointments.
- Parents signed the consent to participate in the study.
- Absence of any systemic disease, which would contraindicate pulp therapy.
- Child didn't have any history of a sensitive reaction to any component of used materials.
- Present half to two third of tooth root or more
- Root with signs or symptoms of infected necrotic pulp or chronic abscess, with or without sinus tract, soft tissue swelling, mobility or tenderness to percussion, and internal or external root resorption or unsuccessful past pulp treatment.
Who cannot join
- All that does not correspond to inclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Calcium Hydroxide Mixed With Gingerols Versus Metapex in Treatment of Primary Teeth With Infected Necrotic Pulp
This study was conducted to evaluate Calcium Hydroxide mixed with Gingerols versus Metapex in treatment of primary teeth with infected necrotic pulp
Read the detailed description
Study compare Calcium Hydroxide mixed with Gingerols versus Metapex in treatment of primary teeth with infected necrotic pulp clinically and radiographically
- Conditions
- Primary Teeth, Pulp Necroses, Infected Pulp, Root Canal Treatment
- Being tested
- Ginge-Cal, Metapex
- Keywords
- Pediatric Dentistry, Pulpectomy, Infected Pulp, Necrotic Pulp, Gingerols, Calcium Hydroxide, Metapex, Ginge-Cal
- 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.
Ginge-CalProcedure or surgery
Fill the infected root canal of of primary teeth with Gingerols extract and Calcium Hydroxide (Ginge-Cal)
MetapexProcedure or surgery
Fill the infected root canal of of primary teeth with Metapex
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Ginge-Cal group: | Experimental | primary molars were filled by creamy mixture pulpectomy paste of Gingerols and Calcium Hydroxide. Receives: Procedure: Ginge-Cal |
| Group 2: Metapex group | Active comparator | primary molars were filled by a ready-made injectable creamy mixture pulpectomy paste of Metapex Receives: Procedure: Metapex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of primary teeth with control necrotic pulp by clinical examination
The primary outcome was evaluated using clinical evaluation methods. Two pediatric dentists who are blind to treated teeth will conduct the clinical evaluation. A third examiner will be consulted if there is a disagreement between the results of the first two. Clinical success will be judged to have occurred when there are no reports of pain, abscess, fistula, or mobility inconsistent with chronological age.
Measured: Up to 18 months
Percentage of primary teeth with control necrotic pulp by radiographic examination
The primary outcome was evaluated using Radiographic evaluation methods. Two pediatric dentists who are blind to treated teeth will conduct the clinical evaluation. A third examiner will be consulted if there is a disagreement between the results of the first two. Radiographic success will be evidenced by a decrease or absence of periapical or furcation area radiolucency and pathological root resorption
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start17 Oct 2020
- Primary completion30 Apr 2022
- Study completion30 Aug 2022
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 Primary TeethStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Model description
- Selected children will be divided randomly into 2 groups: Group 1: Ginge-Cal group: primary molars were filled with a creamy mixture of pulpectomy paste of Gingerols and Calcium Hydroxide. Group 2: Metapex group: primary molars were filled with a ready-made injectable creamy mixture pulpectomy paste of Metapex.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fathi Abdulraqeb Qasem, Mansoura University
- Investigators
- Fathi A Qasem, PhD, Principal investigator, Assistant Professor of Pediatric Dentistry Faculty of Dentistry Thamar University YemenSalwa M Awad, Prof, Study director, Prof. of Pediatric Dentistry and Dental Public Health Faculty of Dentistry Mansoura UniversityRizk A ELagamy, PhD, Study director, Lecturer of Pediatric Dentistry Faculty of Dentistry Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05181813
- Sponsor's protocol ID
- 06030718
- Status last verified
- Jan 2023
- First submitted
- 30 Nov 2021
- Last updated
- 10 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol to other researchers
Publications
Qasem FA, Awad SM, Elagamy RA. Effectiveness of Calcium Hydroxide and Gingerols Mixture as a Novel Obturation Material for Infected Root in Primary Teeth: A Randomized Clinical Trial. Int J Dent. 2024 Feb 8;2024:5528260. doi: 10.1155/2024/5528260. eCollection 2024.
