Condition category
Oral Health
Date applied
10/11/2010
Date assigned
26/01/2012
Last edited
14/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Amelogenesis imperfecta (AI) is a rare genetic disorder that affects the enamel of the teeth. It is caused by the malfunction of proteins that make up the enamel. The condition affects all or nearly all of the teeth in an equal way. The chances of anyone having the condition is dependent on where they live. 1 in 700 people in Sweden have AI, for example, compared to only 1 in 14,000 in the USA. The condition causes a number of problems for those afflicted; these include a lifelong need for dental treatment that is often painful and leads to fear of the dentist, teeth very sensitive to changes in temperature, the appearance of discoloured and misshapen teeth, teeth misalignment leading to an open bite, delayed tooth eruption in children, impacted teeth and pulp obliteration. AI can also affect a person’s self-esteem, and results in a generally lower quality of life, a lesser chance than average of getting married and fewer children. Full-coverage, permanent ceramic crowns can be an effective way of treating the condition. The standard therapy is to treat younger patients by covering the surface of the tooth with plastic fillings, which can then be replaced by the permanent crowns once they have reached the age of 20-25 years. However, there is currently no scientific data to show at what age the permanent ceramic crowns should be fitted and it may be possible to do so earlier than at present. The aim of this study is to analyse the effects of treating younger patients with AI (i.e between 12-25 years) with permanent ceramic crowns. Two different types of crown are compared (Procera and Empress) with a view to answering the following questions:
1. Are there any differences in the ceramic crown treatment for patients with soft surface enamel disturbances compared to those with thin but hard enamel?
2. How do the two different types of ceramic crowns compare?
3. How frequently do complications occur if permanent crowns are fitted at an earlier age?
4. Does quality of life improve after crown therapy treatment?

Who can participate
Patients with AI aged between 12-25 years and referred to the pediatric dental clinic in Dalarna, Sweden.

What does the study involve?
Two types of ceramic crowns are compared: Procera and Empress. They are described as being similar in appearance and durability. A common method called split mouth is applied where all the teeth on one side of the mouth is fitted with one type of crown, and all the teeth on the opposite side, the other type. The side allocated to be fitted with the first type of crown is selected randomly. The front teeth are all treated with the same (randomly selected) type of crown for cosmetic reasons.

What are the possible benefits and risks of participating?
Potential benefits include less teeth sensitivity, improved self-esteem and less mouth pain. Risks include an increase in tooth sensitivity, pulpal complications, porcelain fractures and the development of a visible cervical crown line as the young person gets older.

Where is the study run from?
Patients are treated at the pediatric dentistry specialist clinic in Falun. The scientific analysis is done at the Karolinska Institutet, Department of Dental Medicine, Sweden.

When is the study starting and how long is it expected to run for?
The study started in 2010 and closes to new patients after January 2012. Follow ups will continue to January 2014.

Who is funding the study?
The study is funded by the public dental health service, county of Dalarna, Center for clinical research in the county of Dalarna and American Dental Society of Sweden.

Who is the main contact?
Professor Göran Dahllöf
goran.dahllof@ki.se

Trial website

Contact information

Type

Scientific

Primary contact

Prof Goran Dahllof

ORCID ID

Contact details

Karolinska Institutet
Department of Dental Medicine
Division of Orthodontics and Pediatric Dentistry
POB 4064
Huddinge
SE-14104
Sweden
+46 (0)8 52488335
Goran.Dahllof@ki.se

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Early restorative crown therapy in children and adolescents with amelogenesis imperfecta: a prospective double-blind randomised controlled trial

Acronym

Study hypothesis

Treatment with Procera crown therapy with zirkonia inner couping cemented with Rely X ARC cement results in a better clinical outcome compared to E-MAX crowns with zirkonia inner couping cemented with Rely X ARC in children and adolescents with amelogenesis imperfecta

Ethics approval

Regional Ethics Board, Uppsala University, Sweden, 16/07/2008, ref: 2008/108

Study design

Prospective single-centre double-blind randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet [Swedish]

Condition

Amelogenesis imperfecta

Intervention

Treatment with Procera crown therapy with zirkonia inner couping cemented with Rely X ARC cement or E-MAX crowns with zirkonia inner couping cemented with Rely X ARC in children and adolescents with amelogenesis imperfecta

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

1. Quality of restorations after 1 month, 1 year and a 2-year observation period according to Ryge & De Vinzenci (1983)
2. Sensitivity, measured using the Visual Analogue Scale (VAS) score (0 = no pain, 10 = unbearable pain) at baseline, 1 month and 2 years

Secondary outcome measures

1. Dental caries according to Amarante et al (1998)
2. Gingivitis and periodontitis according to Nyman and Linde (2003)
3. Apical status according to Örstavik (1986)

Overall trial start date

01/01/2009

Overall trial end date

31/12/2013

Reason abandoned

Eligibility

Participant inclusion criteria

Children and adolescents with amelogenesis imperfecta, 6 to 25 years of age, referred for oral rehabilitation

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

80

Participant exclusion criteria

Amelogenesis imperfecta in combination with syndromes including mental retardation

Recruitment start date

01/01/2009

Recruitment end date

31/12/2013

Locations

Countries of recruitment

Sweden

Trial participating centre

Karolinska Institutet
Huddinge
SE-14104
Sweden

Sponsor information

Organisation

Centre for Clinical Reserach, Public Dental Service Dalarna (Sweden)

Sponsor details

PO Box 712
Falun
SE-791 29
Sweden
+46 23 49 00 00
landstinget.dalarna@ltdalarna.se

Sponsor type

Government

Website

http://www.ltdalarna.se/templates/Base____25.aspx

Funders

Funder type

Hospital/treatment centre

Funder name

Center for Clinical Research, Public Dental Service Dalarna (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in https://www.ncbi.nlm.nih.gov/pubmed/25107287
2015 results in https://www.ncbi.nlm.nih.gov/pubmed/25924855
2015 results in https://www.ncbi.nlm.nih.gov/pubmed/26651486
2016 results in https://www.ncbi.nlm.nih.gov/pubmed/27359125

Publication citations

Additional files

Editorial Notes

14/11/2016: Publication references added.