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Checking Occlusion During Stainless Steel Crown Placement

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ClinicalTrials.gov Identifier: NCT02437565
Recruitment Status : Completed
First Posted : May 7, 2015
Last Update Posted : May 7, 2015
Sponsor:
Information provided by (Responsible Party):
Dr Sharat Pani, Riyadh Colleges of Dentistry and Pharmacy

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


Condition or disease Intervention/treatment Phase
Dental Caries Other: Stainless steel crown Other: Occlusal Template Not Applicable

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


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Checking Occlusion During Stainless Steel Crown Placement in Children Under General Anesthesia - Evaluation of a Novel Technique
Study Start Date : August 2013
Actual Primary Completion Date : January 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay

Arm Intervention/treatment
Active Comparator: Control
Placement of stainless steel crown under general anesthesia without the use of an occlusal template
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

Experimental: Impression
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
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

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




Primary Outcome Measures :
  1. Time taken for the completion of oral rehabilitation [ Time Frame: Measured at the end of the clinical procedure ]
    Time taken for the completion of oral rehabilitation under general anesthesia


Secondary Outcome Measures :
  1. Discomfort on Biting [ Time Frame: up to 6 months ]
    Patient complains of discomfort on biting

  2. Radiographic Evidence of Abscess [ Time Frame: up to 6 monhts ]
    Presence of abcess on a periapical radiograph

  3. Dislodgement of crown [ Time Frame: up to 6 months ]
    Loss of retention of the crown resulting in the dislodgement or complete removal of crown



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Ages Eligible for Study:   4 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02437565


Locations
Saudi Arabia
Riyadh Colleges of Dentistry and Pharmacy
Riyadh, Saudi Arabia
Sponsors and Collaborators
Riyadh Colleges of Dentistry and Pharmacy
Investigators
Principal Investigator: Sharat C Pani, MDS Riyadh Colleges of Dentistry and Pharmacy

Responsible Party: Dr Sharat Pani, Assistant Professor, Pediatric Dentistry, Riyadh Colleges of Dentistry and Pharmacy
ClinicalTrials.gov Identifier: NCT02437565     History of Changes
Other Study ID Numbers: FRP/2013/046
First Posted: May 7, 2015    Key Record Dates
Last Update Posted: May 7, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Anesthetics
Salicylic Acid
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Infective Agents
Antifungal Agents
Keratolytic Agents
Dermatologic Agents