Different Treatment Modality in Necrotic Primary Molars

NCT ID: NCT04190914

Last Updated: 2021-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-07

Study Completion Date

2021-09-20

Brief Summary

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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

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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

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Primary Teeth Dental Pulp Regeneration

Keywords

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triple antibiotic paste

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

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

Study Groups

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necrotic primary molar treated with pulpectomy followed by SSC

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

Group Type ACTIVE_COMPARATOR

pulp regeneration for necrotic primary teeth

Intervention Type OTHER

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

necrotic primary molar treated with regeneration using triple

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

Group Type EXPERIMENTAL

pulp regeneration for necrotic primary teeth

Intervention Type OTHER

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

necrotic primary molar treated with regeneration using metape

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

Group Type EXPERIMENTAL

pulp regeneration for necrotic primary teeth

Intervention Type OTHER

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

Interventions

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pulp 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

Intervention Type OTHER

Other Intervention Names

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different treatment options for necrotic primary teeth

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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dina darwish

OTHER

Sponsor Role lead

Responsible Party

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dina darwish

assistant lecture

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Dina D Abd-Elmoneam, masters

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

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Faculty of Dentistry- Ain Shams University

Cairo, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type DERIVED
PMID: 37519971 (View on PubMed)

Other Identifiers

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PED18-4D

Identifier Type: -

Identifier Source: org_study_id