Evaluation of PEEK and BruxZir as Esthetic Space Maintainers in Children

NCT06558968 | Recruiting

• 1 other identifier: PED21-8D
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Compare two band and loop space maintainers made from two tooth colored materials; Polyetherethherketone (PEEK) and monolithic Zirconia (BruxZir) as regards to:

• Clinical performance of space maintainers in terms of frequency of debonding or fracture of the appliance and health of adjacent gingiva during a one-year follow up.
• Wear of the opposing teeth.

Conditions

Pediatric Dentistry

Outcome Measures

Primary Outcomes (2)

• Clinical performance

  regarding debonding or fracture of the appliance. if debonding or fracture occur then this means failure.

  1 year

• Gingival health

  Gingival Index of Loe and Silness. where score 0 indicates normal gingiva, score 1 mild inflammation (slight change in color, slight edema but no bleeding on probing. score 2 indicates moderate inflammation (redness, edema, bleeding on probing and score 3 refers to severe inflammation (marked redness, edema, ulceration with sponatnoeus bleeding.

  1 year

Secondary Outcomes (1)

• Wear of the opposing tooth

  1 year

Study Arms (2)

polyetheretherketone

ACTIVE COMPARATOR

PEEK 'Polyetheretherketone' Victrex® is a type of polymer with suitable mechanical and physical properties. It is a resilient material with high flexural strength and resistance to deformation. Therefore, it can be used in fixed prosthesis and space maintainers

Other: aesthetic functional space maintainers

monolithic zirconia

ACTIVE COMPARATOR

BruxZir® is a type of monolithic zirconia with higher flexural strength and fracture toughness than the classic zirconia and can withstand the changes in temperature in the oral cavity. Therefore it can be used as a space maintainer

Other: aesthetic functional space maintainers

Interventions

aesthetic functional space maintainers OTHER

evaluate the use of Polyetheretherketone 'PEEK' and monolithic zirconia 'Bruxzir' as esthetic functional band and loop space maintainers.

monolithic zirconia; polyetheretherketone

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children requiring bilateral extraction of mandibular first primary molars or those with previously extracted molars no more than 6 months prior to intervention (11) .
• Existence of teeth on the mesial and distal side of edentulous area.
• Angle's Class I molar relationship and/or flush terminal/mesial step primary molar occlusion
• No periapical and/ or furcural pathological condition related to abutment teeth.
• Presence of tooth germ of the succeeding tooth (mandibular first premolars).
• Presence of more than 1 mm of bone overlying the successor tooth germ

You may not qualify if:

• Carious abutment teeth requiring pulp therapy.
• Carious abutment primary teeth requiring a full coverage restoration.
• Patients with history of bruxism or/and clenching.
• Patients with medical, intellectual or physical disabilities.
• Patients with abnormalities as posterior cross-bite, open bite, and deep bite

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt

RECRUITING

Study Officials

• Nagwa Khattab, Professor

  Ainshams U

  STUDY DIRECTOR

Central Study Contacts

Hagar Abozeid, PhD

CONTACT

0201110611169; Hagar_abozeid_22@hotmail.com

Mariem Wassel, Professor

CONTACT

01064871416

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: articipants will be blinded to the type of intervention. Teeth treated will be assigned codes so that outcome evaluators at the follow up appointments are blinded. On the other hand, the operator/ primary investigator cannot be blinded, as she is already familiar with the nature of the materials used. For statistical analysis, codes will also assure blinding and confidentiality. For the patient, both types of space maintainers will have the same color and design.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: August 30, 2021
• First Posted: August 19, 2024
• Study Start: January 3, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: August 19, 2024

Record last verified: 2024-08

Locations

EG (1)