king's college london oral clinical research unit

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Faculties  /  Dentistry Oral & Craniofacial Sciences

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KING'S CLINICAL TRIALS UNIT

Our mission at King’s Clinical Trials Unit is to assure excellence, efficiency and transparency in the design, conduct, analysis and reporting of clinical trials, for the benefit of patients and society.

KCTU is formed of collaborative academic and operational teams, supporting a portfolio of high-quality clinical trials. Centralised expertise streamlines delivery of the most complex aspects of trials.

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Our services, ecrf database, randomisation, imp management system, pharmacy collaboration, health economics, qualitative research.

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The King’s College London CTU is part of the RMID @ King’s College London and has been awarded full CTU registration by the (UKCRC)

Now have 30 participants recruited on to the PROMISE trial, 10% achieved to overall targets! Amazing work everyone! #FMT #Livertwitter #gutmicrobiome

The BEACON trial is comparing, for the first time, three key systemic treatments (taken by mouth or injection) for severe adult eczema. For more information on recruiting sites and to register your interest, visit http://www.beacontrial.org

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To collaborate with KCTU, a brief support request form must be submitted.

We strongly advise that researchers approach KCTU at the grant application stage, ideally 3-4 months in advance of the submission deadline to get the best possible input and consideration.

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Study protocol for the management of impacted maxillary central incisors: a multicentre randomised clinical trial: the iMAC Trial

Affiliations.

• 1 Centre for Craniofacial Development & Regeneration, Faculty of Dentistry, Oral & Craniofacial Sciences, King's College London, Floor 27, Guy's Hospital, London, SE1 9RT, UK. [email protected].
• 2 Maxillofacial Unit, William Harvey Hospital, Kennington Rd., Willesborough, Ashford, TN24 0LZ, UK.
• 3 Department of Orthodontics, Kings College Hospital NHS Foundation Trust, Bessemer Road, London, SE5 9RS, UK.
• 4 Orthodontic Department, St Luke's Hospital, Little Horton Lane, Bradford, BD5 0NA, UK.
• 5 Orthodontic Department, Pinderfields Hospital, Aberford Road, Wakefield, WF1 4DG, UK.
• 6 Academic Unit of Oral Health and Development, School of Clinical Dentistry, Sheffield, S10 2TA, UK.
• 7 Royal United Hospitals, Combe Park, Bath, Avon, BA1 3NG, UK.
• 8 Child Dental Health, Bristol Dental School, Lower Maudlin St, Bristol, BS1 2LY, UK.
• 9 Orthodontic Department, Stoke Mandeville Hospital, Aylesbury, HP17 8UZ, UK.
• 10 Research Portfolio Manager, King's College London, Oral Clinical Research Unit, Faculty of Dentistry, Oral & Craniofacial Sciences (FoDOCS), Room 365, Floor 25 Tower Wing, Guys Hospital, Great Maze Pond, London, SE1 9RT, UK.
• 11 South London CRN SSS Specialist and AcoRD Lead, NIHR Clinical Research Network (CRN), 16th Floor BRC Faculty, Guys Tower, Guys Hospital, London, SE1 9RT, UK.
• 12 Clinic of Orthodontics and Pediatric Dentistry, Center of Dental Medicine, University of Zurich, Plattenstrasse 11, CH-8032, Zurich, Switzerland.
• 13 Population & Patient Health, Floor 18, Tower Wing, Guy's Hospital, London, SE1 9RT, UK.
• 14 Centre for Craniofacial Development & Regeneration, Faculty of Dentistry, Oral & Craniofacial Sciences, King's College London, Floor 27, Guy's Hospital, London, SE1 9RT, UK.
• PMID: 36114553
• PMCID: PMC9479226
• DOI: 10.1186/s13063-022-06711-0

Background: Failure of eruption of the maxillary permanent incisor teeth usually presents in the mixed dentition between the ages of 7 and 9 years. Missing and unerupted maxillary incisors can be regarded as unattractive and have a potentially negative impact on facial and dental aesthetics. The presence of a supernumerary tooth (or odontoma) is commonly responsible for failed eruption or impaction of the permanent maxillary incisors. The primary objective of this trial is to investigate the success of eruption associated with maxillary incisor teeth that have failed to erupt because of a supernumerary tooth in the anterior maxilla.

Methods: This protocol describes an interventional multicentre two-arm randomised clinical trial. Participants meeting the eligibility criteria will be randomised (unrestricted equal participant allocation [1:1]) to either space creation with an orthodontic appliance, removal of the supernumerary tooth and application of direct orthodontic traction or space creation with an orthodontic appliance, removal of the supernumerary tooth and monitoring. The primary outcome of this trial is to determine the prevalence of successfully erupted maxillary central permanent incisors at 6 months following removal of the supernumerary tooth. Secondary outcome measures include (1) the effect of initial tooth position (assessed radiographically) on time taken for the tooth to erupt, (2) time taken to align the unerupted tooth to the correct occlusal position, (3) gingival aesthetics and (4) changes in the self-reported Oral Health Related-Quality of Life (OHRQoL) (pre-and post-treatment).

Discussion: There is a lack of high-quality robust prospective studies comparing the effectiveness of interventions to manage this condition. Furthermore, the UK national clinical guidelines have highlighted a lack of definitive treatment protocols for the management of children who present with an unerupted maxillary incisor due to the presence of a supernumerary tooth. The results of this trial will inform future treatment guidelines for the management of this condition in young children.

Trial registration: ISRCTN Registry ISRCTN12709966 . Registered on 16 June 2022.

Keywords: Eruption; Maxillary central incisor; Orthodontic space opening; Orthodontic traction; Randomised clinical trial; Supernumerary tooth; Unerupted.

© 2022. The Author(s).

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• Clinical Trial Protocol
• Child, Preschool
• Incisor / diagnostic imaging
• Multicenter Studies as Topic
• Prospective Studies
• Quality of Life
• Randomized Controlled Trials as Topic
• Tooth, Impacted* / complications
• Tooth, Impacted* / diagnostic imaging
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• Tooth, Supernumerary* / diagnostic imaging
• Tooth, Supernumerary* / therapy

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Clinical trials

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King’s Health Partners is home to one of the UK’s busiest centres for conducting both NHS and commercial clinical trials.

We have two major centres for clinical trials – the Clinical Trials Office and the Clinical Trials Unit, with around 600 trials running at any one time.

King’s Health Partners Clinical Trials Office

The Clinical Trials Office  aims to support and advise our investigators with the administrative and regulatory requirements that come with conducting clinical research. By providing a dedicated and specialised support function across King’s Health Partners, the Clinical Trials Office ensures quicker start-up times for trials and means that our investigators can focus on the science and medicine of clinical research and concentrate on managing those patients involved. The Office also provides an attractive environment for the commercial market in which to conduct trials. The commercial team includes facilitators, agreement associates, a feasibility specialist and finance support. Investigators also have the support of the Quality Team for training in Good Clinical Practice (GCP) and management of quality issues. 

King’s Health Partners Clinical Trials Unit

The King's Health Partners Clinical Trials Unit  helps research teams throughout the country carry out clinical trials safely and to a high scientific standard , and offers a range of services to help ensure the results are accurate and credible. The Unit’s services are available to researchers based locally at the Institute of Psychiatry, throughout King’s Health Partners and also across the UK.

The Clinical Trials Unit offers comprehensive support to trials across all disease areas in King’s Health Partners, with funding from the National Institute of Health Research (NIHR). 

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A list of open trials is available on the KHP Haematology webpages .

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The Institute of Liver Studies (ILS) at King’s is a clinical academic partnership between King’s College Hospital and King’s College London . It encompasses a multi-disciplinary team devoted to the care of patients will all types of liver diseases and coordinates research and education in this field.

