Early restorative crown therapy in children and adolescents with amelogenesis imperfecta

ISRCTN ISRCTN70438627
DOI https://doi.org/10.1186/ISRCTN70438627
Secondary identifying numbers N/A
Submission date
10/11/2010
Registration date
26/01/2012
Last edited
14/11/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Prof Goran Dahllof
Scientific

Karolinska Institutet
Department of Dental Medicine
Division of Orthodontics and Pediatric Dentistry
POB 4064
Huddinge
SE-14104
Sweden

Phone +46 (0)8 52488335
Email Goran.Dahllof@ki.se

Study information

Study designProspective single-centre double-blind randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use contact details below to request a patient information sheet [Swedish]
Scientific titleEarly restorative crown therapy in children and adolescents with amelogenesis imperfecta: a prospective double-blind randomised controlled trial
Study objectivesTreatment 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(s)Regional Ethics Board, Uppsala University, Sweden, 16/07/2008, ref: 2008/108
Health condition(s) or problem(s) studiedAmelogenesis imperfecta
InterventionTreatment 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 typeProcedure/Surgery
Primary outcome measure1. 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 measures1. 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 study start date01/01/2009
Completion date31/12/2013

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit6 Years
Upper age limit25 Years
SexBoth
Target number of participants80
Key inclusion criteriaChildren and adolescents with amelogenesis imperfecta, 6 to 25 years of age, referred for oral rehabilitation
Key exclusion criteriaAmelogenesis imperfecta in combination with syndromes including mental retardation
Date of first enrolment01/01/2009
Date of final enrolment31/12/2013

Locations

Countries of recruitment

  • Sweden

Study participating centre

Karolinska Institutet
Huddinge
SE-14104
Sweden

Sponsor information

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

PO Box 712
Falun
SE-791 29
Sweden

Phone +46 23 49 00 00
Email landstinget.dalarna@ltdalarna.se
Website http://www.ltdalarna.se/templates/Base____25.aspx

Funders

Funder type

Hospital/treatment centre

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/11/2014 Yes No
Results article results 01/08/2015 Yes No
Results article results 10/12/2015 Yes No
Results article results 30/06/2016 Yes No

Editorial Notes

14/11/2016: Publication references added.