Condition category
Genetic Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Approximately one child in 500-600 is born with a cleft of the lip and/or palate. These arise in the womb when the different components of the lips, the upper jaw and the hard and soft palate fail to complete their growth. One-sided (or unilateral) clefts can include a complete gap in the lip, jaw, and palate. Even with modern surgery to close the cleft, affected children often require lengthy treatment into the late teens to optimise facial and dental appearance, speech, and hearing. The initial surgeries performed in the first year or so of life, are critical in determining the long term outcomes and the need for subsequent treatment. However, there is a great deal of uncertainty and controversy concerning the surgical timing and techniques that should be adopted. The purpose of this study is to compare the success of different surgical techniques for closing complete unilateral clefts of the lip and palate.

Who can participate?
Infants attending cleft lip and palate centres in Denmark, Finland, Norway, Sweden, and the UK

What does the study involve?
Participants are randomly allocated to one of four groups. Those in group 1 undergo lip and soft palate closure at 3-4 months of age and hard palate closure at 12 months/ Those in group 2 have similar treatment than those in group 1 – they just have their hard palate repair at 36 months. Those in group 3 undergo lip repair at 3-4 months and hard and soft palate closure at 12 months. Those in group 4 have their lip and hard palate repaired at 3-4 months and soft palate repaired at 12 months. Records for each group of participants is collected, which includes short term results of the surgery, the recovery period, the need for further surgery, longer term speech and language development, dental and jaw development, and nose/lip appearance.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
A total of 9 Cleft Lip and Palate/ Craniofacial Centres in Denmark, Finland, Norway, Sweden and the UK.

When is the study starting and how long is it expected to run for?
September 1997 to September 2024

Who is funding the study?
European Commission

Who is the main contact?
Professor Gunvor Semb

Trial website

Contact information



Primary contact

Prof Gunvor Semb


Contact details

The University of Manchester
School of Dentistry
NEW ADDRESS: JR Moore Building
Oxford Road
Manchester M13 9PL
Tel. +44- (0)161-2756792
M13 9PL
United Kingdom
+44- (0)161-2756809

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Randomised control trial of primary surgery for cleft lip and palate


Study hypothesis

Null hypothesis that different surgical protocols for closure of complete unilateral cleft lip and palate do not produce different outcomes

Ethics approval

1. Regional Committee for Medical Research Ethics, Norway, Oslo and Bergen (Regional Komite for Medisinsk Forskningsetikk), 29/08/1997, ref: S-971522
2. Research Committee at Karolinska Hospital, Sweden - Stockholm and Linkoping (Forskningskommitten vid Karolinska Sjukhuset), 31/10/1997, ref: 97-372
3. Gothenburg Regional Research Committee at the University of Gothenburg, Sweden (Göteborgs Regionala Forskningskommitten vid Göteborgs Universitet), 21/05/1997, ref: R257-97
4. Science Ethics Committee, Denmark- Copenhagen and Aarhus (Videnskabsetisk Komite), 13/10/1997, ref: 309/97
5. Helsinki University Hospital Ethics Committee ( HYKS Sairaala Eettinen Toimikunta), 04/09/1997
6. Local Research Ethics Committee, UK - Manchester, Salford & Trafford, June 1999, ref: 99/197
7. Queen’s University of Belfast Ethics Committee, 08/06/1999, ref: 79/99

Study design

Family of three RCTs

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use contact details to request a participant information sheet


Complete unilateral cleft lip and palate


One surgical protocol was defined to serve as a common method in each trial against which the established local protocols were compared. The common surgical protocol was lip and soft palate closure at 3-4 months and hard palate closure at 12 months.

Trial 1: compared this with only a variation in timing: hard palate repair at 36 months
Trial 2: compared this with lip repair at 3-4 months followed by hard and soft palate closure at 12 months
Trial 3: compared this with lip and hard palate repair at 3-4 months and soft palate repair at 12 months

The primary outcomes at age 5 were speech and dentofacial development, with a series of perioperative and longer term secondary outcomes.

Intervention type



Drug names

Primary outcome measures

1. Speech and language at age 5 years, via blinded panel assessments using standardised audio/video recordings with regard to consonant proficiency and ratings of velopharyngeal competency and hypernasality
2. Dentofacial development at 5 years, via blinded panel ratings of dentofacial relationship represented by articulated plaster casts of the dentition using the Five Year Yardstick and Huddart-Bodenham Index

Secondary outcome measures

1. Perioperative complications recorded by medical and nursing staff
2. Operation and hospitalisation time
3. Postoperative recovery and feeding recorded by medical and nursing staff
4. Speech at 12 and 18 months and 3 years
5. Symptomatic fistulae
6. Hearing
7. Burden of care
8. Parent satisfaction at age 5 years

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

Caucasian patients born with non-syndromic unilateral complete cleft lip and palate. Patients with a soft tissue bridge (Simonart`s band) could be included as long as the width of the soft tissue bridge was not more than 5mm. The prevailing language of the country where recruited had to be spoken at home.

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Non-caucasian
2. Wide Simonart band
3. Prevailing local language not spoken at home

Recruitment start date


Recruitment end date



Countries of recruitment

Denmark, Finland, Norway, Sweden, United Kingdom

Trial participating centre

Copenhagen/Aarhus Cleft and Craniofacial Centre
2100 Copenhagen

Trial participating centre

Helsinki Cleft and Craniofacial Centre
00029 HUS

Trial participating centre

Gothenburg Cleft and Craniofacial Centre
SE 405 30

Trial participating centre

Linköping Cleft and Craniofacial Centre
S-581 85

Trial participating centre

Stockholm Cleft and Craniofacial
S-171 76

Trial participating centre

Oslo Cleft and Craniofacial

Trial participating centre

Bergen Cleft and Craniofacial

Trial participating centre

Manchester Cleft Centre
M13 9WL
United Kingdom

Trial participating centre

Royal Belfast Hospital for Sick Children
BT 12 6BE

Sponsor information


University of Manchester

Sponsor details

Oxford Rd
M13 9PL
United Kingdom
+44 (0)161 275 6792

Sponsor type




Oslo University Hospital Rikshospitalet

Sponsor details

Sognsvannsveien 20
0372 Oslo
0372 Oslo

Sponsor type

Hospital/treatment centre



Funder type


Funder name

European Commission

Alternative name(s)


Funding Body Type

government organisation

Funding Body Subtype




Results and Publications

Publication and dissemination plan

Ten manuscripts regarding age 5 outcomes and parent satisfaction will be submitted for journal publication in February 2016

Intention to publish date


Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes