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Different Treatment Modality in Necrotic Primary Molars

Primary Purpose

Primary Teeth, Dental Pulp Regeneration

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
pulp regeneration for necrotic primary teeth
Sponsored by
dina darwish
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Teeth focused on measuring triple antibiotic paste

Eligibility Criteria

4 Years - 7 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Faculty of Dentistry- Ain Shams University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

necrotic primary molar treated with pulpectomy followed by SSC

necrotic primary molar treated with regeneration using triple

necrotic primary molar treated with regeneration using metape

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Full Information

First Posted
December 5, 2019
Last Updated
December 3, 2021
Sponsor
dina darwish
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1. Study Identification

Unique Protocol Identification Number
NCT04190914
Brief Title
Different Treatment Modality in Necrotic Primary Molars
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
February 7, 2020 (Actual)
Primary Completion Date
September 7, 2021 (Actual)
Study Completion Date
September 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
dina darwish

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Teeth, Dental Pulp Regeneration
Keywords
triple antibiotic paste

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
participant and outcomes assessor will be blind to which group they belong or assess respectively
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
necrotic primary molar treated with pulpectomy followed by SSC
Arm Type
Active Comparator
Arm Description
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
Arm Title
necrotic primary molar treated with regeneration using triple
Arm Type
Experimental
Arm Description
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
Arm Title
necrotic primary molar treated with regeneration using metape
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
pulp regeneration for necrotic primary teeth
Other Intervention Name(s)
different treatment options for necrotic primary teeth
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Description
the blind outcome assessor will evaluate the clinical success at 6 and 12 years
Time Frame
12 months
Title
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
Description
the blind outcome assessor will evaluate the radio graphic success at 6 and 12 years
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dina D Abd-Elmoneam, masters
Organizational Affiliation
Ain Shams University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Dentistry- Ain Shams University
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Different Treatment Modality in Necrotic Primary Molars

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