Evaluation of 3D-printed Space Maintainers Versus Conventional Space Maintainer : a Randomized Clinical Trial

ConditionTooth Loss
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-8
SponsorCairo University

About this trial

This study aims to compare the clinical evaluation and patients' satisfaction of space maintainers produced by digital workflow using the 3D-printing method (3D-SMs) versus conventional band and loop space maintainers (C-SMs) produced by traditional methods.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Lower first permanent molar in active state of eruption

Patient and parent showing cooperation and compliance.

Medically free children.

According to space analysis available space is less than or equal to needed space

Disqualifiers

Children with previous allergies to stainless steel.

There was less than one year left for the permanent tooth to erupt (to prevent possible abutment toot loss)

The patient's oral hygiene is not sufficient and has periodontal problems (to accurately assess the periodontal effects)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 3D printed space maintainer

    Other intervention

    Digitally fabricated #d printed space maintainer

  • Conventional space maintainer

    Other intervention

    Stainless steel space maintains

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Conventional band and loop space maintainerActive comparator 1 intervention
Group B: 3D printed space maintainerExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Survival rate

Decementation, debonding, solder breakage, loop breakage, band breakage, and abutment tooth fracture will be evaluated clinically for both space maintainers

Time frame
1 year

Secondary outcomes

1

Gingival health of the abutment

Gingival index 0 = normal gingiva; 1 = mild inflammation: slight change in color, slight edema, no bleeding on probing; 2 = moderate inflammation: redness, edema, and glazing, or bleeding on probing; 3 = severe inflammation: marked redness and edema, tendency toward spontaneous bleeding

Time frame
0,6,12 months
2

Plaque accumulation on the abutment tooth

Plaque index Score 0: No Plaque Score 1:Thin plaque layer at the gingival margin, only detectable by scraping with a probe Score 2: Moderate layer of plaque along the gingival margin; interdental spaces free, but plaque is visible to the naked eye Score 3:Abundant plaque along the gingival margin; interdental spaces filled with plaque

Time frame
0,6,12 months
3

Patients' satisfaction about the impression technique

Five- question survey 1. "Was the impression easy and fun?" 2. "Did you have nausea during impression?" 3. "Did you feel any discomfort during the impression (taste, odor, foreign body)?" 4. "Did the impression take a short time?" 5. "Would you like to have this impression experience again?"

Time frame
Immediately after the im- pression/scanning

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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