Different Treatment Modality in Necrotic Primary Molars

NCT04190914 | Completed DMC

• 1 other identifier: PED18-4D
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Teeth; Dental Pulp Regeneration

Keywords

triple antibiotic paste

Outcome Measures

Primary Outcomes (2)

• 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

  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

  12 months

Study Arms (3)

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

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

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

Other: pulp regeneration for necrotic primary teeth

Interventions

pulp regeneration for necrotic primary teeth 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

Also known as: different treatment options for necrotic primary teeth

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

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• dina darwish: lead

Study Sites (1)

Faculty of Dentistry- Ain Shams University

Cairo, Egypt

Location

Related Publications (1)

• 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.

  PMID: 37519971 DERIVED

Study Officials

• Dina D Abd-Elmoneam, masters

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: participant and outcomes assessor will be blind to which group they belong or assess respectively
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: assistant lecture

Study Record Dates

• First Submitted: December 5, 2019
• First Posted: December 9, 2019
• Study Start: February 7, 2020
• Primary Completion: September 7, 2021
• Study Completion: September 20, 2021
• Last Updated: December 17, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)