Checking Occlusion During Stainless Steel Crown Placement

Dental Caries Clinical Trial

Official title:

Checking Occlusion During Stainless Steel Crown Placement in Children Under General Anesthesia - Evaluation of a Novel Technique

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02437565
• Other study ID #: FRP/2013/046
• Status: Completed
• Phase: N/A
• First received: April 24, 2015
• Last updated: May 4, 2015
• Start date: August 2013
• Est. completion date: April 2015

Study information

• Verified date: May 2015
• Source: Riyadh Colleges of Dentistry and Pharmacy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Saudi Arabia: Ministry for Higher Education
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 7 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Caries

Intervention

Other:
• Stainless steel crown
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
• Occlusal Template
Use of an occlusal template for the placement of stainless steel crowns under general anesthesia

Locations

Country	Name	City	State
Saudi Arabia	Riyadh Colleges of Dentistry and Pharmacy	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
Riyadh Colleges of Dentistry and Pharmacy

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time taken for the completion of oral rehabilitation	Time taken for the completion of oral rehabilitation under general anesthesia	Measured at the end of the clinical procedure	No
Secondary	Discomfort on Biting	Patient complains of discomfort on biting	up to 6 months	No
Secondary	Radiographic Evidence of Abscess	Presence of abcess on a periapical radiograph	up to 6 monhts	No
Secondary	Dislodgement of crown	Loss of retention of the crown resulting in the dislodgement or complete removal of crown	up to 6 months	No