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CTRI Number  CTRI/2024/08/071999 [Registered on: 06/08/2024] Trial Registered Prospectively
Last Modified On: 13/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effectiveness of Traditional vs. 3D-Printed Dental Space Maintainers: A Comparative clinical Study 
Scientific Title of Study   Clinical efficacy of conventional and digital 3D fabricated band and loop space maintainer: a randomized controlled 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  Dr UMAMAHESWARI S 
Designation  Post graduate student 
Affiliation  Adhiparasakthi Dental College and Hospital 
Address  Room no:6,first floor,Department of Pediatric and Preventive Dentistry,Adhiparasakthi Dental College and Hospital,Melmaruvathur

Kancheepuram
TAMIL NADU
603319
India 
Phone  9677573058  
Fax    
Email  umasakthivel216@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vasanthakumari A 
Designation  Professor and Head  
Affiliation  Adhiparasakthi Dental College and Hospital 
Address  Room no:6,first floor,Department of Pediatric and Preventive Dentistry,Adhiparasakthi Dental College and Hospital,Melmaruvathur

Kancheepuram
TAMIL NADU
603319
India 
Phone  9443615196  
Fax    
Email  vkpedo@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr UMAMAHESWARI S 
Designation  Post graduate  
Affiliation  Adhiparasakthi Dental College and Hospital 
Address  Room no:6,first floor,Department of Pediatric and Preventive Dentistry,Adhiparasakthi Dental College and Hospital,Melmaruvathur

Kancheepuram
TAMIL NADU
603319
India 
Phone  9677573058  
Fax    
Email  umasakthivel216@gmail.com  
 
Source of Monetary or Material Support  
Adhiparasakthi Dental College and Hospital and Dental camps, Room no:6,first floor, Department of Pediatric and Preventive Dentistry, Adhiparasakthi Dental College and Hospital, Melmaruvathur, Kancheepuram district-603319,Tamilnadu,India. 
 
Primary Sponsor  
Name  Dr UMAMAHESWARI S 
Address  Room no:6,first floor, Department of Pediatric and Preventive Dentistry, Adhiparasakthi Dental College and Hospital, Melmaruvathur-603319 
Type of Sponsor  Other [Self funded] 
 
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 UMAMAHESWARI S  Adhiparasakthi dental college and hospital  Room no:6,first floor, Department of Pediatric and Preventive Dentistry, Adhiparasakthi Dental College and Hospital, Melmaruvathur-603319.
Kancheepuram
TAMIL NADU 
9677573058

umasakthivel216@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Adhiparasakthi dental college and hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K084||Partial loss of teeth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Space Maintainer  In the clinical evaluation of space maintenance, the band will be made and impression will be taken, and then the band will be stabilized and cast will be made. A loop will be made with 19 gauge wire, soldered to the band. The appliance will be checked for interferences and then will be cemented. Following the cementation, the patient will be scheduled for recalls at 1, 3, and 6 months for evaluation of survival rate, caries, gingival health, and patient satisfaction. 
Intervention  Digital 3D fabricated Band and Loop Space Maintainer  In the clinical evaluation of space loss, digital intraoral radiographs will be taken. Intraoral scanning for both upper and lower arches, along with bite registration, will be performed. The space maintainer will be designed using EXOCAD software using CO-CR powder alloy via additive manufacturing. Once designed, the appliance will be checked for interferences and then will be cemented. Following the cementation, the patient will be scheduled for recalls at 1, 3, and 6 months for assessment of survival rate, presence of caries, gingival health, and satisfaction with the space maintainer. 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  1) Systemically healthy children.
2) Grossly mutilated single molars on either side, requiring extraction.
3) Freshly extracted single molars bilaterally in the same arch or opposite arch. Sound and healthy teeth adjacent to the extraction site.
4) No abnormal dental conditions such as cross bite, open bite, and deep bite.
 
 
ExclusionCriteria 
Details  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.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
All cause morbidity at 6 months. The clinical efficacy(survival rate) and gingival health of conventional Band and Loop versus digital 3D fabricated Band and Loop Space Maintainer   At Baseline ,1 month, 3months,6 months 
 
Secondary Outcome  
Outcome  TimePoints 
All cause morbidity at 6 months. Patient satisfaction and cooperativeness (Likert scale)  At Baseline ,1 month, 3months,6 months 
 
Target Sample Size   Total Sample Size="38"
Sample Size from India="38" 
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 3/ Phase 4 
Date of First Enrollment (India)   15/08/2024 
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="0"
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  

Introduction:

Exfoliation of primary teeth and eruption of permanent teeth is a normal physiological process. When this normal process is disrupted, due to factors like premature loss of primary teeth, proximal carious lesions it may lead to mesial migration of teeth resulting in loss of arch length which may manifest as malocclusion in permanent dentition in the form of crowding, impaction of permanent teeth, supraeruption of opposing teeth.Primary teeth are

considered to be the best space maintainer under normal physiological conditions. However, in cases with premature loss of primary teeth, the best way to prevent future malocclusion would be to place an effective, affordable, and perdurable space maintainer.Band and loops has been used since long as a space maintainer with good high success rates but inspite of good patient compliance, disintegration of cement, solder failure, caries formation along the margins of the band and loop construction time are some of the disadvantages associated with them. Intra oral scanning is one of the recent advances which provides patient comfort with high imaging accuracy. This intraoral scanning can be done at ease even in very uncoperative children. Meanwhile the computer aided designing provides precise fit and isfabricated as a single unit which further reduces the laboratory errors.

