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NCT Number: NCT06558968

Evaluation of PEEK and BruxZir as Esthetic Space Maintainers in Children

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.

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Key information

Conditions

Age range

6 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University

Cairo, Egypt

Location status: Recruiting

About this study

After extraction of the mandibular first primary molars in both mandibular quadrants, impressions will be taken with intraoral scanner. Then, it will be sent to the CAD/CAM laboratory to construct functional band and loop space maintainers using PEEK and monolithic zirconia 'BruxZir' blocks with proper shades.

After the fabrication of the space maintainers of both sides, they will be cemented with resin luting cement containing MDP monomer. Photographs will be taken after cementation for the space maintainers and the patient will be informed and educated about the oral hygiene measures. The parents will also be inquired to call if any discomfort, debonding or fracture of the appliances happens.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical inclusion criteria:
  • 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

Radiographic inclusion criteria:

  • 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

Exclusion criteria

  • 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

Treatment and study plan

aesthetic functional space maintainers

Other

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

Primary outcomes

  1. Clinical performance

    Time frame: 1 year

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

  2. Gingival health

    Time frame: 1 year

    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.

Secondary outcomes

  1. Wear of the opposing tooth

    Time frame: 1 year

    using CAD/CAM software Cerec software (Cerec 4.2, DentsplySirona, Bensheim, Germany)volumetric loss on the surfaces were calculated in the last follow up visit after 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Hagar Abozeid, PhD

CONTACT

[email protected]

0201110611169

Mariem Wassel, Professor

CONTACT

01064871416

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Evaluation of Polyetheretherketone and Monolithic Zirconia as Esthetic Functional Space Maintainers in Children (A Randomized Clinical Trial)

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 19, 2024
Registry last updated
Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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