Health TrialsbyHealthPanel

Evaluation of PEEK and BruxZir as Esthetic Space Maintainers in Children

ConditionPediatric Dentistry
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-11
SponsorAin Shams University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • aesthetic functional space maintainers

    Other intervention

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

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: polyetheretherketoneActive comparator 1 intervention
Group B: monolithic zirconiaActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Clinical performance

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

Time frame
1 year
2

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.

Time frame
1 year

Secondary outcomes

1

Wear of the opposing tooth

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

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ain Shams University

Lead sponsor

Source ClinicalTrials.gov
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