| CTRI Number |
CTRI/2025/11/096828 [Registered on: 03/11/2025] Trial Registered Prospectively |
| Last Modified On: |
30/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of space maintainers used for childrens teeth |
|
Scientific Title of Study
|
Clinical Evaluation of Conventional Prefabricated and 3D-Printed Band and Loop Space Maintainers in Children: A Prospective Observational Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KANNEGANTI HIMASREE |
| Designation |
Post Graduate |
| Affiliation |
MNR DENTAL COLLEGE AND HOSPITAL |
| Address |
Room no 8 Department of Pedodontics and Preventive Dentistry MNR Dental college
MNR Nagar,Fasalwadi.
Medak
TELANGANA
502294
India |
| Phone |
7893108564 |
| Fax |
|
| Email |
himasreekanneganti@outlook.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SRIDHAR MUKTINENI |
| Designation |
Professor and HOD |
| Affiliation |
MNR DENTAL COLLEGE AND HOSPITAL |
| Address |
Room no 8 Department of Pedodontics and Preventive Dentistry MNR Dental college
MNR Nagar,Fasalwadi
Medak
TELANGANA
502294
India |
| Phone |
9393812081 |
| Fax |
|
| Email |
sridharneni@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SRIDHAR MUKTINENI |
| Designation |
Professor and HOD |
| Affiliation |
MNR DENTAL COLLEGE AND HOSPITAL |
| Address |
Room no 8 Department of Pedodontics and Preventive Dentistry MNR Dental college
MNR Nagar,Fasalwadi
Medak
TELANGANA
502294
India |
| Phone |
9393812081 |
| Fax |
|
| Email |
sridharneni@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no 8 Department of Pedodontics and Preventive Dentistry MNR Dental college
MNR Nagar,Fasalwadi 502294 |
|
|
Primary Sponsor
|
| Name |
KANNEGANTI HIMASREE |
| Address |
Room no 8 Department of Pedodontics and Preventive Dentistry MNR Dental college
MNR Nagar,Fasalwadi,502294 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr KANNEGANTI HIMASREE |
MNR dental college |
Room no 8, Department of pedodontics and preventive dentistry,MNR NAGAR, FASALWADI
Medak
TELANGANA |
7893108564
himasreekanneganti@outlook.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MNR Institutional committee clearance |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B949||Sequelae of unspecified infectiousand parasitic disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
commercially available pre-fabricated band and loop space maintainers |
A preformed stainless steel band of appropriate size was selected to achieve a snug fit around the abutment tooth. The stainless steel tube component was trimmed using stone burs to precisely match the edentulous space, and the loop was adjusted to the correct length and configuration. After verifying proper adaptation and spatial alignment without occlusal interference, the loop was inserted into the tube and crimped securely. The completed appliance was cemented using glass ionomer luting cement, followed by removal of excess material and assessment for fit and function |
| Intervention |
conventional band and loop space maintainers |
Following topical anesthesia for patient comfort, a stainless steel band (2-inch, 0.8 × 0.015") was carefully adapted around the abutment tooth. A polyvinyl siloxane (PVS) impression was taken with the band retained in position to ensure accurate reproduction during model fabrication using dental stone. A 19-gauge stainless steel wire was bent to form a loop spanning the edentulous space and soldered to the band. The appliance was finished and polished to ensure smooth margins and patient comfort. At the subsequent appointment, the space maintainer was evaluated intraorally for passive fit and occlusal harmony. Upon confirmation, it was luted with Xtra-Lute glass ionomer cement (Medicept Dental, Harrow, England, UK), and excess cement was removed. Final adjustments ensured secure retention and absence of occlusal interferences |
| Comparator Agent |
digitally fabricated 3D-printed band and loop space maintainers. |
Intraoral digital impressions of the full dental arch, including the edentulous space and adjacent anatomical structures, were captured using a Medit i700 intraoral scanner (Medit Corp., Seoul, South Korea). The scan data were exported as STL files and processed using Exocad Webview 1.6.18 software to determine the space dimensions and occlusal contacts. Bands (0.5 mm thickness) and loops (0.8–1.2 mm) were digitally designed to ensure passive fit, smooth contours, and optimal space maintenance. The components were fabricated using cobalt-chromium alloy via Selective Laser Sintering (SLS) in Chamlion NCL-M150X (Nanjing Chamlion Laser Technology Co., Ltd., Nanjing, China), followed by sandblasting and electro-polishing for surface refinement. At the next clinical visit, the appliance was evaluated intraorally for accuracy of fit and occlusion, then luted using glass ionomer cement. Excess cement was removed, and the appliance was confirmed to be stable, functional, and free of occlusal interference |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
systemically healthy children aged 4–8 years with early loss of primary molars due to caries or non-restorable lesions, presence of sound adjacent teeth, and radiographic confirmation of a developing permanent successor with at least 1 mm of bone coverage and less than one-third of root formation. |
|
| ExclusionCriteria |
| Details |
if they had poor oral hygiene, grossly carious adjacent teeth, local oral pathology, systemic conditions, or if they or their parents declined participation |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| prefabricated maintainers offer superior durability in terms of survival rate |
Follow-up visits were scheduled at 1st, 3rd, 6th, and 9th months to assess survival time, gingival health, and acceptance |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| secondary outcomes included gingival health evaluated using the Silness and Loe Gingival Index (1963), patient and parent acceptance assessed through the Likert scale (1932), and clinical fit and occlusal harmony evaluated at insertion and subsequent follow-ups. |
Follow-up visits were scheduled at 1st, 3rd, 6th, and 9th months to assess gingival health, and acceptance |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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
|
N/A |
|
Date of First Enrollment (India)
|
10/11/2025 |
| 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="0"
Months="9"
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 - NO
|
|
Brief Summary
|
The present study aimed to evaluate and compare the clinical performance of three types of band and loop space maintainers - Conventional, Pre-fabricated and 3D-printed over a 9-month follow-up period in pediatric patients. The evaluation was based on three key clinical parameters: gingival health, patient and parent acceptance, and appliance survival rate.
Throughout the study, gingival health remained favorable across all groups, with the 3D-printed and Conventional space maintainers maintaining 100% normal gingiva. A slight gingival response (10% mild gingivitis) was noted only in the Pre-fabricated group at the 9th month. This suggests that all three designs, when placed correctly and maintained properly, are biocompatible and gingiva-friendly. In terms of patient and parent acceptance, 3D-printed space maintainers consistently received the highest satisfaction ratings, with no discomfort reported at any follow-up. This can be attributed to the customized fit and smooth finish achieved through digital fabrication. On the other hand, initial discomfort was observed in both the prefabricated and Conventional groups at the 1-month follow-up, likely due to band tightness or adjustment issues.
Regarding the survival rate, the Pre-fabricated space maintainers performed the best, showing 100% retention over 9 months. The Conventional group followed closely, while the 3D-printed group showed minor early debonding issues, though these were not statistically significant and were likely due to adaptation challenges or bonding technique. Despite these, all three groups demonstrated generally good clinical longevity. Overall, the study highlights that each type of space maintainer has its own set of advantages. While Pre-fabricated maintainers are quick to place and highly durable, 3D-printed maintainers excel in comfort, gingival response, and digital precision. Conventional maintainers remain a dependable option but are more technique-sensitive and require lab work.
|