Gingival HealthNCT07591324
the Objective of This Research is to Compare the Clinical Effectiveness of the Conventional Lingual Arch Space Maintainers With Three-dimensional Printed Space Maintainers.
A study testing Conventional spacemaintainer and 3D printed spacemaintainer in people with Gingival Health and Space Maintenance, run by Suez Canal University at 1 site in Egypt.
Trial summary
the objective of this research is to compare the clinical effectiveness of the conventional lingual arch space maintainers with three-dimensional printed space maintainers. Read more about this study
- Who is it for?
- Ages 7 to 9 years
- Conditions the study is for
- Gingival Health, Space Maintenance, Pain and Anxiety
- What is being tested?
- Conventional spacemaintainer and 3D printed spacemaintainer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Jan 2025to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
- Absence of parafunctional habits or abnormal occlusion conditions such as crossbite, open bite, or deep bite.
- Children's age ranges from 7 to 9 years-old
- Radiographically, presence of permanent successors, more than one millimeter of bone covering the successor tooth germ, and/or only about one-third of the root of the permanent tooth has been formed.
- Parents and children were accepting the new treatment modality.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Suez Canal University
Ismailia, Ismailia Governorate, 41522
Reham M. Principle investigator, Assistant professor, 0545318171, reham_mohamed@dent.suez.edu.eg
Rim M. Co-investigator, Lecturer
About this study
Official title: Comparative Evaluation of the Conventional and Three-Dimensional Printed Lower Lingual Arch Space Maintainers A Randomized Clinical 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.
Read the detailed description
Introduction and Review of literature Primary teeth serve to preserve inborn space until permanent teeth erupt, in addition they help with speech and mastication. It is appropriate to highlight the primary dentition's function as the best space maintainer for permanent teeth. It is possible that premature primary tooth loss will cause undesirable primary and permanent tooth movements, including a loss in arch length. If there is not enough arch length, it is more likely to predict malocclusions such as crowding and ectopic eruption as well as tooth impaction.
Since the largest space loss occurs within a month of losing the deciduous teeth, it is best to use a space maintainer as soon as possible after early tooth loss. Space maintainers are the orthodontic appliance of choice for preventing space loss because they preserve space within the oral cavity.
Conventional space maintainers have significant drawbacks despite their clinical effectiveness. These include the need for patient compliance, extended chairside times, multiple steps in the fabrication process, technique-sensitive impressions and lab procedures, solder failure, and caries formation at band margins.
These disadvantages in the conventional space maintainer recommend the need for more advanced appliance designs and materials, one of which is three-dimensional (3D) printing, The process involves creating 3D objects using a digitally scanned and layered design of the entire object. The design is preserved using a "Standard Tessellation Language" (STL) file.
So, the objective of this research is to compare the clinical effectiveness of the conventional lingual arch space maintainers with three-dimensional printed space maintainers.
- Conditions
- Gingival Health, Space Maintenance, Pain and Anxiety
- Being tested
- Conventional spacemaintainer, 3D printed spacemaintainer
- Keywords
- lingual arch spacemaintainer, 3D printed spacemaintainer
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional spacemaintainerDevice
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 spacemaintainerDevice
An intraoral scan for the patients' lower arch will be taken using a 3D digital dental scanner.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Active comparator | Conventional spacemaintainer Receives: Device: Conventional spacemaintainer |
| Group II | Experimental | 3D printed spacemaintainer Receives: Device: 3D printed spacemaintainer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9 months
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.
- Mild inflammation: slight redness, slight edema, no bleeding on probing.
- Moderate inflammation: redness, edema, glazing, bleeding on probing.
- Severe inflammation: marked redness and edema, ulceration, and a tendency of spontaneous bleeding.
Measured: 9 months
Secondary outcomes (1)
Impression taking experience for the patient assessed by 6-questions survey
Questions Answer by Yes (√) or (No) ×
- Was the impression easy?
- Did you feel nausea during impression taking?
- Any malaise during impression taking ( bad taste,odour, foreign body)?
- Did impression take short time?
- Would you repeat this impression experience again?
