Primary TeethNCT04190914
Different Treatment Modality in Necrotic Primary Molars
A study testing pulp regeneration for necrotic primary teeth in people with Primary Teeth and Dental Pulp Regeneration, run by dina darwish at 1 site in Egypt.
Trial summary
Necrotic primary molars in preschool children will be treated with the regeneration concept to provide a healthy biological environment within the root canal system and regression in clinical signs and symptoms which are the primary outcomes of regeneration treatment. Read more about this study
- Who is it for?
- Ages 4 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Teeth, Dental Pulp Regeneration
- What is being tested?
- pulp regeneration for necrotic primary teeth
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Feb 2020to 20 Sep 2021
- 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 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- A child with one or more necrotic primary teeth
- Presence of abscess/fistula
- Sensitivity to percussion
- Presence of maximum grade 2 mobility ( Not more than 1 mm)
- Increases of the dental lamina dura
- cooperative patients
Who cannot join
- Medically compromised children
- Patient allergic to any of the used materials
- Presence of pathologic root resorption (internal-external) or more than 1/3 of the apical root.
- Presence of vitality in the canals
- Presence of grade 3 mobility
- Non-restorable teeth
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographic Evaluation of Triple Antibiotic Paste and Calcium Hydroxide With Iodoform as Intra-canal Medications in Regenerative Treatment of Necrotic Primary Teeth Randomized Clinical Trial
Necrotic primary molars in preschool children will be treated with the regeneration concept to provide a healthy biological environment within the root canal system and regression in clinical signs and symptoms which are the primary outcomes of regeneration treatment.
Read the detailed description
A convenient sample of preschool children have a necrotic primary second molar randomly allocated to one of the 3 study groups which are: group A (control) treated by the conventional treatment ( pulpectomy followed by stainless steel crown SSC), group B: treated by regeneration using triple antibiotic paste followed by SSC), group 3:(treated by regeneration using calcium hydroxide with iodoform(metapex) followed by SSC.
the 3 groups were evaluated at baseline, 6 months and 12 months for clinical and radiographic success.
- Conditions
- Primary Teeth, Dental Pulp Regeneration
- Being tested
- pulp regeneration for necrotic primary teeth
- Keywords
- triple antibiotic paste
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulp regeneration for necrotic primary teethOther
Also called different treatment options for necrotic primary teeth
a pulp regeneration procedure will be applied for necrotic primary teeth with different intracanal medication compared to conventional pulpectomy used in treatment for necrotic primary teeth
| Study group | Role | What they receive |
|---|---|---|
| necrotic primary molar treated with pulpectomy followed by SSC | Active comparator | control group treated by pulpectomy under rubber dam isolation access cavity will be prepared by a round bur then filling and irrigation will be performed and the tooth will be restored with a temporary filling. After one week all signs and symptoms will be assessed in case of absence of signs and symptoms the tooth will be restored with zin oxide and eugenol and SSC Receives: Other: pulp regeneration for necrotic primary teeth |
| necrotic primary molar treated with regeneration using triple | Experimental | under rubber dam isolation access cavity will be prepared by a round bur then minimal filling and irrigation will be performed then triple antibiotic paste will be inserted into the canals and the tooth will be restored by a glass ionomer (GI) as a temporary filling. After2-4 weeks all signs and symptoms will be assessed in case of absence of signs and symptoms an endodontic file will be used to induce bleeding from the periapical area after hemostasis mineral trioxide aggregate will be applied followed by SSC Receives: Other: pulp regeneration for necrotic primary teeth |
| necrotic primary molar treated with regeneration using metape | Experimental | under rubber dam isolation access cavity will be prepared by a round bur then minimal filling and irrigation will be performed then calcium hydroxide with iodoform (metapex) will be inserted into the canals and the tooth will be restored by a glass ionomer (GI) as a temporary filling. After 2-4 weeks all signs and symptoms will be assessed in case of absence of signs and symptoms an endodontic file will be used to induce bleeding from the periapical area after hemostasis mineral trioxide aggregate will be applied followed by SSC Receives: Other: pulp regeneration for necrotic primary teeth |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients treated in the 3 groups and have a clinical success according to the checklist absence of pain, pain on percussion, mobility, clinical abscess or fistula
the blind outcome assessor will evaluate the clinical success at 6 and 12 years
Measured: 12 months
number of patients treated in the 3 groups and have a radio graphic success according to the checklist absence of radiolucency, internal or external root resorption
the blind outcome assessor will evaluate the radio graphic success at 6 and 12 years
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2019
- Study start7 Feb 2020
- Primary completion7 Sep 2021
- Study completion20 Sep 2021
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.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- dina darwish
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, dina darwish, Ain Shams University
- Investigators
- Dina D Abd-Elmoneam, masters, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04190914
- Sponsor's protocol ID
- PED18-4D
- Status last verified
- Nov 2021
- First submitted
- 5 Dec 2019
- Last updated
- 17 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abdelmoneim DD, Abdelaziz AM, Allam GG, Badran AS. A 1-year Clinical and Radiographic Assessment of Regenerative Endodontic Therapy for Necrotic Primary Molars: A Randomized controlled Trial. Int J Clin Pediatr Dent. 2023 Mar-Apr;16(2):295-301. doi: 10.5005/jp-journals-10005-2536.
