Evaluation of Bioflex Crowns Endocrowns Compared to Ready-Made Zirconia Crowns on Pulpotomized Primary Molars

NCT06433141 | Enrolling By Invitation

• 1 other identifier: 966/5604
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be conducted to evaluate clinical performance, parent's satisfaction, gingival health and bacterial effects of Bioflex crowns \&Endocrowns compared to ready-made zirconia Crowns on Pulpotomized primary molars

Conditions

Primary Teeth

Outcome Measures

Primary Outcomes (4)

• retention of bio-flex crown,zirconia, and endo-crown

  Retention were scored using a modified United States Public Health Service (USPHS) criterion.

  follow up will be 3,6,9,12 month

• marginal adaptation of bio-flex crown,zirconia, and endo-crown

  marginal adaptation were scored using a modified United States Public Health Service (USPHS) criterion.

  follow up will be 3,6,9,12 month

• fracture of restoration of bio-flex crown,zirconia, and endo-crown

  fracture of restoration were scored using a modified United States Public Health Service (USPHS) criterion.

  follow up will be 3,6,9,12 month

• gingival health of bio-flex crown,zirconia, and endo-crown

  • Dental plaque accumulation and gingival condition were assessed using plaque index (PI) and GI.

  follow up will be 3,6,9,12 month

Secondary Outcomes (1)

• parent's satisfaction analysis

  follow up will be 3,6,9,12 month

Other Outcomes (1)

• Microbiological analysis

  follow up will be 3,6,9,12 month

Study Arms (3)

bio-flex crown

ACTIVE COMPARATOR

bio-flex crown will be used as a final restoration for pulp treated primary molar, selection of suitable sized crown , it will be cement with glass ionomer cement after pulpotmy procdure clincal performance, parent satsification ,bacterial adherence will be evaluated with a follow up period 1 year

Procedure: treatment option for primary second molar

endo-crown

ACTIVE COMPARATOR

endo-crown will be used as a final restoration for pulp treated primary molar, after pulpotomy procdure endo-crown preperation design will be done and CAD/CAM, endo crown will be luted according to e-max protocol clincal performance, parent satsification ,bacterial adherence will be evaluated with a follow up period 1 year

Procedure: treatment option for primary second molar

zirconia crown

OTHER

zirconia crown will be used as a final restoration for pulp treated primary molar, selection of suitable sized crown after preperation of tooth and use try-in kit to select siutable size ,zirconia is sensitive for blood contamination , it will be cement with glass ionomer cement after pulpotmy procdure clincal performance, parent satsification ,bacterial adherence will be evaluated with a follow up period 1 year

Procedure: treatment option for primary second molar

Interventions

treatment option for primary second molar PROCEDURE

final restoration for primary second molars

bio-flex crown; endo-crown; zirconia crown

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Parents' and patients' acceptance and cooperation 2- Apparently Healthy children. 3- Child's age ranging from 4 to 8 years old. 4- Primary 2nd molars with deep carious lesion indicated for vital Pulptomy 5- No periapical pathological lesion 6- No root resorption exceeding more than 2/3 of root length.

You may not qualify if:

• Medically compromised children (bleeding disorders, cardiac patient and any systemic diseases could affect oral and gingival health.
• Presence of para-functional habits. Such bruxism, TMJ disorders
• Non-restorable tooth.
• Teeth with non-vital pulp

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Faculity of Dentistry

Cairo, 02, Egypt

Location

Study Officials

• kareem elhosary, master degree

  Al-Azhar University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: head of dental depertment -tanta militery hospital

Study Record Dates

• First Submitted: May 12, 2024
• First Posted: May 29, 2024
• Study Start: December 19, 2023
• Primary Completion: March 30, 2024
• Study Completion: August 30, 2025
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: after 1.5 years

Locations

EG (1)