- Did you feel any stress during impression taking?
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start22 Jan 2025
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gingival HealthStudies of the same condition, open and under way.
- More trials run by Suez Canal UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham Mohamed, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07591324
- Sponsor's protocol ID
- 930/2024
- Other IDs
- Organization's Unique Protocol
- Status last verified
- Dec 2025
- First submitted
- 21 Dec 2025
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: may be after publishing
Publications
Garg A, Samadi F, Jaiswal JN, Saha S. 'Metal to resin': a comparative evaluation of conventional band and loop space maintainer with the fiber reinforced composite resin space maintainer in children. J Indian Soc Pedod Prev Dent. 2014 Apr-Jun;32(2):111-6. doi: 10.4103/0970-4388.130783.
PubMed 24739908
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of the Conventional and Three-Dimensional Printed Lower Lingual Arch Space Maintainers A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07591324
- Acronym / sponsor ID
- 930/2024
- Conditions
- Gingival Health, Space Maintenance, Pain and Anxiety
- Keywords
- lingual arch spacemaintainer, 3D printed spacemaintainer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 22 Jan 2025 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 15 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
the objective of this research is to compare the clinical effectiveness of the conventional lingual arch space maintainers with three-dimensional printed space maintainers.
Detailed description
Introduction and Review of literature Primary teeth serve to preserve inborn space until permanent teeth erupt, in addition they help with speech and mastication. It is appropriate to highlight the primary dentition's function as the best space maintainer for permanent teeth. It is possible that premature primary tooth loss will cause undesirable primary and permanent tooth movements, including a loss in arch length. If there is not enough arch length, it is more likely to predict malocclusions such as crowding and ectopic eruption as well as tooth impaction.
Since the largest space loss occurs within a month of losing the deciduous teeth, it is best to use a space maintainer as soon as possible after early tooth loss. Space maintainers are the orthodontic appliance of choice for preventing space loss because they preserve space within the oral cavity.
Conventional space maintainers have significant drawbacks despite their clinical effectiveness. These include the need for patient compliance, extended chairside times, multiple steps in the fabrication process, technique-sensitive impressions and lab procedures, solder failure, and caries formation at band margins.
These disadvantages in the conventional space maintainer recommend the need for more advanced appliance designs and materials, one of which is three-dimensional (3D) printing, The process involves creating 3D objects using a digitally scanned and layered design of the entire object. The design is preserved using a "Standard Tessellation Language" (STL) file.
So, the objective of this research is to compare the clinical effectiveness of the conventional lingual arch space maintainers with three-dimensional printed space maintainers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Device: Conventional spacemaintainerConventional spacemaintainer |
| Group II | Experimental | Device: 3D printed spacemaintainer3D printed spacemaintainer |
Who may qualify
- Ages
- 7 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
- Absence of parafunctional habits or abnormal occlusion conditions such as crossbite, open bite, or deep bite.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional spacemaintainerTwo 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 | Device | Group I |
| 3D printed spacemaintainerAn intraoral scan for the patients' lower arch will be taken using a 3D digital dental scanner. | Device | Group II |
Primary outcome
Patient satisfaction and pain experienced using the Wong-Baker Faces Test
Time frame: 9 months
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
Time frame: 9 months
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.
1 secondary outcome
Impression taking experience for the patient assessed by 6-questions survey
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Background: PubMed 24739908Garg A, Samadi F, Jaiswal JN, Saha S. 'Metal to resin': a comparative evaluation of conventional band and loop space maintainer with the fiber reinforced composite resin space maintainer in children. J Indian Soc Pedod Prev Dent. 2014 Apr-Jun;32(2):111-6. doi: 10.4103/0970-4388.130783.
- Individual participant dataSharing planned: No. may be after publishing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional spacemaintainer and 3D printed spacemaintainer in people with Gingival Health and Space Maintenance, run by Suez Canal University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Reham M. Assistant Professor, PhD (+966545318171, reham_mohamed@dent.suez.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction and pain experienced using the Wong-Baker Faces Test (time frame: 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07591324, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.