Comparison between three space maintainers used in pediatric dentistry for preserving space for better eruption of permanent teeth.

Comparative evaluation of conventional band and loop s-omega wired bonded and glass fibre reinforced composite space maintainers in children aged 4-8 years: an in-vivo study. - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/03/106047

Enrollment

Registered

2026-03-12

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K006- Disturbances in tooth eruption Health Condition 2: 8- Other Procedures

Interventions

Intervention1: Modified Fixed Bondable Space Maintainer : An innovative design prepared from 20 gauge stainless steel wire to overcome the cons of conventional band and loop space maintainer Interven

Eligibility

Inclusion criteria

Inclusion criteria: CLINICAL CRITERIA: 1. Systemically healthy children. 2. Grossly mutilated single molars on either side, requiring extraction. 3. The absence of any parafunctional habits such as bruxism 4. Sound or healthy teeth adjacent to the extraction site 5. Absence of gingival infection or any pathological conditions around abutment teeth. 6. No abnormal dental conditions such as crossbite, deep bite or open bite. 7. The absence of pathologies, such as dental caries, fluorosis, enamel hypoplasia, and stainless steel crown or extensive restoration on the adjacent teeth. 8. Cooperation level is four according to Frankl Scale. RADIOGRAPHIC CRITERIA: 1. Presence of succedaneous tooth bud 2. Presence of atleast 1mm bone overlying the succedeneous tooth germ with less than 1/3rd of the root formed 3. Absence of periapical pathology 4. No pathology seen on the eruption way of the underlying permanent teeth 5. Abutment teeth do not have any endodontic treatments

Exclusion criteria

Exclusion criteria: 1. Grossly carious teeth were adjacent to the created space 2. Absence of teeth on the mesial or distal side of the teeth to be extracted. 3. Multisurface caries on the abutment teeth 4. Pre-existing co-morbidity 5. Abutment teeth do not have any endodontic treatments 6. Uncooperative children.

Design outcomes

Primary

Measure	Time frame
Painless treatment, better durability and good gingival health using space maintainers categorized under intervention groups Timepoint: 1 Month, 3 Months and 6 Months	—

Secondary

Measure	Time frame
Effective Space Maintenance ResultsTimepoint: 1 Month, 3 Months & 6 Months	—

Countries

India

Contacts

Public ContactDr Debapriya Pradhan

Hitkarini Dental College and Hospital

kns1397@gmail.com08319186110

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 4, 2026