the Objective of This Research is to Compare the Clinical Effectiveness of the Conventional Lingual Arch Space Maintainers With Three-dimensional Printed Space Maintainers.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-9
SponsorSuez Canal University

About this trial

the objective of this research is to compare the clinical effectiveness of the conventional lingual arch space maintainers with three-dimensional printed space maintainers.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Apparently, healthy cooperative children have recently prematurely loss of more than one mandibular primary molar in any of the quadrants, full erupted mandibular first permanent molars in both sides, and whose lower permanent incisors have erupted

The permanent successors of the lost primary molars were not expected to erupt within 6 months

Angle's class 1 occlusion with normal primary molar relation

Caries-free and periodontally healthy abutment teeth

Disqualifiers

children exhibited poor oral hygiene, para-functional oral habits, severe crowding, space loss, and abnormal occlusion

Extraction of primary molars exceeding three months.

Radiographically, absence of permanent successor.

uncooperative children

Trial design

Design model

Parallel

Treatments tested in this trial

  • Conventional spacemaintainer

    Device

    Two bands will be selected and checked for fit and adaptation around the distal abutment teeth, then an alginate impression will be taken and will be sent to the laboratory for fabrication

  • 3D printed spacemaintainer

    Device

    An intraoral scan for the patients' lower arch will be taken using a 3D digital dental scanner.

Treatment groups

44 Participants
are divided into 2 treatment groups
Group A: Group IActive comparator 1 intervention
Group B: Group IIExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Patient satisfaction and pain experienced using the Wong-Baker Faces Test

Patient satisfaction and pain experienced during conventional and digital impression and cementation will be evaluated using the Wong-Baker Faces test and subsequently recorded for clinical satisfaction at 3 months, 6 months and 9 months for both patient groups to evaluate appliance acceptance and convenience for the patients.

Time frame
9 months
2

Gingival health will be evaluated using Sillness and Loe Gingival Index

gingival health will be evaluated by Sillness and Loe Gingival Index Evaluation of the gingival health according to the (GI) described by (Loe and Silness, 1963): Score Criteria for the Gingival Index 0 No inflammation. 1. Mild inflammation: slight redness, slight edema, no bleeding on probing. 2. Moderate inflammation: redness, edema, glazing, bleeding on probing. 3. Severe inflammation: marked redness and edema, ulceration, and a tendency of spontaneous bleeding.

Time frame
9 months

Secondary outcomes

1

Impression taking experience for the patient assessed by 6-questions survey

Questions Answer by Yes (√) or (No) × 1. Was the impression easy? 2. Did you feel nausea during impression taking? 3. Any malaise during impression taking ( bad taste,odour, foreign body)? 4. Did impression take short time? 5. Would you repeat this impression experience again? 6. Did you feel any stress during impression taking?

Time frame
Day 1

Other outcomes

Sponsors and contacts

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