Clinical craniofacial research group
The clinical craniofacial research group is based within the Health Sciences research theme at Manchester.
|Name||Job title||Email address|
Professor of Orthodontics and Dentofacial Development
|Gunvor Semb||TOPS Scandinavian Coordinatorfirstname.lastname@example.org|
|Phil Eyres||Research Assistantemail@example.com|
|Linda Norman||TOPS Trial Administratorfirstname.lastname@example.org|
|Dieter Weichart||TOPS Trial Project Manageremail@example.com|
|Loretta Carney-Venters||TOPS Data Managerfirstname.lastname@example.org|
|Badri Thiruvenkatachari||Academic Clinical Lecturer in Orthodonticsemail@example.com|
About our research
Cleft lip and palate are among the most common congenital malformations with an overall incidence of around 1 in 700 individuals.
Researchers in this group have a long history of involvement in randomised trials for complex orthodontic care. Currently we are leading on two major ongoing international clinical trials:
The Scandcleft Project (ISRCTN29932826) was developed and executed by 10 North European cleft teams: Denmark (Copenhagen/Århus), Finland (Helsinki), Sweden (Stockholm, Linköping, and Gothenburg), Norway (Oslo and Bergen) and the UK (Belfast and Manchester). Gunvor Semb is the principal investigator of this trial.
Scandcleft is composed of three concurrent randomised control trials (RCTs) of primary cleft closure, and outcomes recorded include speech; dentofacial development at age 5; and perioperative and longer term secondary outcomes. Starting in 1997, it recruited 448 infants over a nine-year period, with high subsequent retention of participants in each trial. A series of publications describing details and results of this international trial are available.
Based on the collaborations and expertise of the Scandcleft project, an application for a major international trial was created, which lead to the TOPS (Timing of Primary Surgery for Cleft Palate) trial.
Timing of Primary Surgery for Cleft Palate trial
TOPS (Timing of Primary Surgery for Cleft Palate; NCT00993551) is an international randomised trial of children born with cleft palate. It aims to determine whether palate surgery at age 6 months or age 12 months gives better results for speech development.
The study is funded by the NIDCR, which is the National Institute for Dental and Craniofacial Research (one of the institutes of the National Institutes of Health, an agency of the United States Department of Health and Human Services).
This trial is coordinated by The University of Manchester (administrative centre) and the Medicines for Children Clinical Trials Unit at the University of Liverpool (data coordinating centre). Bill Shaw is principal investigator of TOPS.
The first phase of this trial was funded with an award of $5.6m to The University of Manchester, and a parallel award of $1.2m to the University of Liverpool.
558 infants have been recruited to the TOPS trial, and recruitment was concluded in July 2015. A new grant by the NIDCR ($7.6m) was awarded to The University of Manchester in 2015 to continue the follow-up of all participants until they are 5 years old, which means until 2020. The first trial publications are now being produced, initially focusing on the methods developed for this trial. Further information is available at the TOPS trial website.