NCT02437565

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

April 24, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 7, 2015

Completed
Last Updated

May 7, 2015

Status Verified

May 1, 2015

Enrollment Period

1.4 years

First QC Date

April 24, 2015

Last Update Submit

May 4, 2015

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Discomfort on Biting

    up to 6 months

  • Radiographic Evidence of Abscess

    up to 6 monhts

  • Dislodgement of crown

    up to 6 months

Study Arms (2)

Control

ACTIVE COMPARATOR

Placement of stainless steel crown under general anesthesia without the use of an occlusal template

Other: Stainless steel crown

Impression

EXPERIMENTAL

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 crownOther: Occlusal Template

Interventions

Stainless steel crownOTHER

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

ControlImpression
Occlusal TemplateOTHER

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

Impression

Eligibility Criteria

Age4 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • ASA class II or above
  • Initial treatment plan cannot be carried out
  • Need for extraction or pulpectomy in one or more primary molar

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riyadh Colleges of Dentistry and Pharmacy

Riyadh, Saudi Arabia

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Sharat C Pani, MDS

    Riyadh Colleges of Dentistry and Pharmacy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Pediatric Dentistry

Study Record Dates

First Submitted

April 24, 2015

First Posted

May 7, 2015

Study Start

August 1, 2013

Primary Completion

January 1, 2015

Study Completion

April 1, 2015

Last Updated

May 7, 2015

Record last verified: 2015-05

Locations

SA(1)