Objectives:

The primary outcome of the study is to compare the clinical efficacy and gingival health of conventional Band and Loop versus digital 3D fabricated Band and Loop Space Maintainer

Patient satisfaction and the coperativeness is measured as the secondary outcome.

MATERIALS AND METHODS:

This study is a comparative study. Patients in the age range of 4 to 9 years visiting the Out- patient Department of Pediatrics and Preventive Dentistry, APDCH,, wIll be screened and the patients who either required extraction of the primary first/second molar or having pre-extracted primary 1st or 2nd molar in any of the arches will be selected for the purpose of study. These patients will be  further screened on the basis of inclusion criteria.A brief history will be  recorded and clinical examination will be  done. Intraoral periapical radiographs will be  taken in areas of tooth loss. Study models will be  prepared, and space analysis will be  carried out for every child. For every selected child, oral prophylaxis will be done prior to placement of space maintainer. Thirty-six patients will be selected, and these children were further divided into  2 groups .

Group 1(19) patients -Conventional band and loop.

Group 2 (19) patients - Digital 3D Fabricated Band and Loop .

A conventional Band and Loop was fabricated according to the technique described by finn .

Digital 3D Fabricated Band and Loop was made by DMLS using Co-Cr alloy.

 Assessment of clinical performance to be evaluated at 1 month 3 months 6 months  in terms of survival rate ,caries,gingival health and patient satisfaction and cooperativeness.

 

SOURCE OF SAMPLE TO BE TAKEN:

Out patients from the Department of Pediatric and Preventive dentistry, Pediatric dental out patient(MAPIMS), school dental camps.

INCLUSION CRITERIA

1)      Systemically healthy children.

2)      Grossly mutilated single molars on either side, requiring extraction.

3)      Freshly extracted single molars bilaterally in the same arch or opposite arch. Sound and healthy teeth adjacent to the extraction site.

4)      No abnormal dental conditions such as cross bite, open bite, and deep bite.

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.

 

Methodology:

Group 1 -Conventional band and loop space maintainer

Clinical evaluation of space loss will be assessed.Digital Intraoral periapical radiographs will be taken in the areas of tooth loss A 0.180×0.005 inch thickness of band material was taken and a ring was made. This band material was seated in the patient’s mouth with a band pusher and contoured with a Johnsons contouring plier and then a straight hoe was used to approximate the ends of ring . This ring was then pinched as close to tooth surface as possible and then spot welded .This band was then seated in patient’s mouth and excess band material was cut off with band cutting scissors . The remaining band material was adapted along the contours of band . Band was then festooned and trimmed and ensured that the band coveredthe entire surface of tooth.Impression was made with alginate, band was removed from the patient’s mouth with a band removing plier and was stablised in impression and then it was poured in dental stone. A loop was then made with a stainless steel 19 gauge wire using universal plier and it followed the contours of the gingiva. The loop spanned the edentulous area to contact abutment just below the contact point. The buccolingual width of the loop was such to permit the eruption of the cusps of the underlying permanent tooth. A silver solder was used to solder loop with the band at the middle one-third.The appliance was checked for any occlusal or gingival interferencesinterference prior to cementation.

 

 

 

Group 2- Digital 3D fabricated band and loop space maintainer

Clinical evaluation of the space loss will be assessed. Digital intraoral periapical radiographs will be taken in the areas of tooth loss. Intraoral scanning will be done using the intraoral scanner for upper and lower arch along with the bite .Then the scanned STF will be send to the EXOCAD software in which designing of the space maintainer will be made following which the space maintainer is fabricated accordingly. The designed space maintainer will be luted using resin modified GIC. Instructions for oral hygiene and appliance maintenance were given to the children and parents.

Statistical analysis: Chi-square test and P value will be performed

 

Clinical efficacy outcome:

Survival Rate

The survival rate was checked as per following comparable criteria 4(Tulonglu O et al (2005)

Lost to follow-up (LF):Patients who were non-complaint with a regular follow up schedule.

Failed (F):Patients who returned after insertion of the appliance before the first appointment at the third month due to the loss or breakage of the appliance or the lack of willingnesss to wear the appliances.The appliance deteriorated either as a consequence of the degradation in cement breakages at the loop or soldered parts, or soft tissue lesions.

Successful (S):Those patients who wore their appliances and were still under observation until the eruption of permanent teeth and adhered to the recall schedule.

Censored at the end of study (C): Those patients whose appliance were inserted at dates close to the ending date of the study and who were successfully wearing their appliance at that time.

Caries

The presence of dental caries was checked visually and with a explorer at 1, 3, 6, 12 months according to the following scale:

Presence of caries – ‘P’

Absence of caries – ‘A’

Gingival Health

Plaque deposition of the abutment tooth of the space maintainer was evaluated according to the index used by Sillness and Loe H.Implications:

The clinical efficacy of digital 3D fabricated band and loop space maintainer will be non inferior to conventional band and loop space maintainer. Patient co-operation and satisfaction will be more in digital 3D fabricated band and loop space maintainer in comparison with conventional band and loop space maintainer.

References:

1) 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

2) Tokuc M, Yilmaz H. Comparison of fit accuracy between conventional and CAD/CAM- fabricated band-loop space maintainers. Int J Paediatr Dent. 2022 Sep;32(5):764-771.

3) Setia V, Kumar Pandit I, Srivastava N, Gugnani N, Gupta M. Banded vs Bonded Space Maintainers: Finding Better Way Out. Int J Clin Pediatr Dent. 2014 May-Aug; 7(2): 97–104.

4) Tulunoglu O, Ulusu T, Genç Y. An evaluation of survival of space maintainers: a six-year follow-up study. J Contemp Dent Pract. 2005 Feb 15;6(1):74-84.

 

 
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