| CTRI Number |
CTRI/2023/03/050536 [Registered on: 10/03/2023] Trial Registered Prospectively |
| Last Modified On: |
24/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
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A split mouth clinical trial to compare and evaluate clinical and radiographic success, gum health and adhesion of S.Mutans bacteria to metal and tooth coloured crowns in childrens teeth. |
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Scientific Title of Study
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Comparative evaluation of clinical and
radiographic success, gingival health and adhesion of S.Mutans to stainless steel and zirconia crowns in primary molars: A split mouth clinical trial study. |
| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr VAISHNAVI KAMATH K |
| Designation |
POST GRADUATE STUDENT- DEPT OF PEDIATRIC AND PREVENTIVE DENTISTRY |
| Affiliation |
GOVERNMENT DENTAL COLLEGE AND RESEARCH INSTITUTE, BENGALURU |
| Address |
Room no. 5, Department of Pediatric and Preventive dentistry, Government Dental College and Research Institute, Victoria Hospital campus, Kalasipalayam, near City Market, Bengaluru, Karnataka
Bangalore
KARNATAKA
560002
India |
| Phone |
7795357599 |
| Fax |
|
| Email |
vaishnavikamathk97@gmail.com |
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Details of Contact Person
Scientific Query
|
| Name |
Dr S K SRINATH |
| Designation |
PROF. AND HEAD OF THE DEPT OF PEDIATRIC AND PREVENTIVE DENTISTRY |
| Affiliation |
GOVERNMENT DENTAL COLLEGE AND RESEARCH INSTITUTE, BENGALURU |
| Address |
Room no.5, Department of Pediatric and Preventive Dentistry, Government Dental College and Research Institute, Victoria Hospital campus, Kalasipalayam, near City Market, Bengaluru, Karnataka
Bangalore
KARNATAKA
560002
India |
| Phone |
9845592166 |
| Fax |
|
| Email |
srinath.krishnappa@yahoo.com |
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Details of Contact Person
Public Query
|
| Name |
Dr SASALAWAD SHILPA |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
GOVERNMENT DENTAL COLLEGE AND RESEARCH INSTITUTE, BENGALURU |
| Address |
Room no.5, Department of Pediatric and Preventive dentistry, Government Dental College and Research Institute, Victoria Hospital campus, Kalasipalayam, near City Market, Bengaluru, Karnataka
Bangalore
KARNATAKA
560002
India |
| Phone |
8105779808 |
| Fax |
|
| Email |
shilpa.sasalawad@gmail.com |
|
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Source of Monetary or Material Support
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| DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY,GOVERNMENT DENTAL COLLEGE AND RESEARCH INSTITUTE,VICTORIA HOSPITAL CAMPUS, NEAR CITY MARKET, KALASIPALAYAM,BENGALURU 560002 |
| DEPT OF MICROBIOLOGY, BOWRING AND LADY CURZON HOSPITAL,LADY CURZON ROAD, SHIVAJI NAGAR, BENGALURU 560001 |
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Primary Sponsor
|
| Name |
Dr. VAISHNAVI KAMATH K |
| Address |
Government dental college and Research Institute, Victoria Hospital campus, Kalasipalayam, near City Market, Bengaluru, Karnataka, 560002 |
| Type of Sponsor |
Other [SELF] |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vaishnavi Kamath K |
Government Dental College and Research Institute |
Room no 5: Department of Pediatric and Preventive dentistry, Government Dental College and Research Institute, Victoria Hospital Campus, Kalasipalayam, near City Market
Bangalore
KARNATAKA |
7795357599
vaishnavikamathk97@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee of Government Dental College and Research Institute |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
25 children in the age group of 6-9 years who have received pulp therapy (IPC, pulpotomy and
pulpectomy) or with multi surface carious lesions of primary mandibular molars, bilaterally. |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, (2) ICD-10 Condition: K040||Pulpitis, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Comparator Agent |
Stainless steel crowns |
A split mouth study design will be adopted with 25 participants, who will receive stainless steel crowns on
one of the primary mandibular molars. |
| Intervention |
Zirconia crowns |
A split mouth study design will be adopted with 25 participants, who will receive zirconia crowns on
one of the primary mandibular molars. |
|
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Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
Healthy, Co-operative patients aged 6–9 years with primary mandibular molars treated with pulp therapy (IPC, Pulpotomy, Pulpectomy) or with multi-surface carious lesions, bilaterally. |
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| ExclusionCriteria |
| Details |
Tooth with internal resorption and root resorption.
Patients with very poor oral hygiene.
