Checking Occlusion During Stainless Steel Crown Placement
Primary Purpose
Dental Caries
Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Stainless steel crown
Occlusal Template
Sponsored by
About this trial
This is an interventional treatment trial for Dental Caries
Eligibility Criteria
Inclusion Criteria:
- Clinical Diagnosis of Severe Early Childhood Caries
- Have behavioral problems that require management under general anesthesia
- ASA class I
- Deep Dental Caries involving the pulp in all eight primary molars
Exclusion Criteria:
- ASA class II or above
- Initial treatment plan cannot be carried out
- Need for extraction or pulpectomy in one or more primary molar
Sites / Locations
- Riyadh Colleges of Dentistry and Pharmacy
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control
Impression
Arm Description
Placement of stainless steel crown under general anesthesia without the use of an occlusal template
Placement of stainless steel crown under general anesthesia with the use of an occlusal template prepared after making an impression of the teeth using a fast setting polyvinyl siloxane material
Outcomes
Primary Outcome Measures
Time taken for the completion of oral rehabilitation
Time taken for the completion of oral rehabilitation under general anesthesia
Secondary Outcome Measures
Discomfort on Biting
Patient complains of discomfort on biting
Radiographic Evidence of Abscess
Presence of abcess on a periapical radiograph
Dislodgement of crown
Loss of retention of the crown resulting in the dislodgement or complete removal of crown
Full Information
NCT ID
NCT02437565
First Posted
April 24, 2015
Last Updated
May 4, 2015
Sponsor
Riyadh Colleges of Dentistry and Pharmacy
1. Study Identification
Unique Protocol Identification Number
NCT02437565
Brief Title
Checking Occlusion During Stainless Steel Crown Placement
Official Title
Checking Occlusion During Stainless Steel Crown Placement in Children Under General Anesthesia - Evaluation of a Novel Technique
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Riyadh Colleges of Dentistry and Pharmacy
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Stainless steel crowns are arguably the most successful posterior restorations in primary teeth and have been so for more than 50 years. Stainless steel crowns offer durability and success rates in excess of 95% making them the restoration of choice for posterior primary teeth in children treated under general anesthesia.
Failures of stainless steel crowns placed on primary teeth have been documented using several criteria including marginal adaptation, recurrent caries, abscess formation or root resorption, loss of the crown due to faulty retention and even perforation of the crown . Despite the probability that factors such as root resorption and failure of endodontic treatment could be due to traumatic occlusion, surprisingly little evidence is available in literature on the attempts made to check or evaluate the occlusion of stainless steel crowns placed under general anesthesia The aim of this study was to compare the time taken for placement and the overall success of bilateral multiple stainless crowns placed under general anesthesia using an occlusal index and compare them to crowns placed without such an index, using a randomized control study design
Detailed Description
A total of 60 patients (32 male and 28 female) aged between 4 and 7 years (Mean age 4.8 years, SD +/- 1.09 years) who met the inclusion criteria were recruited after obtaining informed consent from the parent. No financial incentives were offered for participation in the study. A total of 51 (29 male and 22 female) patients completed the six month follow up requirement (Fig 2).
Evaluation Crowns and the Procedure All patients were evaluated at 24 hours, one week, three months and six months post-operatively. Clinical criteria evaluated included the reporting of pain, discomfort, difficulty in mastication or high points reported by the patient. Tenderness on percussion, presence of premature mobility and clinical evidence of an abscess or fistula were checked by one of the investigators (SCP). Periapical digital radiographs were taken using a digital sensor (Schick Elite, Sirona Dental Inc. Long Island NY. USA) and were evaluated by the same examiner for radiographic evidence of failure. In order to ensure blinding the investigator (SCP) recording the findings was not made aware of which group the patient belonged to. The time taken for each procedure was calculated from the time of placement of the throat pack to the time of removal of the throat pack and was obtained from the intra-operative anesthesiologist notes. If failure of the crown occurred at 3 months, these teeth were excluded from the 6 month evaluation.
Statistical Analyses The parametric values of the control and case groups were compared using the student's t test. The non-parametric values of the control and case groups were compared using the Mann Whitney U test. All tests were conducted at p value of 0.05
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Placement of stainless steel crown under general anesthesia without the use of an occlusal template
Arm Title
Impression
Arm Type
Experimental
Arm Description
Placement of stainless steel crown under general anesthesia with the use of an occlusal template prepared after making an impression of the teeth using a fast setting polyvinyl siloxane material
Intervention Type
Other
Intervention Name(s)
Stainless steel crown
Intervention Description
Placement of stainless steel crowns for teeth that have undergone pulpotomy for the treatment of pulpitis induced by severe early childhood caries under general anesthesia
Intervention Type
Other
Intervention Name(s)
Occlusal Template
Intervention Description
Use of an occlusal template for the placement of stainless steel crowns under general anesthesia
Primary Outcome Measure Information:
Title
Time taken for the completion of oral rehabilitation
Description
Time taken for the completion of oral rehabilitation under general anesthesia
Time Frame
Measured at the end of the clinical procedure
Secondary Outcome Measure Information:
Title
Discomfort on Biting
Description
Patient complains of discomfort on biting
Time Frame
up to 6 months
Title
Radiographic Evidence of Abscess
Description
Presence of abcess on a periapical radiograph
Time Frame
up to 6 monhts
Title
Dislodgement of crown
Description
Loss of retention of the crown resulting in the dislodgement or complete removal of crown
Time Frame
up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical Diagnosis of Severe Early Childhood Caries
Have behavioral problems that require management under general anesthesia
ASA class I
Deep Dental Caries involving the pulp in all eight primary molars
Exclusion Criteria:
ASA class II or above
Initial treatment plan cannot be carried out
Need for extraction or pulpectomy in one or more primary molar
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharat C Pani, MDS
Organizational Affiliation
Riyadh Colleges of Dentistry and Pharmacy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riyadh Colleges of Dentistry and Pharmacy
City
Riyadh
Country
Saudi Arabia
12. IPD Sharing Statement
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Checking Occlusion During Stainless Steel Crown Placement
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