PubMed 37519971
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Triple Antibiotic Paste and Calcium Hydroxide With Iodoform as Intra-canal Medications in Regenerative Treatment of Necrotic Primary Teeth Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04190914
- Acronym / sponsor ID
- PED18-4D
- Conditions
- Primary Teeth, Dental Pulp Regeneration
- Keywords
- triple antibiotic paste
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- dina darwishUniversity, hospital or other
- Study start
- 7 Feb 2020 (actual)
- Primary completion
- 7 Sep 2021 (actual)
- Study completion
- 20 Sep 2021 (actual)
- First posted
- 9 Dec 2019 (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.
Necrotic primary molars in preschool children will be treated with the regeneration concept to provide a healthy biological environment within the root canal system and regression in clinical signs and symptoms which are the primary outcomes of regeneration treatment.
Detailed description
A convenient sample of preschool children have a necrotic primary second molar randomly allocated to one of the 3 study groups which are: group A (control) treated by the conventional treatment ( pulpectomy followed by stainless steel crown SSC), group B: treated by regeneration using triple antibiotic paste followed by SSC), group 3:(treated by regeneration using calcium hydroxide with iodoform(metapex) followed by SSC.
the 3 groups were evaluated at baseline, 6 months and 12 months for clinical and radiographic success.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| necrotic primary molar treated with pulpectomy followed by SSC | Active comparator | Other: pulp regeneration for necrotic primary teethcontrol group treated by pulpectomy under rubber dam isolation access cavity will be prepared by a round bur then filling and irrigation will be performed and the tooth will be restored with a temporary filling. After one week all signs and symptoms will be assessed in case of absence of signs and symptoms the tooth will be restored with zin oxide and eugenol and SSC |
| necrotic primary molar treated with regeneration using triple | Experimental | Other: pulp regeneration for necrotic primary teethunder rubber dam isolation access cavity will be prepared by a round bur then minimal filling and irrigation will be performed then triple antibiotic paste will be inserted into the canals and the tooth will be restored by a glass ionomer (GI) as a temporary filling. After2-4 weeks all signs and symptoms will be assessed in case of absence of signs and symptoms an endodontic file will be used to induce bleeding from the periapical area after hemostasis mineral trioxide aggregate will be applied followed by SSC |
| necrotic primary molar treated with regeneration using metape | Experimental | Other: pulp regeneration for necrotic primary teethunder rubber dam isolation access cavity will be prepared by a round bur then minimal filling and irrigation will be performed then calcium hydroxide with iodoform (metapex) will be inserted into the canals and the tooth will be restored by a glass ionomer (GI) as a temporary filling. After 2-4 weeks all signs and symptoms will be assessed in case of absence of signs and symptoms an endodontic file will be used to induce bleeding from the periapical area after hemostasis mineral trioxide aggregate will be applied followed by SSC |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- A child with one or more necrotic primary teeth
- Presence of abscess/fistula
- Sensitivity to percussion
- Presence of maximum grade 2 mobility ( Not more than 1 mm)
- Increases of the dental lamina dura
Key exclusion criteria (6 listed)
- Medically compromised children
- Patient allergic to any of the used materials
- Presence of pathologic root resorption (internal-external) or more than 1/3 of the apical root.
- Presence of vitality in the canals
- Presence of grade 3 mobility
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 |
|---|---|---|
| pulp regeneration for necrotic primary teethAlso: different treatment options for necrotic primary teetha pulp regeneration procedure will be applied for necrotic primary teeth with different intracanal medication compared to conventional pulpectomy used in treatment for necrotic primary teeth | Other | necrotic primary molar treated with pulpectomy followed by SSC, necrotic primary molar treated with regeneration using metape, necrotic primary molar treated with regeneration using triple |
Primary outcome
number of patients treated in the 3 groups and have a clinical success according to the checklist absence of pain, pain on percussion, mobility, clinical abscess or fistula
Time frame: 12 months
the blind outcome assessor will evaluate the clinical success at 6 and 12 years
number of patients treated in the 3 groups and have a radio graphic success according to the checklist absence of radiolucency, internal or external root resorption
Time frame: 12 months
the blind outcome assessor will evaluate the radio graphic success at 6 and 12 years
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 17 Dec 2021.
- Derived from this study: PubMed 37519971Abdelmoneim DD, Abdelaziz AM, Allam GG, Badran AS. A 1-year Clinical and Radiographic Assessment of Regenerative Endodontic Therapy for Necrotic Primary Molars: A Randomized controlled Trial. Int J Clin Pediatr Dent. 2023 Mar-Apr;16(2):295-301. doi: 10.5005/jp-journals-10005-2536.
- Individual participant dataSharing planned: No
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This Feasibility Study Will Evaluate the Study Protocols for Treatment and Follow-up Controls of Primary Molars With Caries in Children Treated With Stainless Steel Crowns or Conventional Fillings. Treatment Success and Potential Failures Will be Followed at 3, 6 and 12 Months Post Treatment.
Dental Caries, Early Childhood Caries (ECC)
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.
Dina D Abd-Elmoneam, masters principal investigator
Ain Shams 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 pulp regeneration for necrotic primary teeth in people with Primary Teeth and Dental Pulp Regeneration, run by dina darwish 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 6 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 17 Dec 2021. 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?
number of patients treated in the 3 groups and have a clinical success according to the checklist absence of pain, pain on percussion, mobility, clinical abscess or fistula (time frame: 12 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 NCT04190914, 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 17 Dec 2021.