CTRI

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CTRI Number

CTRI/2025/08/093067 [Registered on: 14/08/2025] Trial Registered Prospectively

Last Modified On:

13/08/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Dentistry

Study Design

Randomized, Parallel Group Trial

Public Title of Study

Comparative evaluation of 3D Zirconia vs Prefabricated Band and loop space maintainers in children aged 4-10 years

Scientific Title of Study

Comparative Evaluation of Clinical Outcomes of Band and loop Space Maintainers: Prefabricated vs 3D Designed Zirconia in Children of Aged 4-10 years– Randomised Controlled Trial (Academic Trial)

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Ginjupalli Laharee
Designation	Junior Resident
Affiliation	AIIMS Mangalagiri
Address	Room no 444,Fourth floor, Department of Dentistry, OPD Block, AIIMS Mangalagiri, Guntur, 522503. Guntur ANDHRA PRADESH 522503 India
Phone	9849267185
Fax
Email	m02jan025018@aiimsmangalagiri.edu.in

Details of Contact Person
Scientific Query

Name	DrCheranjeevi Jayam
Designation	Additional professor
Affiliation	AIIMS MANGALAGIRI
Address	Room no 444,Fourth floor, Department of Dentistry, OPD Block, AIIMS Mangalagiri, Guntur, 522503. Guntur ANDHRA PRADESH 522503 India
Phone	8894337313
Fax
Email	drjayam.dental@aiimsmangalagiri.edu.in

Details of Contact Person
Public Query

Name	Ginjupalli Laharee
Designation	Junior Resident
Affiliation	AIIMS Mangalagiri
Address	Room no 444,Fourth floor, Department of Dentistry, OPD Block, AIIMS Mangalagiri, Guntur, 522503. Guntur ANDHRA PRADESH 522503 India
Phone	9849267185
Fax
Email	m02jan025018@aiimsmangalagiri.edu.in

Source of Monetary or Material Support

AIIMS Mangalagiri

Primary Sponsor

Name	AIIMS MANGALAGIRI
Address	AIIMS MANGALAGIRI, Mangalagiri, Andhra Pradesh, 522503.
Type of Sponsor	Research institution and hospital

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Ginjupalli Laharee	AIIMS MANGALAGIRI	Room no 444, Dental Departmentm 4th floor,AIIMS Mangalagiri, Mangalagiri, Guntur, Andhra Pradesh, 522503 Guntur ANDHRA PRADESH	9849267185 m02jan025018@aiimsmangalagiri.edu.in

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
All India Institute of Medical Sciences, Mangalagiri, Andhra Pradesh	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: K029\|\|Dental caries, unspecified,

Intervention / Comparator Agent

Type	Name	Details
Intervention	3D Designed Zirconia	Digital impression of the dental arch is acquired using intraoral scanner, exported to the computer-aided design (CAD) software as an STL file, printed using pre sintered zirconia
Comparator Agent	Prefabricated	prefabricated band with the tube will be selected and trial fitted based on the mesiodistal width of the abutment tooth and preformed loop is selected and adjusted

Inclusion Criteria

Age From	4.00 Year(s)
Age To	10.00 Year(s)
Gender	Both
Details	CLINICAL CRITERIA: 1.Child within the age group of 4-10 2.Single primary tooth loss requiring space maintenance programme 3.Otherwise healthy children 4.Sound abutment teeth RADIOGRAPHIC CRITERIA: 5.Presence of succedaneous tooth 6.Presence of more than 1mm bone covering succedaneous tooth radiographically 7.Less than two-thirds of root formation with succedaneous tooth.(Up to Nollas stage 8)

ExclusionCriteria

Details

1.Children with known systematic illness contraindicating placement of band and loop space maintainer
2.Grossly decayed abutment teeth
3.Cases requiring long band and loop space maintainer
4.High caries index
5.Children with poor oral hygiene
6.Multiple carious teeth in same quadrant
7.Prolonged loss of teeth which may need for any space regaining schedule
8.Abnormal sequence of eruption
9.Patient with developing class II and class III malocclusion
10.Presence or anticipated arch length and tooth size discrepancy
11.Otherwise abnormal functional and muscular oral activity

Method of Generating Random Sequence

Permuted block randomization, variable

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
To evaluate space maintenance efficiency of 3D Designed space maintainer versus Prefabricated band and loop space maintainer assessed by comparing the mesiodistal spaces pre- and post- 9 months follow-up (3, 6, 9 months) taken from intraoral scans.	At the time of procedure, At 3 months, At 6 months, At 9 months.

Secondary Outcome

Outcome	TimePoints
To analyse survival rates of other clinical outcomes (De-cementation, Loop Breakage, Band Breakage, & Secondary Caries) over 9 months (3, 6, 9 months).	At the time of procedure, At 3 months, At 6 months, At 9 months.
To evaluate most common type of failure associated with 3D Designed band & loop space maintainer & prefabricated band & loop space maintainer over 9 months(3, 6, 9 months).	At the time of procedure, At 3 months, At 6 months, At 9 months.

Target Sample Size

Total Sample Size="46"
Sample Size from India="46"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

Phase 4

Date of First Enrollment (India)

27/08/2025

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="1"
Months="6"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - YES

What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identiﬁcation (text, tables, ﬁgures, and appendices).

What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.

For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.

By what mechanism will data be made available?
Response - Proposals should be directed to [m02jan025018@aiimsmangalagiri.edu.in].

For how long will this data be available start date provided 08-06-2027 and end date provided 08-06-2032?
Response - Beginning 3 months and ending 5 years following article publication.

Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL

Brief Summary

This is a prospective, randomized, parallel clinical trial conducted in a pediatric dental setting. The study aims to compare the effectiveness of 3d Designed zirconia band and loop space maintainer and prefabricated band and loop space maintainer in children on aged 4 to10 years.participants are randomly allocated into two groups such as interventional group 3D Designed zirconia band and loop space maintainer and comparator group of prefabricated band and loop space maintainer of 23 each, evaluation of space maintainence efficiency and other clinical outcomes such as decementation, band breakage, loop breakage, secondary caries over 9 months at followup visits of 3, 6, 9, months. The study will help to identify the effective space maintainer for children. A total of 46 participants will be enrolled at a single centre in India