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Different Treatment Modality in Necrotic Primary Molars

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04190914
Enrollment
54
Registered
2019-12-09
Start date
2020-02-07
Completion date
2021-09-20
Last updated
2021-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Pulp Regeneration, Primary Teeth

Keywords

triple antibiotic paste

Brief 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.

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.

Interventions

OTHERpulp regeneration 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

Sponsors

dina darwish
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

participant and outcomes assessor will be blind to which group they belong or assess respectively

Eligibility

Sex/Gender
ALL
Age
4 Years to 7 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
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 fistula12 monthsthe 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 resorption12 monthsthe blind outcome assessor will evaluate the radio graphic success at 6 and 12 years

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026