Patients with known allergy to nickel and local anaesthetic solutions |
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Method of Generating Random Sequence
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Not Applicable |
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Method of Concealment
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Not Applicable |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
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| Outcome |
TimePoints |
| Clinical and radiographic success of Zirconia crowns in comparison to Stainless steel crowns. |
Clinical success - 1,3,6,12 months
Radiographic success - at placement and 12 months |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Adhesion of S. Mutans to Zirconia crowns in comparison to Stainless steel crowns. |
6 & 12 months |
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Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
Final Enrollment numbers achieved (Total)= "25"
Final Enrollment numbers achieved (India)="25" |
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Phase of Trial
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N/A |
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Date of First Enrollment (India)
|
15/03/2023 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
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Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
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Publication Details
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None yet |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
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NEED FOR STUDY: Preservation of primary teeth is essential to ensure normal development of the child. Deeply decayed primary teeth require endodontic treatment and comprehensive restoration. Stainless steel crowns are widely used and are very popular in paediatric dentistry due to its superiority and durability compared to multi surface amalgam restorations. However, the major disadvantage is poor esthetics. Aesthetic management of primary teeth has become essential, as parents are more involved in the clinical decision-making and are more demanding of aesthetic restorations. Zirconia crowns have been used for over two decades in permanent dentition with high acceptability. In 2008, EZ Pedo introduced the first commercially available paediatric zirconia crown. Advantages of zirconia crown are excellent aesthetics, biocompatibility and full coverage of the treated tooth. Adhesion and colonization of oral microbes on tooth surfaces and restorations is crucial in the development of secondary caries and periodontal disease. Hence, evaluation of S. mutans adhesion to tooth surfaces and restorative materials is of most importance for their success. Keeping in mind the paucity of literature, this study is designed to explore clinical and radiographic success, gingival health and adhesion of S. Mutans to zirconia crowns against the Stainless-Steel Crowns in primary molars. Research Question: Are Zirconia crowns better than stainless steel crowns in terms of clinical and radiographic success, gingival health maintenance and lowered adhesion of S. Mutans in primary molars? Research Hypothesis: Zirconia crowns are better than stainless steel crowns in terms of clinical and radiographic success, gingival health maintenance and lowered adhesion of S. Mutans in primary molars. METHODOLOGY: • 25 children of age group 6-9 years who fulfil the inclusion criteria will be enrolled for the study, procedure will be carefully explained and informed consent will be obtained from parents. • A split mouth design will be adopted where all patients will receive Stainless steel crowns (Group A) and Zirconia crowns (Group B) on either side primary mandibular molars which will be randomly assigned. • Oral prophylaxis will be done prior to crown placement and oral hygiene instructions will be given and reinforced at every visit. • The tooth preparation and crown placement will be done by a single operator trained in the field of Pediatric dentistry. • Local anesthetic will be administered prior to preparation of the tooth in both Group A and Group B. • Occlusion will be checked followed by rubber dam application. • Group A- Tooth preparation for Stainless Steel crowns (SSC) will be done by reducing the occlusal surface uniformly by 1–1.5 mm using a No.169L bur. The interproximal reduction of the mesial and distal surfaces will be done using the long-tapered bur. The line angles will be rounded off. The buccal and lingual surfaces will not be reduced as they serve as a retentive feature. A feather edge finish line will be given. The SSC will be selected by trial-and-error method. The crown will be trimmed accordingly using a green stone bur. The crown will be adapted by contouring and crimping with the use of pliers. Once the snap fit is obtained, the crown will be cemented using Type I GIC. Consistent finger pressure will be placed while waiting for the cement to set. The excess cement will be removed with a sharp explorer buccally and lingually and with the help of dental floss proximally, and the occlusion will be checked. • Group B, Crown size will be selected according to the mesiodistal width of the teeth prior to crown preparation. Occlusal reduction of 1 to 1.5 mm will be done using No.169L bur. Tapered diamond bur will be used for proximal reduction. The tooth will be trimmed circumferentially by 0.5 to 1.25 mm as per requirement. Feather edge finish line will be given. The point angles and line angles will be rounded with 169L bur and trial fit of the crown will be done. Followed by cementation with dual cure resin cement according to manufacturer’s instructions. • The performance of the 2 crowns will then be evaluated for clinical success and gingival health at 1,3,6 and 12 months follow up respectively. The crowns will be evaluated for clinicals success and gingival health using customised scoring criteria prepared using previous studies. | Crown retention | 0 = yes 1 = no | | Stain resistance | 0 = no change 1 = minor staining 2 = noticeable staining | | Surface abrasion of the antagonist teeth | 0 = no abrasion 1 = minor abrasion of the cusps 2 = abrasion more than on the cusps | | Position of the crowns regarding gingival margin | 0 = subgingival 1 = supragingival | | Occlusion | 0 = contact (marked or superficial) 1 = no contact | | Location on the arch curve | 0 = normal 1 = with rotation 2 = wrong position | | Proximal contacts | 0 = good (floss passing) 1 = weak contacts 2 = no contact | | Gingival index | 0 = normal gingiva 1 = Mild Inflammation 2 = Moderate Inflammation 3 = Severe Inflammation | | Plaque index | 0 = no plaque 1 = a thin film of plaque adhering to free gingival margin 2 = moderate plaque adhering to free gingival margin 3 = abundance of plaque adhering to free gingival margin | · Radiographic examination will be done using bitewing radiographs. A standardized angulation of the X-ray will be applied using the Rinn XCP positioning device. Radiographic success will be measured at placement and 12 months, using following scoring criteria:
| Radiographic evaluation of pulpal treatment | 0 = appropriate treatment 1 = short 2 = overflowed root canal treatment | | Radiographic evaluation of crown margins | 0 = Well adapted at CEJ 1 = Too short of CEJ 2= extending beyond CEJ | | Radiographic evaluation of presence of pathology | 0 = healthy, no pathology 1 = presence of a pathology that does not require immediate treatment 2 = presence of pathology requiring immediate treatment | Assessment of S. Mutans adhesion to stainless steel crowns and zirconia crowns: • Plaque sample will be collected with sterile cotton swabs from buccal and occlusal surfaces of both the crowns. • Swabs will then be immersed in 1mL phosphate buffered saline and stored at 40C and transported to the laboratory in transport containers. • Prior to plating, the sample will be vortexed and serially diluted. 0.1mL of this diluted sample will be inoculated and plated on to TYCSB (Tryptone-Yeast-Cystine-Sucrose-Bacitracin) Agar. The plates will be incubated at 370C in 5-10% CO2 for 48hrs. The number of Colony Forming Units (CFU) will then be counted manually.
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