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Completed

NCT Number: NCT02437565

Checking Occlusion During Stainless Steel Crown Placement

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

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Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

4 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riyadh Colleges of Dentistry and Pharmacy

Riyadh, Saudi Arabia

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stainless steel crown

Other

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

Other

Use of an occlusal template for the placement of stainless steel crowns under general anesthesia

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Riyadh Colleges of Dentistry and Pharmacy

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
May 7, 2015
Registry last updated
May 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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