PubMed 38362239
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Calcium Hydroxide Mixed With Gingerols Versus Metapex in Treatment of Primary Teeth With Infected Necrotic Pulp
- ClinicalTrials.gov ID
- NCT05181813
- Acronym / sponsor ID
- 06030718
- Conditions
- Primary Teeth, Pulp Necroses, Infected Pulp, Root Canal Treatment
- Keywords
- Pediatric Dentistry, Pulpectomy, Infected Pulp, Necrotic Pulp, Gingerols, Calcium Hydroxide, Metapex, Ginge-Cal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 17 Oct 2020 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 6 Jan 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.
This study was conducted to evaluate Calcium Hydroxide mixed with Gingerols versus Metapex in treatment of primary teeth with infected necrotic pulp
Detailed description
Study compare Calcium Hydroxide mixed with Gingerols versus Metapex in treatment of primary teeth with infected necrotic pulp clinically and radiographically
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Selected children will be divided randomly into 2 groups: Group 1: Ginge-Cal group: primary molars were filled with a creamy mixture of pulpectomy paste of Gingerols and Calcium Hydroxide. Group 2: Metapex group: primary molars were filled with a ready-made injectable creamy mixture pulpectomy paste of Metapex.
| Arm | Type | Receives |
|---|---|---|
| Group 1: Ginge-Cal group: | Experimental | Procedure: Ginge-Calprimary molars were filled by creamy mixture pulpectomy paste of Gingerols and Calcium Hydroxide. |
| Group 2: Metapex group | Active comparator | Procedure: Metapexprimary molars were filled by a ready-made injectable creamy mixture pulpectomy paste of Metapex |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- The cooperation of the child and parents, during the treatment plan, and the commitment to attend the follow-up appointments.
- Parents signed the consent to participate in the study.
- Absence of any systemic disease, which would contraindicate pulp therapy.
- Child didn't have any history of a sensitive reaction to any component of used materials.
- Present half to two third of tooth root or more
Key exclusion criteria (1 listed)
- All that does not correspond to inclusion criteria.
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 |
|---|---|---|
| Ginge-CalFill the infected root canal of of primary teeth with Gingerols extract and Calcium Hydroxide (Ginge-Cal) | Procedure or surgery | Group 1: Ginge-Cal group: |
| MetapexFill the infected root canal of of primary teeth with Metapex | Procedure or surgery | Group 2: Metapex group |
Primary outcome
Percentage of primary teeth with control necrotic pulp by clinical examination
Time frame: Up to 18 months
The primary outcome was evaluated using clinical evaluation methods. Two pediatric dentists who are blind to treated teeth will conduct the clinical evaluation. A third examiner will be consulted if there is a disagreement between the results of the first two. Clinical success will be judged to have occurred when there are no reports of pain, abscess, fistula, or mobility inconsistent with chronological age.
Percentage of primary teeth with control necrotic pulp by radiographic examination
Time frame: Up to 18 months
The primary outcome was evaluated using Radiographic evaluation methods. Two pediatric dentists who are blind to treated teeth will conduct the clinical evaluation. A third examiner will be consulted if there is a disagreement between the results of the first two. Radiographic success will be evidenced by a decrease or absence of periapical or furcation area radiolucency and pathological root resorption
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
- Derived from this study: PubMed 38362239Qasem FA, Awad SM, Elagamy RA. Effectiveness of Calcium Hydroxide and Gingerols Mixture as a Novel Obturation Material for Infected Root in Primary Teeth: A Randomized Clinical Trial. Int J Dent. 2024 Feb 8;2024:5528260. doi: 10.1155/2024/5528260. eCollection 2024.
- Individual participant dataSharing planned: Yes. Study Protocol to other researchers
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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.
Fathi A Qasem, PhD principal investigator
Assistant Professor of Pediatric Dentistry Faculty of Dentistry Thamar University Yemen
Salwa M Awad, Prof study director
Prof. of Pediatric Dentistry and Dental Public Health Faculty of Dentistry Mansoura University
Rizk A ELagamy, PhD study director
Lecturer of Pediatric Dentistry Faculty of Dentistry Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ginge-Cal and Metapex in people with Primary Teeth and Pulp Necroses, run by Mansoura University at 1 site in Egypt.
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 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: finished, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of primary teeth with control necrotic pulp by clinical examination (time frame: Up to 18 months). The study lists 2 primary outcomes in all. 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 NCT05181813, 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 10 Jan 2023.