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Centre for Craniofacial & Regenerative Biology

Our research goes beyond the mouth. if we understand how the entire face and head forms, we can repair damage and regenerate cells. if we unravel the causes of diseases, we can treat patients successfully. if we solve these problems, our discoveries will improve health worldwide. .

Our team of more than 100 researchers is driven by a diverse range of interests – from tissue engineering to techniques that have the potential to restore hearing loss.

Working together, we take our research beyond the lab with clinical trials, screenings to spot abnormalities earlier, and information for parents of children with birth defects.

Through sharing our discoveries with students, we show them how we are moving the field forward and how they themselves can make new discoveries as researchers. As the next generation of clinicians, they will be in the position to apply the new scientific approaches into practice and use our treatments to cure disease. 

• Research Groups

CCRB Scanco Micro-Computed-Tomography Scanner (micro-CT)

The micro-CT scanner uses X-rays to obtain high-resolution 3D images of small specimens from 3 mm to…

Centre for Craniofacial & Regenerative Biology news

24 April 2024

New potential avenues for cancer therapies through RNA-binding proteins

A new paper highlights the role of two RNA binding proteins – LARP4A and LARP4B – in the development…

19 April 2024

Faculty of Dentistry, Oral & Craniofacial Sciences Staff Awards

The Faculty of Dentistry, Oral & Craniofacial Sciences held their first ever Staff Awards on…

5 December 2023

Odontodes: The Developmental and Evolutionary Building Blocks of Dentitions

Professor Moya Meredith Smith and Dr Aaron LeBlanc contribute to a newly published book on the…

6 November 2023

CCRB Pumpkin Carving Competition!

The Centre for Craniofacial & Regeneration Biology held their annual Halloween pumpkin carving with…

Head of Centre: Professor Andrea Streit

"A solid understanding of genetics and developmental biology is vital in our field. To build the skills of future generations of clinicians, we’re making sure our research has a strong impact on our teaching. Our discoveries lead to new tools and techniques, and dentists need to be clued up on the latest technologies to be able to keep their patients informed."

• See Professor Andrea Streit's profile

Principal Investigators of the Centre for Craniofacial & Regenerative Biology

Dr Cynthia Andoniadou

Reader in Stem Cell Biology

Ana Angelova Volponi

Reader in Regenerative Dentistry

Professor M. Albert Basson

Professor of Developmental Neurobiology

Dr Mads Bergholt

Senior Lecturer in Biophotonics

Dr Ciro Chiappini

Senior Lecturer in Nanomaterials and Biointerfaces

Professor Martyn Cobourne

Professor of Orthodontics

Professor Philippa Francis-West

Professor of Developmental and Cell Biology

Professor Eileen Gentleman

Professor in Bioengineering

Professor Jeremy Green

Professor of Developmental Biology

Professor Agamemnon (Agi) Grigoriadis

Professor of Bone and Cartilage Cell Biology

Dr Robert Knight

Reader in Developmental Genetics

Professor Karen Liu

Professor of Genetics and Development

Dr Grace Hui-Chun Lu

Lecturer in Bioinformatics & Computational Biology

Dr Zoe Mann

Lecturer in Cell Metabolism

Professor Moya Meredith Smith

Professor of Evolutionary Dentoskeletal Biology

Dr Isabelle Miletich

Lecturer in Stem Cell Biology

Dr Maisa Seppala

Senior Clinical Lecturer and Honorary Consultant in Orthodontics

Dr Andrea Serio

Reader in Neural Tissue Engineering

Professor Paul Sharpe

Dickinson Professor of Craniofacial Biology

Professor Andrea Streit

Head of Centre for Craniofacial & Regenerative Biology

Professor Abigail Tucker

Dean for Research

Dr Danielle Whittaker

Research Fellow

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