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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Conventional spacemaintainer
DeviceTwo 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
DeviceAn intraoral scan for the patients' lower arch will be taken using a 3D digital dental scanner.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
Secondary outcomes
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?
Sponsors and contacts
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